Category: Covid-19 Vaccine

Introduction

The coronavirus disease 2019 (COVID-19) pandemic is a global pandemic. As of December 23, 2021, the World Health Organization (WHO) data platform showed a total of 275,233,892 confirmed cases of COVID-19 and 5,364,996 deaths worldwide.1 The Delta variant and highly mutated Omicron variant have made the COVID-19 pandemic even worse.2,3 Because the population at large is generally susceptible to COVID-19, vaccination against COVID-19 is an effective means of preventing transmission.4 Patients with rheumatic disease are more likely to be infected with COVID-19 than the general population.5 Another study by Ungaro et al suggested that the systemic use of corticosteroids may add to the risk of severe COVID-19 for patients with autoimmune and chronic inflammatory diseases.6 A number of guidelines at home and abroad recommend that eligible patients with rheumatic disease receive the COVID-19 vaccine when their condition is stable.7,8 At present, however, the general population generally does not have strong vaccination intentions and hesitates to get vaccinated, which leads to delays in vaccination and prevention.911 In this study, we investigated the perceptions of COVID-19 infection in patients with rheumatic disease in our hospital through an online questionnaire on the Wenjuanxing platform (web link: http://www.wjx.cn), analyzed the factors influencing their willingness to receive a COVID-19 vaccine, and analyzed the characteristics of patients who had been vaccinated in an attempt to better counsel patients with rheumatic disease regarding vaccination.

Data from patients with rheumatic disease who presented to the Rheumatology and Immunology Department Outpatient Clinic at our hospital from July 320, 2021, were collected in the database. After cluster sampling by disease, these patients data were randomly sequenced using a random number table, and then patients were randomly selected. They completed the questionnaire under the instruction of a blinded medical worker. Four hundred sixty-three questionnaires were distributed, and 463 were effectively returned (recovery rate = 100%).

The inclusion criteria for patients with rheumatic immune disease were as follows: 1. Patients with rheumatoid arthritis who met the classification criteria for rheumatoid arthritis formulated by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2010; 2. Patients with systemic lupus erythematosus (SLE) who met the SLE classification criteria established by the EULAR/ACR in 2019; 3. Patients with Sjgrens syndrome who met the 2016 ACR/EULAR classification criteria for Sjgrens syndrome; 4. Patients with polymyositis/dermatomyositis who met the dermatomyositis diagnostic criteria developed by Bohan and Pete in 1975; 5. Patients with gout conforming to the gout classification criteria formulated by the ACR/EULAR in 2015; 6. Patients with osteoarthritis who met the diagnostic criteria for osteoarthritis revised by the ACR in 1995;

7. Patients with ankylosing spondylitis who met the classification criteria for axial spondylarthritis (SpA) recommended by the ASAS (International Spondylarthritis Expert Collaboration Group) in 2009; 8. Patients with psoriatic arthritis who met the 2006 CASPAR classification diagnostic criteria; 9. Patients who underwent enteroscopy and were diagnosed with inflammatory bowel disease-associated arthritis that is consistent with the diagnosis of ulcerative colitis and Crohns disease with peripheral arthritis and axial joint disease, in which the diagnosis could be made by excluding other joint diseases; 10. Patients with systemic sclerosis who met the 2013 ACR/EULAR classification criteria for systemic sclerosis;

11. Patients with Takayasu arteritis who met the 1990 ACR diagnostic criteria for Takayasu arteritis; 12. Patients with Antineutrophil cytoplasmic antibody-associated vasculitis who met the provisional classification criteria of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis included in the 2017 EULAR-ACR criteria; 13. Adult patients with Stills disease who met the 1992 Japanese Yamaguch criteria; 14. Patients with polymyalgia rheumatica who met the 2005 ACR/EULAR PMR classification criteria for polymyalgia rheumatica; 15. Patients with IgG4-related diseases who met the 2019 ACR/EULAR IgG4-related disease classification criteria; 16. Patients with mixed connective tissue disease who met the 1983 Kahn diagnostic criteria; 17. Patients with undifferentiated connective tissue disease with one or more typical symptoms or signs of rheumatism, one or more high-titer autoantibodies, and for whom the course of disease was > 2 years, excluding patients with any other connective tissue disease; and 18. Patients with antiphospholipid antibody syndrome who met the 2006 revised classification criteria for Sapporo antiphospholipid syndrome. Patients were evaluated for disease remission or acute exacerbation according to their symptoms, signs and auxiliary examinations according to the diseases evaluation criteria; for example, patients received a DAS28 score for rheumatoid arthritis (a DAS score <2.6 indicates remission), an SLE-DAI score for SLE (an SLEDAI score 4 indicates inactivity), and an ASDAS score for ankylosing spondylitis (an ASDAS score < 1.3 indicates inactivity). The exclusion criteria included patients aged <18 years old, patients who were illiterate, patients with a loss of comprehension and expression ability, and critically ill patients.

Each patient could only complete the questionnaire once. Verification of validity was established through a questionnaire setting the quality control conditions as follows: 1) Only when the response to Question 8 of the Questionnaire (Are you a patient with rheumatic immune disease? [single-choice question, if you choose yes, please continue to answer; if you choose no, the questionnaire is invalid]) was affirmative was the questionnaire considered valid; 2) A total answering time <10 s or > 2 min invalidated the questionnaire; and 3) Each question must be completed before the next question was presented. Incomplete answer sheets were not collected. The information of all questionnaires was checked by the Wenjuanxing online system and double-checked by the investigator. Forty-six (9.9%) invalid questionnaires were excluded; thus, 417 were valid.

The participants scanned the QR code of Wenjuanxing on WeChat and completed the self-designed online questionnaire titled A Survey on the Willingness of Patients with Rheumatic Disease to Receive a COVID-19 Vaccine. There were 25 questions in the questionnaire, covering the basic information of the respondents and assessing their rheumatic disease status, their perceptions of COVID-19 infection risk and its impact on rheumatic disease, their perception levels and willingness to receive a COVID-19 vaccine, and their COVID-19 vaccination status. The Cronbachs alpha coefficient of the questionnaire reliability test was 0.715, which was acceptable The KaiserMeyerOlkin (KMO) test of validity was 0.5, and the cumulative variance interpretation rate was 62.41%.

The survey data from the questionnaires were exported and analyzed using SPSS (version 22.0) statistical software. Univariate analysis was performed by a 2 test, and multivariate analysis was performed by logistic regression (=0.05, two-sided test). Analysis of variance (ANOVA) was used to analyze the impact of six variables, including the sex, age, marital status, educational level, place of residence, and occupation (medical or nonmedical) of the respondent, the respondents family members, relatives, and friends perceptions of COVID-19 infection risk, as well as the impact of the patients perception of COVID-19 infection on rheumatic disease. Twelve factors, including the sex, age, marital status, educational level, place of residence, and occupation (medical or nonmedical) of the respondent, the respondents family members, relatives and friends perceptions of COVID-19 infection risk, disease assessment, risk perception of COVID-19 infection, perception of the impact of COVID-19 infection on rheumatic disease, perception of the impact of COVID-19 vaccination on rheumatic disease, and vaccination with other vaccines in the last 5 years (other than the COVID-19 vaccine), were analyzed as independent variables and the willingness to receive COVID-19 vaccination was analyzed as a dependent variable in logistic linear regression analysis.

Since this was a survey study, the study was granted an exemption from the requirement of written informed consent by the institutional ethics committee of Heping Hospital Affiliated to Changzhi Medical College. Oral consent was obtained from the participants (or their parent/legal guardian/next of kin) for participation in the study. This study was conducted ethically in accordance with the World Medical Association Declaration of Helsinki and complied with the guidelines for human studies.

The demographic characteristics of the respondents are presented in Table 1. Among the participants, the majority were female (292 [70.02%]). The age distribution was as follows: 39 respondents were aged 1829 years (9.35%); 77 were aged 3039 years (18.47%); 123 were aged 4049 years (29.50%); 122 were aged 5059 years (29.26%); 39 were aged 6065 years (9.35%); and 17 were aged > 65 years (4.08%). Most of the respondents were married (376 [90.17%]). The respondents places of residence were as follows: 184 lived in cities (44.12%); 96 lived in counties (23.02%); 32 lived in towns (7.67%); 104 lived in villages (24.94%); and 1 had no permanent residence (0.24%). The occupations of the participants were as follows: 19 were medical workers (4.56%); and 398 were nonmedical workers (95.44%). The occupations of the respondents family members, relatives, and friends were as follows: 124 were medical workers (29.74%); and 293 were nonmedical workers (70.26%).

Table 1 Demographic Details of the Study Participants

Among the participants, 350 (83.93%) were in the remission stage of rheumatic disease, while 67 (16.07%) were in the active stage. Four hundred seventeen participants had 448 episodes of rheumatic disease. The composition of rheumatic disease among the participants was as follows (the respondents were permitted to choose more than one option): 171 had rheumatoid arthritis (38.17%); 74 had SLE (16.52%); 65 had ankylosing spondylitis (14.51%); 31 had gout (6.92%); 26 had Sjogrens syndrome (5.8%); 18 had osteoarthritis (4.02%); 14 had connective tissue disease (3. 13%); 7 had systemic sclerosis (1.56%); 5 had Takayasu arthritis (1.12%); 4 had polymyalgia rheumatica (0.90%); 3 had psoriatic arthritis (0.67%); 3 had ANCA-related vasculitis (0.67%); 3 had antiphospholipid antibody syndrome (0.67%); 2 had polymyositis (0.45%); 2 had dermatomyositis (0.45%); 2 had undifferentiated spondyloarthropathy, 2 (0.45%); 2 had adult-onset Stills disease (0.45%); and 16 had other rheumatic diseases (3.57%).

Among the participants, 127 (30.46%) believed they had no risk of COVID-19 infection, while 199 (47.72%) were uncertain about their risk. The results of ANOVA showed that the sexes had different risk perceptions of COVID-19 infection (p<0.05), while age, marital status, place of residence, respondent occupation (medical or nonmedical), and the occupations of the respondents family members, relatives, and friends had no statistical significance on the risk perception of COVID-19 infection (P > 0.05, Table 2). A chi-square test was performed regarding the risk perception of COVID-19 infection among the sexes: specifically, 36.80% of the men chose no risk at all compared to 27.74% of the women; 17.60% of the men chose basically no risk compared to 10.62% of the women; and 53.08% of the women chose unclear compared to 35.20% of the men (p<0.05; Table 3).

Table 2 Analysis of the Impact of Demographic Details on the Perception of COVID-19 Infection Risk

Table 3 Analysis of the Impact of Sex on the Perception of COVID-19 Infection Risk

Among the participants, 64 (15.35%) thought that even if they were infected with COVID-19, it would have no impact on their rheumatic disease, 30 (7.19%) thought it would have a negligible impact, 20 (4.8%) thought it would have a moderate impact, 29 (6.95%) thought it would have a considerable impact, 27 (6.47%) thought it would have an enormous impact, and 247 (59.23%) were not certain about the impact (Table 4). The results of ANOVA showed that the occupation (medical or nonmedical) of the respondents was significantly associated with the impact of COVID-19 infection on rheumatic disease (P <0.05); however, sex, age, marital status, place of residence, occupations of the respondents family members, relatives, and friends (medical or nonmedical), and the perception of the impact of COVID-19 infection on rheumatic disease were not statistically significant (P > 0.05). Chi-square test analysis showed that 31.58% and 26.32% of the participants who were medical workers chose no impact at all and unclear, respectively, compared to 14.57% and 60.89% of nonmedical workers, respectively (P <0.05; Table 5).

Table 4 ANOVA Between Demographic Details and the Perception of the Impact of COVID-19 Infection on Rheumatic Disease

Table 5 Chi-Square Analysis Between the Occupations (Medical versus Nonmedical) of the Participants and Their Perceptions of the Impact of COVID-19 Infection on Rheumatic Disease

Among the 417 collected questionnaires regarding COVID-19 vaccination willingness, 38 (9.11%) of the participants completely rejected vaccination, 5 (1.20%) were uncertain but inclined to reject vaccination, 7 (1.68%) were partially inclined to reject vaccination, and 52 (12.47%) wanted to postpone vaccination. In contrast, 21 (5.04%) of the participants partially intended to accept vaccination, 26 (6.24%) intended to accept vaccination but were also unsure, and 268 (64.27%) were willing to accept vaccination.

