Category: Covid-19 Vaccine

PTI, May 17, 2024, 8:59 AM IST

Nearly one-third of the individuals who received Bharat Biotechs anti-Covid vaccine Covaxin reported adverse events of special interest, or AESI, according to a one-year follow up study conducted by a team of researchers at BHU.

Nearly 50 per cent of 926 study participants in the study complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.

Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.

Published in the journal Springer Nature, the study comes in the wake of UK pharmaceutical giant AstraZeneca admitting its Covid vaccine can cause rare side-effects of blood clotting and lowering of platelet count in UK court.

Close to one third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine, the study, conducted from January 2022 to August 2023, said.

The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine. The participants were interviewed telephonically about long-term adverse events of special interest after 1 year of vaccination.

New-onset skin and subcutaneous disorders (10.5 per cent), general disorders (10.2 per cent), and nervous system disorders (4.7 per cent) were the common AESIs in adolescents.

General disorders (8.9), musculoskeletal disorders (5.8 per cent), and nervous system disorders (5.5 per cent) were the common AESIs in adults.

Menstrual abnormalities were noticed in 4.6 per cent of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7 per cent and 0.6 per cent of participants Four deaths (three female individuals, one male individual) were reported in adults, the study added.

All four had diabetes, while hypertension in three, and a history of pre-vaccination COVID-19 was present in two of them.

Stroke was the main contributor in two deaths and one fatality was due to post-COVID-19 rhinocerebral mucormycosis, which supposedly disseminated after vaccination as reported by the caregivers.

The fourth death happened in a woman with multiple episodes of unconsciousness post-vaccination, the etiology of which remained unidentified till death. In the absence of a definite causality association, no conclusions can be drawn from these events.

With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs, the study underlined.

Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immunemediated phenomena post-COVID-19 vaccination .

Female individuals, adolescents with pre-vaccination COVID-19, those with co-morbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs.

Adults with co-morbidities had more than two times higher odds of AESIs and persistent AESIs, the study stated.

Adults receiving three doses and those receiving one dose of BBV152 were respectively at four and two times higher risk of AESIs compared with adults receiving two doses of the Covaxin, the study said.

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Over 30% Covaxin takers reported adverse events, claims BHU study - Udayavani English

The AstraZeneca COVID-19 vaccine, developed in collaboration with Oxford University and sold as Covishield in India and Vaxzevria in Europe, has been linked to an increased risk of Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT), a rare but potentially fatal blood clotting disorder. Researchers announced these findings, noting that VITT emerged as a new disease during the height of the COVID-19 pandemic in 2021, associated with adenovirus vector-based vaccines.

According to the American Society of Haematology, VITT is caused by an unusually dangerous blood autoantibody directed against a protein called platelet factor 4 (PF4). Separate studies in 2023 by scientists from Canada, North America, Germany, and Italy identified a similar disorder with the same PF4 antibody following natural adenovirus (common cold) infections, which was fatal in some cases.

Recent research from Flinders University in Australia and international experts discovered that the PF4 antibodies in both adenovirus infection-associated VITT and classic adenoviral vector VITT share identical molecular signatures. Professor Tom Gordon from Flinders University highlighted that these findings indicate that the pathways of lethal antibody production in these disorders are virtually identical and have similar genetic risk factors.

These insights have significant clinical implications, suggesting that lessons learned from VITT could apply to rare cases of blood clotting after adenovirus infections. Moreover, these findings could impact future vaccine development.

Thrombosis refers to the formation of blood clots within blood vessels, which can impede blood flow and cause serious complications. Society of Critical Care Medicine shared that the symptoms of thrombosis can vary depending on the location of the clot:

If you or someone you know has received a COVID-19 vaccine and develops any of the above symptoms, it is crucial to seek medical attention immediately. Early diagnosis and treatment of VITT can significantly improve outcomes.

Heres how VITT is treated:

VITT is a rare but serious condition that requires prompt medical attention. Understanding the symptoms of both thrombosis and thrombocytopenia can help ensure timely diagnosis and treatment. If you suspect VITT, contact healthcare professionals immediately to ensure appropriate care.

