Category: Covid-19 Vaccine

White House issues warning on new COVID variants

The Biden administration is calling on people to exercise caution about COVID-19, emphasizing the importance of getting booster shots for those who are eligible and wearing masks indoors as two new transmissible variants are spreading rapidly. (July 12)

AP

COVID-19 isonce again surging around the country, asBA.4 and BA.5, two highly infectioussubvariants of omicron, are responsible for a majority of new cases.

Currently, only adults ages 50 and older and a few younger groupsmoderately or severely immunocompromised are eligible to receive a second booster. But what about everyone else?

Here's what the Centers for Disease Control and Prevention recommends as we face the latest variant of COVID-19.

COVID-19: Is my at-home test still good? What you need to know

CDC upgrades COVID-19 level to 'high': Indoor masking recommended in 8 Greater Cincinnati counties

BA.5 may be the most infectious strain of COVID-19 to date, according to Yale Medicine.

The CDC's COVID-19 data tracker Nowcast estimates circulating variants, and it is updated every Tuesday. According to the most recent update, the BA.5 variant currently makes up around 81.9% of cases, while the BA.4 variant is responsible for 12.9%.

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The CDC's tracking map shows that in the Midwest, which includes Ohio, BA.5 is responsible for 83.4% of cases and BA.4 is responsible for 11.3%.

The CDC currentlyrecommends for anyone ages 5 and older to get one booster after completing their primary COVID-19 vaccine series.

Adults ages 50 and older and some people ages 12 and older who are moderately or severely immunocompromised are recommended to get a second booster, and have been able to get one since March.

Here's which vaccines are authorized for a first or second booster dose, and for whom:

Novavax is currently not authorized to be used as a booster.

In June, members of the Food and Drug Administration's advisory panel voted to reformulate COVID-19 booster shots for the fall to more directly target the omicron variant.

No final decision has been made yet about boosters for people younger than 50. The Biden administration and federal officials are still deciding whether to recommend a second booster shot for people under 50 before the fall, when the redesigned boosters that target omicron will probably be available for distribution.

The CDC does not recommend mixing vaccines for the primary series for example, you shouldn't get Pfizer as a first dose and Moderna as a second but people 18 and older can get a different vaccine as a booster.

Children and teens ages 5 to 17 who got Pfizer as their primary vaccine must get a Pfizer booster, the CDC says.

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COVID-19: Do you need a second vaccine booster? What to know. - The Cincinnati Enquirer

A coalition of advocacy groups on Tuesday implored U.S. President Joe Biden not to give control of emerging, publicly funded coronavirus vaccine technology to profit-seeking corporations, warning such a move would double down on a privatized approach that has failed to ensure equitable vaccine access worldwide.

Released ahead of the White House's Summit on the Future of Covid-19 Vaccines that kicked off Tuesday morning, a new open letter signed by 29 progressive organizations argues "there is no compelling reason to offer this technology on a monopoly basis to a corporation, and a profoundly compelling reason to make the technology as open and readily accessible as possible across the globe."

"It is crucial that we learn from earlier mistakes in managing publicly funded vaccine technology."

The technology in question is the so-called pan-coronavirus vaccine that the U.S. Army's Walter Reed Institute of Research has been developing and testing in recent months.

Dubbed a potential "super vaccine," the Walter Reed shot is aimed at providing protection against all current and future strains of Covid-19 as well as other coronaviruses. The vaccine has reportedly yielded promising results in early trials.

The advocacy coalitionwhich includes Public Citizen, Physicians for Human Rights, Health GAP, and the Revolving Door Projectwrote in their letter Tuesday that the Biden administration must "maintain public control of the Walter Reed vaccine and share its benefits and technology openly with the world."

Such a strategy would contrast sharply with the current, deeply unequal coronavirus vaccination effort, which is dominated by a handful of pharmaceutical corporations that are reaping huge profits.

Even though they received massive sums of federal funding and made use of government technology to develop their shots, companies such as Pfizer and Moderna have monopoly control over vaccine production, artificially constraining supply as billions of people around the world go without access to the lifesaving shots more than two years into the pandemic.

"The public investments in coronavirus research, dating back nearly two decades and including the period after the origin of Covid-19, helped spur amazing inventions that have saved millions of lives," the new letter notes. "However, private, monopoly control over those vaccines contributed to shortages, rationing, and excessive prices. It is crucial that we learn from earlier mistakes in managing publicly funded vaccine technology."

"To date, development of the Walter Reed vaccine has been a triumph of government investment in public health," the letter continues. "We ask for it to remain that way as the Army seeks partners for further trials and mass production."

Peter Maybarduk, director of the Access to Medicines program at Public Citizen, said Tuesday that "the first task in preparing for the future of Covid vaccines is learning from the calamitous past, including the failure to share vaccines early in the pandemic and equip the world against the virus."

"The White House has the power and responsibility to ensure publicly-developed Covid technologies are made available to everyone, everywhere," Maybarduk added.

Revolving Door Project senior researcher Timi Iwayemi agreed, pointing out that "current production and distribution agreements have empowered corporations while limiting the promise of lifesaving coronavirus vaccines."

