EU and UK regulators continue to recommend shooting AstraZeneca despite possible blood clots

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

A British government advisory group said the vaccine should not be given to people under 30 where possible, although an official said it was “extremely careful, rather than because we have serious safety issues”.

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

Now, increasing infections caused by more contagious variants threaten to overwhelm the hospitals of many EU countries – where the rate of vaccinations is far behind in Britain and the United States – forcing France and others to re-establish social and economic closures to adjust.

According to Sabine Straus, chair of the EMA’s safety committee, the European Medicines Agency (EMA) received reports in early April of 169 cases of the rare brain blood clot, after 34 million doses were administered in the European Economic Area. The EEA consists of the 27 EU countries plus Iceland, Norway and Liechtenstein.

By comparison, four women out of 10,000 would get blood clots due to oral contraception.

In its statement, the EMA said it reminded health workers and recipients to remain aware of “the possibility of very rare cases of blood clots combined with low platelet counts occurring within two weeks of vaccination”.

NO NEW GUIDELINES

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

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

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

EU health ministers met shortly after the EMA statement.

The AstraZeneca recording is sold at a few dollars per dose. It is by far the cheapest and most volumetric introduced to date, and does not meet the extreme cooling requirements of some other COVID-19 vaccines.

After widespread use in Britain and mainland Europe, it will be the mainstay of vaccination programs in many of the developing countries.

The World Health Organization’s Vaccine Safety Advisory Panel said a causal link with low blood platelet counts “is considered plausible but not confirmed”.

Experts believe that even if a causal link is proven, the risks for the general population of getting a severe blood clot are negligible compared to the risks of possible COVID-19 infection, which can also cause similar blood clots, or from many other commonly used drugs such as the birth control pill.

“The risk of death from COVID is far greater than the risk of death from these rare side effects,” said EMA CEO Emer Cooke.

BENEFITS WEIGHTING RISKS

Nevertheless, AstraZeneca’s shares fell 1.2% at a two-week low.

But the shot has been in question since late last year when the drugmaker and the University of Oxford published trial data with two different efficiencies due to a dosing error.

The firm announced early results of its late-stage U.S. clinical trial last month that the shot was 79% effective, but then had to scramble to release more data following a rare reprimand from U.S. health officials, who said the data was obsolete.

The head of Britain’s medical 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 lower.

Wei Shen Lim, COVID-19 chair of the UK Advisory Committee on Vaccines and Immunization, said it was preferable for adults under the age of 30 to be re-vaccinated without underlying health conditions.

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

Scientists are investigating several possible causes for the rare cerebral sinus blood clots. One theory suggests that the vaccine in rare cases causes an unusual antibody; other investigators are investigating a possible link with birth control pills.

But there is no definitive evidence yet, and many experts believe it is not clear whether or not the AstraZeneca vaccine would cause a problem that is not shared by other vaccines targeting a similar part of the virus.