By Thomas Moore, Science correspondent @SkyNewsThomas
Wednesday 8 May 2024 13:28, UK
AstraZeneca has begun the worldwide withdrawal of its COVID vaccine - ending an era in which it saved millions of lives while being dogged by controversy.
The jab, developed at Oxford University, was once hailed as "the vaccine for the world" because it could be stored in fridges rather than the ultra-cold freezer temperatures originally required for alternative mRNA shots, making it more suitable for developing countries.
But AstraZeneca (AZ) said demand for the jab had tailed off as more up-to-date vaccines target newer variants of the virus. It no longer manufactures nor supplies the vaccine.
The voluntary withdrawal has started in the EU, with the European Medicines Agency announcing that the vaccine is no longer authorised for use.
In a statement, AZ said: "According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.
"Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.
"We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the COVID-19 pandemic."
The vaccine had only been in use for a few months before reports emerged of unusual blood clots.
Read more: Dad who suffered brain injury days after COVID vaccine sues AstraZeneca 'Next pandemic is around the corner,' expert warns
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Thrombosis with thrombocytopenia, or TTS, occurred in around one in 50,000 patients and was sometimes fatal.
Several European countries and some Canadian provinces suspended use of the vaccine as a result.
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In the UK, medicines regulators responded by first recommending the vaccine only for people over 30, before raising the age cut-off to 40.
The vaccine hasn't been used in the UK since the start of the booster programme, though the government says this was because mRNA vaccines were more effective, not because of concern over side effects.
However, more than 50 people who developed clots after vaccination are taking legal action against AZ in the High Court, claiming that the company failed to adequately inform them of a potential risk.
The company says the clinical trials and real-world evidence have shown the vaccine has "an adequate safety profile".
NEW DELHI: AstraZeneca on Tuesday announced that it has started the global withdrawal of its Covid-19 vaccine, days after the UK pharmaceutical company admitted that its vaccine has the potential to cause a rare side effect called Thrombosis with Thrombocytopenia Syndrome (TTS). The company said the withdrawal was due to a "surplus of available updated vaccines" since the pandemic. According to media reports, the Anglo-Swedish drugmaker had previously admitted in court documents that the vaccine causes side effects such as blood clots and low blood platelet counts. The company also said its decision to remove the vaccine Vaxzevria's marketing authorizations within Europe, noting that this oversupply has resulted in a decrease in demand for Vaxzevria, which is no longer being produced or distributed. "As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca which collaborated with the University of Oxford to create the vaccine is currently dealing with a lawsuit that claims their vaccine has caused deaths and severe harm to those who received it. The UK-based pharma company also collaborated with the Serum Institute of India (SII), the largest vaccine producer globally, to provide the vaccine (Covishield) to the Indian government. The Telegraph, which initially reported the news, said that AstraZeneca's application to withdraw the vaccine was submitted on March 5 and became effective on May 7. Previous year, Jamie Scott, a father of two, took legal action after suffering from a blood clot that left him unable to work. Scott said that he developed a blood clot and a bleed on his brain, leaving him with a lasting brain injury following his vaccination in April 2021. According to The Telegraph, Scotts wife Kate said, "The medical world has acknowledged for a long time that vaccine-induced immune thrombocytopenia and thrombosis (VITT) was caused by the vaccine." However, in May 2023, the company informed Scott's lawyers that they do not acknowledge that TTS is induced by the vaccine on a general level. Later in the legal document submitted to the high court, the multinational pharmaceutical company said, "It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known." Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines, AstraZeneca said in a statement.
What is the rare side effect of AstraZeneca?