"Continuing down a path that restricts widespread manufacturing and distribution of Covid vaccines," Iwayemi said, "would lead to unnecessary deaths and easier opportunities for the virus to mutate."

In a column for The American Prospect earlier this year, Iwayemi observed that "so far, development of the [Walter Reed] vaccine has been a public triumph."

"But this next phase is where the pharmaceutical industry can get in on a vaccine developed by and for the public," Iwayemi cautioned. "To protect the broader public, governments must adopt an open system that will support smooth transfer of vital technologies globally. This would mean choosing public funding, open-source research, and transparent nonexclusive licensing contracts over restrictive government-granted monopolies."

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Biden Told Not to Give Publicly Owned Covid-19 Vaccine Tech Over to Corporations - Common Dreams

The U.S. Centers for Disease Control and Prevention(CDC)has endorsedNovavaxs two-doseCOVID-19 vaccine as another COVID-19 vaccine primaryseries option for adults ages 18 and older, following its Advisory Committee on Immunization Practices (ACIP) recommendation and the U.S. Food and Drug Administrations emergency use authorization (EUA).

Now Louisianans have a fourth option when it comes to the COVID-19 vaccine, one that uses a more traditional, familiar vaccine technology.Unlike the mRNA vaccines developed by Pfizer-BioNTech and Moderna, the Novavax vaccine is a protein-based shot. Protein-based vaccines have been used for decades to combat diseases including Hepatitis B and influenza.

"We welcome this news from CDC.Now, residentshave even more options to keep themselves and their families safeagainst severe complications fromCOVID-19, which continues to surge in Louisiana," said State Health Officer Dr. Joseph Kanter. "If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millionsofLouisiananswho have been vaccinated."

LDH has notified all healthcare providers that this guidance is effective immediately, and they can start ordering the vaccine now. The Novavax vaccine is expected to become available in the coming weeks.

Both CDC and LDH recommend that everyone ages 6 months and up get vaccinated against COVID-19 and that everyone ages 5 and up get a booster as soon as they are eligible.

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CDC recommends Novavaxs COVID-19 vaccine for adults ages 18 and older | La Dept. - Louisiana Department of Health - Louisiana.gov

COVID19 vaccine effectiveness against hospitalization due to SARSCoV2: A testnegative design study based on Severe Acute Respiratory Infection (SARI) sentinel surveillance in Spain  Wiley

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COVID19 vaccine effectiveness against hospitalization due to SARSCoV2: A testnegative design study based on Severe Acute Respiratory Infection (SARI)...

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The Impact of the COVID-19 Vaccine on Spread of Disease - Contemporary Pediatrics

Period of engagement: Consultant will work on average 20 hours per/week for 12 to 20 weeks.

Project Description/Background:

The INGO COVID-19 Vaccine Collaborative is a group of six organizations (CARE, Catholic Relief Services, International Rescue Committee, Mercy Corps, Save the Children, and World Vision) working together to advocate for and implement programming related to equitable COVID-19 Vaccine uptake. One major undertaking by the collaborative has been to develop a COVID-19 Vaccine Information and Response Dashboard which presents the work done by both local and international NGOs, while providing greater insight into what is happening in countries utilizing a unique viewpoint that only these organizations can provide. This mapping exercise will help large international donors better direct resources to address the issues which are most impacting communities.

Description of Services:

The consultant will be responsible for collecting and organizing data utilizing pre-written surveys and informal interviews to input into the dashboard. This individual will work closely with all members of the Collaborative and other international and national NGOs to gather information, focusing primarily on the 18 countries that have been prioritized by GAVI and other countries where the Collaborative is working. The consultant will contact and interview an initial set of contacts from collaborative members and may also collect input from other local NGOs as necessary. The countries are list in the full SOW here. Note that the country list may expand or contract.

The consultant will display strong interview and data collection skills to gather information about the work done in these priority countries by as many NGOs in each country as possible. They will also document observations by the Country Offices and work with the Dashboard team to craft succinct and effective narratives detailing the barriers to vaccination, and how these INGOs are well placed to address the barriers.

Deliverables and Timeline:

By October 31, the consultant will have completed the following:

Qualifications:

The successful consultant will have the following qualifications:

Management of Consultancy:

The consultants technical work will be managed by Jeanne Koepsell, Senior Advisor, Digital Health and Community Case Management. All operational aspects will be managed by Daniel Sweeney, Sr. Administrator, Program Operations.

Submit your resume detailing your relevant qualifications and proposed daily rate to Daniel Sweeney (dsweeney@savechildren.org) by Friday, August 5.

Visit link:

INGO Collaborative COVID-19 Vaccine Information and Response Data Collection - ReliefWeb

As the United States clamors with anti-vax protests, researchers seek to understand what social and behavioral values are keeping patients from electing to vaccinate themselves against the coronavirus disease 2019 (COVID-19) virus. Over the past year, the race to vaccinate has become less about developing working vaccines and more about finding ways to encourage vaccine uptake.This paper examines the question of vaccine hesitancy in rural Chemung County, NY. In identifying various psychosocial barriers to patient vaccination, which we hypothesize will be mostly political, we seek to understand the local mindset in the hopethat our data guidethe way to change it.

