Category: Covid-19 Vaccine

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Do boosters make you more likely to get COVID? There’s no evidence – The Dallas Morning News

January 22, 2024

HAMPTON, N.H. During his presidential campaign, Florida Gov. Ron DeSantis has emphasized the speed with which he opened his state during the coronavirus pandemic. He argued this move unleashed the economy when many other states were struggling because of pandemic-related shutdowns.

After initially supporting the coronavirus vaccine during its wide rollout in early 2021, DeSantis and his allies have expressed skepticism about them. DeSantis hand-picked state surgeon general, Joseph Ladapo, for example, argued that small DNA fragments in the vaccines could pose a unique and elevated risk to human health. PolitiFact found the scientific consensus says they dont.

During a visit to this Atlantic Ocean beach town, more than 100 supporters packed into Wallys restaurant to hear DeSantis speak and take questions.

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DeSantis urged caution about the coronavirus vaccine that medical officials and most doctors still urge Americans to get. He said people who get the vaccine are likelier to get sick.

Every booster you take, youre more likely to get COVID as a result of it, DeSantis said.

DeSantis said something similar in January 2023: Almost every study now has said with these new boosters, youre more likely to get infected with the bivalent booster. We rated that False.

For this article, we checked back with experts to say whether any developments changed their assessment during the subsequent year. All disagreed with DeSantis.

Neither the DeSantis campaign nor his gubernatorial office responded to an inquiry for this report.

Broadly speaking, COVID-19 vaccines are not designed to prevent infection; they prevent the virus from spreading within the body and causing severe illness.

COVID-19 vaccines, including boosters, have now been shown to be most effective against severe disease, said Monica Gandhi, a professor of medicine and associate chief in the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco.

Gandhi said the most recent boosters were tailored to target one variant, XBB1.5. She said the boosters have been shown to significantly reduce COVID-19 hospitalizations in people older than 65, including in a recent study from Denmark.

DeSantis comments hint that he is holding the vaccine to a standard complete protection against infection that it was never intended to provide.

One study DeSantis office cited for our story a year ago came from the Cleveland Clinic and was discussed in an opinion article in The Wall Street Journal.

But Dr. Nabin Shrestha, an infectious disease physician and one of the studys authors, told PolitiFact at the time that, contrary to DeSantis remark, the data did not find a link between getting the shot and having a higher risk of contracting COVID-19.

What drove coverage in outlets such as The Wall Street Journal was an unexpected association researchers found between the number of prior vaccine doses and an increased risk of contracting COVID-19. People with three or more doses of the vaccine had a higher chance of getting infected.

However, experts told PolitiFact that the study population was not reflective of the general public; it consisted of younger, relatively healthy health care workers and included no children and few elderly or immunocompromised people. Therefore, experts said, the study cannot simply be extrapolated to the population at large.

Ren Najera, an epidemiologist and director of the Center for Public Health at the College of Physicians of Philadelphia, told PolitiFact last year that the population tested would be more likely to be exposed and more likely to be vaccinated as well. The findings would only be applicable to health care workers in large settings such as the Cleveland Clinic, not the general public.

Gandhi and other medical professionals told PolitiFact that studies like the Cleveland Clinics are imperfect, because it is hard to conduct real-world experiments that gauge infection rates, especially for vulnerable populations. Studies tend to get participants who are healthy and are likelier to get boosters, Gandhi said.

Therefore, studies of this sort are subject to massive bias, said Babak Javid, associate director of bench science at the University of California-San Francisco Center for Tuberculosis Medicine.

Javid says theres also significant overlap among the people who get the new booster and those who test themselves frequently. Since infection status can only be documented if a test is performed, it could easily explain how more vaccinated people are in the infected camp, he said. People who are not getting vaccinated or tested simply wont be counted, skewing attempts at making comparisons.

Another complication in tracking infection rates is that coronavirus vaccines present the same dynamics as any vaccine. That is, by protecting against one strain, or just a few strains, of a given virus, vaccinated people are still liable to get infected by a different strain that the vaccine doesnt cover, said Jill Roberts, an associate professor in the College of Public Health, Global and Planetary Health at the University of South Florida.

Thats why many vaccines, such as flu and COVID-19 shots, need frequent updating, experts said.

Gandhi said that although the boosters have long been known to offer only modest protection, if at all, against COVID-19 infection ... there is no evidence to suggest that boosters actually increase the risk of COVID-19 infection.

Thus, she said, DeSantis is incorrect in saying boosters will lead to more frequent infections.