Logistic linear regression analysis showed that sex, the occupations of the respondents, their family members, relatives, and friends (medical or nonmedical), and the perception of the impact of COVID-19 infection on rheumatic disease had a statistically significant effect on the willingness to receive the COVID-19 vaccine (P <0.05; Table 6). ANOVA was performed regarding the degree of vaccination willingness and the four factors influencing vaccination willingness. Sex, occupation, the perception of the impact of COVID-19 infection on rheumatic disease, and vaccination willingness were analyzed by ANOVA (P <0.05) as follows: males (6.351.30) were more willing than females (5.552.12) to receive vaccination, nonmedical workers (5.841.89) were more willing than medical workers (4.632.65) to receive vaccination, and patients who thought COVID-19 infection had no impact on rheumatic disease (6.581.48) were more willing than those who were uncertain about vaccination (5.722.04) to receive vaccination; the OR values were negatively correlated (Table 7).

Table 6 Logistic Regression Analysis of Factors Influencing COVID-19 Vaccine Willingness

Table 7 ANOVA of the Degree of Willingness and Factors Influencing the Degree of Willingness to Be Vaccinated Against COVID-19

Among the 417 participants, 167 (44.60%) received the COVID-19 vaccine, and 231 (55.40%) did not. Of the 167 patients in the vaccinated group, 152 (91.02%) had no adverse reactions, while 15 (8.98%) had adverse reactions, including 3 with mild pain at the injection site, 3 with aggravated joint pain, 2 with mild dizziness, 2 with mild nausea, 2 with mild abdominal pain, 2 with mild rash, and 1 with a runny nose. Of the patients in the unvaccinated group, 245 options chose not to be vaccinated. The respondents were permitted to choose more than one option. Fourteen responses (5.71%) did not understand the vaccination process or found it to be too troublesome, 13 (5.31%) found it difficult to make an appointment due to the shortage of vaccines, 2 (0.82%) were not satisfied with the preventive effect of the vaccine, 44 (17.96%) were worried about the quality or side effects of the vaccine, 12 (4.90%) claimed their vaccinations had been scheduled but it was not time for the appointment, 117 (47.76%) thought they did not belong to the population that needed to be vaccinated, and 43 (17.55%) chose other reasons.

The results of this questionnaire survey showed that different sexes had different risk perceptions regarding COVID-19 infection. The proportion of men who thought there was no risk at all and that the risk was negligible was greater than that of women, while the proportion of women who chose unclear was greater than that of men, which indicated that men tend to underestimate the risk perception of COVID-19 infection, while women lack awareness of the risk of COVID-19 infection. There was a difference between medical workers and nonmedical workers in the perception of the impact of COVID-19 infection on rheumatic disease. The proportion of medical workers who thought there was no impact was 31.58%, which was greater than that of nonmedical workers (14.57%). The proportion of nonmedical workers who were unclear about the level of impact was 60.80%, which was greater than that of medical workers (26.32%). These results suggested that a large number of people are still unaware of or lack knowledge about the impact of COVID-19 infection on rheumatic disease, while a very high proportion of medical workers believe that there is no impact at all. A multicenter study showed that female sex, a fear of being infected, and the nursing profession are the main factors affecting vaccination for the population with mental health disturbances.12 Another study among adult participants found that males have a poor perception of the risk of COVID-19 and do not practice self-quarantining.13 Our results showed that sex and the medical profession have a significant impact on the perception of COVID-19 infection risk, which is consistent with published reports.1215

Among unvaccinated patients with rheumatic disease, 64.27% were completely willing to be vaccinated against COVID-19, while 26.62% were hesitant. The factors that influenced willingness to vaccinate included sex, occupation, and the perception of the impact of COVID-19 infection on rheumatic disease. The vaccination willingness of male patients was higher than that of female patients, and the vaccination willingness of nonmedical workers was higher than that of medical workers. The survey results by Yurttas et al compared the willingness to be vaccinated among the healthy population, patients with rheumatic diseases and medical workers and found that males and medical workers were more willing to be vaccinated.16 Therefore, clinically, male patients with rheumatic diseases are more likely to be persuaded to be vaccinated. The perception of the impact of COVID-19 infection on rheumatic disease was negatively correlated with vaccination willingness. The greater a patient thought of the impact of COVID-19 vaccines, the lower their vaccination willingness, which was consistent with the results of previous research.1720 High perceived susceptibility to COVID-19 also makes people more inclined to receive a COVID-19 vaccine.10 A survey in 2021 shows that only 54.9% of patients with rheumatic and musculoskeletal diseases were willing to receive the COVID-19 vaccine, although they perceived themselves to be at risk of being infected.21 Similar to the survey,21 64.27% of the patients with rheumatic disease in our study were willing to receive the vaccine, which indicates that their concept of vaccination should be improved.

In this survey, 167 patients (44.60%) with rheumatic disease received the COVID-19 vaccine. Looking at the management experience of other infectious diseases, herd immunity can help vaccination programs and protect unvaccinated, immunocompromised populations.22 A vaccination rate of 70%-80%, or more, will be effective in achieving herd immunity.22 A vaccination rate of 6072% is recommended for herd immunity, although a rate of 8490% is much better.23 The adverse reactions in the unvaccinated patients were mild pain at the injection site, dizziness, nausea, rash, a runny nose, and aggravated joint pain, which were general adverse reactions. As reported, pain, headache, and fatigue were the most frequent adverse reactions to COVID-19.24 Our results did not differ from the existing reports. The incidence of adverse reactions was 8.98%, which was higher than that in the COVID-19 vaccine surveillance report (11.86/100,000 doses) released by the China CDC on May 28, 2021.25 The relatively high rate of adverse reactions may be due to the relatively low immunity of patients with rheumatic disease. The reaction to the vaccine would be intensified, but because there were no serious adverse reactions, it can be concluded that the safety of the vaccine is relatively high. Among the unvaccinated participants, as many as 47.76% said that they did not receive the vaccine because they did not think they were among the population that needed to be vaccinated. This finding is closely related to a persons perception of COVID-19, as previously reported.1820

The global COVID-19 pandemic has not been controlled, and there have been many local outbreaks in China. Only when the vaccination rate reaches the level of herd immunity can the disease be controlled.23 Due to the characteristics of rheumatic disease, such as multisystem damage, repeated recurrence, long-term survival of patients with the disease, and massive application of immunosuppressive drugs, a number of vaccination guidelines and expert opinions have been published for this special population with rheumatic immune diseases at home and abroad.8,26 Patients with rheumatic disease are more susceptible to COVID-19 infection than the general population, have a high mortality rate and are very likely to have adverse reactions.8,26 The experts suggest that these patients should receive vaccines as early as possible, while adjusting their therapies against rheumatic disease;8,26 however, a patients low awareness of the risk of COVID-19 infection and vaccination and excessive anxiety about the disease have led to low vaccination willingness and a low vaccination rate.1720 Indeed, the publicity of professional medical knowledge should be enhanced. With the help of health care experts and social media, health communication campaigns should be improved and populations at risk should be targeted.27 We should provide verified communication from physicians offices to the public via multiple channels, such as the internet, newspapers, radio, television, popular medical science platforms, and health education programs, to eliminate hesitation for vaccination and comprehensively enhance confidence in vaccination.28 Under the requirement of herd immunity against COVID-19 infection, it is even more important to strengthen international cooperation, play a leading role in the government, and strengthen the quality control of COVID-19.29 According to our results and previous reports,1720,2329 we should improve the perception and education of patients with low immune capacity, thereby improving their vaccination willingness, achieving safe vaccination, accomplishing herd immunity as soon as possible, and avoiding the health hazards aggravated by COVID-19.

A limitation of this study was that this was a single-center small sample survey, so it is still necessary to expand the sample size to verify the results.

The sex of patients with rheumatoid diseases, whether they were medical workers or not, the level of knowledge about the risk of COVID-19 infection and the impact of vaccination on the disease were shown to be key factors influencing patients willingness to receive a COVID-19 vaccine. The vaccination rate of patients with rheumatic disease was correspondingly low, and the rate of adverse reactions was slightly higher than that in the general population.

The authors report no conflicts of interest in this work.

1. World Health Organization; [Coronavirus disease (COVID-19) pandemic]. 2021. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019. Accessed July 28, 2022.

2. Kumar S, Thambiraja TS, Karuppanan K, Subramaniam G. Omicron and Delta variant of SARS-CoV-2: a comparative computational study of spike protein. J Med Virol. 2021;94:16411649.

3. Thakur V, Ratho RK. OMICRON (B.1.1.529): a new SARS-CoV-2 variant of concern mounting worldwide fear. J Med Virol. 2021;94:18211824.

4. Lin DY, Zeng D, Mehrotra DV, Corey L, Gilbert PB. Evaluating the efficacy of coronavirus disease 2019 vaccines. Clin Infect Dis. 2021;73(8):15401544. doi:10.1093/cid/ciaa1863

5. Zhong J, Shen G, Yang H, et al. COVID-19 in patients with rheumatic disease in Hubei province, China: a multicentre retrospective observational study. Lancet Rheumatol. 2020;2(9):e557e564. doi:10.1016/S2665-9913(20)30227-7

6. Ungaro RC, Agrawal M, Park S, et al. Autoimmune and chronic inflammatory disease patients with COVID-19. ACR Open Rheumatol. 2021;3(2):111115. doi:10.1002/acr2.11221

7. Curtis JR, Johnson SR, Anthony DD, et al. American College of Rheumatology Guidance for COVID-19 vaccination in patients with rheumatic and Musculoskeletal diseases: version 3. Arthritis Rheumatol. 2021;73(10):e60e75. doi:10.1002/art.41928

8. Santosa A, Xu C, Arkachaisri T, et al. Recommendations for COVID-19 vaccination in people with rheumatic disease: developed by the Singapore Chapter of Rheumatologists. Int J Rheum Dis. 2021;24(6):746757. doi:10.1111/1756-185X.14107

9. Alley SJ, Stanton R, Browne M, et al. As the pandemic progresses, how does willingness to vaccinate against COVID-19 evolve? Int J Environ Res Public Health. 2021;18(2):797. doi:10.3390/ijerph18020797

10. Guidry JPD, Laestadius LI, Vraga EK, et al. Willingness to get the COVID-19 vaccine with and without emergency use authorization. Am J Infect Control. 2021;49(2):137142. doi:10.1016/j.ajic.2020.11.018

11. Yoda T, Katsuyama H. Willingness to receive COVID-19 vaccination in Japan. Vaccines. 2021;9(1):48. doi:10.3390/vaccines9010048

12. Gorini A, Fiabane E, Sommaruga M, et al. Mental health and risk perception among Italian healthcare workers during the second month of the Covid-19 pandemic. Arch Psychiatr Nurs. 2020;34(6):537544. doi:10.1016/j.apnu.2020.10.007

13. Abir T, Kalimullah NA, Osuagwu UL, et al. Factors associated with the perception of risk and knowledge of contracting the SARS-Cov-2 among adults in Bangladesh: analysis of online surveys. Int J Environ Res Public Health. 2020;17(14):5252. doi:10.3390/ijerph17145252

14. Alsharawy A, Spoon R, Smith A, Ball S. Gender differences in fear and risk perception during the COVID-19 pandemic. Front Psychol. 2021;12:689467. doi:10.3389/fpsyg.2021.689467

15. Rana IA, Bhatti SS, Aslam AB, Jamshed A, Ahmad J, Shah AA. COVID-19 risk perception and coping mechanisms: does gender make a difference? Int J Disaster Risk Reduct. 2021;55:102096. doi:10.1016/j.ijdrr.2021.102096

16. Yurttas B, Poyraz BC, Sut N, et al. Willingness to get the COVID-19 vaccine among patients with rheumatic diseases, healthcare workers and general population in Turkey: a web-based survey. Rheumatol Int. 2021;41(6):11051114. doi:10.1007/s00296-021-04841-3

17. Nehal KR, Steendam LM, Campos Ponce M, van der Hoeven M, Smit GSA. Worldwide vaccination willingness for COVID-19: a systematic review and meta-analysis. Vaccines. 2021;9(10):1071. doi:10.3390/vaccines9101071

18. Qunaibi EA, Helmy M, Basheti I, Sultan I. A high rate of COVID-19 vaccine hesitancy in a large-scale survey on Arabs. Elife. 2021;10:e68038.