The SARS-CoV-2 virus that resulted in the coronavirus disease 2019 (COVID-19) pandemic was first detected in Wuhan, China, in December 2019.This novel coronavirus spread rapidly around the world, and in March 2020, the World Health Organization (WHO) declared COVID-19 a worldwide pandemic [1]. Current statistics show over 520 million cases worldwide, with more than six million deaths as of May2022 [2].

Since the first case of COVID-19 emerged over a year ago, the extent of its consequences has been devastating in many ways. The global health, social, and economic effects of this pandemic will be felt for years to come. Before the production of efficacious vaccines, efforts to prevent the spread of COVID-19 relied heavily on social distancing, self-isolation, hand hygiene, mask mandates, travel restrictions, and widespread testing.

As vaccines became available between December 2020 and March 2021, the next step in preventing the spread of COVID-19 became mass vaccination to reach herd immunity, which is defined as a high enough vaccination percentage within the community to prevent the massive spread ofdisease [3,4]. Vaccines available and deemed effective by the Centers for Disease Control and Prevention (CDC) are Johnson & Johnson, Moderna, and Pfizer [5]. Over 11 billion vaccine doses have been given worldwide; however, in Chemung County, NY, where this study was conducted, the vaccination rate is only 58.99% [6].

Vaccine hesitancy is defined as a motivational state of being conflicted about the effects or safety of a certain vaccine or being opposed to vaccination in general [7]. Vaccine hesitancy is not a single entity; it lies between complete acceptance and refusal of all vaccines. Within the context of this pandemic, the term anti-vaxer may apply only to the COVID-19 vaccine rather than as a blanket term for those who refuse all vaccines. In researching the reasoning of the unvaccinated, our terminology must expand with our understanding of their personal barriers [1,8].

The dilemma of COVID-19 vaccine hesitancy is multifactorial and comprises many barriers. Of primary concern is the politicization of vaccine uptake and a growing sense of distrust in the government and mainstream medias representation of health facts on the news [9]. Additional factors include whether to trust the vaccine or the provider of the vaccine. Dror et al. found that geopolitical concerns over the vaccine's country of origin were likely to impact the uptake of the vaccine globally [10].Moreover, the concerns of Americans include factors such as the speed of the vaccines development, its components, efficacy, the rigor of testing, and its potential for causing long-term adverse effects [9]. Many patients also struggle to understand the value of the vaccineand they lack convenient access to it [11].

Many employers under the guidance of New York State, especially within health care, have introduced vaccination mandates for employees to reduce the burden of COVID-19 among healthcare workers. These mandates were an ultimatum: be vaccinated or be unemployed. In many places, mandates were met with hostility and a mass exodus of healthcare workers who stated similar reasons for vaccine distrust as listed above. In rural New York, where our study was conducted, the medical center lost 80 employees to vaccine mandates. Some employees resigned voluntarily before the deadline due to disagreement with the mandate, and those who refused to be vaccinated by the deadline were terminated. These individuals were willing to risk their financial security rather than receive the vaccine, believing that the act of a mandate inherently violates the principle of their autonomy [12]. New York State was dumbfounded by the negative response to these mandates, namely, severe staffing shortages, and in February 2022, decided that despite the original intent of its mandate, the state would not be enforcing the mandate regarding booster shots [13]. This decision was not based on health data but rather a response to social behaviors that dictated the necessity of removing a mandate to staff hospitals amidst the crisis of a pandemic, further illustrating the complexity of questions and problems regarding the vaccination of American citizens. More data on the consequences of vaccination mandates on the attitudes of employees will be required to understand the impact of the concept on global health and the economy in other democratic states.

Anti-vaccine attitudes and beliefs that pre-date the COVID-19 pandemic pose another significant barrier to vaccine uptake along with a pervasive lack of trust in pharmaceutical companies and government agencies such as the CDC. People with conservative political beliefs, residence in non-metropolitan areas, and recent refusal of the seasonal influenza vaccine are other major factors and obstacles to COVID-19 vaccine uptake [7].

Public health awareness about the risks of COVID-19 and the benefits of vaccination needs to be communicated in ways that are easily accessible and understandable within the community [14]. This study is valuable as a means to decipher which types and routes of communication may be useful in targeting the vaccination rate in rural America.

This study received IRB exemption and was approved by Arnot Healths System Review Board and Privacy Committee.

Conducted in November 2021, this study is cross-sectional in nature. A self-administered electronic SurveyMonkey questionnaire, included in the Appendix, was sent via e-mail three times over the course of a two-week period.Each group of emails was sent to the same 1243 patient body to increase the response rate. All patients utilized for this survey had verified emails in the clinics electronic medical record. No patient identifying information other than age, gender, and race/ethnicity was recorded. The study targeted patients aged 18 years and above who visited the Eastside Primary Care Clinic in Elmira, NY, between 06/01/2021 and 10/01/2021.

The questionnaire was designed and developed specifically for this study, utilizing only questions deemed necessary for establishing the demographics of the patient base and their opinions regarding vaccination. Participants were briefly informed about the objective of the study and the handling of their personal information. Two research experts independently reviewed and validated the questionnaire, and the final version consisted of three domains: socio-demographic variables, beliefs toward COVID-19 vaccination, and potential barriers that may prevent participants from choosing vaccination. Respondents who refused to get the vaccine underwent further analysis within the questionnaire. These questions consisted of both answer choices about their possible reasons for refusal and a free-form response box. Free-form responses were analyzed individually.