NEW DELHI: UK-based drug major AstraZeneca's decision to withdraw its Covid-19 vaccine globally, days after admitting to side effects, prompted Serum Institute of India to disclose that it had stopped manufacturing Covishield in Dec 2021 due to a fall in demand as well as the emergence of new variants. "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly. Consequently, since Dec 2021, we have stopped the manufacture and supply of additional doses of Covishield," said a SII spokesperson. The global drug giant had recently admitted to Vaxzervria causing Thrombosis with Thrombocytopenia (TTS) in very rare cases. Covishield accounted for nearly 80% of Covid-19 vaccine doses administered in India. AstraZeneca said its decision to withdraw marketing authorisation of Vaxzevria was due to a "surplus of available updated vaccines" since the pandemic. The SII spokesperson said the company fully understood the ongoing concerns. " We have disclosed all rare to very rare side effects, including Thrombosis with TTS, in the packaging insert in 2021," the spokesperson said. TTS refers to the formation of blood clots with low platelet counts. The condition is rare but is usually serious, particularly when the blood clot happens in major vessels, say doctors. The epidemiologic data on TTS among Indians is not known but in the UK, researchers have found 2.4 cases of TTS per lakh vaccines. "As the number of cases are small, studies face challenges in establishing risk factors. However, the UK study found that male gender and age above 65 years put people at higher risk of TTS . Moreover, chronic diseases of heart, kidney, liver, neurological diseases and cancer were found to place such affected persons at higher risk of developing TTS," Dr Kameshwar Prasad, former head of neurology at AIIMS told TOI.
SII disclosed Covishield's rare side-effects in 2021, AstraZeneca withdrew global vaccine due to surplus, TTS. India halted manufa... Read More SII disclosed Covishield's rare side-effects in 2021, AstraZeneca withdrew global vaccine due to surplus, TTS. India halted manufacturing, faced mutant strains. Health experts note TTS involves blood clots, low platelet counts in major vessels. Read Less PUNE: City-based Serum Institute of India (SII) on Wednesday said it had disclosed all rare to very rare side-effects of Covid-19 vaccine, supplied under the name Covishield, in the packaging insert in 2021 itself. Serum Institute's statement follows UK-based drug major AstraZeneca's move to withdraw its Covid-19 vaccine globally because of a "surplus of available updated vaccines" since the Covid-19 pandemic. The drug major had earlier admitted to a UK court that its vaccine, in very rare cases, could cause a side-effect called thrombosis with thrombocytopenia syndrome (TTS). AstraZeneca's Covid-19 vaccine formula was used by SII to manufacture Covishield. "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly. Consequently, since Dec 2021, we have stopped the manufacturing and supply of additional doses of Covishield," a statement issued by SII stated. On the potential side-effects of the vaccine, the Serum Institute of India statement stated that the firm fully understood the concerns. "From the outset, we have disclosed all rare to very rare side effects, including thrombosis with thrombocytopenia syndrome [TTS], in the packaging insert in 2021," the statement read. TTS refers to the formation of blood clots with low platelet counts. The condition is rare, but usually serious, particularly when the blood clot happens in major vessels, health experts said. Steffy Thevar is a Pune-based senior correspondent working for th... Read More Steffy Thevar is a Pune-based senior correspondent working for the Times of India. She writes on health, urban infrastructure and gender parity issues. She has worked in Mumbai for three years and shifted to Pune and covered the Covid19 pandemic. She had completed her masters in Journalism and Mass Communication from Savitribai Phule Pune University's department of Mass Communication and Journalism. She also writes on a range of issues including housing, human rights and environment.Read Less
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AstraZenecas COVID-19 vaccine Vaxzevria is no longer being manufactured or supplied due to declining demand, the company said Wednesday.
It is also withdrawing the vaccines authorization to be marketed or sold in countries that are part of the European Union, AstraZeneca said.
As multiple variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied, the company told Global News in an email Wednesday.
AstraZeneca has therefore taken the decision to initiate withdrawal of the Marketing Authorizations for Vaxzevria within Europe.
Alongside Pfizer-BioNTech and Moderna, AstraZenecas Vaxzevria was one of three primary vaccines administered worldwide against COVID-19 beginning in 2021.
2:19 NACIs latest AstraZeneca vaccine advice leaves Canadians confused
However, safety concerns arose in March 2021 when Canadas National Advisory Committee on Immunization (NACI) recommended the vaccine not be administered to people under age 55 following reports of blood clots.
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The committee said majority of the cases of the adverse effect known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) were identified in women under the age of 55.
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Ontario and Alberta both paused the use of Vaxzevria a few months later out of caution.
Dr. David Williams, Ontarios chief medical officer of health at the time, said the decision was also made, in part, because of an increased and reliable supply of the Pfizer-BioNTech and Moderna vaccines and a continued downward trend in COVID-19 cases.