DeSantis said, Every booster you take, youre more likely to get COVID as a result of it.

Experts say there is no hard evidence that infection is greater in people who have had boosters.

Part of the reason is that determining infection rates among all members of society is difficult. Most studies rely on younger and healthier patients, who are not necessarily typical. Also, people who are not getting vaccinated or tested simply wont be counted, skewing attempts at comparisons, experts said.

We rate the statement False.

By Louis Jacobson, PolitiFact staff writer

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Do boosters make you more likely to get COVID? There's no evidence - The Dallas Morning News

Study reveals intestinal helminth infection diminishes T cell response to COVID-19 mRNA vaccine – News-Medical.Net

January 22, 2024

In a recent study posted to the bioRxiv preprint* server, researchers examined the impact of helminth infection on the effectiveness of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid (mRNA) vaccine.

Helminths infect more than 25% of the global population. Hookworms, whipworms, and roundworms are responsible for most human helminth infections. Healthy individuals usually present asymptomatic helminth infection, with adult worms persisting in the gastrointestinal (GI) tract for years.

However, in immunocompromised individuals and children, infection in the GI tract could result in substantial morbidity. Helminth infections have a negative impact on immune responses to tuberculosis, hepatitis B, influenza, and measles vaccines. Nevertheless, the effect of infection on SARS-CoV-2 vaccine efficacy remains unknown.

Study: Intestinal helminth infection impairs vaccine-induced T cell responses and protection against SARS-CoV-2. Image Credit:olgaru79/ Shutterstock

*Important notice: bioRxiv 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.

In the present study, researchers evaluated the impact of enteric helminth infection on coronavirus disease 2019 (COVID-19) vaccine efficacy in mice. C57BL/6J mice were primed with an mRNA encoding the SARS-CoV-2 Wuhan-1 spike; animals were boosted three weeks later. Heligmosomoides polygyrus bakeri (Hpb) was inoculated twice, 12 days pre-prime and 12 days pre-boost (P/B).

Two additional groups were infected with Hpb, pre-prime (P) or pre-boost (B). Enzyme-linked immunosorbent assay (ELISA) revealed that non-infected, vaccinated animals elicited immunoglobulin G (IgG) antibodies specific to the viral spike and its receptor-binding domain (RBD) by day 15 post-first dose, which was enhanced by day 15 post-second dose.

Infected groups (P, B, and P/B) also had similar antibody responses; however, animals in the B group had significantly reduced IgG to spike and RBD, and those in the P/B group had reduced response to RBD compared to non-infected vaccinated mice. Further, there were no differences in spike-specific B-cell responses in infected and non-infected animals.

Regardless of infection status, all vaccinated animals induced comparable neutralizing antibody (nAb) titers against SARS-CoV-2 WA1/2020 D614G. Nevertheless, serum from all vaccinated groups had no or little inhibitory activity against Omicron BA.1 or BA.5. Besides, spike-specific clusters of differentiation 8-positive (CD8+) T cells were detectable in the spleen at day 15 post-boost.

Interferon (IFN)+ and tumor necrosis factor (TNF)+ CD8+ T cell responses were marked reduced in Hpb-infected vaccinated mice. These animals also had reduced numbers of IFN+ TNF-, IFN+ interleukin 2 (IL-2+), and IFN+ TNF+ CD8+ T cells, suggesting that Hpb infection suppressed CD8+ T cell effector responses. Infection also suppressed IFN+ TNF+ CD4+ T cell responses.

Further, helminth infection skewed towards T-helper 2 (Th2) differentiation, and this response was unaffected by vaccination. Next, the team examined responses to Janssens adenoviral-vectored Ad26.COV2.S vaccine. Mice received the vaccine 12 and 30 days after Hpb infection. The number of spike-specific CD8+ T cells declined two-fold 10 days post-boost.

Further, the numbers and percentages of IFN+ TNF+, IFN+ IL-2+, and IFN+ TNF CD8+ T cells were reduced in Hpb-infected vaccinated mice compared to non-infected vaccinated animals. Infection also depleted IFN+ TNF+ CD4+ T cells in vaccinated mice. Overall, Hpb infection impaired Ad26.COV2.S-induced CD4+ and CD8+ responses but to a lesser extent than with mRNA vaccination.