Analysis of all responses was conducted with SurveyMonkey (Momentive Inc., San Mateo, CA) and Microsoft Excel (Microsoft Corporation, Redmond, WA).

A total of 118 responses were collected from 1243 patients surveyed, yielding a 10% response rate. Of patients,79% indicated previous acceptance of the vaccine, and 21% indicated that they were not willing to take a COVID-19 vaccine. Of the cohort of 25 individuals indicating they were unwilling to accept a vaccine, 80% were women and 20% were men. Of patients, 60% belonged to the age group of 31-50 years, and 88% were White Americans. A total of 72% had been offered COVID-19 vaccination but refused it, and 28% reported not having been offered vaccination. See Table 1for the breakdown of respondents by demographics.

When asked to explain their reservations about the vaccine, 23% of respondents said that they feared the vaccine was not safe, 18% were concerned about a lack of long-term safety data, 9% feared potential side effects, 32% disagreed with mandating the vaccine, and 18% believed that the vaccine is not effective. This question, shown in Figure 1, was conducted via choosing the most important reason for vaccine refusal, but patients also had the option to leave comments to elaborate on their choices.

Figure 2 outlines a question about additional information that could be offered to help patients make the decision to get vaccinated, and within the question, they could select any and all options that they felt applied to their opinion. The box labeled, "no amount of information will change my mind" was selected 16 times. "Long-term safety data" was selected 10 times. "More educational materials" was selected three times, and "further discussion from a health professional" was selected twice.

The free-form responses indicated other lesser reasons for refusing vaccination including pushback against the existence of mandates, concerns that mRNA-based vaccines confront religious beliefs, and personal experiences that they believed to outweigh any clinical data on the subject. One patient responded that she had been hospitalized for COVID-19 and recovered without lasting effects and would like to see a vaccine that lasts longer than a year. Another respondent stated, whether you receive the vaccine or not, you can still catch COVID!

Additionally, five patients refused to fill out the survey but emailed us back instead with their negative responses toward the COVID-19 vaccine.

The most cited reason for not getting vaccinated regarded distrust toward the government andgovernmental policy on COVID-19. In addition, fear about adverse reactions and the rapid vaccination approval process were related to hesitancy regarding vaccination, which is consistent with previous studies. In a report released by the World Health Organization (WHO), congruous, transparent, compassionate, and proactive communication about vaccines was cited to help build trust in COVID-19 vaccines [14]. Avenues such as those discussed in the report may be of benefit to this population of patients with specific fears about the components of the vaccines and their long-term safety.

The key reasons for vaccine refusal in this population were as expected: patients were concerned about the lack of long-term safety data, indignant atmandates, and bothered by the apparent influence of the political sphere on the vaccines creation and distribution, a consistent finding within the literature search [8].

The most striking finding of this study was that 66% of unvaccinated respondents said that no amount of information would change their minds about receiving a vaccine, while the remaining participants suggested that more data about long-term safety and provider recommendations could convince them to get vaccinated. A closer examination of these responses indicated pervasive mistrust of the system, which ultimately thwarts the desired outcome of this study: education and increased vaccination rates. It is much easier to collect data and educate a population about the benefits of vaccination than it is to sway the conviction of an individual firm in the belief that taking a vaccine violates his basic rights to autonomy and beneficence. In community settings where these convicted individuals abound, herd immunity becomes less an attainable reality than it is a "pipe dream" of improbability.

This project contains important limitations. With responses from only 118 individuals, of which just 25 were unvaccinated, the small sample size prevents the extrapolation of the data to a larger population. Additionally, several non-vaccinated patients were offended at the mere mention of COVID-19 and chose not to participate in the survey, further limiting responses within the target demographic. While the questionnaire used was validated by an internal team, it was novel and designed solely for the purpose of this study, which limits theability to compare itto other studies of this type. The questionnaire was also self-administered, and some patients chose to skip questions, which narrows the response rate for portions of the survey and provokes questions about the reliability of self-administered patient surveys.

The data clearly showed that for one-third of patients, education and personal recommendations from physicians may be enough to convince them to vaccinate, but for the remaining two-thirds of patients vehemently committed against vaccination for personal and political reasons, simple education measures may not be enough to change minds. The questions then become, how do we remove the politicalized stigma of the COVID-19 vaccine, and is non-partisan marketing enough? Where appeals to ethos and pathos have failed, what ultimately motivates the individual to set aside his convictions? Given the rates of unemployment and severe understaffing in health institutions, mandates were not the answer to this question; thus, more studies on a sociological-economic level will need to be completed to answer these questions.

Meanwhile, providers should broach the subject of vaccination with their patients armed with the most current research and a willingness to appeal to what motivates patients on an individual basis. This recommendation requires more of a grassroots effort than can be accomplished with wide-reaching advertisements ontelevision or social media marketing, but it may prove to be a local solution to a local problem.