19. Sarwar A, Nazar N, Nazar N, Qadir A. Measuring vaccination willingness in response to COVID-19 using a multi-criteria-decision making method. Hum Vaccin Immunother. 2021;17:18.

20. Unroe KT, Evans R, Weaver L, Rusyniak D, Blackburn J. Willingness of long-term care staff to receive a COVID-19 vaccine: a single State survey. J Am Geriatr Soc. 2021;69(3):593599. doi:10.1111/jgs.17022

21. Priori R, Pellegrino G, Colafrancesco S, et al. SARS-CoV-2 vaccine hesitancy among patients with rheumatic and musculoskeletal diseases: a message for rheumatologists. Ann Rheum Dis. 2021;80(7):953954. doi:10.1136/annrheumdis-2021-220059

22. Mallory ML, Lindesmith LC, Baric RS. Vaccination-induced herd immunity: successes and challenges. J Allergy Clin Immunol. 2018;142(1):6466. doi:10.1016/j.jaci.2018.05.007

23. Kadkhoda K. Herd Immunity to COVID-19. Am J Clin Pathol. 2021;155(4):471472. doi:10.1093/ajcp/aqaa272

24. Cai C, Peng Y, Shen E, et al. A comprehensive analysis of the efficacy and safety of COVID-19 vaccines. Mol Ther. 2021;29(9):27942805. doi:10.1016/j.ymthe.2021.08.001

25. Prevention CCfDCa. China CDC released 31,434 cases of ADR monitoring of vaccination in COVID-19. Mod Hosp. 2021;21(6):884.

26. Arnold J, Winthrop K, Emery P. COVID-19 vaccination and antirheumatic therapy. Rheumatology. 2021;60(8):34963502. doi:10.1093/rheumatology/keab223

27. Benis A, Khodos A, Ran S, Levner E, Ashkenazi S. Social media engagement and influenza vaccination during the COVID-19 pandemic: cross-sectional survey study. J Med Internet Res. 2021;23(3):e25977. doi:10.2196/25977

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29. Grammes N, Millenaar D, Fehlmann T, et al. Research output and international cooperation among countries during the COVID-19 pandemic: scientometric analysis. J Med Internet Res. 2020;22(12):e24514. doi:10.2196/24514

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Rheumatic disease and COVID-19 vaccination | PPA - Dove Medical Press

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant (lineage B.1.1.529) is currently the dominant circulating strain in most nations. Although millions of children have been affected by SARS-CoV-2 globally, accurate data on the pediatric burden of the coronavirus disease 2019 (COVID-19) is not available due to underreporting of cases and testing limitations.

Study:Anti-SARS-CoV-2 antibodies in breast milk during lactation after infection or vaccination: a cohort study. Image Credit: Rohappy / Shutterstock.com

Currently, COVID-19 messenger ribonucleic acid (mRNA) vaccines are the main protective measure for children against SARS-CoV-2 infection.

The United Nations International Childrens Emergency Fund (UNICEF) has reported over 12,300 deaths in children younger than 20 years of age due to COVID-19. More specifically, 42% of these deaths were reported in children between the ages of zero and nine years. Although short-term neonatal SARS-CoV-2 infection outcomes are rare, the long-term effects of COVID-19 on neurological and physical development remain unclear.

The vertical transfer of pathogen-specific immunoglobulin G (IgG) antibodies from the mother to fetus through the placenta has been reported. Aside from the passive immunity conferred to the infant from prior infection, recent studies have similarly demonstrated that the administration of COVID-19 mRNA vaccines during pregnancy reduces the risk of hospitalization among infants younger than six months who were born to these mothers.

Breast milk consists of several immunoprotective factors, including secretory immunoglobulin A (sIgA), as well as sIgG and sIgM, which confer protection to the infant against infections. However, this form of passive immunity is not as well understood as the transfer of antibodies to the infant through the placenta.

Natural infection with SARS-CoV-2, along with BNT162b2 mRNA vaccination, during pregnancy leads to the development of neutralizing SARS-CoV-2 antibodies that are capable of binding to different regions of the viral spike protein. These antibodies are also secreted in breast milk.

In a new Journal of Reproductive Immunology study, researchers assess the protection conferred by breast milk and serum in previously infected and/or vaccinated mothers against an early SARS-CoV-2 isolate (HH-1) and the Omicron variant for newborns for up to six months after delivery.

The current German study was conducted between February 2020 and December 2021, in which a total of 21 pregnant women were included. Sixteen of the study participants had previously tested positive for COVID-19 and recovered during pregnancy. Seven of the study participants had received at least one dose of the BNT162b2 mRNA vaccine.

Study participants who recovered from COVID-19 were referred to as the R group, while those who have recovered from COVID-19 and were vaccinated were referred to as RV group. Five pregnant women who had received two doses of the BNT162b2 vaccine and had not been infected with SARS-CoV-2 were referred to as V group .

Blood and breast milk samples were collected from the women during lactation for a maximum of six months post-delivery. The humoral response to natural infection and/or vaccination was evaluated by qualitative anti-SARS-CoV-2 IgA enzyme-linked immunosorbent assay (ELISA), quantitative anti-S1-RBD-SARS-CoV-2 assay, and anti- SARS-CoV-2 TrimericS IgG assay. Neutralization assays using Omicron and HH-1 isolates were also conducted.

The median age of all study participants was 36 years. A total of 16 study participants had previously been infected with SARS-CoV-2, two of whom had experienced severe COVID-19. Of those who had received one or two doses of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine, no serious adverse effects were reported.

The median neutralizing antibody levels against the SARS-CoV-2 receptor binding domain (RBD) within the serum were 12,223 AU/ml, 1427 AU/ml, and 198 AU/ml for the RV, V, and R groups, respectively.

The levels of these antibodies within the breast milk were lower; however, a positive correlation was observed between serum and breast milk S1-RBD antibody levels. Similar patterns were observed for the anti-SARS-CoV-2 IgA levels within the serum and breast milk.

The anti-SARS-CoV-2 TrimericS IgG assay revealed median IgG levels of 6,860 BAU/ml, 704 BAU/ml, and 159 BAU/ml for the RV, V, and R groups, respectively. These same antibody levels within breast milk were below the detection level.

A single vaccine dose was found to increase SARS-CoV-2 specific antibody titers in breast milk. Additionally, breast milk samples with positive anti-RBD Ig neutralized both the HH-1 isolate and Omicronin vitro. However, lower antibody titers were observed against the SARS-CoV-2 Omicron variant.

The current study confirmed the presence of anti-SARS-CoV-2 antibodies in breast milk that were capable of neutralizing both an early pandemic SARS-CoV-2 isolate as well as the Omicron variant. Notably, mRNA vaccination improved maternal immune responses and provided passive protection in newborns.

Further studies are needed to determine the correlation that exists between maternal antibody levels and infant immune protection.

The sample size of the current study was small. Due to the limited number of remaining breast milk samples, neutralization assays could include only eight samples. A final limitation was that the six-month follow-up analysis was not available for all the participants.

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COVID-19 vaccination increases antibodies in breast milk significantly - News-Medical.Net

Even before the COVID-19 vaccine was authorized, there was a plan to discredit it.

Leaders in the anti-vaccination movement attended an online conference in October 2020 two months before the first shot was administered where one speaker presented on The 5 Reasons You Might Want to Avoid a COVID-19 Vaccine and another referred to the untested, unproven, very toxic vaccines.

But that was only the beginning. Misinformation seeped into every corner of social media, onto Facebook feeds and into Instagram images, pregnancy apps and Twitter posts. Pregnant people emerged as a target. A disinformation campaign preyed on their vulnerability, exploiting a deep psychological need to protect their unborn children at a moment when so much of the country was already gripped by fear.

Its just so powerful, said Imran Ahmed, the founder and chief executive officer of the U.S. nonprofit Center for Countering Digital Hate, which tracks online disinformation.

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A majority of the disinformation came from a group of highly organized, economically motivated actors, many of them selling supplements, books or even miracle cures, he said. They told people the vaccine may harm their unborn child or deprive them of the opportunity to become parents. Some even infiltrated online pregnancy groups and asked seemingly harmless questions, such as whether people had heard the vaccine could potentially lead to infertility.

The Center for Countering Digital Hate found that nearly 70% of anti-vaccination content could be traced to 12 people, whom they dubbed The Disinformation Dozen. They reached millions of people and tested their messaging online, Ahmed said, to see what was most effective what was most frequently shared or liked in real time.

The unregulated and unmoderated effects of social media where people are allowed to spread disinformation at scale without consequences meant that this took hold very fast, Ahmed said. Thats had a huge effect on women deciding not to take the vaccine.

Some people, such as Robert F. Kennedy Jr., seized on the initial dearth of research into vaccines in pregnant people. With no data showing COVID vaccines are safe for pregnant women, and despite reports of miscarriages among women who have received the experimental Pfizer and Moderna vaccines, Fauci and other health officials advise pregnant women to get the vaccine, Kennedy posted in February 2021 on Facebook. Kennedy did not respond to requests for comment.

Disinformation flourished, in part, because pregnant people were not included in the vaccines initial clinical trials. Excluding pregnant people also omitted them from the data on the vaccines safety, which created a vacuum where disinformation spread. Unsure about how getting the shots might affect their pregnancy and without clear guidance at the time from the Centers for Disease Control and Prevention pregnant people last year had some of the lowest vaccination rates among adults.

The decision to delay or avoid vaccination, often made out of an abundance of caution and love for the baby growing inside of them, had dire consequences: Unvaccinated women who contracted COVID-19 while pregnant were at a higher risk of stillbirths the death of a fetus at 20 weeks or more of pregnancy and several other complications, including maternal death.

Although initial clinical trials did not include pregnant people, the Food and Drug Administration ensured that vaccines met a host of regulatory safety standards before authorizing them. Citing numerous studies that have since come out showing the vaccine is safe, the CDC now strongly recommends that people who are pregnant, breastfeeding or planning to become pregnant get vaccinated. The major obstetric organizations, including The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, also urge pregnant people to get vaccinated.

But two and a half years into the pandemic, misinformation is proving resilient.

A May 2022 Kaiser Family Foundation poll found more than 70% of pregnant people or those planning to become pregnant believed or were unsure whether to believe at least one of the following popular examples of misinformation about the COVID-19 vaccine: that pregnant people should not get vaccinated; that its unsafe to get vaccinated while breastfeeding; or that the vaccine has been shown to cause infertility. None of which are true.

Dr. Laura Morris, a University of Missouri, Columbia family physician who delivers babies, has heard all those falsehoods and more from her patients. She has long relied on science to help encourage them to make well-informed decisions.

But when officials rolled out the vaccine, she found herself without her most powerful tool, data. The disinformation didnt have to completely convince people that the vaccine was dangerous; creating doubt often was sufficient.

That level of uncertainty is enough to knock them off the path to accepting vaccination, Morris said. Instead of seeing vaccines as something that will make them healthier and improve their pregnancy outcomes, they havent received the right information to make them feel confident that this is actually healthy.

Before COVID-19, Morris typically saw one stillbirth every couple of years. Since the pandemic started, she said she has been seeing them more often. All followed a COVID-19 diagnosis in an unvaccinated patient just weeks before they were due. Not only did Morris have to deliver the painful news that their baby had died, she also told them that the outcome might have been different had they been vaccinated. Some, she said, felt betrayed at having believed the lies surrounding the vaccine.

You have to have that conversation very carefully, Morris said, because this is a time where the people are feeling awful and grieving and theres a lot of guilt associated with these situations thats not deserved.

In December 2021, the Federation of State Medical Boards found a proliferation of misinformation about COVID-19 among health care workers. Two-thirds of state medical boards reported an increase in complaints about misinformation, but fewer than 1 in 4 of them reported disciplining the doctors or other health care workers.

Dr. Sherri Tenpenny, an osteopath, was the speaker at the October 2020 conference who called the COVID-19 vaccine toxic. She later testified at an Ohio state House Health Committee hearing on the Enact Vaccine Choice and Anti-Discrimination Act. She falsely claimed that the vaccine could magnetize people. They can put a key on their forehead, it sticks, she said. They can put spoons and forks all over them, and they could stick. She also questioned the connection between the vaccine and 5G towers.

Despite her statements, the State Medical Board of Ohio has not taken any disciplinary action against her. Her medical license remains active. Tenpenny did not respond to requests for comment.

