Misleading Claims on Well-Known Rare Risk of AstraZeneca COVID-19 Vaccine – FactCheck.org

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A rare risk of dangerous blood clots associated with the AstraZeneca COVID-19 vaccine was identified and reported in early 2021. This month, the company announced it was pulling the vaccine off the market globally, citing a decline in demand. Social media posts misleadingly linked the decision to the company having admitted the rare side effect for the first time in court documents and used it to impugn all vaccines.

The association between the AstraZeneca COVID-19 vaccine and a rare and dangerous blood clotting condition combined with low blood platelets has been known for more than three years.The condition is known as thrombosis with thrombocytopenia syndrome, or TTS, in general, and vaccine-induced thrombotic thrombocytopenia, or VITT, when it implies an association to vaccines.

The European Medicines Agency, which regulates vaccines in the European Union,first warnedof the possible link between the vaccine and very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets on March 18, 2021. In astatementissued that same day, the pharmaceutical company acknowledged the finding and said it recognises and will implement EMAs recommendations, including updating the product information to warn about the reported cases.

A few weeks later, in April 2021, the EMAconcludedthe unusual blood clots should be listed as very rare side effects of the vaccine.TTS is included in the possible side effects section in the package leaflet for users for Vaxzevria (page 30), one of the brand names of the vaccine along with Covishield. TTS has also been listed in Covishields product insert under the special warnings section, as a side effect in the fact sheet for recipients since at least August 2021, and as a possible adverse reaction in an FAQ page from its manufacturer that was updated on July 5, 2021.

In September 2021, the National Health Service in England reportedthat the rare condition affected approximately 1 in 50,000 AstraZeneca COVID-19 vaccine recipients under 50 years old and 1 in 100,000 recipients older than 50. Between May 2021 and May 2022, there were 443 cases of TTSreported following vaccination in the U.K.; 81 of them were fatal. (In July 2021, thevaccinewas also linked to rare cases of Guillain-Barr syndrome, a neurological disorder that leads to muscle weakness and, at times, paralysis. The World Health Organization said that most people recover fully.)

The vaccinewas never used in the U.S. outside clinical trials AstraZeneca decidednot to file the application for approval.But the vaccine was widely used in the rest of the world, especially during 2021.

In March, the European Commission withdrewAstraZenecas authorization to market its COVID-19 vaccine in the European Union, at the companys request, and on May 7, the company announced it was pulling the vaccine from the market globally. Social media posts misleadingly framed the companys recent decision as a consequence of admitting the rare TTS condition for the first time in court documents, as part of a lawsuit in the U.K. The claim was also shared in Spanish.

AstraZenecahad saidthe decision was based on a decline in demand. Other COVID-19 vaccine manufacturers had developed new versions to target variants of the virus that causes COVID-19.As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines, the company said in a statement sent to us.

AstraZeneca finally WITHDRAW Covid vaccine worldwide, months after the pharmaceutical giant admitted for the first time in court documents that it can cause a rare and dangerous side effect. Never forget how they cancelled anyone who questioned its safety, reads aviral postshared across social media platforms.

The U.K. news website the Telegraphhad reportedon April 28 that AstraZeneca had admitted its COVID-19 vaccine could cause TTS in an apparent about-turn that could pave the way for a multi-million pound legal payout in a class action lawsuit in which the company is being sued for death and serious injury in dozens of cases. The article said the company hadnt said that in a court document before.But the story went on to say that a link between the vaccine and the rare blood clotting condition was identified in March 2021, as we said.

On May 7, the Telegraph reported that AstraZeneca was being withdrawn worldwide, months after the pharmaceutical giant admitted for the first time in court documents that it can cause a rare and dangerous side effect. The next day, the Independent, a British online newspaper, published a story with the headline AstraZeneca withdraws Covid vaccine worldwide after admitting it can cause rare blood clots.

Christina Pagel, professor of operational research at University College London, said the headlines were needlessly scary on her blog on May 8, and days later in an op-ed with Sheena Cruickshank, immunologist at the University of Manchester,in the New Statesman, a U.K. publication.

Fundamentally, the situation is this: there isnt a new smoking gun; the AZ vaccine was one of the first and cheapest vaccines; it saved millions of lives globally; and there are better vaccines out there now, adapted to new variants, they wrote.

