EU and UK regulators still recommend firing 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 its importance in protecting people from COVID-19.

A British government advisory group said the vaccine should not be given to children under 30 when possible, although an official said this was “really out of the utmost caution, rather than serious problems”. of security”.

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

Now, the rise in infections caused by more infectious variants threatens to overwhelm hospitals in many EU countries – where the pace of vaccinations lags far behind Britain and the United States – and force France and others to reimburse economic and social closures.

The European Medicines Agency (EMA) received reports of 169 cases of rare cerebral blood clots in early April, after 34 million doses had been administered in the European Economic Area, according to Sabine Straus, president 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 get a blood clot by taking oral contraceptives.

In its statement, the EMA said it reminded health professionals and recipients who were aware of “the possibility of very rare cases of blood clots combined with low levels of blood platelets during the two weeks following vaccination “.

NO NEW GUIDELINES

“To date, most reported cases have occurred in women under the age of 60 in the two weeks following vaccination,” she added. But he did not publish any new guidelines.

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

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

EU health ministers began meeting shortly after the EMA statement.

The AstraZeneca shot is sold at a price, for a few dollars a dose. It is by far the cheapest and highest ever launched to date and has none of the extreme cooling requirements of other COVID-19 vaccines.

After extensive use in Britain and continental Europe, it is intended to be the cornerstone of vaccination programs in much of the developing world.

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

Experts say that even if a causal link is demonstrated, the risks to the general population of getting a severe clot are very small compared to the risks of a possible COVID-19 infection, which can also cause similar clots, or many other medications such as the birth control pill.

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

BENEFITS RISKS OF PES

Still, AstraZeneca shares fell 1.2% in a two-week low.

But the shot has been facing questions since late last year, when the drug maker and Oxford University released test data with two different efficacy readings as a result of a dosing error. .

The firm last month released the first results of its final-stage clinical trial in the United States showing that the shot was 79% effective, but then had to struggle to publish more data after a rare disapproval from health officials. of the United States, who said the data was obsolete.

The head of the British drug regulator, June Raine, said the benefits outweighed the risks for the vast majority, but that they were more balanced for younger people, for whom the risks of coronavirus infection are , on average, minors.

Wei Shen Lim, chairman of COVID-19 of the British Joint Advisory Committee on Vaccines and Vaccinations, said it was preferable for adults under 30 without underlying health conditions to receive another vaccine.

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

Scientists are exploring several possible causes of rare cerebral sinus vein clots. One theory suggests that the vaccine triggers an unusual antibody in rare cases; other researchers are studying a possible link with 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 not shared by other vaccines targeting a similar part of the virus.