EU regulator: AstraZeneca vaccine effective; Blood clots can be a rare side effect


Updated April 7, 2021 at 11:52 a.m. ET

The European Union’s medicines regulatory agency said Wednesday that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks, but that rare blood clotting events occur should be listed as a possible side effect.

The European Medicines Agency’s assessment comes after a panel of experts reviews reports of unusual blood clots in some vaccine recipients. Officials stressed that these events are rare, saying that while they appear to be more common in women under the age of 60, there is insufficient evidence to confirm certain risk factors such as age, gender or history.

They said it was important for healthcare providers and the public to be aware of the signs and symptoms of these unusual events – including shortness of breath, persistent abdominal pain, and leg swelling – and that the vaccine product information be updated to list them as a possible side effect. They still recommend its use, stressing that the vaccine has been shown to prevent serious illness, hospitalizations, and death.

“The risk of death from COVID is much greater than the risk of death from these side effects,” said Emer Cooke, Executive Director of the European Medicines Agency. “I think it’s important that we get the message across that vaccines will help us fight COVID and we need to keep using those vaccines.”

In one opinionthe agency said health professionals and vaccine recipients should be aware of the “possibility of very rare cases of blood clots combined with low platelets that occur within 2 weeks of vaccination”.

The Regulatory Authority’s Pharmacovigilance Risk Assessment Committee found that the recorded blood clots occurred in veins in the brain and abdomen, as well as in arteries, with low platelet counts and “sometimes bleeding”.

As of Sunday, the European Union’s drug safety database recorded in the European Economic Area and the United Kingdom – where around 34 million people had received the vaccine.

Dr. Sabine Straus, the chair of the committee, said there was a “likely causal link” between the rare clots and the vaccine. It’s too early for the European Medicines Agency to find one definitive Determine the cause of the rare disease, conclusively determine risk factors, or recommend specific risk mitigation measures, officials said.

They found that a plausible explanation for the combination of blood clots and low platelets is an immune response that triggers a condition similar to that occasionally seen in patients treated with the blood thinner Heparin.

The agency said it will continue to monitor the cases and issue new recommendations if necessary. It has also commissioned further research from AstraZeneca.

“This case clearly shows one of the challenges large-scale vaccination campaigns pose,” said Cooke. “When millions of people receive these vaccines, very rare events that were not identified during clinical trials can occur.”

But it also shows that the region’s pharmacovigilance system is working, she said, as the unusual events can be quickly identified, analyzed and acted on.

The UK drug and health products regulator also released additional ones Results on Wednesday a “possible link” was drawn between the AstraZeneca vaccine and extremely rare blood clots.

It said the benefits of the syringe still outweigh any risk, but it was recommended that people at higher risk for certain types of blood clots due to a medical condition “think carefully”.

It did not recommend age restrictions on the use of the vaccine, but the UK Joint Committee on Vaccination and Immunization did called on the same day that it would be better if adults under 30 years of age were offered an alternative without any preconditions.

“We don’t advise people of any age to stop vaccinating,” said Wei Shen Lim, COVID-19 chairman of that committee, at a briefing, according to Reuters. “We recommend moving one vaccine for a certain age group over another, really out of extreme caution, and not because we have serious safety concerns.”

Last month, reports surfaced of dozens of blood clots after vaccination, several of which were fatal. That prompted more than a dozen countries, mostly in Europe, too expose temporary use of the AstraZeneca vaccine, although the European Medicines Agency and World health organization both continued to recommend its use.

Many of these countries resumed Vaccinations after an investigation by the European Medicines Agency Last month found that the vaccine’s benefits far outweigh its risks, with officials indicating that the number of “thromboembolic events” reported after vaccination was actually lower than expected in the general population.

The regulator announced on. at March 18 that his preliminary investigation concluded that the vaccine was safe, effective and that the overall risk of blood clots associated with its use was not increased, although some questions remained unanswered.

Several of the countries resuming AstraZeneca vaccinations have done so subject to conditions; French health authorities are for example recommend it only for people aged 55 and over, Germany exposed the “routine use” of the vaccine for people under the age of 60 and South Korea said Wednesday it would temporarily withhold the vaccine for anyone under the age of 60.

And on Tuesday the University of Oxford announced It paused a small study in the UK to test the vaccine on people ages 6-17 while waiting for more data on the clotting reports.

The AstraZeneca vaccine has been approved by many countries around the world, and its affordability – at just $ 4 per dose – and minimal handling requirements make it ideal for worldwide use as NPR reported.

The WHO approved the emergency vaccine in February, which is to be rolled out worldwide COVAX, an international effort to help low and middle income countries fight the pandemic. And the Biden administration said last month it was closed plans to lend Millions of cans to Mexico and Canada.

It is not currently used in the United States. The company has announced that it will be looking for it Emergency response Approval from the U.S. Food and Drug Administration, making it the fourth coronavirus vaccine available in the country.

This process also has raised some questions After an independent monitoring body said the company released data showing an incomplete picture of its effectiveness. AstraZeneca then published results that showed slightly decreased efficacy numbers: 76% effective against symptomatic COVID-19 and 100% effective against severe or critical illness and hospitalization.

Dr. Anthony Fauci, the senior medical advisor to the Biden government, said Reuters Earlier this month the US may not need to vaccinate the entire population.

“My general feeling is that given the contractual relationships we have with a number of companies, we have enough vaccine to meet all of our needs without using AstraZeneca,” said Fauci.

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