Canadas authorization for use of Vaxzevria was officially cancelled in December of 2023.
AstraZeneca said in its email to Global News that its working with regulators and partners to align on a clear path forward to conclude its chapter on the COVID-19 pandemic.
We are incredibly proud of the role Vaxzevria played in ending the global pandemic, the company said.
with files from Global News Nick Westoll, Nicole Gibillini, Amanda Connolly and Hannah Jackson
2024 Global News, a division of Corus Entertainment Inc.
AstraZeneca was one of the first pharma laboratories to launch a COVID vaccine on the market at the end of 2020, a year after the virus appeared.
Pharmaceutical giant AstraZeneca has requested that the European authorisation for its COVID-19 vaccine be pulled, according to the EU medicines regulator.
In an update on the European Medicines Agencys (EMA) website Wednesday, the regulator said that the approval for AstraZenecas Vaxzevria had been withdrawn "at the request of the marketing authorisation holder".
AstraZenecas COVID-19 vaccine was first given the nod by the EMA in January 2021.
Within weeks, however, concerns grew about the vaccines safety, when dozens of countries suspended the vaccines use after unusual but rare blood clots were detected in a small number of immunized people.
The EU regulator concluded AstraZenecas shot didnt raise the overall risk of clots, but doubts remained.
Partial results from its first major trial - which Britain used to authorise the vaccine - were clouded by a manufacturing mistake that researchers didnt immediately acknowledge.
Insufficient data about how well the vaccine protected older people led some countries to initially restrict its use to younger populations before reversing course.
Billions of doses of the AstraZeneca vaccine were distributed to poorer countries through a UN-coordinated programme, as it was cheaper and easier to produce and distribute.
But studies later suggested that the pricier mRNA vaccines made by Pfizer-BioNTech and Moderna provided better protection against COVID-19 and its many variants, and most countries switched to those shots.
For more on this story, watch the report in the media player above.
AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a "surplus of available updated vaccines" since the pandemic.
The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe.
"As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.
The firm's application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.
London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.
Published 08 May 2024, 01:19 IST
By BRUCE SHIPKOWSKI (Associated Press)
An Ohio doctor who drew national attention when she told state legislators that COVID-19 vaccines made people magnetic has had her medical license reinstated after it was suspended for failing to cooperate with an investigation.
The Ohio State Medical Board recently voted to restore Sherri Tenpennys license after she agreed to pay a $3,000 fine and cooperate with investigators.
Tenpenny, an osteopathic doctor, has been licensed in Ohio since 1984. She drew national attention in 2021 when she testified before a state legislative panel in support of a measure that would block vaccine requirements and mask mandates.
During her remarks, Tenpenny claimed that COVID-19 vaccines made their recipients magnetic, interface with cell towers and interfered with womens menstrual cycles.
Roughly 350 complaints were soon filed about Tenpenny with the medical board, which regulates physicians and can discipline them for making false or deceptive medical statements. A probe was launched but Tenpenny refused to meet with investigators, answer written questions or comply with a subpoena ordering her to sit for a deposition.
Tenpennys license was suspended in August 2023 on procedural grounds for failing to cooperate with the investigation. Her attorney had told the board she wouldnt participate in an illegal fishing expedition.
The board voted 7-2 last month to restore her license, with proponents saying she had met the requirements for reinstatement.
Tenpenny announced the reinstatement in a post made on the X social platform.
Standing strong and steadfast! she wrote. Thank you all for your unwavering love and support but most importantly for your prayers during these challenging times.
'I am told I'm not real.'
The COVID-19 vaccines are estimated to have prevented millions of hospitalizations and deaths. However, even the best vaccines can lead to rare but serious side effects, which doesn't negate the vaccines' benefit or suggest people should stop taking them, Mandavilli reports.
Nearly 667 million doses of COVID-19 vaccines have been doled out. Now, some Americans believe their serious conditions are a result of their vaccinations, but feel they aren't receiving much support or acknowledgement.