Its difficult to know exactly how many doctors were disciplined, a term that can mean anything from sending them letters of guidance to revoking their license. State medical boards in some cases refused to disclose even the number of complaints received.

Some records were made public if formal disciplinary action was taken, as in the case of Dr. Mark Brody. The Rhode Island physician sent a letter to his patients that the state medical board determined contained several falsehoods, including claims that there exists the possibility of sterilizing all females in the population who receive the vaccination. The Rhode Island Board of Medical Licensure and Discipline reprimanded him for the letter, then suspended his medical license after other professional conduct issues were uncovered. He surrendered his license in December.

Brody said in an interview that he stands by the letter. He said the word misinformation has been politicized and used to discredit statements with which people disagree.

This term doesnt really apply to science, he said, because science is an ever-evolving field where todays misinformation is tomorrows information.

The Washington Medical Commission has received more than 50 complaints about COVID-19 misinformation since the start of the pandemic, a spokesperson there said. California does not track misinformation complaints specifically, but a Medical Board of California spokesperson said that, in that same time period, the group received more than 1,300 COVID-19-related complaints. They included everything from fraudulent promotion of unproven medications to the spreading of misinformation.

We were certainly surprised that more than half of boards said they had seen an increase in complaints about false or misleading information, said Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, which in April adopted a policy stating that false information is harmful and dangerous to patients, and to the public trust in the medical profession.

Other groups, including The American College of Obstetricians and Gynecologists, warned doctors about spreading misinformation. In October, the organization asked its members to sign a letter endorsing the COVID-19 vaccine, writing that the spread of misinformation and mistrust in doctors and science is contributing to staggeringly low vaccination rates among pregnant people. But the letter was never published. We didnt achieve the numbers we had hoped, a spokesperson for the organization said, and did not want to release it if it was not going to be compelling to patients.

The fact that some medical professionals have been spreading disinformation or failing to engage with their patients about the vaccine is profoundly disappointing, said Dr. Rachel Villanueva, a clinical assistant professor of obstetrics and gynecology at New York Universitys Grossman School of Medicine and president of the National Medical Association, which represents Black doctors.

Research has shown that hearing directly from a health care provider can increase the likelihood that patients get vaccinated. And doctors, Villanueva said, have a responsibility to tell their patients the benefits of getting vaccinated and the risks of choosing not to. She has explained to her patients that although the vaccine development program was named Operation Warp Speed, for example, manufacturers followed proper safety protocols.

Before COVID, there already existed a baseline distrust of the health care system, especially for women of color, feeling marginalized and feeling dismissed in the health care system, she said. I think that just compounded the already lack of confidence that existed in the system.

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How Misinformation About COVID Vaccines and Pregnancy Took Root Early On and Why It Wont Go Away - CT News Junkie

Study population

The study was conducted among 331 healthy individuals mainly including health care personnel at Saarland University Medical Center, who either received homologous regimens with ChAdOx (n=62), BNT (n=43), or mRNA-1273 (n=59), or heterologous vaccinations with ChAdOx-priming followed by a boost with either the BNT (n=66) or the mRNA-1273 vaccine (n=101) (Fig.1 and Table1). Despite no known history of SARS-CoV-2 infection, one female was positive for nucleocapsid-specific IgG, and was excluded from further analysis. Due to convenience sampling based on current recommendations, the mean time between the two vaccinations was shorter for the homologous mRNA regimens (5.70.7 weeks) as compared to the vector-based regimens (11.90.9 weeks). In addition, the group showed some differences in age and gender (Table1). Blood sampling was carried out at a median of 14 (IQR 2) days after the second vaccination. In differential blood counts, leukocyte and granulocyte numbers differed between the groups with the highest numbers found after homologous mRNA-1273 vaccination. The numbers of monocytes, lymphocytes, and lymphocyte subpopulations such as B cells, CD4, and CD8 T cells did not differ. Among B cells, plasmablast numbers, which were identified as CD38 positive cells among IgD-CD27+ CD19-positive switched-memory B cells were also highest in individuals after homologous mRNA-1273 vaccination (Table1).

Schematic representation of the five vaccine regimens (three homologous: ChAdOx/ChAdOx n=62, BNT/BNT n=43, mRNA-1273/mRNA-1273 n=59; two heterologous: ChAdOx/BNT n=66, ChAdOx/mRNA-1273 n=101). Shown are the time frames between the first (prime) and the second (boost) vaccination, and between the boost vaccination and the day of blood analysis. #One individual of the mRNA-1273/mRNA-1273 group was excluded from further analysis due to detectable IgG towards the SARS-CoV-2 nucleocapsid.

Spike-specific IgG was detectable in all individuals, but their levels were significantly higher in individuals boosted with mRNA vaccines as compared to individuals after homologous ChAdOx vaccination (Fig.2a, p<0.0001). When comparing heterologous regimens, boosting with mRNA-1273 led to numerically higher IgG levels (6043 (IQR 4396) BAU/ml) than boosting with BNT (4275 (IQR 4080) BAU/ml). Likewise, among homologous regimens, IgG levels were higher after mRNA-1273 vaccination (5529 (IQR 5755) BAU/ml) than in BNT vaccinated individuals (3438 (IQR 3287) BAU/ml), although the differences did not reach statistical significance. As with IgG levels, neutralizing inhibitory capacity of spike-specific antibodies determined using a surrogate assay was high and reached a maximum of 100% in the majority of mRNA-boosted individuals, which contrasted with significantly lower neutralizing activity after homologous ChAdOx vaccination (median 77.8% (IQR 33.5%), p<0.0001, Fig.2a).

Cellular and humoral immune parameters were analyzed 1318 days post vaccination and compared between individuals with different homologous or heterologous COVID-19 vaccine regimens: homologous ChAdOx vaccination (n=62), heterologous ChAdOx/BNT vaccination (n=66), heterologous ChAdOx/mRNA-1273-vaccination (n=101), homologous BNT vaccination (n=43) or homologous mRNA-1273-vaccination (n=58). a ELISA and surrogate neutralization assays were performed to quantify levels of spike-specific IgG and neutralizing antibodies. Intracellular cytokine staining after antigen-specific stimulation of whole blood samples allowed for flow-cytometrical determination of SARS-CoV-2 spike-specific (b) and SEB-reactive (c) CD4 and CD8 T-cell levels. Reactive cells were identified by co-expression of CD69 and IFN among CD4 or CD8 T cells and subtraction of reactivity of respective negative control stimulations. CTLA-4 expression was determined on d spike-specific and e SEB-reactive CD4 and CD8 T cells in all samples with at least 20 cytokine-positive CD4 and CD8 T cells. f Correlation matrix of spike-specific T-cell and antibody responses among each group. Bars in ae represent medians with interquartile ranges. Differences between the groups were calculated using two-sided KruskalWallis test with Dunns multiple comparisons post-test. Correlations in f were analyzed according to two-tailed Spearman (see also Supplementary Table1). Dotted lines indicate detection limits for antibodies in a, indicating negative, intermediate, and positive levels or levels of inhibition, respectively as per manufacturers instructions, and detection limits for SARS-CoV-2-specific CD4 T cells in b and c. Source data are provided as a Source Data file. IFN Interferon, MFI median fluorescence intensitiy, SEB Staphylococcus aureus enterotoxin B.

Vaccine-induced CD4 and CD8 T cells were quantified after stimulation with overlapping peptides encompassing the spike protein. Activation-induced T cells were identified based on CD69 and IFN, TNF, and IL-2. A representative example of CD69-positive spike-specific CD4 and CD8 T cells producing IFN from a 49-year-old female after the second homologous mRNA-1273 vaccination is shown in Supplementary Fig.1, and data from all individuals analyzed after the second vaccination are summarized in Fig.2b. Spike-specific CD4 T-cell levels in the homologous ChAdOx vaccine group were significantly lower than in all other groups. Among mRNA-boosted regimens, median levels of spike-specific CD4 T cells were highest after heterologous ChAdOx1/mRNA-1273 vaccination (0.29% (IQR 0.23%)). Not only did a boost with mRNA-1273 outperform heterologous boosting with BNT after ChAdOx-priming (0.18% (IQR 0.17%), p<0.01), but CD4 T-cell levels were also higher after homologous vaccination with mRNA-1273 (0.24% (IQR 0.27%) than with BNT (0.10% (IQR 0.08%), p<0.0001). Interestingly, the two heterologous regimens also led to a strong induction of spike-specific CD8 T cells (0.29% (IQR 0.57%) for BNT and 0.40% (IQR 0.60%) for mRNA-1273), with significantly higher levels than all three homologous regimens (Fig.2b, p<0.0001). All vaccine-induced effects on CD4 and CD8 T cells were specific, as no differences in Staphylococcus aureus Enterotoxin B (SEB)-reactive CD4 and CD8 T cells were observed between the five groups (Fig.2c). Finally, in line with a pronounced induction of vaccine-induced T cells, CTLA-4 expression was strongly induced on spike-specific CD4 and CD8 T cells of all individuals after heterologous vaccination and in both homologous mRNA regimens, whereas CTLA-4 expression on specific T cells after homologous ChAdOx vaccination was significantly lower (Fig.2d). These differences in CTLA-4 expression were also spike-specific, as CTLA-4 expression on SEB-reactive CD4 and CD8 T cells were similarly low in all five groups (Fig.2e).

When analyzing correlations between spike-specific IgG levels, neutralizing activity, and spike-specific CD4 and CD8 T cells (Fig.2f and Supplementary Table1), neutralizing activity showed a strong correlation with IgG levels in each vaccine subgroup. Likewise, spike-specific CD4 and CD8 T cells showed a significant correlation. In line with the previous findings3, CD4 T cells correlated with IgG in ChAdOx/ChAdOx and ChAdOx/BNT vaccinated individuals only. In addition, it is interesting to note that IgG levels correlated with CD8 T-cell levels in the three homologous vaccine groups only, whereas no such correlation was found for the two heterologous vaccine groups, which may be a result of the exceptionally high CD8 T-cell response in these two groups (see Fig.2b).

As the five groups differed in age and gender due to convenience sampling and recruitment according to national recommendations (Table1), a subgroup analysis was performed among 40 individuals per vaccination regimen which were matched for age and gender (Supplementary Table2). As shown in Supplementary Fig.2, between-group differences in IgG levels, neutralizing activity and spike-specific T cells largely remain the same. In the whole cohort, adjusting for age and gender as confounders in a non-parametric regression analysis showed that both confounders did not have any significant effect on immunological parameters (Supplementary Table3). When testing for interactions of age within each vaccine group with the homologous ChAdOx group as a reference, age had no effect on T-cell levels and neutralizing antibody activity; the only effect of age was found for IgG levels within each of the two homologous regimens (p=0.003 for BNT/BNT and p=0.015 for mRNA-1273/mRNA-1273, Supplementary Table3).

Based on national recommendations, the interval between the first and the second dose was longer for ChAdOx-primed groups than for individuals on homologous mRNA regimens (see Table1). If within-group comparisons were restricted to regimens with the same interval, differences between the respective groups remain the same as those indicated in Fig.2.

Apart from IFN, we also analyzed spike-specific induction of the cytokines TNF and IL-2. As with IFN, differences between the groups were similar for CD4 T cells producing TNF or IL-2 (Fig.3a, b), or for cells producing any of the three cytokines alone or in combination (Fig.3c). This also held true for spike-specific CD8 T cells, except for IL-2 producing CD8 T cells, where levels were generally lower and only showed subtle differences between the groups (Fig.3b). To assess functionality on a single cell level, cytokine profiles of spike-specific CD4 and CD8 T cells were characterized after Boolean gating (Supplementary Fig.3). This allowed distinction of seven subpopulations including polyfunctional cells simultaneously expressing all three cytokines, two cytokines or one cytokine only (Fig.4). The cytokine-expression profiles showed significant differences between the vaccine regimens, and the highest percentage of polyfunctional CD4 T cells was observed for the three vector-primed regimens. These three regimens also showed the highest percentage of CD8 T cells expressing IFN and TNF, which was the dominant fraction among spike-specific CD8 T cells (Fig.4a). The differences in cytokine-expression profiles were spike-specific, as SEB-reactive cytokine expression did not differ among the groups (Fig.4b).