Further, K18-hACE2 mice were infected with Hpb and subsequently immunized with two mRNA vaccine doses. Nave mice and Hpb-infected non-vaccinated mice were controls. Animals were challenged with WA1/2020 D614G or Omicron BA.5.5 four to five weeks after the second vaccine dose. D614G infection of control animals reduced their body weight four to five days post-infection. However, regardless of infection, all vaccinated mice were protected from weight loss.

Hpb-infected vaccinated mice showed decreased viral burdens, suggesting that Hpb infection had not affected protection against D614G. By contrast, all vaccinated groups had poor nAb titers against BA.5.5. Hpb-infected vaccinated animals lost about 15% of the weight. Furthermore, Hpb-infected vaccinated mice demonstrated increased viral RNA and infectious virus in the lungs compared to non-infected, vaccinated mice.

Additional experiments suggested that Hpb infection resulted in defective vaccine-induced CD8+ T cell responses. Next, the researchers evaluated whether signal transducer and activator of transcription 6 (STAT6) signaling mediated Hpb-triggered defective CD8+ T cell responses. To this end, vaccination and helminth infection were repeated in congenic wild-type and Stat6-/- mice. mRNA vaccination elicited equivalent CD8+ T cell responses in non-infected WT and Stat6-/-.

Effector cytokine response and CD8+ T cell responses were diminished similarly in infected WT and Stat6-/- mice. This indicated that helminth-associated suppression of CD8+ T cell response to mRNA vaccine was independent of STAT6 signaling. As such, the researchers explored alternative mechanisms and found that helminth-induced IL-10 was the likely suppressor, as IL-10 blockade in Hpb-infected animals restored the vaccine-elicited T-cell response.

In sum, the study evaluated the impact of helminth infection on COVID-19 vaccine responses. The findings suggest that helminth infection did not substantively impact vaccine-elicited antibodies; however, infection affected T-cell responses. This defective T-cell response was irrespective of whether mice were infected before the first or the second dose.

Additionally, Hpb infection compromised protection against Omicron BA.5.5 without substantively impairing protection against the D614G strain. Taken together, the findings illustrate the detrimental effect of intestinal helminth infection on vaccine-induced T-cell responses, and impairment was likely through an IL-10-dependent pathway. Therefore, helminths should be deemed vital factors that could modulate COVID-19 vaccine efficacy and immunogenicity.

*Important notice: bioRxiv 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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Study reveals intestinal helminth infection diminishes T cell response to COVID-19 mRNA vaccine - News-Medical.Net

COVID-19 Vaccine Information – Tacoma-Pierce County Health Department

January 22, 2024

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COVID-19 Vaccine Information - Tacoma-Pierce County Health Department

Allegheny County dodges the measles, COVID-19 continues to take a toll – 90.5 WESA

January 22, 2024

Pennsylvania's recent measles outbreak has not reached Allegheny County for that, Allegheny County Health Department's Dr. Barbara Nightingale is thankful. During Wednesday's Board of Health meeting, Nightingale even knocked on the wooden podium while addressing the board.

"In Allegheny County, we've been very lucky," said Nightingale, the department's deputy director of clinical services. "We haven't detected a case since 2019."

Measles is a highly contagious viral illness that spreads through the air; it can cause severe brain infections and death. However, a two-dose vaccine is 97% effective. Adults who were born before 1957 are considered immune to the disease.

The patients infected in the current measles outbreak, which was first reported in early December, were all unvaccinated. The state's health department reports that six individuals reside in the state's southeastern corner, and one lives in northcentral Pennsylvania.

The state Health Department said the northcentral case is not linked to the other six. However, all seven people were infected after traveling, living abroad, or having contact with an infected person who was recently out of the country.

"Historically, January through May is the peak time for importation of measles infections to the United States," said the state Health Department. Allegheny County's 2019 measles outbreak occurred in May and was also travel-related.

Regarding other infectious diseases, COVID-19 continues to present a threat: Nightingale noted that about one Allegheny County resident dies every day from the virus, and hundreds are hospitalized weekly.

So far, six people have died and 19 hospitalized due to influenza since the start of October, which marks the beginning of the respiratory virus season. There have been 202 hospitalizations from RSV, but no deaths.

Though county-level vaccination data isn't available, the National Immunization Survey shows that Pennsylvania-wide, just 21.1% of adults and 10.7% of kids have gotten the most recent COVID-19 shot the numbers are better for the flu: 44.4% of adults and 51.1% of children.

In addition to respiratory illnesses, the county health department is expanding its mosquito-mitigation efforts to new areas, including Wilkinsburg and McKees Rocks. Warmer and more humid weather caused by climate change contributes to a rise in vector-borne diseases such as West Nile virus.