Michelle Zimmerman, 37, said that within minutes of receiving her COVID-19 vaccine from Johnson & Johnson (J&J), she felt pain racing up her left arm to her left ear and down her fingertips. Days later, she was extremely sensitive to light and had difficulty remembering simple facts.
Zimmerman has a Ph.D. in neuroscience and, until then, was able to ride her bicycle 20 miles, teach a dance class, and give a lecture on artificial intelligence all in one day. Now, over three years later, she lives with her parents and has been diagnosed with brain damage, unable to work, drive, or stand for long periods of time.
Shaun Barcavage is a 54-year-old nurse practitioner in New York City who worked on clinical trials for HIV and COVID-19. He said ever since his first COVID-19 shot, standing up caused his heart to race, a symptom that suggests postural orthostatic tachycardia syndrome a neurological disorder linked to both COVID-19 and, less often, vaccination in some studies.
He's also experienced stinging pain in his eyes, mouth, and genitals, which has gone away, as well as tinnitus, which is still around.
"I can't get the government to help me," Barcavage said. "I am told I'm not real. I'm told I'm rare. I'm told I'm coincidence."
Renee France, a 49-year-old physical therapist in Seattle, developed a form of facial paralysis called Bell's palsy as well as a dramatic rash across her face. Bell's palsy is a known side effect of some vaccines and has been linked to COVID-19 vaccines in other studies, Mandavilli reports.
France said that doctors were dismissive of any potential connection between her conditions and COVID-19 vaccines. The rash, which ended up being a bout of shingles, debilitated France for three weeks, so she reported it to federal databases twice.
"I thought for sure someone would reach out, but no one ever did," she said.
Gregory Poland, the editor in chief of the journal Vaccine, said a loud whooshing sound in his ears accompanied every movement since he received his first shot, but his appeals to colleagues at CDC to explore his tinnitus haven't led anywhere.
He received polite email responses, but "I just don't get any sense of movement," he said, adding "If they have done studies, those studies should be published."
Similarly, Buddy Creech, who led multiple COVID-19 vaccine trials at Vanderbilt University, said he experienced tinnitus and a racing heart for around a week after each COVID-19 shot. "It's very similar to what I experienced during acute Covid, back in March of 2020," he said.
It's possible research may find most reported side effects are unrelated to the vaccine, Creech said. "Regardless, when our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can," he said.
Federal health officials say they don't believe COVID-19 vaccines caused the illnesses described by patients like Barcavage, Zimmerman, and France, Mandavilli reports. It's possible the vaccines could cause reactions like swelling, fatigue, and fever, according to CDC, but the agency has only documented four serious but rare side effects.
Two of those side effects are associated with the J&J vaccine, which isn't available in the United States anymore Guillain-Barr syndrome, which is a known side effect of other vaccines, and a blood-clotting disorder.
CDC has linked mRNA vaccines made by Pfizer-BioNTech and Moderna to heart inflammation, or myocarditis, especially in boys and young men. CDC has also warned of anaphylaxis, which could occur after any vaccination.
Other country's health systems have linked other side effects to COVID-19 vaccines.
For example, the government in Hong Kong analyzed centralized medical records of patients after vaccination and paid people to come forward with any problems. This identified "a lot of mild cases that other countries would not otherwise pick up," said Ian Wong, a researcher at the University of Hong Kong.
That includes finding that in rare instances, the Pfizer-BioNTech vaccine led to a bout of shingles serious enough to require hospitalization.
Meanwhile, the European Medicines Agency (EMA) has linked both the Pfizer and Moderna vaccines to facial paralysis, tingling sensations, and numbness. EMA also considers tinnitus a side effect of the J&J vaccine, though American health agencies don't.
While many Americans have claimed they've experienced serious side effects of the COVID-19 vaccines, as of April, just 19% of over 13,000 vaccine-injury compensation claims have been reviewed. Of those, only 47 were deemed eligible for compensation, and just 12 paid out at an average of around $3,600.
Some experts worry that patients with real injuries aren't receiving the help they need and believe more needs to be done.
"At least long Covid has been somewhat recognized," said Akiko Iwasaki, an immunologist and vaccine expert at Yale University. However, people who say they have post-vaccination injuries are "just completely ignored and dismissed and gaslighted."