Levels of TNF and IL-2-expressing T cells and combined expression of either of the cytokine IFN, TNF and/or IL-2 were compared between individuals who either received homologous ChAdOx vaccination (n=62), heterologous ChAdOx/BNT vaccination (n=66), heterologous ChAdOx/mRNA-1273-vaccination (n=101), homologous BNT vaccination (n=43) or homologous mRNA-1273 vaccination (n=58). Percentages of CD69+ TNF+ (a), CD69+ IL-2+ b or CD69-positive cells co-expressing at least one of the cytokines TNF, IL-2, or IFN (c) among total CD4 (upper panel) or CD8 T cells (lower panel) were determined after stimulation of whole blood samples with overlapping peptides of SARS-CoV-2 spike protein and subtraction of background reactivity from negative control stimulations. Bars represent medians with interquartile ranges and two-sided KruskalWallis test with Dunns multiple comparisons post-test was used to calculate differences between the groups. Source data are provided as a Source Data file. IFN interferon, IL interleukin, SEB Staphylococcus aureus enterotoxin B, TNF tumor necrosis factor.

After antigen-specific stimulation (a) or polyclonal stimulation with Staphylococcus aureus enterotoxin B (SEB, b) of whole blood samples from individuals with different homologous or heterologous vaccination regimens, cytokine-expressing CD4 and CD8 T cells were subclassified into seven subpopulations according to single or combined expression of IFN, IL-2, and TNF. Blood samples from all individuals were analyzed. To ensure robust statistics, only samples with at least 30 cytokine-expressing CD4 or CD8 T cells after normalization to the negative control stimulation were considered (with the number of samples in each vaccine group indicated in the figures). Bars in a and b represent means and standard deviations, and ordinary one-way ANOVA tests were performed. Source data are provided as a Source Data file. IFN interferon, IL interleukin, TNF tumor necrosis factor.

Local and systemic adverse events within the first week after the first and the second vaccination were self-recorded using a questionnaire (Fig.5 and Supplementary Tables4 and 5). Irrespective of the vaccine type, local adverse events such as pain at the injection site were reported with similar frequency in individuals after the first vaccination. Swelling at the injection site was overall less frequently observed with the lowest percentage among BNT-primed individuals (Fig.5b). Systemic adverse events including fever, headache, fatigue, chills, gastrointestinal manifestations, myalgia, and arthralgia after priming were most frequent in individuals after ChAdOx vaccination, which also was associated with more frequent use of antipyretic medication (Fig.5c and Supplementary Table4). After the second vaccination, local adverse events were least frequent after homologous ChAdOx vaccination, and most frequent in both heterologous and in the homologous mRNA-1273 regimens. The occurrence of systemic adverse events clearly dominated in individuals after heterologous boosting with mRNA-1273, followed by homologous mRNA-1273 vaccination and heterologous BNT-boosting (Fig.5a, c, Supplementary Table5). Individual perception of severity was scored higher after secondary vaccination in both homologous mRNA regimens (Fig.5d). In contrast, more than 75% of subjects after both the homologous ChAdOx and heterologous BNT vaccination were more affected by the primary vaccination with the vector. Despite the strong reactogenicity after vector-priming, it was interesting to note that a sizable fraction of subjects after heterologous boosting with mRNA-1273 was more severely affected by the secondary vaccination, which contrasts with observations in the heterologous BNT vaccine group. Likewise, among individuals after homologous vaccination, the second vaccination with mRNA-1273 was more frequently perceived as more severe, although this vaccine was already strongly reactogenic after the primary vaccination. Overall, it therefore appeared that both the homologous and the heterologous regimens that included BNT were better tolerated than the respective mRNA-1273 regimens.

According to their COVID-19 vaccine regimens, individuals were classified into three groups after dose 1 (ChAdOx vector (n=229), BNT (n=43) or mRNA-1273 vaccine (n=58)) and five groups after dose 2 (homologous: ChAdOx/ChAdOx, n=62; BNT/BNT, n=43; mRNA-1273/mRNA-1273, n=58; heterologous: ChAdOx/BNT, n=66; ChAdOx/mRNA-1273, n=101). Self-reported reactogenicity within the first week after each vaccine dose was assessed using a standardized questionnaire. The presence of local or systemic adverse events in general (a), substantial local (b) or systemic adverse events (c), and individual perception of which of the two vaccinations affected more (d) are shown. Statistical analyses of differences between the groups after the first and the second vaccination are shown in Supplementary Tables2 and 3. Source data are provided as a Source Data file.

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Comparative immunogenicity and reactogenicity of heterologous ChAdOx1-nCoV-19-priming and BNT162b2 or mRNA-1273-boosting with homologous COVID-19...

Both Pfizer and Moderna are working on bivalent boosters: vaccines made up of both the old formula and a new one that targets the Omicron BA.4 and BA.5 subvariants of the coronavirus.

But cases are high now. There are about 124,000 new cases reported each day -- far from the levels reported during the Omicron surge, but nearing peak case rates from the Delta wave -- and cases are more undercounted than ever.

Some experts wonder whether the Omicron-specific boosters will come in time to make a difference and if they will actually offer more protection than the current shots.

A prediction game

The current shots are based on the original strain of the virus and offered nearly full protection, even from infection, early on. With new variants in circulation, the vaccines still are good at keeping people out of the hospital, but most scientists think people need a vaccine that offers more protection.

Dr. Michael Chang, a pediatric infectious disease specialist at Memorial Hermann Health System in Houston, thinks vaccines with an Omicron component will be helpful -- within limits.

"I just wish that the timing had been sooner so that we could actually be dealing with the kind of BA.5 surge that we have right now," he said.

With the highly contagious BA.5 subvariant now dominant, the goal of minimizing the number of infections is "kind of lost," but the new vaccines should help keep hospitalizations and deaths down, Chang said.

"I do think, anytime you can introduce additional strains or variants into a vaccine, the human body's immune response tends to be a little bit broader and more durable and potentially longer-lasting," he said.

Dr. Edward Michelson, chair of the Department of Emergency Medicine at Texas Tech University Health Sciences Center in El Paso, is seeing many patients again, even those who had Omicron earlier in the year.

"Omicron is not protecting people even a few months after they got sick with it. These subvariants are getting them again, much to my surprise," Michelson said. "The good news is, most of the patients don't need hospitalization."

'A new vaccine could really pay dividends'

While scientists are still trying to determine exactly how well the new vaccines will protect people, Lessler said, the model assumes that the reformulated vaccine would have about 80% efficacy against infection with the currently circulating strains. But that depends on how many people actually get an updated booster.

"Absent any real new variants, that kind of efficacy would be enough to really tamp down the current circulation if we have a broad uptake of the vaccines," Lessler said. "A new vaccine could really pay dividends, particularly if we can get it to a broad swath of the population."

Ideally, public health campaigns could be built to encourage people to get a flu vaccine and a Covid-19 vaccine at the same time, he said.

Lessler presented an earlier version of the model to the FDA's independent vaccine advisers, who voted in June to recommend that the vaccine makers include BA.4 and BA.5 in the fall booster. They said that including an Omicron element would offer more protection.

"While it's impossible for anyone to predict which variants will be circulating at the time, the goal as I see it is to add the subvariants that are most likely to give us that broad spectrum of antibodies that will hopefully prevent serious disease, which is really what we're trying to do," said Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science and a member of the FDA's Vaccines and Related Biological Products Advisory Committee.

Europe's approach

"Our program continues to focus on all variants of concern and we remain committed to the public health needs as defined by regulators, Europe and elsewhere," a spokesperson for Pfizer told CNN in an email.

In the United States, a vaccine updated for BA.4/5 got the go-ahead for fall.

Dr. Larry Corey, a vaccine development expert and professor of medicine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle, said the data makes a strong case for the addition. Research on infections shows that the BA.4 and BA.5 subvariants seem to induce stronger immune response than BA.1 and BA.2.

"We don't have the data yet. Certainly, we will know by the end of August," Corey said.

As with so much during the pandemic, scientists are making educated guesses and figuring things out as they go.

"We'll start sleeping better in a month, see whether it does well in animals, and we'll feel we made the right decision when we boost a bunch of people with the BA.4/BA.5 variants," Corey said.

A virus that breaks all the rules

Even as the virus changes, there is only so much vaccine makers can do, says University of Michigan epidemiologist Arnold Monto, who has served as acting chair of the FDA's vaccine advisory panel.

"Basically, we can only use those viruses that we know about," Monto said.

Omicron was a big change from previous variants, he said, and most evolutionary virologists don't think there will be such a big leap again. Rather, the changes will probably be along the Omicron lines.

But then again, "this has been a tricky virus. It has broken all the rules."

Regardless, Monto is confident that adding the BA.4/BA.5 element to the new vaccines will help.

"While we know that the latest viruses that we are encountering that will go into the vaccine probably are not going to the be the viruses in the coming fall and winter, the answer is not to chase them but to try and catch up and broaden them," he said.

In other words, vaccine makers will want to have a wide a distribution of immunity in the population. That's why they'll continue to include the original strain as well as Omicron.

It seems possible that we'll be facing different variants in the fall, but Dr. Eric Rubin, an adjunct professor of immunology and infectious disease at Harvard T.H. Chan School of Public Health, said there is a "very reasonable argument" that having some diversity in the immune response is still a good thing.

"For me, the most important thing we can measure right now is the breadth of immunity and not try to guess which strain is going to be there. That's probably more important than trying to guess what comes up in the fall," said Rubin, who is also on the FDA's vaccine advisory committee but was not a part of the Omicron booster discussion.

Evolution is trying to find its own path, however, and the virus will do whatever works for it as opposed to us. Down the line, he hopes we'll have even better vaccines that will prevent not just severe disease but infections as well.

"I don't think a perpetual game of catchup is going to work forever. We need to think about new approaches," Rubin said.

But he emphasized that more people should get vaccinated and boosted in order to keep cases, hospitalizations and deaths down.

Some people should still get boosted now

The FDA is still encouraging adults 50 and older and those with compromised immune systems to get a second booster now, with the current formula. That would leave enough of an interval for them to get an updated booster in the fall.

Once boosters are updated for the fall, the FDA said, people who get boosted now "may consider getting one." Scientists say it will be important to get this updated version.

"The current vaccines do a pretty great job at keeping people out of hospitals," Rubin said. "I don't really want to dismiss what we've got there. Of course, we always want better."

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Updated Covid-19 boosters are expected in September. Will it be too late? - CNN

The low number of children under 5 receiving the COVID-19 vaccine on Long Island has pediatricians worried kids will not be protected in time for school and another possible wave in the fall.

Just 4,727 children inthe age group in Nassau and Suffolk counties have received a first dose of the vaccine, according to state data. That's3.1% of the eligible population.

I'm a little surprised and a little disappointed, said Dr. Eve Meltzer Krief of Huntington Village Pediatrics. Most people just don't understand that in the last wave, they were the ones that were hospitalized more than any other pediatric age group. Most people just really think that COVID doesn't affect young children and that couldn't be farther from the truth.

On June 18, the Centers for Disease Control and Prevention released its recommendation that all children 6 months through 4years of age receive a COVID-19 vaccine. That opened up the vaccine to almost 20 million additional children across the country, the agency said.

WHAT TO KNOW

The Moderna vaccine is a two-shot regimen administered one month apart. The Pfizer-BioNTech COVD-19 vaccine is a three-shot course for children in the youngest age group. The first two doses are given three weeks apart with the third at least 8 weeks after the second dose.

That time lag could explain some of the lower numbers for fully vaccinated children on Long Island, 733 eligible children ages 4 and younger have been fully vaccinated against COVID-19, according to the state Health Department.

Across the country, vaccinations of children under 5 have lagged behind other age groups.

About 2.8% of children under the age of 5 in the United States, or about 544,000,had received at least one COVID-19 vaccine dose as of July 20, according to the Kaiser Family Foundation.

When KFF compared it with the same point in the earlier rollout of vaccines for children between the ages of 5 and 11, 5.3 million or 18% of children in that age group had received their first dose.

In New York, children younger than 5 have the lowest vaccination rates of all age groups, statistics show.

Less than 1% of kids four and younger, or 9,139, have been fully vaccinated, according to the state Health Department. More than 53,000 or about 4.7% of the eligible 1.1 million population has received at least one shot.