The current research follows AstraZeneca's legal acknowledgement in February that its COVID vaccine can, in very rare cases, cause Thrombotic Thrombocytopenic Syndrome (TTS), a rare side effect that leads to blood clots and a low platelet count. TTS has been linked to at least 81 deaths in the UK and hundreds of serious injuries. Consequently, AstraZeneca has voluntarily withdrawn the marketing authorisation for its COVID vaccine in Europe and other global markets.

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AstraZeneca COVID Vaccine Linked To Another Fatal Blood Clotting Disorder How Covishield May Cause VITT - Onlymyhealth

Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Plcs Covid-19 shots were caused by an autoimmune reaction that some people are predisposed to, researchers found, a discovery that they say will shape development of future vaccines.

Adenovirus-based vaccines, like the J&J and AstraZeneca shots that were later pulled from the market, contain a component that, in genetically susceptible people, can trigger the production of unusually structured antibodies against a protein involved in blood clotting, scientists said Wednesday in a letter to the New England Journal of Medicine. Researchers plan to identify the culprit and then try to remove it using genetic engineering.

Read More: How COVID-19 Vaccines and Infections Are Tweaking Our Immunity

An extremely similar deleterious antibody response occurs in susceptible patients after infection with adenoviruses, which often infect the airways and lead to cold-like symptoms, the study found. Its not known how many people may be susceptible to the complication, said Tom Gordon, head of immunology at Flinders University in South Australia, whose molecular sleuthing led to the finding.

The immune reaction linked to the shot is a new disease, he said in an interview. Hematologists and intensive care specialists are likely to spot more cases as they become familiar with it, he said.

Its a kind of autoimmunity where we know the trigger, said immunologist James McCluskey, assistant vice chancellor of the University of Melbourne, who wasnt involved in the research. Thats unusual. In most cases we never get a handle on the trigger.

Out of more than 18 million people who received the single-dose J&J vaccine,60 casesof the clotting disorder were reported and nine people died, according to the Yale School of Medicine.

A small number of clot-related deaths tied to the AstraZeneca vaccine led to its withdrawal or restriction in Denmark, Norway and other countries in 2021. The complication occurred in about 2-3 people per 100,000 vaccinated with the Astra shot under age 60 in Australia, where it hasnt been available since March 2023. The European Commission withdrew the marketing authorization for the immunization in March 2024.

AstraZeneca welcomes any further examination of the possible underlying mechanism of thrombosis with thrombocytopenia syndrome (TTS), given that, despite extensive investigation, we do not yet understand the mechanism that can in very rare cases be a trigger for TTS, a spokesperson for the company said.

J&J also said it supports research that helps guide development of safe and effective vaccines.

Read More: The Miracle Workers: Vaccine Scientists Are TIMEs 2021 Heroes of the Year

More data are needed to fully understand potential factors that may be associated with this rare event, including its potential relationship with adeno- and other viruses, to draw appropriate conclusions about the underlying pathogenesis, the company said in an email.

Both shots played an important role in vaccine programs during the early stages of the pandemic. One analysis found the Astra vaccine saved an estimated 6.3 million lives in 2021.

The mRNA vaccines made by the Pfizer Inc.-BioNTech SE partnership and Moderna Inc. were later found to be more effective at protecting against Covid and have been updated to tackle more recent virus variants.

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Genetics Played a Role in Blood Clots Linked to COVID-19 Shots - TIME

image:

Flinders University immunology researchers Dr Jing Jing Wang and Professor Tom Gordon.

Credit: photo courtesy Flinders Foundation

New research led by Flinders University and international experts is expanding understanding of vaccine-induced immune thrombocytopenia and thrombosis (known as VITT).

At the height of the COVID-19 pandemic in 2021,VITT emerged as a new disease following adenovirus vector-based vaccines notably the Oxford-AstraZeneca vaccine.

VITT was found to be caused by an unusually dangerous blood autoantibody directed against a protein termed platelet factor 4 (or PF4).

In separate research in 2023, researchers from Canada, North America, Germany and Italy described a virtually identical disorder with the same PF4 antibody that was fatal in some cases after natural adenovirus (common cold) infection.

Flinders University researchers Dr Jing Jing Wang and Flinders Professor Tom Gordon, Head of Immunology at SA Pathology in South Australia,led a previous studyin 2022 which cracked the molecular code of the PF4 antibody and identified a genetic risk factor related to an antibody gene termed IGLV3.21*02.