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Allegheny County dodges the measles, COVID-19 continues to take a toll - 90.5 WESA

Nonpharmaceutical Interventions Reduced Hospitalizations, Deaths in Early COVID-19 Pandemic – Drug Topics

January 22, 2024

A new study has revealed that nonpharmaceutical interventions (NPIs) were generally associated with reduced rates of cases, hospitalizations, and deaths during the first 6 months of the COVID-19 pandemic. Findings were published in AJPM Focus.1

The unprecedented nature of the COVID-19 pandemic demanded a global response unlike any issued before. In the absence of standardized protocols, a patchwork of interventions emerged across nations. To this day, there exists controversy as to whether these responses worked or whether government officials made the best choices to protect people from the novel virus.

Although previous research has delved into the impact of these responses on alleviating the burden of the pandemic, investigators of the current study sought to create a more comprehensive picture of the impact of nonpharmaceutical interventions during its early stages.

During the first wave (January 2020June 2020), the unprecedented rapid spread of COVID-19 sparked varied responses from around the worldeach country was reacting in a way that they believed to be most effective, study authors said. Still, there is much debate as to which NPIs are most impactful in mitigating the COVID-19 burden on related cases, hospitalizations, and deaths. This information can be extremely valuable to policy makers and government officials facing future waves of the pandemic and other viral outbreaks.

In their meta-analysis, investigators extended previous literature by evaluating the impact of 10 NPIs on 3 outcome variables at 2, 3, and 4 weeks periodic lags after their implementation during the first wave of the pandemic. This time frame is important, authors noted, because by the second wave of the pandemic, governments and individuals had begun adapting to intervention measures.

When assessing the impact of NPIs, considering the duration of effectiveness after implementation has paramount significance, study authors wrote. Although some NPIs may reduce the COVID-19 impact, others can disrupt the mitigative progression of containing the virus after 3 weeks. Policymakers should be aware of both the scale of their effectiveness and duration of impact when adopting these measures for future COVID-19 waves.

Whereas past literature has studied the impact of NPIs on general health outcomes and mortality, investigators more thoroughly assigned the proportion of cases, hospitalizations, and deaths averted as their outcome variables. To compare like results, estimates were measured using 3 metrics that commonly appeared across the 44 papers included in the final analysis: cumulative, growth rate, and per capita effects.

Among the selected papers, 8 measured estimates for NPIs overall, 10 for policy stringency, 16 for shelter-in-place orders (SIPOs), 4 for social distancing, 7 for mask wearing, 6 for limited gatherings, 7 for business closures, 3 for bar/restaurant closures, 6 for school closures, and 7 for traveling restrictions/border closures.

Investigators found that policy stringency was associated with decreased per capita mortality across all lags (0.13, 0.24, and 0.24 per 100,000, respectively) and that mask wearing was associated with mitigative effects for both cases (2.76 per 100,000) and deaths (0.19 per 100,000). Restaurant closures and travel restrictions were associated with decreased mortality after 4 weeks of implementation, translating to 1.08 fewer deaths per 100,000. SIPOs showed delayed impacts after 2 weeks of implementation on cases (2.9 per 100,000).

Although results suggested that the 10 NPIs generally corresponded to decreases in case, hospitalization, and mortality rates in the first 6 months of the pandemic, there were some exceptions, authors wrote. Results that revealed that business closures did not produce negative point estimates after their fourth week suggest that their effects may have been temporary. Similarly, limited gatherings were linked to increased per capita mortality after the 2- and 4-week lags, suggesting that this intervention may not have been worthwhile.

We found that wearing masks led to an estimated reduction of about 2.76 cases per 100,000 people and 0.19 in mortality. These effects sound small but are statistically significant, James A. Peters, MSCM, PhD student and study author, said, noting the importance of the reviews results.2 When you scale these numbers up to the millions, these measures could be preventing hundreds or thousands of deaths.

Study authors further noted how their results could help facilitate understanding of the usefulness of intervention measures and prepare for future pandemics.

If and when another pandemic occurs, we should be more prepared. We should know which policies are most effective at mitigating not only mortality, but cases and hospitalizations as well, Peters concluded.