Surveys have shown many parents are reluctant to have children in this youngest age group vaccinated citing myriad reasons. Some said they wanted to wait several months while others point to figuresshowing children are less likely to becomeseverely ill from COVID-19 than adults.

The CDC said that while most children with COVID-19 might have mild symptoms or no symptoms at all, theycan still become very ill and even die from the virus.

Dr. Matthew Harris, medical director of Northwell Healths vaccine program and a pediatric emergency medicine specialist, said there has been an increase in positive COVID-19 cases, including children in this youngest age group.

It really is absolutely important that pediatricians and family doctors continue to encourage vaccination for all their patients against COVID-19 and take every opportunity to counsel patients and parents about the benefits, said Harris, a father of three who had his own infant son vaccinated in June.

Harris pointed out trends in the pandemic have shown upticks in COVID-19 vaccinations tend to follow increases in cases and hospitalizations.

At that point, however, parents may have missed the ball, he said.

Meltzer Krief, who sits on the executive council of the Long Island-Brooklyn/Queens chapter of the American Academy of Pediatrics, said parents of young children under 5 might mistakenly think their child does not need to be vaccinated if they dont attend preschool or day care.

Parents have to realize, unless they live in a bubble, they could bring it home to their young children, she said. And those who are going to be in day care and preschool, where masks aren't required, that is where youre going to be seeing a lot of transmission happening, particularly this new variant that really wasn't circulating in the spring they're going to be sitting in classrooms, not really with any protection, transmitting this potentially very serious disease to each other.

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COVID-19 vaccination rates for kids under 5 lagging, worrying doctors - Newsday

In a new study published on the preprint server medRxiv*, researchers describe failures of the French healthcare system as reflected by increased hospitalizations due to certain acute cardiovascular diseases in 2021, which was coincident with the coronavirus disease 2019 (COVID-19) pandemic.

Study:Change in incidence of cardiovascular diseases during the covid-19 pandemic and vaccination campaign: data from the nationwide French hospital discharge database. Image Credit: crystal light / Shutterstock.com

Throughout the world, cardiovascular diseases remain the leading cause of death among men and women. Although COVID-19 primarily affects the respiratory system, it is also associated with several non-pulmonary consequences, including effects on the cardiovascular system.

Although rare, COVID-19 vaccines have been associated with cardiovascular manifestations. For example, the Pfizer-BioNTech messenger ribonucleic acid (mRNA)-based COVID-19 BNT162b2 vaccine was found to induce myocarditis in some individuals, whereas vector-based vaccine caused thrombotic thrombocytopenia in rare instances.

In France, cardiovascular diseases were the second most common cause of hospitalization in 2019. After the initial detection of COVID-19 in January 2020, France faced a shortage of healthcare management services. Three lockdowns were subsequently implemented between March 2020 to May 2021 to reduce the transmission of COVID-19 and the burden on healthcare services.

The current retrospective cohort study analyzed variations in the incidence of cardiovascular diseases pre- and post-COVID-19 in France. This analysis also considered the ways in which COVID-19 vaccination may have altered incident case rates.

The French National Uniform Hospital Data Set Database (PMSI) provided data from 2019-2021, with 2019 considered as the reference year. COVID-19 vaccination data were acquired from the French Ministry of Solidarity and Healthcare web portal.

International Statistical Classification of Diseases and related health problems, 10th revision (ICD10) codes were used to identify cardiovascular pathologies, with a primary focus on inflammatory and thromboembolic processes. These diseases were divided into five categories, which included:

For each pathology, only cases that were hospitalized for the first time in two years between 2019 and 2021 were included.

A total of 919,514 patients were studied for ten pathologies. A significant decline in hospitalizations was observed for all pathological conditions preceding the first lockdown between March 2020 and April 2020.

During this period, the rate of angina pectoris and arterial thrombosis/embolism declined by more than 35%, whereas a decline of about 30% was observed for patients with DVT. MI, TIA, and myocarditis rates also declined by 20-23%, whereas the incidence of pericarditis- and stroke-related hospitalizations declined by 13% and 14%, respectively. PE hospitalizations declined by 4%.

Four pathological groups with similar temporal patterns were identified based on the case ratios between each year, case trend, and annual relative risk. These groups were defined as sustained decrease, attenuated decrease, partial rebound, and increase.

In group A, which was otherwise known as the sustained decrease group, the incidence and relative risk of hospitalizations significantly declined each year and overall. Angina pectoris and DVT cases were included in this group.

In group B, otherwise known as the attenuated decrease group, a significant decrease in hospitalizations was reported by 2020 and was followed by an unchanged rate of hospitalizations between 2020 and 2021. This group included TIA, stroke, other venous thromboses, and pericarditis cases.

In the partial rebound group C, a significant decrease in 2020 cases was followed by a significant increase in hospitalizations in 2021. MI, arterial embolism, and thrombosis hospitalizations were included in this group.

In the increasing group D, PE and myocarditis cases were associated with an increase in their relative risk for hospitalization and overall incidence. These changes were independent of 2019 to 2020 changes.

Further analysis revealed a progressive rise in myocarditis-related hospitalizations from May to August 2020, until ultimately declining between September and October 2021. Notably, myocarditis occurred more frequently in men between the ages of 10 and 19, as well as those between 20 and 29 years of age, in 2021 as compared to 2019.

Myocarditis, caseload per sex and age, per year.

Conversely, a more even distribution of excess cases was observed in terms of both the age and sex of PE patients. The most notable differences were observed in elderly patients, particularly females over 70 years of age.

Pulmonary embolism, caseload per sex and age, per year.

When vaccination data was considered for non-COVID-19-related hospitalizations, a significant increase in myocarditis hospitalizations was reported among men between 10-29 years of age in March 2020. A similar rise in myocarditis cases was reported between June and October 2021 in this age group, which corresponded to when they were eligible for their first dose of COVID-19 vaccines.

A similar trend was reported among women aged 70 years and older with PE and their first COVID-19 vaccine doses.

Except for PE and myocarditis, all other targeted cardiovascular pathologies were found to decline between January and October 2021 as compared to 2019. These declined admission rates reflect the significant number of patients throughout France who did not have access to hospital services at this point in the pandemic.

The subsequent rise in acute coronary atherothrombosis reported in 2021 may be a re-normalization of necessary hospital care after this period. These findings suggest that the healthcare system in France faced significant challenges in providing important cardiac care to patients in 2021, despite any lessons that they may have learned during the first year of the pandemic.

The rise in myocarditis cases may be attributed to limited access to cardiac care in hospitals, as well as adverse reactions to current COVID-19 vaccines. Similarly, the rise in PE cases also occurred simultaneously when certain patient groups were eligible for their first COVID-19 vaccine doses.

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

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French study on cardiovascular disease incidence during COVID pandemic and vaccination campaign - News-Medical.Net

Late one afternoon last October, Dr. Shelley Odronic sat in her office and, just as she had thousands of times before, slid a rectangular glass slide onto her microscope.

A pathologist who works in rural Ohio, Odronic leaned forward to examine tissue from the placenta of a woman who had recently given birth. She increased the magnification on the microscope. Never had she seen so many tiny, congealed reservoirs of blood or such severe inflammation of the tissue, a sign the placenta had been fighting an infection.

Right away, I knew it wasnt compatible with life, Odronic said.

She asked her secretary to print out the patients chart. In dark letters were the words fetal demise. A stillbirth, the death of a fetus at 20 weeks or more of pregnancy. But that didnt solve the mystery. Odronic had examined many placentas from pregnancies that ended in stillbirth. None looked like this withered and scarred.

Odronic kept reading. No chronic medical conditions. Good prenatal care. Then, buried in the middle of the report, she spotted something. Seven days before the stillbirth, the mother had tested positive for COVID-19. Odronic wondered if the virus could explain the damage to the placenta. In the world of placenta pathology, a new affliction is unusual, especially one so dramatic in presentation and so devastating in effect.

Her mind traveled to Dr. Amy Heerema-McKenney, a pathologist at Cleveland Clinic and an expert on the placenta, who had trained Odronic during residency. Odronic went to sleep that night with a pit in her stomach and a plan to call her former teacher in the morning.

Heerema-McKenney was in her office when the phone rang. As she listened, she knew that what Odronic was describing was what she and her colleagues had observed repeatedly over the past several months: a patient positive for the coronavirus, a placenta destroyed by COVID-19, a baby stillborn.

Their next discovery was equally stunning. None of the stillbirths they studied involved a pregnant person who had been fully vaccinated. The doctors checked with colleagues across the country and around the world. The fatal pattern held.

Unvaccinated women who contracted COVID-19 during pregnancy were at a higher risk of stillbirths. They also were more likely to be admitted to the intensive care unit, give birth prematurely or die. Yet their greatest protection the COVID-19 vaccine sat largely untouched, buried under doubt, polluted by disinformation.

Pharmaceutical companies and government officials failed to ensure that pregnant people were included in the early development of the COVID-19 vaccine, a calamitous decision made amid the urgency of a rapidly spreading pandemic. That decision left pregnant people with little research to rely on when making a critical decision on how best to keep the babies growing inside of them safe.

At the same time that research was excluding pregnant people from vaccine trials, a full-scale assault on vaccination was unfolding online. Taking advantage of the lack of data, conspiracy theorists, anti-vaxxers and even some medical professionals spread false claims about the vaccines safety in pregnancy, leading many pregnant people to delay or refuse the vaccine. Even now, with numerous studies unequivocally announcing the safety of the vaccine for pregnant people, some doctors have failed to communicate the dangers of COVID-19 to pregnant people or the vaccines role in mitigating it.

The Centers for Disease Control and Prevention contributed to the confusion with vague early messaging about whether pregnant people should get vaccinated. While Americans lined up at pharmacies and stalked vaccine websites in hopes of securing a shot last year, pregnant people had some of the lowest vaccination rates among adults, with only 35% fully vaccinated by last November. Meanwhile, many Americans were already moving on to their boosters after federal officials that month expanded eligibility for the additional shots to anyone 18 or older. And much of the country was beginning to return to pre-pandemic life. The Sunday after Thanksgiving, for instance, set the record for the busiest day of air travel since March 2020.

November also marked a key moment in the understanding of COVID-19s impact on stillbirths. A CDC study looking at 1.2 million births in the first 18 months of the pandemic found that more than 8,000 pregnancies ended in stillbirths, including more than 270 of them in patients with a documented COVID-19 diagnosis at the time of delivery.

Although stillbirths were rare overall, babies were dying. The risk of a stillbirth nearly doubled for those who had COVID-19 during pregnancy compared with those who didnt. And during the spread of the delta variant, that risk was four times higher.

Indeed, doctors discovered that some stillbirths resulted from COVID-19 directly infiltrating the placenta, a condition they named SARS-CoV-2 placentitis. Cases were found even in people whose COVID-19 symptoms were mild or nonexistent. In some cases, however, placentas were discarded with medical waste without being tested for COVID-19, and parents never learned what led to their babys stillbirth.

COVID-19 also led to stillbirths among pregnant people who became exceedingly ill after contracting the virus. It damaged their lungs and clotted their blood, putting their babies in such severe distress that they were born before they could take their first breath.

These are pregnancies that should not have ended, Heerema-McKenney said.

She and others had tried to alert the CDC as well as maternal and state health organizations to their findings, but she said they either didnt get a response or were told they needed to collect more data and publish studies. Pathologists are experts in disease diagnosis, dealing with death and illness from the safe distance of their labs. Convincing obstetricians who met with patients daily or doctors who were making policy recommendations was a challenge.

I tried to sound the alarm. We tried so hard to get people to listen, Heerema-McKenney said. It was a really frustrating place to be as pathologists doing these autopsies, looking at these placentas and saying, God, no, not another case.

Around the same time Heerema-McKenney was examining the damaged placentas, Ginger Munro was on life support in a hospital 250 miles away in another part of Ohio.

She and her husband, Kendal, had been trying to have a child for five years. They hadnt expected that shed get pregnant in the middle of a pandemic. But when her pregnancy test came back positive in the spring of 2021, she rushed to post a picture of it in an online pregnancy group. Is it just me or can you see the 2 lines?? she asked.

The pandemic had already brought much change to their lives. Ginger, who lives in the small town of Washington Court House in southwest Ohio, quit her job as assistant nutrition director with the countys Commission on Aging. She stationed hand sanitizer throughout her house and in her car, and she only went grocery shopping early in the morning. If she noticed someone in an aisle, she skipped it.