Now, the Flinders group has collaborated with this international group of researchers to find that the PF4 antibodies in both adenovirus infection-associated VITT and classic adenoviral vectored VITT share identical molecular fingerprints or signatures.

The research will also have implications for improving vaccine development, says Flinders University researcher Dr Wang, first author on the new article to be published in the eminentNew England Journal of Medicineon Thursday (embargoed 16 May 2024).

These findings, using a completely new approach for targeting blood antibodies developed at Flinders University, indicate a common triggering factor on virus and vaccine structures that initiates the pathological pF4 antibodies, explains Professor Gordon.

"Indeed, the pathways of lethal antibody production in these disorders must be virtually identical and have similar genetic risk factors.

"Our findings have the important clinical implication that lessons learned from VITT are applicable to rare cases of blood clotting after adenovirus (a common cold) infections, as well as having implications for vaccine development," he says.

Key points:

The original research letter, Correspondence entitled 'Antibody Fingerprints Linking Adenoviral Anti-PF4 Disorders' (2024), by Jing Jing Wang (Flinders University), Linda Schnborn (Greifswald University Hospital, Germany), Theodore E Warkentin (McMaster University, Canada), Tim Chataway (Flinders University), Leonie Grosse (Ludwig Maximilians University, Germany), Paolo Simioni (Padova University Hospital, Italy), Stephan Moll (University of North Carolina School of Medicine, US), Andreas Greinacher (Greifswald University Hospital, Germany) and Tom P Gordon (SA Pathology, South Australia) will be published in theNew England Journal of Medicine.DOI: 10.1056/NEJMc2402592

Disclaimer:The views expressed in this letter are those of the authors and do not necessarily represent the position of the European Medicines Agency.

Acknowledgements: The research was supported by the German Research Foundation (Deutsche Forschungsgemeinschaft) and a European Medicines Agency service contract. Dr Schnborn was supported by theASH Global Research Award from the American Society of Hematology and by the Gerhard Domagk Research Program through the Medical University of Greifswald. Dr Wang was supported by a Flinders Foundation Health Seed Grant.

New England Journal of Medicine

Observational study

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Antibody Fingerprints Linking Adenoviral Anti-PF4 Disorders

16-May-2024

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Link between COVID-19 vaccine complication and rare 'common cold' blood disease - EurekAlert

Australian researchers have uncovered a link between an "unusually dangerous" COVID-19 vaccine complication and rare but potentially fatal blood disease contracted by some people who caught a cold.

The antibodies from the two conditions vaccine-induced immune thrombocytopenia and thrombosis (VITT), and an adenovirus VITT-like disorder share almost identical molecular signatures or fingerprints, Adelaide's Flinders University announced today.

"These findings, using a completely new approach for targeting blood antibodies developed at Flinders University, indicate a common triggering factor on virus and vaccine structures that initiates the pathological PF4 antibodies," the university's Professor Tom Gordon said.

READ MORE: mRNA cancer vaccine shows 'promising' results, US study finds

"Indeed, the pathways of lethal antibody production in these disorders must be virtually identical and have similar genetic risk factors."

The research comes after VITT emerged as a complication that occurred in some rare cases after receiving some COVID-19 vaccines, including the Oxford-AstraZeneca jab used in Australia.

"VITT was found to be caused by an unusually dangerous blood autoantibody directed against a protein termed platelet factor 4 (or PF4)," Flinders University said in a statement.

READ MORE: Why the budget's predicting lower inflation but same old interest rates

Separately to research into the vaccine side-effect, experts from North America and Europe last year found an almost-identical blood disease with the same PF4 antibody that was fatal for some people who had recently had a common cold.

Flinders researchers Gordon and Dr Jing Jing Wang led a study in 2022 that "cracked the molecular code of the PF4 antibody and identified a genetic risk factor", the university said.

The latest COVID-19 strain spreading across the world

The groups from Flinders University and overseas collaborated to find the matching molecular fingerprints, publishing their findings in the New England Journal of Medicine today.

Both Gordon and Wang said the findings would play an important role in improving vaccine safety.

"Our findings have the important clinical implication that lessons learned from VITT are applicable to rare cases of blood clotting after adenovirus (a common cold) infections, as well as having implications for vaccine development," Gordon said.

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Link between dangerous vaccine complication and potentially fatal common cold blood disease uncovered by researchers - 9News

Children Who Are Not Vaccinated

Children aged 6 months4 years should get two or three doses of updated COVID-19 vaccine depending on which vaccine they receive.