Even though the rare risk associated with the AstraZeneca COVID-19 vaccine was reported early on and was well-known, some social media users took the Telegraphs news reports as vindication.

Now they admit it,wroteconservative commentator Dan Bongino in a Facebook post, linking to a Rumble video titled AstraZeneca Makes SHOCKING Admission About COVID Vax We Were Right All Along.

Others used the apparent news to cast shade on all other COVID-19 vaccines. Its not just the Astra Zeneca, one Facebook post said.

A commenter to a post on Instagram wrote, Whens the class action lawsuit against the US Government?, although the vaccine was not authorized for use in the U.S. Another one wrote, When will Pfizer finally step up and do the same?, although the Pfizer/BioNTech COVID-19 vaccine has not been linked to TTS.

Just like other COVID-19 vaccines authorized or approved for use, the AstraZeneca COVID-19 vaccine, co-developed by Oxford University,wasfoundtobesafe and effective for people over 18 years old in clinical trials and in further studies.The efficacy of the vaccine in preventing symptomatic diseasein clinical trials was 74%, which was lower than its mRNA counterparts, namely the Pfizer/BioNTech and Moderna vaccines.

After the potentially deadly blood clot side effect was identified in 2021, many countriesrestricted the AstraZeneca vaccine usefor only older populations. The reported TTS cases were more prevalent among those younger than 50.

Because AstraZenecas vaccine wascheaper and easier to distributethan other COVID-19 vaccines, it was among thefirst vaccinessent to poorer countries byCOVAX, a global initiative that allowed for equitable access to COVID-19 vaccines.

Since its rollout, more than 3 billion doses were distributed in over 180 countries,accordingto a 2022 statement from thevaccine developers, with approximately two-thirds of the doses going to poorer countries. A2022 analysis by Airfinity, a disease-forecasting company, showed that the vaccine saved 6.3 million lives from December 2020 to December 2021.The company used data from a study by scientists with the Imperial College London on the global impact of COVID-19 vaccination during that year.

As we said, the AstraZeneca COVID-19 vaccine was not used in the U.S. outside clinical trials.

The Johnson & Johnson COVID-19 vaccine, though, uses the same platform as the AstraZeneca vaccine. Both use a modified, harmless adenovirus, a type of virus that typically causes the common cold, to trigger an immune response. The J&J vaccine was granted an emergency use authorization in February 2021, but soon after, in April of that year, the Food and Drug Administration and the Centers for Disease Control and Prevention reported casesof TTS following the administration of the vaccine and recommended a pause in its use. The FDA also reportedrare cases of GBSin July 2021.

The FDAlimited the authorizationof the J&J vaccine to certain people in May 2022, and the vaccine was ultimately discontinued in 2023. As of April 7, 2022, the CDC and FDA had confirmed 60 cases of TTS, including nine deaths, among more than 18.6 million J&J vaccines administered. In September 2023, the CDC said TTS after J&J COVID-19 vaccination has occurred in approximately 4 cases per one million doses administered.

The first two COVID-19 vaccines authorized and approved in the U.S., the Pfizer/BioNTech and Moderna vaccines, are both mRNA vaccines. The mRNA COVID-19 vaccines were widely used in the U.S., and neither has been linked to TTS. For context, as of April 26, 2023, approximately 367 million doses of the Pfizer/BioNTech vaccine, 232 million doses of the Moderna vaccine and 19 million doses of the J&J vaccine had been administered in the country.

Both mRNA vaccines have been shown to be safe, with rare serious side effects reported, and effective at preventing severe COVID-19 disease and death. One estimate published in December 2022suggeststhat COVID-19 vaccines prevented more than 18 million hospitalizations and 3 million deaths in the U.S.

Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets. Press release. European Medicines Agency. 18 Mar 2021.

UK and EU regulatory agencies confirm COVID-19 Vaccine AstraZeneca is effective and generally well-tolerated. Statement. AstraZeneca. Updated 9 Mar 2022.

AstraZenecas COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. Press release. European Medicines Agency. 7 Apr 2021.

Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on reports of Guillain-Barr Syndrome (GBS) following adenovirus vector COVID-19 vaccines. Statement. WHO. 26 Jul 2021.

