EU and UK regulators still recommend shooting AstraZeneca, despite possible link to blood clots

LONDON (Reuters) – European and British regulators said on Wednesday they had found possible links between the AstraZeneca vaccine and very rare cases of blood clots, but reaffirmed their importance in protecting people from COVID-19.

A British government advisory group said the vaccine should not be given under the age of 30, where possible, although an official said it was “really prudent, rather than because we have serious safety concerns.” ”.

More than a dozen countries have at one time suspended the use of the vaccine, which has been administered to tens of millions in Europe. But most have resumed and some, including France, the Netherlands and Germany, have set a minimum age.

Now, growing infections caused by several infectious variants threaten to overwhelm hospitals in many EU countries – where vaccination rates lag far behind Britain and the United States – and force France and other states to reimpose social and economic bottlenecks.

The European Medicines Agency (EMA) received reports of 169 cases of rare blood clots as early as April, after 34 million doses had been administered in the European Economic Area, according to Sabine Straus, chair of the EMA safety committee. . The EEA comprises the 27 EU countries plus Iceland, Norway and Liechtenstein.

In comparison, four women in 10,000 would receive a blood clot from oral contraception.

In its statement, the EMA said it reminded health professionals and beneficiaries to remain aware of “the possibility of very rare cases of blood clots combined with low levels of blood platelets that occur within 2 weeks of vaccination.”

NO NEW GUIDELINES

“So far, most reported cases have occurred in women under the age of 60 within 2 weeks of vaccination,” she added. But he did not issue any new guidelines.

Professor Frederic Adnet, head of emergency services at Avicenne Hospital in Bobigny, France, said the statement would still affect the takeover in France, where skepticism about vaccines is high.

“Today’s EMA communication will undoubtedly affect confidence in the AstraZeneca vaccine,” he said.

EU health ministers began meeting shortly after the EMA statement.

The image of AstraZeneca is sold at a price of a few dollars per dose. It is by far the cheapest and largest volume released to date and has none of the extreme refrigeration requirements of other COVID-19 vaccines.

After widespread use in the UK and continental Europe, it will be the main vaccination program in most developing countries.

The World Health Organization’s advisory panel said a causal link to low blood clot blood clots “is considered plausible, but not confirmed.”

Experts say that even if it turns out to be a causal link, the risks to the general population of getting a serious clot are very small compared to the risks of a possible COVID-19 infection, which can also cause similar clots or many other uses. widely used drugs such as the birth control pill.

“The risk of mortality from COVID is much higher than the risk of mortality from these rare side effects,” said EMA Executive Director Emer Cooke.

THE BENEFITS OF EXTERNAL RISKS

However, AstraZeneca shares fell 1.2% to a 2-week low.

But the shooting faced questions from the end of last year, when the drugmaker and Oxford University released test data with two different efficacy readings due to a dosing error.

The company published the early results of its US clinical trial last month, which show that the shot was 79% effective, but then had to fight to release more data after a rare reprimand from US health officials. , who said the data is out of date.

The head of the UK’s drug regulator, June Raine, said the benefits outweighed the risks for the vast majority, but are more balanced for younger people – for whom the risks of coronavirus infection are, on average, lower.

Wei Shen Lim, chairman of COVID-19 for the UK Joint Advisory Committee on Vaccines and Immunization, said it was preferable for unhealthy adults under 30 to be offered another vaccine.

AstraZeneca said its own studies found no higher risk of blood clots in vaccinated people than in the general population.

Scientists are exploring several possible causes of rare clots of cerebral sinuous veins. One theory suggests that the vaccine triggers an unusual antibody in rare cases; other investigators are looking for a possible link to birth control pills.

But there is still no definitive evidence and many experts say it is unclear whether or why the AstraZeneca vaccine would cause a problem that is not shared by other vaccines that target a similar part of the virus.