Children aged 6 months4 years who got COVID-19 vaccines before September 12, 2023, should get one or two doses of updated COVID-19 vaccine depending on which vaccine and the number of doses theyve previously received.

People ages 65 years and older should receive 1 additional dose of any updated (20232024 formula) COVID-19 vaccine (i.e., Pfizer-BioNTech, Moderna, or Novavax) at least 4 months following the previous dose of updated (20232024 Formula) COVID-19 vaccine.

People aged 65 years and older who have not previously received any COVID-19 vaccine doses and choose to get Novavax should get 2 doses of updated Novavax vaccine, followed by 1 additional dose of any updated 20232024 COVID-19 vaccine to be up to date.

You areup to datewhen you get 1 age-appropriate updated COVID-19 vaccine.

You areup to date when you get all recommended doses, including at least 1 dose of updated COVID-19 vaccine.

You are up to date when you have received 2 updated 20232024 COVID-19 vaccine doses.

People aged 65 and older who have not previously received any COVID-19 vaccine doses and choose to get Novavax should get 2 doses of updated Novavax vaccine, followed by 1 additional dose of any updated 20232024 COVID-19 vaccine to be up to date.

You are up to date when you get 1 updated COVID-19 vaccine.

COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and dying. As with other vaccine-preventable diseases, you are best protected from COVID-19 when you stay up to date with the recommended vaccinations.

COVID-19 vaccines currently recommended for use in the United States:

As of October 3, 2023, the 2023-2024 updated Novavax vaccine was recommended by CDC for use in the United States.

As of September 12, 2023,the20232024 updated Pfizer-BioNTech and Moderna COVID-19 vaccines were recommended by CDC for use in the United States.

The 20232024 updated COVID-19 vaccines more closely targets the XBB lineage of the Omicron variantand could restore protection against severe COVID-19 that may have decreased over time. We anticipate the updated vaccines will be better at fighting currently circulating variants.

There is no preferential recommendation for the use of any one COVID-19 vaccine over another when more than one licensed or authorized, recommended, and age-appropriate vaccine is available.

If you recently had COVID-19, you still need to stay up to date with your vaccines, but you may consider delaying your vaccine by 3 months.

Reinfection is less likely in the weeks to months after infection. However, certain factors could be reasons to get a vaccine sooner rather than later, such as:

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Stay Up to Date with COVID-19 Vaccines - CDC

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New research led by Flinders University and international experts is expanding understanding of vaccine-induced immune thrombocytopenia and thrombosis (known as VITT).

At the height of the COVID-19 pandemic in 2021, VITT emerged as a new disease following adenovirus vector-based vaccinesnotably the Oxford-AstraZeneca vaccine.

VITT was found to be caused by an unusually dangerous blood autoantibody directed against a protein termed platelet factor 4 (or PF4).

In separate research in 2023, researchers from Canada, North America, Germany and Italy described a virtually identical disorder with the same PF4 antibody that was fatal in some cases after natural adenovirus (common cold) infection.

Flinders University researchers Dr. Jing Jing Wang and Flinders Professor Tom Gordon, Head of Immunology at SA Pathology in South Australia, led a previous study in 2022 which cracked the molecular code of the PF4 antibody and identified a genetic risk factor related to an antibody gene termed IGLV3.21*02.

Now, the Flinders group has collaborated with this international group of researchers to find that the PF4 antibodies in both adenovirus infection-associated VITT and classic adenoviral vectored VITT share identical molecular fingerprints or signatures.

The research will also have implications for improving vaccine development, says Flinders University researcher Dr. Wang, first author on the article published in the New England Journal of Medicine and titled "Antibody Fingerprints Linking Adenoviral Anti-PF4 Disorders."

"These findings, using a completely new approach for targeting blood antibodies developed at Flinders University, indicate a common triggering factor on virus and vaccine structures that initiates the pathological pF4 antibodies," explains Professor Gordon.

"Indeed, the pathways of lethal antibody production in these disorders must be virtually identical and have similar genetic risk factors.

"Our findings have the important clinical implication that lessons learned from VITT are applicable to rare cases of blood clotting after adenovirus (a common cold) infections, as well as having implications for vaccine development," he says.