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Nonpharmaceutical Interventions Reduced Hospitalizations, Deaths in Early COVID-19 Pandemic - Drug Topics

Characteristics of long COVID and the impact of COVID-19 vaccination on long COVID 2 years following COVID-19 … – Nature.com

January 9, 2024

Study participants and design

This prospective cohort study enrolled adult patients in Korea with polymerase chain reaction-confirmed COVID-19 infection between February 17, 2020, and March 24, 2020, and data were collected between August 31, 2020, and March 29, 2022. Initially, 5,252 adult patients with COVID-19 infection were identified from the Daegu Center for Infectious Disease Control and Prevention registry in Daegu and contacted individually by mobile phone. After excluding deceased patients, we included those who agreed to participate and were able to visit the study hospital. Patients were recruited to be evenly distributed by age to reduce age-related bias.

Participants visited Kyungpook National University Hospital four times in the 24months following the onset or diagnosis of COVID-19. Enrolled patients were those who consented to participate and completed all four hospital visits. A survey was conducted using a modified version of the International Severe Acute Respiratory and Emerging Infection Consortium protocol, translated into Korean22 (Supplementary Table S1). Long COVID was defined by 38 symptoms: fever, chills, myalgia, arthralgia, fatigue, cough, sore throat, rhinorrhea, sputum production, dyspnea, palpitations, arrhythmia, chest discomfort, headache, dizziness, cognitive dysfunction, difficulty concentrating, amnesia, abnormal directional sensibility, seizure, paresthesia, globus pharyngeus, hallucination, insomnia, social phobia, depression, anxiety, obsessive thinking, anorexia, diarrhea, nausea or vomiting, anosmia, ageusia, tinnitus, alopecia, skin rashes, pruritis, and COVID toes.

The survey included questions on the following: sex, birth date, COVID-19 diagnosis date, COVID-19 symptom onset date, height, weight, smoking history, quarantine site during acute COVID-19 infection, oxygen treatment history including ventilator usage, extracorporeal membrane oxygenation (ECMO), dialysis at the time of hospitalization, intensive care unit admission history, COVID-19 vaccination history, underlying diseases, symptoms or diseases newly identified after COVID-19 infection, hospitalization history after acute COVID-19 infection, and COVID-19 reinfection history. Disease severity during acute COVID-19 infection was classified into five categories ranging from asymptomatic to critical illness. Clinical data, including symptoms and disease severity during acute COVID-19 infection, was confirmed using the Daegu Center for Infectious Disease Control and Prevention registry.

Long COVID was defined as having at least one newly identified intermittent or continuous symptom 3months after the initial SARS-CoV-2 infection, lasting for at least 2months, with no other explanation23. Vaccination was considered complete in patients after at least (a) 2weeks after receiving the second dose in a two-dose COVID-19 vaccine series or (b) 2weeks after receiving a single dose COVID-19 vaccine.

The study investigated the clinical characteristics of long COVID and the impact of vaccination on long COVID symptoms, focusing on quality of life and mental health using several scales. These included the EuroQol 5-dimension 5-level (EQ5D) tool, Korean version of the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the Post-Traumatic Stress Disorder (PTSD) Checklist-5-Korean version (PCL-5-K) scores. The EQ5D score comprises five categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each category has five levels to indicate the severity of problems (none, slight, moderate, severe, and extreme). Respondents indicated their health status by selecting the most appropriate statement for each category. The scores for the five categories were then combined to form a five-digit number representing the respondents health status24. PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring the severity of depression. PHQ-9 scores were rated using a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total score can range from 0 to 27, with high scores indicating more severe depression. Based on the original validation studies, the total score is then interpreted to represent no (04), mild (59), moderate (1014), moderately severe (1519), or severe (2027) depression. A cutoff score of 10 suggests a possible diagnosis of depressive disorder25. The GAD-7 is a seven-item self-reported instrument with each item scored on a four-point Likert scale indicating symptom frequency, ranging from 0 (not at all) to 3 (nearly every day). Total scores represent none/minimal (05), mild (610), moderate (1115), and severe (>16) anxiety symptoms. The GAD-7 score can range from 0 to 21, with a score10 indicative of generalized anxiety disorder25. The PCL-5-K consists of five, single-factor items scored dichotomously as either yes (1 point) or no (0 points). Higher scores indicate more severe symptoms, and 3 is the cutoff score for significant PTSD26. In addition to using these standardized scales, we also evaluated other changes in lifestyle habits potentially related to long COVID.