Kiely, Eugene and Catalina Jaramillo. The Facts on the Recommended J&J Vaccine Pause. FactCheck.org. Updated 6 May 2022.

Coronavirus (COVID-19) Update: July 13, 2021. Press release. FDA. 13 Jul 2021.

Robertson, Lori. A Guide to Johnson & Johnsons COVID-19 Vaccine. FactCheck.org. Updated 19 Apr 2024.

AstraZeneca pulls its COVID-19 vaccine from the European market. AP. 8 May 2024.

Robbins, Rebecca. AstraZeneca Is Withdrawing Its Covid Vaccine Worldwide, Citing Low Demand. New York Times. 8 May 2024.

Davey, Melissa. AstraZeneca withdraws Covid-19 vaccine worldwide, citing surplus of newer vaccines. The Guardian. 7 May 2024.

AstraZeneca global media team. Email to FactCheck.org. 16 May 2024.

Investigations team and Robert Mendick. AstraZeneca admits its Covid vaccine can cause rare side effect in court documents for first time. The Telegraph. 28 Apr 2024.

Mendick, Robert, and Patrick Sawer. AstraZeneca withdrawing Covid vaccine worldwide. The Telegraph. 7 May 2024.

Rai, Arpan. AstraZeneca withdraws Covid vaccine worldwide after admitting it can cause rare blood clots. The Indipendent. 8 May 2024.

Pagel, Christina. The Astra Zeneca Covid vaccine saved millions of lives globally. Diving into Data & Decision making. 8 May 2024.

Pagel, Christina and Sheena Cruickshank. The AstraZeneca vaccine saved millions of lives it should not be demonised. The New Stateman. 16 May 2024.

The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know. WHO. Updated 13 Jun 2022.

Ramasamy, Maheshi N., et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet. Volume 396, Issue 10267, 19 Dec 2020.

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults. ClinicalTrials.gov. 5 Feb 2024.

Falsey, Ann R., et al. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine. The New England Journal of Medicine. 29 Sep 2021.

Vaccine-induced Immune Thrombotic Thrombocytopenia. American Society Hematology. 9 May 2022.

Some countries limit AstraZeneca vaccine use, U.S. pauses J&J shot. Reuters. 25 Mar 2021.

Vaccine-induced thrombocytopenia and thrombosis (VITT) Support for patients family members. NHS England. 14 Sep 2021.

Hippisley-Cox, Julia, et al. Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study. BMJ. 27 Aug 2021.

AstraZeneca no longer pursuing U.S. approval for COVID vaccine. Reuters. 10 Nov 2022.

Mallapaty, Smriti and Ewen Callaway. What scientists do and dont know about the OxfordAstraZeneca COVID vaccine. Nature. 25 Mar 2021.

Callaway, Ewen and Smriti Mallapaty. Latest results put OxfordAstraZeneca COVID vaccine back on track. Nature. 25 Mar 2021.

First COVID-19 COVAX vaccine doses administered in Africa. Press release. WHO. 1 Mar 2021.

Boosting with AstraZenecas vaccine provides high protection against Omicron, equivalent to mRNA COVID-19 vaccines. Press release. AstraZeneca. 8 Sep 2022.

Oxford vaccine saved most lives in its first year of rollout. University of Oxford. 15 Jul 2022.

AstraZeneca and Pfizer/BioNTech saved over 12 million lives in the first year of vaccination. Press release. Airfinity. 12 Jul 2022.

Lane, Samantha, and Saad Shakir. Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data. Drug Safety. 4 Aug 2022.

Watson, Oliver J., et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. The Lancet. 23 June 2022.

Selected Adverse Events Reported after COVID-19 Vaccination. CDC. 12 Sep 2023.

Fitzpatrick, Meagan C., et al. Two Years of U.S. COVID-19 Vaccines Have Prevented Millions of Hospitalizations and Deaths. The Commonwealth Fund. 13 Dec 2022.

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR Product information. EMA. 7 Apr 2024.

ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) COVISHIELD. Serum Institute of India website. Accessed 22 May 2024.

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Misleading Claims on Well-Known Rare Risk of AstraZeneca COVID-19 Vaccine - FactCheck.org