EU and UK Regulators Still Recommend AstraZeneca Injection Despite Possible Link to Blood Clots

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

A UK government advisory group said the vaccine should not be given to anyone under 30 whenever possible, although an official said this was “really out of the utmost caution, rather than because we have serious safety concerns.”

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

Now increasing infections caused by more contagious variants threaten to overwhelm the hospitals of many EU countries – where the pace of vaccinations lags far behind Britain and the United States – and force France and others to reimpose social and economic blocks.

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

In comparison, four out of 10,000 women would develop a blood clot from oral contraception.

In its statement, the EMA said it reminded health professionals and recipients to remain aware of “the possibility of very rare cases of blood clots associated with low platelet counts within 2 weeks of vaccination.”

NO NEW GUIDELINES

“So far, most of the reported cases have occurred in women under 60 years of age within 2 weeks of vaccination,” it added. But it has not issued any new guidelines.

Professor Frederic Adnet, chief of emergency services at Avicenne Hospital in Bobigny, France, said the statement would nevertheless influence admission in France, where vaccine skepticism is high.

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

EU health ministers met shortly after the EMA statement.

AstraZeneca’s shot is sold at cost, for a few dollars per dose. It is by far the cheapest and most bulky launched to date, and falls short of the extreme cooling requirements of some other COVID-19 vaccines.

After extensive use in Great Britain and mainland Europe, it is becoming the mainstay of vaccination programs in much of the developing world.

The World Health Organization’s Vaccine Safety Advisory Panel said a causal relationship to blood clots with low platelets “is considered plausible, but has not been confirmed.”

Experts say that even if a causal relationship is proven, the risks for the general population of getting a serious clot are astonishingly small compared to the risks of possible COVID-19 infection, which can also cause similar clots, or of many other commonly used medicines such as the contraceptive pill.

“The risk of death from COVID far outweighs the risk of death from these rare side effects,” said Emer Cooke, EMA director.

BENEFITS OUTSIDE RISKS

Nevertheless, AstraZeneca’s shares fell 1.2% from its 2-week low.

But the shot ran into questions late last year, when the drug manufacturer and the University of Oxford published trial data showing two different efficacy values ​​due to a dosing error.

The company released the first results of its late-stage clinical trial in the US last month, showing the shot was 79% effective, but then rushed to release more data after a rare rebuke from US health officials, saying said the data was out of date.

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

Wei Shen Lim, COVID-19 Chair of the UK Joint Advisory Committee on Vaccines and Immunization, said it is preferable for adults under 30 with no underlying health problems to offer another vaccine.

AstraZeneca has said its own studies have not found a higher risk of blood clots in vaccinees than in the general population.

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

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