Descriptive statistics were used to assess demographic differences. Other categorical and noncategorical variables were compared using Fishers exact test, chi-square test, Students t-test, or MannWhitney U test as appropriate. Clinical characteristics were compared between the symptomatic group and asymptomatic group at 24months following acute COVID-19 infection to identify the factors affecting thedevelopment of long COVID. The frequency of each long COVID symptom was calculated at 6, 12, 18, and 24months following acute COVID-19 infection and shown as a percentage of the respondents. In addition, we conducted univariate analysis to identify the impact of vaccination on long COVID symptoms. The score distributions from PHQ-9, GAD-7, and PCL-5-K scales were compared between 12-month and 24-month timepoints after acute infection to identify the long-term impact of COVID-19 on psychiatric symptoms. The PHQ, GAD-7, and PCL-5-K scores at 12, 18, and 24months after acute COVID-19 infection were analyzed with respect to disease severity, using violin plots to show the distribution and peak of the scores from each scale. Furthermore, Sankey flow diagrams were generated to identify changes in the distribution and interaction of major long COVID symptoms over time. For all tests, differences were considered statistically significant at P<0.05. R Statistics version 4.0.2 was used for all statistical analyses (The R Foundation; https://www.r-project.org).

This study was reviewed and approved by the Institutional Review Board of Kyungpook National University Hospital (approval no.: 202102-003). All methods were performed in accordance with the relevant guidelines and regulations by including a statement in the methods section. All respondents provided digital informed consent before the questionnaire was administered.

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Characteristics of long COVID and the impact of COVID-19 vaccination on long COVID 2 years following COVID-19 ... - Nature.com

Analysis: COVID Vaccine Strongly Effective in Young People – Penn Medicine

January 9, 2024

PHILADELPHIA Children and adolescents who received one of the main COVID-19 vaccines were significantly protected from the illness and showed no increased signs of cardiac complications compared to young people who were not vaccinated, according to a new real-world study led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Childrens Hospital of Philadelphia (CHOP). When the Delta variant rose to prominence, the study showed that vaccinated young people were 98 percent less likely to be infected than their unvaccinated peers, and data indicated that the vaccines effectiveness decline slightly when the Omicron variant became dominant. The paper was published today in Annals of Internal Medicine.

In their analysis of 250,000 patients, with around half of them received at least one dose of the BNT162b2 vaccine (the vaccine produced by a collaboration between Pfizer and BioNTech), the researchersled by Yong Chen, PhD, and Jeffrey Morris, PhD, both professors of Biostatistics at the Perelman School of Medicine, and Christopher Forrest, MD, PhD, a professor of Pediatrics at CHOP and Penncovered the periods in which the Delta and Omicron variants became dominant, in mid-2021 and 2022, respectively.

While previous clinical trials established that the vaccines provided strong protection against infection for children and adolescents, limited evidence of the vaccines performance existed beyond controlled settings. So, the researchers conducted one of the largest "real-world" COVID-19 vaccine studies of children and adolescents in the United States with the assistance of data from electronic health records gleaned from a national network of pediatric medical centers, known as PEDSnet.In so doing, the study provides a picture of the vaccine's effectiveness outside of controlled trial conditions, in the "real world" of visits to pediatricians, family medicine doctors, emergency departments, and more.

Our study has longer follow-up than any previous study, which enabled us to evaluate the real-world, long-term durability of vaccine protection against Delta and Omicron variants, said Chen. Further, it covered a diverse representation of U.S. pediatric populations from primary care, specialty care, emergency department, testing centers, and inpatient settings.

One of the main ideas behind the work, as stated by the studys first authorsQiong Wu, PhD, a postdoctoral research fellow at Penn Medicine and Jiayi Tong, a PhD candidate in Biostatistics at Pennwas to help address under-reporting in vaccine status to give a clearer picture of its effects.

Yet, infection prevention wasnt the studys only area of focus. The researchers also explored potential effects on risk of heart conditions.

We found no indication of increased cardiac risks during either variant phase, said Morris.

During the period of time in which the Delta variant of the SARS-CoV-2 virus emerged and became dominant, the researchers found that adolescents (defined as patients who were 12-to 20-years old) who received the vaccine were approximately 98 percent less likely to be infected or have severe disease compared to those who did not receive it, with no evidence of increased cardiac complications or significant waning infection protection over the subsequent four months.

Vaccination proved strongly protective against the Omicron wave, albeit at a lower magnitude than during Delta. Among adolescents, those who were vaccinated were roughly 86 percent less likely to be infected compared to unvaccinated peers, and their protection against severe illness and ICU admission was similarly high, being approximately 85 and 91 percent less likely, respectively, than the unvaccinated.