I knew the virus was real, she said, but I was terrified to take the vaccine.

Ginger worried that the vaccines development had been rushed, and she hadnt seen any data showing it was safe for pregnant people. At this point, the CDC had not explicitly recommended the vaccine during pregnancy. Ginger already worried she was tempting fate by getting pregnant at 40; she said she didnt want to risk endangering her baby by taking the vaccine.

Besides, if it was really important, her doctor would have mentioned it, and, she said, she would have followed his advice. But, she said, he never did. Her family hadnt gotten vaccinated either. In a mostly rural county where less than half of the residents were vaccinated, they were hardly alone.

Her doctor declined to comment through a spokesperson at the hospital system where he works; the spokesperson said the hospital couldnt disseminate information about the vaccine to pregnant patients before it was recommended.

Gingers pregnancy progressed without complications. She and Kendal shared the news of a new baby with Gingers two daughters from a previous marriage. At their kitchen table, near a sign that read eat cake for breakfast, Sophia, then 14, covered her mouth with both hands while Hailee, then 18, simply beamed.

At a backyard gender reveal three months later, Gingers growing belly resembled a basketball against her tiny frame. She leaned in to kiss her husband, her long, dark hair falling onto her shoulders. Red confetti rained down on the deck.

Kendal, an aircraft maintenance and avionics manager at an airport two counties away, worked through the pandemic. In the summer, when they realized his cough was actually COVID-19, it was too late. Ginger was sick.

Having trouble reaching her doctor, she went to two different emergency rooms. One, she said, declined to treat her with monoclonal antibodies, which research had shown can be an effective treatment for pregnant people with COVID-19. The other, which described her in medical records as an exceedingly pleasant individual admitted with symptomatic COVID-19 pneumonia, transferred her about an hour away to the University of Cincinnati Medical Center. There, records show, she was admitted with acute respiratory distress syndrome due to COVID-19.

The University of Cincinnati doctor asked Ginger and Kendal who was on FaceTime because of the hospitals COVID-19 protocols about fetal priority. Ginger made her wishes clear: Save the baby, their baby, the baby they had tried so hard to have. Kendal, who was worried about both his wife and their unborn child, said he went along with Ginger in that moment.

You were so scared, Kendal wrote in a notebook that night. We told each other over and over how much we loved each other.

They hung up so the doctors could insert a breathing tube. Before they could begin, Kendal called back three more times just to hear her voice.

Doctors put Ginger on ECMO, a form of life support reserved for the sickest patients. Kendal, Hailee, Sophia and Gingers mother and sister were later allowed in the hospital two at a time, and they prayed at her bedside nearly every night. Ginger was sedated, her face swollen and obscured by tubing, her cheeks flattened by the crush of the ventilator straps, her wrists tied down so she wouldnt accidentally pull out her breathing tube.

Her family took solace in knowing the babys heartbeat was steady and her ultrasounds were normal. The doctors gave Ginger medication to help the babys lungs mature in case she was born early. After more than 30 days on ECMO, doctors took Ginger off the machine only to put her back on the next morning. She was the first patient in the hospitals history to be placed on ECMO twice.

The plan, records show, was to deliver at 28 weeks. But the day after Ginger was put back on life support, Kendal got the call telling him the baby was on her way. As doctors prepared for the delivery in Gingers intensive care room, the family camped out in the waiting room, jittery from excitement and vending machine snacks. They talked about baby names and future family outings. They pulled the waiting room chairs together to form makeshift beds and covered themselves with blankets they brought from home.

They dont know if they actually fell asleep before a nurse burst through the doors screaming at them to follow. Shes coming! Shes coming! They didnt make it far before they were blocked by doctors and nurses, some huddled over an incubator in the middle of the hall and the rest crowded around Ginger.

Hailee tried to peer over the sea of blue scrubs to catch the first glimpse of her little sister. She smiled beneath her black mask. Shell be OK, she said to herself.

But after a few minutes of trying to revive the baby, a doctor told Kendal it was time. Kendal nodded, asked for a chair and collapsed as he tried to process his daughters death.

Then another wave of grief washed over him. Someone would have to tell Ginger.

Gingers medical records describe a baby born at 27 weeks without signs of life after an uncomplicated delivery. Her placenta had separated from the wall of the uterus, the risk of which studies have shown increases with COVID-19.

When Ginger woke up, she looked down at her sunken belly and realized she had given birth. She assumed her daughter was in the newborn intensive care unit. Ginger was barely able to speak around the tube in her trachea, but after a few days in which no one brought the baby to her, she couldnt wait any longer. Ginger turned to her mother and sister and mouthed the words, Wheres the baby?

The room fell silent. They called Kendal, who rushed to the hospital. He told her what had happened. He described their daughters dark hair and her long fingers and toes, just like her mothers.

Ginger, who had always loved the sweet smell of a newborns breath, whispered to her husband.

Did you smell her breath?

She wasnt breathing, he said.

In the hurried quest for a safe and effective COVID-19 vaccine, pharmaceutical companies and government officials did not include pregnant people in their initial plans. Its a failure that continues to reverberate.

They absolutely should have been included in COVID vaccine trials from the beginning, said Kathryn Schubert, president and CEO of the Society for Womens Health Research, a Washington, D.C.-based nonprofit that advocates for the inclusion of women in research and clinical trials.

Researchers and advocates have spent more than four decades trying to dismantle the belief that its unsafe or unethical for pregnant women to participate in clinical trials. A couple years ago, it seemed like they had finally prevailed.

Shortly before leaving office, President Barack Obama signed into law the 21st Century Cures Act, which established the Task Force on Research Specific to Pregnant Women and Lactating Women. The group found longstanding obstacles, including liability concerns, to including pregnant and lactating people in clinical research. It concluded that recommending halting medication or forgoing treatment while pregnant may actually endanger the health of the mother and her fetus more than the treatment itself.

The need for everything from asthma to depression medication doesnt stop when a person gets pregnant, and when a catastrophic event such as a pandemic hits, experts said, pregnancy should not preclude someone from receiving life-saving treatment.

Around the same time, researchers discovered that the Zika virus, which was mainly transmitted through mosquitoes, could pass from a pregnant person to their fetus and cause severe birth deformities. A second group of experts joined together to develop separate guidance on including pregnant people in the research, development and deployment of pandemic vaccines.

Both groups pushed to remove pregnant women from a list of vulnerable populations that required additional review before being allowed to participate in research. Instead of proving that pregnant women should be included, manufacturers would need to provide compelling evidence for why they shouldnt.

In 2018, the federal task force issued recommendations calling for including pregnant and breastfeeding people in biomedical research, and the Department of Health and Human Services adopted some of the guidance. But a gap remained between what the task force and others insisted was needed and what was actually happening.

We were frustrated because COVID-19 provided an opportunity to implement the recommendations of the task force, said Dr. Diana Bianchi, the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the chair of the task force.

In February 2021, Bianchi and her colleagues published an article lamenting the exclusion of those who were pregnant or breastfeeding from the initial COVID-19 vaccine clinical trials. Pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research, they wrote.

Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics, helped lead the group that issued the guidance after Zika. She and others urged manufacturers to include pregnant people in the development of the COVID-19 vaccine as part of Operation Warp Speed, the federal program that provided billions of taxpayer dollars to pharmaceutical companies to speed up vaccine production.

There is a playbook in place so that when the U.S. launches Operation Warp Speed, it should be pretty obvious what should be done, she said. Its not like no one knows how to do this, either ethically or technically.

Nevertheless, it doesnt happen, Faden added. Once again, pregnant people are left behind.

A spokesperson for Pfizer said the company followed guidance from the Food and Drug Administration. Although pregnant people were not included in the initial vaccine clinical trials, Pfizer tested its vaccine on pregnant rats and did not identify any safety concerns. The company subsequently launched a clinical trial with pregnant women but halted it because at that point the vaccine had already been recommended for pregnant people.

Similarly, Moderna also studied its vaccine on pregnant animals, but the company said it made the decision to prioritize the study of the safety and efficacy of the vaccine in adults who werent pregnant. It called that approach consistent with the precedent to study new vaccines in pregnant women only after demonstration of favorable benefit and risk in healthy adults.

In response to questions from ProPublica, Johnson & Johnson referred a reporter to its website, which didnt address the relevant issues.

Some government officials, including several from the Food and Drug Administration, said they support having pregnant women take part in clinical studies of vaccines for emerging infectious disease, including COVID-19. A spokesperson for the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, said the agency did not dictate the protocol development for the trials and said that responsibility lies with the companies.

The failure to include pregnant people early on in COVID-19 vaccine trials was, at least in part, a casualty of the tremendous urgency to respond to an intense public threat and develop the vaccine as quickly as possible, Faden said. But multiple groups had published road maps on how to ethically include pregnant people without slowing down that process.

I cant tell you how many pregnant people might not have died or how many stillbirths might not have occurred if the playbook had been followed, she said, but Im willing to bet it was a significant chunk that would have been prevented if there had been a full-throated, evidence-based recommendation for COVID-19 vaccines in pregnancy almost simultaneous to when it was available for the rest of the adult population.

By the time the CDC specifically recommended the vaccine for pregnant people, in August 2021, the damage had been done.

A dizzying and vague series of advisories led to confusion and delayed vaccinations. When the COVID-19 vaccines were first made available in December 2020, the CDC said health care workers and residents of long-term care facilities should be prioritized, but the shots were not explicitly recommended for pregnant people. Instead, the agency said on its webpage for vaccines and pregnancy that pregnant health care workers may choose to be vaccinated. In explaining that decision, the CDC said that experts had considered how mRNA vaccines, which do not contain the live virus, work. They concluded that the vaccines are unlikely to pose a risk for people who are pregnant.

However, the CDC added, the potential risks of mRNA vaccines to the pregnant person and her fetus are unknown because these vaccines have not been studied in pregnant women.

In January, the World Health Organization recommended against pregnant people getting the vaccine unless they faced increased risk, such as complicating comorbidities or exposure to the virus due to a job in health care, but the agency later reversed course.

A few months later, in March 2021, the CDC continued its lukewarm messaging that pregnant people may choose to be vaccinated. The agency listed some points for pregnant people to consider discussing with their health care providers, starting with how likely they are to be exposed to COVID-19.

After a promising study showed that the vaccine was safe for pregnant people, CDC Director Dr. Rochelle Walensky said at a White House briefing in late April that the CDC was recommending the vaccine for them. But the CDC did not update its website to reflect her comments and said the agencys guidance had not changed: Pregnant people may choose to be vaccinated.

Once again, pregnant people were put in the precarious position of receiving ambiguous and inconsistent recommendations. In May 2021, the CDC reiterated that pregnant people faced an increased risk of getting severely ill from COVID-19, but the language surrounding the vaccine If you are pregnant, you can receive a COVID-19 vaccine was noncommittal.

A CDC spokesperson, responding to questions from ProPublica, said in an email that pregnant people were part of the first recommendations in December 2020 that encouraged people 16 and older to get vaccinated. At that time, data about the safety and efficacy of the vaccine during pregnancy was limited because pregnant people had been excluded from pre-authorization clinical trials, so the CDC included additional supporting language for pregnant people, saying they were eligible and could choose to receive the vaccine. The agency said its recommendations were based on available evidence and evolved throughout the pandemic.

Before making changes to its guidance, the CDC had its team of scientists review available data to ensure that there was an abundance of evidence.

For each update to the statement of risks during pregnancy, multiple types of studies and the strength of evidence for each were reviewed, another CDC spokesperson said. These reviews of the evidence were accompanied with discussions among subject matter experts both internally and externally with clinical partners for an ultimate determination of risk.

Dr. Cynthia Gyamfi-Bannerman, a perinatologist and chair of the department of obstetrics, gynecology and reproductive sciences at the University of California, San Diego School of Medicine, shared the daunting task of making vaccine recommendations for pregnant people as part of COVID-19 task forces for two leading organizations, The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.

In the beginning, she said, the only pregnancy-specific data they had came from a few dozen participants who were inadvertently included after becoming pregnant during the clinical trials and from some pregnant animal data.

It played out in real time in the COVID pandemic because we see the effects of not including pregnant people in these trials, Gyamfi-Bannerman said. We couldnt make a strong recommendation, so pregnant people were hesitant. I think that directly led to fewer people using the vaccine than we would have wanted.