You are invited to participate in a research study about COVID-19 VACCINE barriers. If you have a moment to spare, please fill out this short survey. It will take less than a minute. The goal of this research study is to identify the barriers and the ways to encourage people to get vaccinated. Wed greatly appreciate your feedback.

This study is being conducted by Dr. Richard Terry, Dr. Aeman Asrar, and Samantha Lavertue (medical student).

Patients who had been to Eastside Primary Care Clinic between 06/01/2021 and 10/01/2021 and 18 years or older qualify to participate in the study.

Participation in this study is voluntary. If you agree to participate in this study, you would be asked to answer some simple questions via an online survey (attached below) about your vaccination status. If you chose not to be vaccinated, we would ask you some questions about why you decided not to receive the vaccine.

Participating in this study will help us learn about attitudes toward COVID vaccination in our community. The questions we would ask you about the decisionto not be vaccinated are the sorts of things you might discuss with family or friends.

The information you will share with us if you participate in this study will be kept completely confidential to the full extent of the law. The answers you give to any questions are completely anonymous and will not affect in any way the care you receive.

We will be using SurveyMonkey to administer the surveys. SurveyMonkey will not record your computers IP numbers and no patient identifying information other than age and gender will be recorded. Again, your answers will be kept completely anonymous.

If you have any questions about this study, please contact Dr. Aeman Asrar at [emailprotected]

By completing this survey, you are consenting to participate in this study.

We thank you for devoting one minute of your time.

Gender:

* Male

* Female

Age:

* 18-30 years

* 31-50 years

* 51-64 years

* 65+ years

Ethnicity:

* White American

* African American

* Asian

* Hispanic

* Other

* Prefer not to answer

1. Were you offered COVID-19 vaccination?

a. Yes

b. No

If you answered NO to this question, you have completed the survey and do not need to answer any further questions.

2. Did you receive COVID-19 vaccine?

a. Yes

b. No

If you answered YES to this question, you have completed the survey and do not need to answer any further questions.

3. If you were offered vaccination but decided not to get it, please tell us the reason for this decision.

a. Fear that vaccine is not safe because of its rapid development

b. Lack of long-term safety data

c. Fear of potential side effects

d. Personal reasons (disagree with any mandate)

e. I believe the vaccine is not effective

f. Other (please describe) ___________________________

4. What information would you want to receive to help you make the decision to get vaccinated?

a. Long-term safety data

b. More educational material

c. Further discussion from a health professional

d. No amount of information will change my mind

5. Where have you received information about the COVID vaccine? (Check as many as applicable)

a. Print media

b. Broadcast media (television and radio)

c. Internet

d. Word of mouth

6. Do you believe that approved/authorized vaccines are effective at preventing COVID-19?

a. Yes, in most cases

b. No, I don't believe so

c. Yes, but may dependon general health status

7. What strategies do you follow to protect yourself from COVID-19?

a. Wash your hands often with plain soap and water

b. Cover your mouth and nose with a mask when around others

c. Avoid large gatherings and practice social distancing (stay at least six feet apart from others)

d. Nothing

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COVID-19 Vaccine Hesitancy in a Rural Primary Care Setting - Cureus

Few serious side effects have been reported from the administration of the various new vaccines that were developed during the coronavirus pandemic [1]. However, vaccine-induced thrombotic thrombocytopenia (VITT) is a very rare prothrombotic syndrome that has been reported in some patients after receiving coronavirus vaccination with the adenovirus vector-based vaccines: AstraZeneca (ChAdOx1 nCoV-19) and Johnson and Johnson (Ad26.COV2.S) [2].

VITT is a thrombotic syndrome that involves the development of immunoglobulin G (IgG) antibodies that bind to the Fc portion of the IgG receptor on platelet factor-4 (PF4). Platelet activation occurs upon binding, a phenomenon similar to heparin-induced thrombocytopenia (HIT). The immunopathology of VITT differs from HIT since the antibodies bind to a different epitope on PF4, and VITT is not dependent on exposure to heparin products. The mechanism in which VITT causes antibody formation is still unclear. Some theories suggest vaccine components may generate a neoantigen when bound to PF4 [2]. VITT is a very rare complication of the adenoviral-vector-based COVID-19 vaccines, with the CDC estimating an incidence of 1 in 533,333 [3].

In this report, we present a case of VITT in an adult female with no previous medical issues.

A 37-year-old female with no previous health conditions presented to the ED with an 11-day history of headachez following vaccination with the Johnson and Johnson COVID-19 adenovirus-based vaccine. The headache was localized to the bi-temporal region, was constant in nature, and had been progressively worsening since the time of vaccination. The patient had a past surgical history of cholecystectomy and Cesarean section. She had no known medical conditions and was a current cigarette smoker with a 10-pack-year history. The patient reported a positive history of blood clots in her sister and mother, with no known diagnoses of hereditary coagulopathies. Vital signs on arrival were within the normal limits: temperature of 98.1, heart rate of 72 beats per minute, blood pressure of 114/78 mmHg, and oxygen saturation of 96% on room air. Labs in the ED were significant for thrombocytopenia, with a platelet count of 22,000. Other pertinent lab values include an elevated C-reactive protein (CRP) of 3.19 mg/dL. -HCG was negative, and urinalysis showed no evidence of urinary tract infection. At the time of presentation, the patient had no signs of active internal bleeding, petechiae, purpura, or ecchymosis. Physical examination was unremarkable, although the patient appeared to be in significant distress because of the headache. A non-contrast CT scan of the head was ordered and showed no acute abnormalities. A chest X-ray was also performed and demonstrated no acute cardiopulmonary disease. The COVID-19 rapid antigen test was positive, and a polymerase chain reaction (PCR) test was ordered. A full respiratory serology panel was performed and was negative. The patient received a 500 mL bolus of sodium chloride, 30 mg of IV ketorolac, and 10 mg of IV dexamethasoneand was admitted to the general medical floor for observation and management of thrombocytopenia.