Among children, (those who were 5-to-11 years old at the time of vaccination during Omicron), the protection against infection was 74 percent better than unvaccinated peers. Their comparative protection against severe illness and ICU admission stood at 76 and 85 percent, respectively.

During the Omicron wave, the data showed some reduction in effectiveness in the four months following vaccination, while the vaccinated actually had a lower risk of cardiac complications during this time period.

In a follow-up study, the researchers are conducting further work to characterize the direct and indirect impacts of vaccination on outcomes tied to Long COVID, the phenomenon in which symptoms related to the illness linger for months or even years.

Additionally, the researchers believe even longer-term work is needed to better understand how well the vaccines continue to protect their recipients.

Children and adolescents were the last age group to be enrolled in COVID-19 vaccine clinical trials. Although the pandemic has been declared over, the risk of COVID-19 is present throughout U.S. communities, Forrest said. Thus, more information is needed on effectiveness of vaccination delivered to children and adolescents during more recent time periods.

This research was funded, in part, by the National Institutes of Health (OT2HL161847-01, 1R01LM012607, 1R01AI130460, 1R01AG073435, 1R56AG074604, 1R01LM013519, 1R56AG069880, 1R01AG077820, 1U01TR003709) and the Patient-Centered Outcomes Research Institutes Project Program Awards (ME-2019C3-18315 and ME-2018C3-14899).

Penn Medicineis one of the worlds leading academic medical centers, dedicated to the related missions of medical education, biomedical research, excellence in patient care, and community service. The organization consists of theUniversity of Pennsylvania Health System and PennsRaymond and Ruth Perelman School of Medicine, founded in 1765 as the nations first medical school.

The Perelman School of Medicine is consistently among the nation's top recipients of funding from the National Institutes of Health, with $550 million awarded in the 2022 fiscal year. Home to a proud history of firsts in medicine, Penn Medicine teams have pioneered discoveries and innovations that have shaped modern medicine, including recent breakthroughs such as CAR T cell therapy for cancer and the mRNA technology used in COVID-19 vaccines.

The University of Pennsylvania Health Systems patient care facilities stretch from the Susquehanna River in Pennsylvania to the New Jersey shore. These include the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Chester County Hospital, Lancaster General Health, Penn Medicine Princeton Health, and Pennsylvania Hospitalthe nations first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.

Penn Medicine is an $11.1 billion enterprise powered by more than 49,000 talented faculty and staff.

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Analysis: COVID Vaccine Strongly Effective in Young People - Penn Medicine

COVID is way up in Boston-area wastewater, vaccinations urged – Boston.com

January 9, 2024

Health

Boston wastewater data reveals that theres been a concerning spike in COVID-19 cases and medical professionals are urging Bostonians to get vaccinated.

The weekly average of COVID-19 found in wastewater south of Boston was 2,110 copies per milliliter whereas north of Boston was looking at 2,084 copies in the most recent data update. While this isnt a whole lot compared to numbers seen in early 2021, there still is a marked increase from the early November data.

The Department of Public Health reported there were 5,955 confirmed cases of COVID-19 last week, a marked increase from the 2,121 new cases in a week in early November.

The physicians of the Massachusetts Medical Society are seeing a concerning and marked rise in cases of influenza and COVID-19 among out patients, said Barbara Spivak, the president of the Massachusetts Medical Society to The Boston Herald. It is not too late in the season to get vaccinated against the flu and to get the most updated COVID-19 vaccines, and we urge people to contact their health care provider to schedule an appointment to do so as soon as possible.

According to the website COVID Act Now, the Boston area has a medium level of COVID threat with an increase in cases and people admitted to the hospital, according to the websites data.

Transmissible diseases may be a nuisance over the course of a few days and not trigger serious symptoms in most healthy people, but it is critically important to take every available measure to protect those among us who are most vulnerable, said Spivak.

Masks are being urged by local businesses and community hubs, with Boston hospitals renewing their mask policy before the end of 2023.

A location to find a COVID-19 booster or vaccination can be searched here.

According to USAFacts, 95% of Bostons population has received at least one dose of the COVID-19 vaccine. 84% are fully vaccinated as of May 2023 and 44% have received the full dosage of the vaccine and a booster.

Stay up to date on all the latest news from Boston.com

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COVID is way up in Boston-area wastewater, vaccinations urged - Boston.com

Moderna Stock Is Rising. Sales Fell a Bit Less Than Expected in 2023. – Barron’s

January 9, 2024

Moderna on Monday said 2023 product sales hit $6.7 billion, slightly above the companys latest guidance for at least $6 billion, down 63.6% from 2022. Sales for 2023 also beat the consensus estimate for $6.3 billion, according to FactSet.