Federal officials have insisted that serious side effects of COVID-19 vaccines are extremely rare and that surveillance efforts are more than sufficient to detect any patterns of adverse events.
"Hundreds of millions of people in the United States have safely received Covid vaccines under the most intense safety monitoring in U.S. history," said Jeff Nesbit, a spokesperson for HHS.
However, former acting FDA Commissioner Janet Woodcock said she believes some recipients of the COVID-19 vaccines had uncommon but "serious" and "life-changing" reactions.
"I feel bad for those people," Woodcock said. "I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously."
Scientists at CDC are monitoring large databases with medical information on millions of Americans for any patterns that could suggest a currently unknown side effect of vaccination, according to Demetre Daskalakis, director of CDC's National Center for Immunization and Respiratory Diseases.
"We toe the line by reporting the signals that we think are real signals and reporting them as soon as we identify them as signals," he said. CDC's systems for monitoring vaccine safety are "pretty close" to ideal, he added.
Those databases include the Vaccine Adverse Event Reporting System, which is the largest database but also the least reliable, as reports of side effects can be submitted by anyone and aren't vetted, Mandavilli reports.
Researchers also look through databases that combine electronic health records with insurance claims on tens of millions of Americans and monitor the data for 23 conditions that could occur following COVID-19 vaccination.
However, there are some gaps, experts said. For example, the COVID-19 shots administered at mass vaccination sites weren't recorded in insurance claims databases, and medical records in the United States aren't centralized.
"It's harder to see signals when you have so many people and things are happening in different parts of the country, and they're not all collected in the same system," said Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations.
The fragmented healthcare system in the United States also makes monitoring vaccine side effects difficult, as the process depends on large amounts of data, Mandavilli reports.
For example, there isn't a central repository of vaccine recipients or medical records and no easy way to collect the data.
"I mean, you're not going to find 'brain fog' in the medical record or claims data, and so then you're not going to find" a signal that it could be linked to vaccination, Woodcock said. If that kind of side effect isn't acknowledged by federal officials, "it's because it doesn't have a good research definition," she added. "It isn't, like, malevolence on their part."
The rise of the anti-vaccine movement has also made it difficult for scientists to address potential side effects, some experts said.
"The sheer nature of misinformation, the scale of misinformation, is staggering, and anything will be twisted to make it seem like it's not just a devastating side effect but proof of a massive cover-up," said Joshua Sharfstein, a vice dean at Johns Hopkins University.
Ultimately, the only way to determine what conditions are side effects of COVID-19 vaccines and what are simply coincidences is intense research, Mandavilli reports.
However, NIH is conducting almost no studies on COVID-19 vaccine safety, experts noted. William Murphy, a cancer researcher who worked at NIH for 12 years, has been pushing federal officials to begin these studies since 2021.
The officials responded with "that very tired mantra: 'But the virus is worse,'" Murphy said. "Yes, the virus is worse, but that doesn't obviate doing research to make sure that there may be other options." (Mandavilli, New York Times, 5/3 [1]; Mandavilli, New York Times, 5/3 [2])
The Oxford-AstraZeneca COVID-19 vaccine is being withdrawn worldwide, according to the company.
>> Read more trending news
The announcement comes months after AstraZeneca admitted in court documents that it can cause a rare and dangerous side effect, Reuters is reporting.
The vaccine can no longer be used in the European Union after the company voluntarily withdrew its marketing authorization, according to The Independent.
As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines, the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
The company faced a class-action lawsuit that claimed the vaccine caused TTS which stands for Thrombosis with Thrombocytopenia Syndrome. TTS causes people to have blood clots and a low blood platelet count, according to The Associated Press.
The application to withdraw the vaccine was made on March 5 and went into effect on Tuesday.
Similar applications will be made in the coming months in the UK and in other countries that have approved the vaccine, according to according to The Independent.
TTS has been linked to at least 81 deaths in the UK as well as hundreds of serious injuries. AstraZeneca is facing lawsuits from more than 50 alleged victims or their surviving families, according to The Independent.
In a statement the company said: We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.
Our efforts have been recognized by governments around the world and are widely regarded as being a critical component of ending the global pandemic.
As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorizations for Vaxzevria within Europe.