On day 1 of hospitalization, the patient woke up with sudden excruciating right lower extremity pain. At this time, she was diaphoretic, tachycardic, and flushed. The pain was associated with numbness, tingling, and decreased sensation around the right ankle with preserved motor function. The dorsal pedal, posterior tibial, and popliteal pulses were non-palpable and non-Dopplerable. Labs showed a high d-dimer level of 6.01 (normal 0.19-0.5), a low platelet count of 20,000, and an elevated immature platelet fraction of 14.3%. Fibrinogen was normal at 217, and coagulation studies, including prothrombin time (PT), partial thromboplastin time (PTT), and International Normalized Ratio (INR), were within the normal limits. CRP was elevated at 2.67, and procalcitonin was normal at 0.06 ng/mL. Venous duplex ultrasound of the right lower extremity showed no evidence of deep vein thrombosis. A computed tomography angiography (CTA) scan of the abdominal aorta with runoff was ordered and showed a right common femoral artery embolus extending into the origin of the superficial femoral and profunda artery, a left distal popliteal trifurcation embolism with segmental occlusion, a small pulmonary embolism in the right lower lobe, and a mural thrombus of soft plaque in the anterior wall of the infrarenal abdominal aorta (Figures 1-3). The patient was not a candidate for thrombolysis due to thrombocytopenia, so an open thrombectomy of the right common and superficial femoral arteries was done with an embolectomy catheter. Post-operatively, the patient received anticoagulation with argatroban.

Following the procedure, the patients platelet count had decreased to 12,000, the WBC was elevated at 12,400, hemoglobin (Hb) was low at 11.6, and PTT was increased to 39.9. She was admitted to the ICU and was started on 10 mg IV dexamethasone Q6H for four days. The COVID-19 PCR test came back negative, confirming a false-positive rapid antigen test. Pathology was consulted to examine a peripheral blood smear, which showed normal platelet morphology with a decrease in the number of platelets. The pathologist suggested that this may be secondary to peripheral consumption and SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia. The patients serum was tested for heparin-platelet factor 4 (heparin-PF4) antibodies. Heparin-PF4 antibody enzyme-linked immunosorbent assay (ELISA) was positive with 100% heparin-PF4 antibody inhibition and an optical density of 2.265. Hematology was consulted and suggested that thrombosis is related to a HIT-like mechanism, even without known exposure to heparin products. This was concluded by cases in the literature that showed immune-induced thrombocytopenia with vascular thrombotic events after COVID-19 vaccination, mostly after receiving the AstraZeneca vaccine. It was recommended that low-weight molecular heparin and platelet transfusions should be avoided to prevent worsening thrombosis. Hematology requested that the patient be started on IV immunoglobulin (IVIG) for two days if there was worsening thrombocytopenia or any signs of bleeding.

On hospital day two, morning labs showed that the platelet count dropped to 8000. The patient received her first day of IVIG. WBC count at this time increased to 14,300. Immature platelet fraction had increased to 19.6%, and PTT increased to 41.4. At this time, hematology suggested that platelet transfusions should be withheld unless active bleeding is present. Venous duplex ultrasound of the unaffected left leg was taken and showed no evidence ofdeep vein thrombosis (DVT). Venous duplex ultrasounds of the bilateral upper extremities showed acute DVT in the left brachial vein. MRI of the brain showed no evidence of acute infarct, parenchymal hemorrhage, cerebral edema, or cerebellar tonsillar ectopia. Magnetic resonance angiogram (MRA) showed no significant stenosis of the major intracranial arteries and did not identify any medium or large-sized aneurysms. Magnetic resonance venography (MRV) showed no evidence of dural venous thrombosis. CT scan of the brain and head with contrast showed no evidence of dural venous sinus or cavernous sinus thrombosis and no acute intracranial hemorrhage or mass effect. Repeat afternoon labs showed some improvement in platelet count, rising to 14,000. WBC count at this time continued to trend upward to 16,200. Immature platelet fraction increased to 21.6%. Coagulation studies showed prolonged PT of 16.3 and PTT of 45. Other lab abnormalities include low fibrinogen of 135 and an elevated aspartate aminotransferase (AST) of 123.

On hospital day three, the platelet count continued to trend upwards to 20,000, WBC count remained stable at 14,500, Hb was low at 10.3, immature platelet fraction remained stable at 22.3%, PTT remained stable at 44.5, and AST was high but trending downwards to 105. The head CT scan showed no evidence of dural venous sinus or cavernous sinus thrombosis and no acute intracranial hemorrhage. The patient received day two of IVIG.