At the end of June 2021, the CDC added a general update to its website to reflect the dangers of the delta variant tearing across much of the country. Getting vaccinated prevents severe illness, hospitalizations, and death, it wrote. Unvaccinated people should get vaccinated and continue masking until they are fully vaccinated.

But it wasnt until Aug. 11, eight months after the first vaccine was administered, that the CDC issued its formal recommendation that pregnant and breastfeeding people get vaccinated.

The vaccines are safe and effective, Walensky said in a statement at the time, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.

August would prove to be the deadliest month for COVID-19-related deaths of pregnant people. The CDC issued an emergency call the next month strongly recommending the vaccine to pregnant people, noting that approximately 97% of pregnant people hospitalized with COVID-19 were unvaccinated. The dangers to symptomatic pregnant people included a 70% increased risk of death, and their developing babies could face a host of perils, including stillbirths.

Researchers have yet to determine exactly why some pregnant people with COVID-19, vaccinated and unvaccinated alike, deliver stillborn babies, while others do not. Attempts to answer that question have been hindered, in part, by incomplete data. The CDCs statistics on COVID-19-related fetal and maternal deaths are undercounts. The CDC has data on less than 73,000 birth outcomes following a mothers confirmed COVID-19 diagnosis in 2020 and 2021, of which 579 were pregnancy losses.

That information was sent in by fewer than three dozen health departments, and those estimates dont include states like Mississippi, which in September reported 72 COVID-19-related stillbirths since the start of the pandemic, nearly double what the state would have expected, according to data from the Mississippi State Department of Health. Preliminary state data shows total stillbirths increased there in 2020 then dipped in 2021, but were still higher than pre-pandemic numbers.

A separate CDC database shows more than 220,000 COVID-19 cases and at least 305 deaths among pregnant people.

CDC recognizes that pregnant people faced challenging decisions about how to best protect themselves in the setting of uncertainty related to both the infection and the COVID-19 vaccine, a CDC spokesperson said, adding, COVID-19 vaccination remains one of the best ways to protect yourself and your family from serious illness from COVID-19.

Heartbroken and determined, Jaime Butcher has emerged as an unofficial ambassador for the vaccine, posting in online pregnancy and stillbirth forums about the risks of being pregnant and unvaccinated.

No one, she said, told her of the risks. Doctors, the CDC and health officials, she continued, arent doing enough to inform people. Even now, well into the pandemics third year, the message still isnt getting through.

I kept seeing it happening more and more to women and it wasnt talked about, she said. They just say, Oh, get the vaccine, which is great, but they dont talk about what getting the virus can do to pregnant women.

As a wedding planner, Butcher was surrounded by love. She found it with her husband, then in the daughter growing in her belly, who they named Emily after Butchers grandmother.

Butcher suffered five miscarriages before, she said, she opened an email from an in-vitro fertilization clinic confirming her pregnancy in the summer of 2020. She screamed, and her husband rushed to wrap her in a hug.

They waited until she was five months along to announce her pregnancy at Thanksgiving. The next day, Black Friday, they bought a high chair, a tummy time mat and pink onesies.

They were taking precautions, Butcher said, especially since the vaccine wasnt yet available to her or her husband. But a week later, she woke up with a runny nose, though she didnt think much of it. Still, she went to the hospital to make sure everything was OK. An ultrasound came back normal.

When her daughters kicking slowed the next morning, she called her doctors office again. They told her to eat something sweet to get the baby moving. She tried everything she could find: orange juice, Cheerios, Twix, graham crackers, peanut butter and jelly. Nothing worked.

A few hours later, Butcher drove herself to the hospital, where she followed her daughters heartbeat on the screen. Steady. Then slow. Then still.

She delivered at 23 weeks. Butcher didnt know she had COVID-19 until they tested her at the hospital. A lab report later revealed extensive damage to the placenta.

I was in shock. I was in shock that I lost my daughter, in shock that I had COVID, Butcher said. She should be alive, but its because of COVID that I lost her.

A week later, she parked in front of Kohls to return the high chair, the clothes still on tiny hangers and the stroller her mom gave her. As she made her way to the register, she saw a baby in an identical stroller. The tears stung all the way down her cheeks.

You see what you want right in front of you, she said, and its like, My baby should be here. This shouldnt have happened.

Even before the pandemic, almost a quarter of all stillbirths may have been preventable. The stillbirth crisis has simmered silently in the U.S., claiming the lives of more than 20,000 babies annually. But parents often suffer alone, overwhelmed by grief and guilt.

Originally posted here:

Confusion Over COVID Vaccine Safety Led to Many Avoidable Stillbirths - Truthout

Dr. Fauci: Youll get into trouble if youre not up to date on COVID vaccines and boosters here are 3 stocks that could get a shot in the arm

With summer travel season under full swing, the COVID-19 pandemic may seem like a thing of the past.

But if you dont stay up to date on your vaccines and boosters, the consequences could be dire, according to President Bidens chief medical advisor Dr. Anthony Fauci.

If they dont get vaccinated or they dont get boosted, theyre going to get into trouble, Dr. Fauci told KNX News 97.1 a Los Angeles radio station earlier this week.

He points out that the vaccine and booster rates in America are quite discouraging.

According to the Kaiser Family Foundation, 228 million Americans (or 70% of the U.S. population) were not up to date with COVID-19 vaccines as of July 20, 2022. Staying up to date on vaccines means having received the primary series and at least one booster dose.

Its hard to say whether Dr. Faucis warning will lead to more Americans getting COVID-19 vaccines and booster shots. But it does give investors a reason to check in on companies making those vaccines.

Right now, the most dominant strain of COVID in the U.S. is Omicrons BA.5 subvariant. And Moderna could help the country fight it.

Earlier this week, the companys CEO Stphane Bancel told Yahoo Finance that they are working really hard to get a variant-specific booster ready this fall.

We are already making the BA.4/5 vaccine as we speak, he says. We'll give more data as we get closer to it, but we know how important it is. And know every day matters.

In Q2, Moderna generated $4.7 billion of total revenue, up from $4.4 billion earned a year ago. Management attributed the top line increase to higher product sales of the companys COVID-19 vaccine.

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But Moderna shares are not immune to the market sell-off this year. They have fallen about 20% in 2022.

Piper Sandler analyst Edward Tenthoff has an overweight rating on Moderna and a price target of $214 roughly 14% above where the stock sits today.

BioNTech is another big name in the COVID vaccine business.

According to Statista, more than 355,396,322 doses of Pfizer-BioNTech COVID-19 vaccine have been administered in the U.S. as of July 20 more than vaccines made by any other manufacturer.

On June 25, Pfizer and BioNTech announced that their Omicron-adapted vaccine candidates showed high immune response against Omicron.

Theres also hope for tackling new subvariants.

Preliminary laboratory studies demonstrate both Omicron-adapted candidates neutralize Omicron BA.4 and BA.5 though to a lesser extent than they do for BA.1, the companies said as they continue to collect additional study data on Omicron BA.4/BA.5.

BioNTech will be reporting Q2 earnings on Monday Aug. 8 before the bell.

Previously, management said that they expect BioNTech COVID-19 vaccine revenue to come in between 13 billion and 17 billion for full-year 2022.

Last month, SVB Securities analyst Daina Graybosch upgraded BioNTech from market perform to outperform. Her price target of $233 on the shares implies a potential upside of 28%.

When it comes COVID vaccine stocks, Novavax is a new name worth considering.

Last month, the U.S. Food and Drug Administration granted emergency use authorization to Novavax COVID-19 vaccine Adjuvanted (NVX-CoV2373). In the critical Phase 3 clinical trial, the two-dose vaccine was 90.4% effective in preventing mild, moderate, or severe COVID-19.

This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues, said Novavaxs president and chief executive officer Stanley C. Erck in a press release.

Novavax shares, however, have been pummeled its down a staggering 57% year to date.

B. Riley Securities analyst Mayank Mamtani sees a rebound on the horizon. He has a Buy rating on Novavax and a price target of $171.

Considering that Novavax currently trades at around $60 per share, Mamtanis price target implies a potential upside of 185%.

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Dr. Fauci: Youll get into trouble if youre not up to date on COVID vaccines and boosters here are 3 stocks that could get a shot in the arm - Yahoo...

Recently, my 1-year-old received her first dose of the COVID-19 vaccine. Ellie was a trooper, crying for only about 30 seconds after the nurse delivered the dose. She was bouncing around the house as soon as we got home.

I got my first dose while pregnant to protect Ellie and me, as the immunity I received transferred safely to her. I delivered a perfectly healthy baby, and Ellie had no reaction to the first dose she received.

Of course, my decisions to get us both vaccinated were made only after poring over data and consulting with my doctor.

As the senior adviser for the California Department of Public Healths vaccine task force, I am inundated with coronavirus infection trends, surrounded by research and data day-in and day-out. Ive learned that COVID-19 is one of the top five causes of child death. During last winters omicron surge, COVID-19 hospitalizations for kids ages 4 and under were five times higher than when the delta variant was circulating earlier and 1 in 5 kids hospitalized with the virus was admitted to the intensive care unit. My husband also works in health care, where he hears cases of patients in the ICU fighting for their lives.

These are all constant reminders of how COVID-19 continues to ravage families and why we need to continue to look out for one another.

Knowing these facts firsthand had made me anxious while pregnant and during Ellies infancy. As parents, we want to do everything we can to protect the proverbial lights of our lives. I felt helpless without a vaccine during Ellies delicate first year.

That concern for loved ones spills over into the home that we share with my parents. My mother takes care of Ellie while my husband and I work, and my dad is highly vulnerable to the most serious consequences of COVID-19. Years ago, he was diagnosed with lung cancer, and his surgical treatment left him with about 75% lung capacity.

Like other multigenerational households, weve taken extraordinary care to keep ourselves and one another protected against the virus masking, isolating if we dont feel well, limiting interactions with non-family members and receiving all eligible vaccine doses. We are extra careful to avoid places where the coronavirus might be circulating. Regrettably, our family has missed out on a lot of activities.

Thats why I was thrilled when vaccines for all family members finally became available. I was heartened to know that thousands of infants and toddlers as young as 6-months-old were part of robust clinical trials that demonstrated the vaccines safety and effectiveness for our youngest children.

I feel fortunate to live in a country that rigorously researches and tests vaccines before they are authorized by the Food and Drug Administration and endorsed by the Centers for Disease Control and Prevention and for Californias added layer of review through an independent panel in partnership with Washington, Oregon and Nevada that examines the data.

In fact, the COVID-19 vaccine is just one of many proven vaccinations helping to keep my toddler healthy by protecting her from infectious diseases like whooping cough, measles and influenza, among others.

Now that our whole family has been vaccinated, we have a newfound peace of mind knowing that weve done everything we can to keep one another healthy. My parents can freely embrace Ellie with less worry, and she can safely spend more time with others outside our household.

We are among the nearly 29 million Californians who have been vaccinated against COVID-19. Nearly 67% of the states children ages 12 to 17 and more than 36% of those 5 to 11 have received doses of these safe and effective vaccines. This is good news, as research has shown that the vaccine protects children against the worst outcomes of COVID-19, including hospitalization, long COVID, multisystem inflammatory syndrome in children and death.

On Ellies first birthday, we celebrated her doljabi, a Korean tradition that determines ones destiny. As we watched her choose from a myriad of items before her, I secretly hoped shed choose the yarn that signifies long life. Of course, we knew wed be happy no matter what she chose, especially knowing she is better protected in her early years. We have so much to celebrate.

If you or other members of your family are not yet vaccinated against COVID-19, now is a good time to consider the tools available, including the recently authorized Novavax vaccine a new option for adults that uses a protein-based technology.

Whether to have your children vaccinated against COVID-19 is an important decision for every parent and caregiver to make. As a parent, I urge you to discuss any questions you have with your childs health care provider. If youre ready to take the step toward full-family protection against COVID-19, call your provider or community health clinic to get your child vaccinated. Or go to myturn.ca.gov or call 833-422-4255 to find a vaccination site near you.

Sonya Logman Harris is the senior adviser to Californias Vaccinate ALL 58 campaign and oversees the COVID-19 Vaccine Task Forces statewide outreach and education efforts. She previously served as chief of staff for the 2020 census in California.

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COVID is one of the top five causes of child death. I'm relieved my 1-year-old finally got her first vaccine dose - San Francisco Chronicle