More information: Jing Jing Wang et al, Antibody Fingerprints Linking Adenoviral Anti-PF4 Disorders, New England Journal of Medicine (2024). DOI: 10.1056/NEJMc2402592

Journal information: New England Journal of Medicine

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Link between COVID-19 vaccine complication and rare 'common cold' blood disease - Medical Xpress

Katherine E. Fleming-Dutra, MD

Lead, Vaccine Effectiveness and Policy Team, Coronavirus and Other Respiratory Virus Division, Centers for Disease Control and Prevention, Atlanta, Georgia

Disclosure: Katherine E. Fleming-Dutra, MD, has disclosed no relevant financial relationships.

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5 Things to Know: COVID-19 Vaccines for Immunocompromised People - Medscape

The Biden Administration will end a program which provides free COVID-19 vaccines to uninsured adults.

On Wednesday, the Centers for Disease Control and Prevention announced that the CDCs Bridge Access Program for COVID-19 Vaccines will end in August of 2024. The program has provided over 1.4 million free COVID-19 vaccines since September 2023.

After August, there may be a small amount of free vaccine available through health department immunization programs, but supply would be very limited, said CDC spokesperson David Daigle We dont yet know if the manufacturers will have patient assistance programs.

In the programs place, Daigle only offered the promise of the CDCs Vaccines for Adults proposal, which would provide non-influenza vaccines to 24 million uninsured adults. The public health proposal is currently part of President Joe Bidens 2025 budget, he said.

If enacted by Congress, this program would reduce disparities, protect communities from vaccine-preventable diseases, and enhance and maintain the infrastructure needed for responding to future pandemics, he said.

The decision is a strong reversal for the Biden administration, which previously stated in the run up to the 2020 election that, No one should pay a dollar out of pocket for coronavirus testing or treatment.

Over the course of Bidens presidency, the government has steadily weakened federal COVID-19 restrictions and guidance as a response to a decrease in hospitalizations and deaths, and an increase in so-called herd immunity. In March, the CDC reversed its recommendation that those with COVID-19 undergo a five-day isolation period.

However, health experts say that fewer people are keeping up with updated immunizations, leading to more needless deaths, as Americans of all ages continue to develop debilitating long-term symptoms.

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CDC Will No Longer Supply Free COVID-19 Vaccines for Uninsured Adults - The Daily Beast

Mumbai: Earlier today, The Economic Times published a story that a third of the participants of an observational study on the side effects of Bharat Biotech's COVID-19 vaccine Covaxin reported adverse events of special interest (AESI), according to a report on SpringerLink.

As per the report, researchers found that female adolescents and those with a history of allergy were at a higher risk of AESI after receiving Covaxin. Of the 1,024 individuals enrolled, 635 adolescents and 291 adults could be contacted during the one-year follow-up. According to the study, 304 (47.9 per cent) adolescents and 124 (42.6 per cent) adults reported viral upper respiratory tract infections.

continued below

Recently, there has been a whirlwind of reports on several COVID-19 vaccines and their adverse events globally. AstraZeneca has admitted that its jab causes a rare side effect and is withdrawing its vaccine worldwide. The company has already withdrawn its EU marketing authorisation for the vaccine, which was branded Vaxzevira in Europe and Covishield in India and manufactured by the Serum Institute of India (SII).

Another report titled 'COVID-19: Two rare vaccine side effects detected in large global study' published in Vaccine, confirmed previously identified rare safety signals for myocarditis and pericarditis after a mRNA vaccine (Pfizer and Moderna) and Guillain-Barr syndrome and cerebral venous sinus thrombosis (CVST) after viral vector vaccines (AstraZeneca).

These recent studies highlight notable adverse events globally caused by COVID-19 vaccines, regardless of the technology and manufacturer. Bharat Biotech has emphasised the need for more comprehensive data to ensure unbiased and informative safety evaluations. Several studies have reported rare side effects from AstraZeneca's vaccine and mRNA vaccines by Moderna and Pfizer.

This underscores the ongoing need for rigorous safety monitoring and transparent reporting. Ensuring the safety of not only COVID-19 vaccines but every vaccine that is approved remains paramount, and continued research is crucial for improving vaccine safety and public confidence. Manufacturers need to take patient safety as a top priority when developing vaccines.

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The baggage of COVID-19 : Global concern lingers over vaccine safety - ETHealthWorld