On hospital day four, the platelet count increased to 47,000. The WBC count trended downwards to 13,100. Hb remained low but stable at 10, PT remained elevated but stable at 24.3, PTT was high but stable at 50, and AST continued to trend down to 69.

On hospital day five, the platelet count improved to 101,000. WBCs trended down to 12,200, Hb was 10.4, PTT was 48.4, and AST was 42, trending towards normal. The patient was discontinued on argatroban and started on oral apixaban 10 mg two times a day (BID) every 12 hours (Q12H) for seven days. The dexamethasone changed from IV to 10 mg per os (PO) today, and she was transferred from the ICU to the medical floor. Pathology confirmed that the content analyzed from the femoral arteries was consistent with a thrombus.

On hospital day six, the platelet count improved to 143,000. WBC count was elevated at 17,500, Hb increased to 11.7, and AST trended down to 52. Dexamethasone was tapered to 10 mg BID, then discontinued upon discharge. The patient was told to decrease the apixaban dose to 5 mg BID after seven days.

Lab values recorded during the hospital stay are summarized in Table 1.

VITT is an uncommon but potentially life-threatening complication that has developed after vaccination with AstraZeneca and Johnson and Johnson COVID-19 adenoviral-based vaccines. This led to safety concerns as several individuals received these vaccinations during the COVID-19 pandemic. However, studies reveal that there is no association between the development of VITT and the BioNTech Pfizer vaccine [4]. One case report has also been published on fatal thrombotic events following vaccination with Moderna. However, it is unknown if this was a direct result of VITT or was related to a prior illness [5].

We reported a case of VITT following the Janssen (Johnson and Johnson) COVID-19 vaccination. A case report in the UK that included 220 cases of definite or probable VITT stated that the median time of diagnosis post-vaccination is 14 days, ranging from 5 to 48 days [6]. This study showed a female predominance among cases, with 55% of patients being female, making this a significant risk factor for VITT [6]. Over half of the patients studied had multiple thrombi present in different locations. The patient in our case report had similar demographics to this study as she presented to the hospital with symptoms 11 days post-vaccination, is female in gender, and had four different thrombotic sites. In systematic reviews, the headache was shown to be the most common presenting symptom in patients with VITT and cerebral venous sinus thrombosis (CVST) [7]. Despite our patients presentation of an unremitting headache, no signs of CVST or neurological abnormalities were found on imaging.

Sites of venous thrombosis in VITT can vary but are more commonly seen as deep vein thrombosis of the lower extremities and thromboembolism to the lungs [1,8]. Some rare but observed sites of thrombosis in VITT include the splenic, portal, mesenteric, adrenal, cerebral, and ophthalmic veins [1,8]. CVST is an uncommon but serious complication of VITT, where thrombosis of the cerebral sinuses occurs, leading to intracranial hypertension [9]. Thrombosis in the presence of VITT can be diagnosed through MRI with venography or CT venography. This was done after our patient developed thrombosis in the setting of thrombocytopenia, thus ruling out dural sinus thrombosis as a cause of the headache [1,9].

Arterial thrombosis caused by VITT has been displayed through reports of middle cerebral artery stroke and occlusion of peripheral arteries [10]. Our patients sites of thrombosis are consistent with these locations as they include the femoral arteries, popliteal artery, pulmonary vasculature, and abdominal aorta. The median platelet count for patients with VITT is 20,000-25,000 [2]. In this report, the patients platelet count dropped as low as 8000 but mostly remained within the 10,000-20,000 range.

VITT is diagnosed by using PF4 antibody tests [11]. A diagnosis is based on a positive PF4 antibody assay and the presence of thrombocytopenia or thrombosis. The test used on our patient was the ELISA, which is the recommended screening test [11]. Other screening tests include serotonin release assay, which can be used in patients with suspected VITT with a negative or equivocal ELISA [12]. Patients diagnosed with VITT from case reports in the UK had high optical densities on ELISA, ranging between a density of 2 and 3 [2]. The patient in our report had an optical density of 2.265.

Our patient was treated for two days with IVIG infusions, one of the mainstays of treatment in VITT, as it substantially improves the patients platelet count while stabilizing coagulative events [13]. IVIG interferes with the ability of PF4 to activate platelets by blocking FcRyIIA receptors, as seen in HIT [14]. Plasma exchange is another potential treatment that temporarily reduces the PF4 antibodies, thus decreasing coagulability [7]. It is important to note that platelet infusions should be avoided in the case of VITT to prevent further antibody formation and thrombosis [14]. The long-term complications of PF4 antibodies have not yet been established [13]. An observational study showed that VITT patients had a negative platelet functional assay within a median time of 15.5 weeks [15]. However, 7.5% of subjects showed persistently high levels of antibodies and optical densities, and two out of these five patients had a recurrent episode of thrombocytopenia [15]. Due to the new emergence of this condition, the prolonged implications of VITT and PF4 antibodies will be an essential topic for research in the coming years.

Our patient presented with a case of vaccine-induced thrombotic thrombocytopenia, a recent illness that arose with the development of vaccines produced in light of the COVID-19 pandemic. VITT can be life-threatening if not recognized quickly and treated adequately.