The announcement, which came ahead of a presentation by Moderna executives at J.P. Morgans annual healthcare conference scheduled for Monday afternoon, largely repeated guidance that the company laid out in early November.

Moderna said its Covid-19 vaccine sales were $6.1 billion for the year. The balance of the product sales consisted of about $600 million the company said it received as deferred revenue related to its supply agreements with GAVI, The Vaccine Alliance, an international nongovernmental organization that provided Covid-19 vaccines to low- and middle-income countries.

Moderna said it had cash, cash equivalents, and investments of more than $13 billion at the end of 2023, up from $12.8 billion as of Sept. 30, 2023.

The company also said its Covid-19 vaccine has had 48% of the U.S. market share in the current winter season so far, up from 37% in 2022, a sign of commercial success in a shrinking market competitor Pfizer .

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Moderna stock jumped 1.2% on Monday. Moderna shares have suffered a steep selloff since mid-2021, amid declining investor expectations around the long-term value of its Covid-19 vaccine, but the stock has been climbing in recent months, and is up 49.1% since the start of November.

Moderna said again on Monday that it expects revenue to drop again to just $4 billion in 2024, for sales to begin to grow again in 2025, and for the company to break even in 2026.

The company continues to expect regulatory approvals for its respiratory syncytial virus vaccine for older adults to begin in the first half of this year. That shot will compete with similar products from GSK and Pfizer , though Moderna says that it believes its shot will be more convenient for providers.

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Moderna also expects data from a Phase 3 study of a new refrigerator-stable Covid-19 vaccine in the first half of the year, and data from a Phase 3 study of a vaccine that protects against both flu and Covid-19.

We are preparing for the launch of Modernas second product, our RSV vaccine. 2024 is going to be an exciting year for the Company with multiple milestones across our nine late-stage programs, Moderna CEO Stphane Bancel said in a statement. Through these product launches, we are focused on returning to sales growth in 2025.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Moderna Stock Is Rising. Sales Fell a Bit Less Than Expected in 2023. - Barron's

Moderna Covid vaccine sales plunge by two-thirds in 2023, but meet company’s $6 billion forecast – CNBC

January 9, 2024

Moderna's announcement, which came ahead of its presentation at the annual JPMorgan Healthcare Conference, shows the steep drop in demand for Covid products last year as cases and public concern about the virus dwindled from their pandemic peaks. Weakening demand for the company's shot, its only commercially available product, led shares of Moderna to fall nearly 45% last year.

Roughly $6.1 billion of Moderna's revenue related to the shot came from sales of the vaccine. Another $600 million was deferred revenue related to the company's work with Gavi, a nongovernmental global vaccine organization that coordinated a global shot distribution program, Moderna said in a release.

Moderna, during its third-quarter earnings report in November, forecast at least $6 billion in full-year Covid vaccine sales, but did not provide a range for that guidance. Notably, that forecast did not include contributions from Gavi, Moderna CFO Jamey Mock told CNBC during an interview.

In August, before the rollout of its latest version of the jab, the company said it expected the shot to rake in between $6 billion and $8 billion in revenue.

The company noted that the vaccine won 48% of the U.S. Covid vaccine market share last year. That's up from the 37% market it captured in 2022.

The size of the U.S. market for Covid shots in 2023 is likely around 40 million and 60 million doses during the fall and winter season, which is consistent with what the nation saw in 2022, according to Mock.

But the biotech company expects sales from the shot to drop even further in 2024. It reiterated its companywide full-year sales guidance of roughly $4 billion on Monday. Notably, that forecast includes revenue from its vaccine against respiratory syncytial virus, or RSV, which could win U.S. Food and Drug Administration approval in April.

Moderna said it expects to return to sales growth in 2025 with the launch of new products. The company currently has 45 products in development, nine of which are in late-stage trials. They include Moderna's combination shot targeting Covid and the flu, which could win approval as early as 2025.

Mock said combination vaccines should be "very helpful" in terms of providing more convenience to patients and health-care providers and reducing the costs of goods sold, among other factors, which might have a positive impact on Covid vaccination rates overall.

The company said it expects to "break even" by 2026.

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Moderna Covid vaccine sales plunge by two-thirds in 2023, but meet company's $6 billion forecast - CNBC

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