In this case, the patient was treated surgically and medically for multiple thrombotic events in the presence of thrombocytopenia, leading to a full recovery prior to discharge. VITT is a very rare complication of the adenoviral-vector-based COVID-19 vaccines, and although it can result in serious medical issues, the benefits of protection against COVID-19 heavily outweigh any associated risks.

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A Case of COVID-19 Vaccine-Induced Thrombotic Thrombocytopenia - Cureus

Deputy head of the National Health Commission (NHC) Zeng Yixin said on Saturday that "all China's incumbent state and party leaders" have been vaccinated against Covid-19 with domestically made shots, referring to top officials at the national and deputy national level -- a category that includes Xi, Premier Li Keqiang, and other senior leaders.

It is exceptionally rare for health-related information about Chinese leaders to be made public, but the statement was made amid a recent wave of Covid-19 infections and public concerns about the safety of vaccines.

Zeng didn't specify when the officials had been vaccinated or if they received booster shots. The vaccination status of Xi had not previously been disclosed to the public.

China has repeatedly sought to address questions around the safety of its vaccines and to boost its vaccination rates, especially among the elderly. While nearly 90% of China's vaccine eligible population has been fully vaccinated, only 61% of people over the age of 80 have been fully vaccinated and only 38.4% have received booster shots, according to the NHC.

On Saturday, the NHC addressed online speculation on the safety of the vaccines, including accusations they cause leukemia and diabetes in children, saying statistics show no evidence of these diseases linked to vaccines.

Of the nearly 3.4 billion doses of Covid-19 administered in China, only around 70 people per million have reported side effects -- a percentage far lower than other vaccines like polio, measles, hepatitis B, rabies and Influenza, the NHC said.

China has so far only approved domestically made vaccines to be used in mainland, including those by Sinopharm and Sinovac which use inactivated virus instead of the genetically engineered mRNA vaccines. In trials, these vaccines have shown lower efficacy than their mRNA counterparts -- a criticism dismissed by Beijing as a "bias-motivated ... smear." Beijing has instead pointed to the vaccines' effect in reducing severe cases and deaths as a metric of their success.

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China says Xi Jinping and other leaders have been given domestic Covid-19 vaccines, amid public concern over safety - CNN

One of the former U.S. officials who led the COVID-19 response during the Trump administration said July 22 that COVID-19 vaccines were not expected to protect against infection.

I knew these vaccines were not going to protect against infection. And I think we overplayed the vaccines. And it made people then worry that its not going to protect against severe disease and hospitalization,Deborah Birx, the White House COVID-19 response coordinator under former President Donald Trump, said during an appearance on Fox News.

The Moderna and Pfizer COVID-19 vaccines were granted emergency use authorization in late 2020 to prevent symptomatic COVID-19, and were promoted by many health officials, including Birx.

This is one of the most highly-effective vaccines we have in our infectious disease arsenal. And so thats why Im very enthusiastic about the vaccine, Birx said on an ABC podcast at the time.

She made no mention of concerns the vaccines might not protect against infection.

Data shows the vaccines did prevent infection from early strains oftheCCP (Chinese Communist Party) virus, which causes COVID-19, but that the protection waned over time. The vaccines have proven increasingly unable to shield even shortly after administration, and provide little protection against the Omicron virus variant and its subvariants.

The vaccines continue to protect against severe disease and hospitalization, Birx said on Friday. But lets be very clear50 percent of the people who died from the Omicron surge were older, vaccinated, she said.

So, thats why Im saying, even if youre vaccinated and boosted if youre unvaccinated, right now, the key is testing and Paxlovid, she added.

Paxlovid is a COVID-19 pill produced by Pfizer that has had uneven results in clinical trials and studies, but is recommended by U.S. health authorities for both unvaccinated and vaccinated COVID-19 patients to prevent progression to severe disease.

President Joe Biden, who tested positive this week, was prescribed Paxlovid by his doctor.

There are signs the protection from vaccines against severe illness is also dropping quickly as new strains emerge.

That protection was just 51 percent against emergency department or urgent care visits, and dropped to just 12 percent after five months, according to a recent study. Against hospitalization, protection went from 57 percent to 24 percent. A booster increased protection but the shielding quickly dropped to substandard levels.

Dr. Anthony Fauci also helped lead the U.S. pandemic response along with Birx and once said that vaccinated people would not get infected.

What was true two years ago, a year and a half ago, changes because the original ancestral strain did not at all have the transmission capability that were dealing with with the omicron sublineages, particularly BA. 5. So the vaccine does protect some people, not 95 percent, from getting infected, from getting symptoms, and getting severe disease. It does a much better job at protecting a high percentage of people from progressing from severe disease, Fauci said on Fox.

He said that vaccines with updated compilations, which are expected to debut in the fall, are necessary.

We need vaccines that are better. That are better because of the breadth and the durability, because we know that immunity wanes over several months. And thats the reason why we have boosters, he said. But also, we need vaccines that protect against infection.

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Zachary Stieber covers U.S. and world news. He is based in Maryland.

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Birx Says COVID-19 Vaccines Were Never 'Going to Protect Against Infection' - The Epoch Times