The European Medicines Agency (EMA) said on Wednesday that a specific combination of unusual blood clots with a low platelet count should be listed as a side effect of the vaccine, but that its use should be restricted. The benefits of the shot outweigh the risks and Covid-19 is a ‘very serious disease’, he added.
British regulators have taken a more cautious approach, saying that healthy adults should get among 30 other vaccines. Officials described the move as a ‘course correction’ that would not derail the country’s rapid vaccination program.
EMA officials said they looked at 18 deaths in their analysis. These deaths have been reported in 62 cases of coagulation in the sinuses draining blood from the brain, and 24 cases of coagulation in the abdomen. The cases were reported in an EU safety database of European countries, including the United Kingdom, where about 25 million people received the AstraZeneca vaccine.
“First of all, I would like to start by saying that our safety committee (the Pharmacovigilance and Risk Assessment Committee or PRAC) … has confirmed that the benefits of the AstraZeneca vaccine to prevent Covid-19 in general outweigh the risks of side effects, “Emer Cooke, executive director of the EMA, said at a news conference.
PRAC chairperson Sabine Straus reiterated that cases of severe blood clotting with a low platelet count were extremely rare, but when journalists disputed this, it was conceded that the EMA did not have the data to understand the extent to which the benefits may still outweigh the risks for specific groups, according to age. or sex, for example.
“At the moment, this is something that is very difficult to answer because of the clinical trials … we do not have all the age-stratified data available,” Straus said, adding that the agency plans to obtain the data and further analysis to undertake.
Cooke said no clear risk profile was found when the safety committee looked at the age and gender of people reporting these rare side effects, although a statement published earlier by the EMA made clear that most cases reported in women under 60 years of age. age within two weeks after vaccination. ”
The EMA statement said health workers and people receiving the vaccine were asked to “remain aware of the possibility that very rare cases of blood clots may be combined with a low platelet count within two weeks of vaccination.”
UK authorities have also concluded that the benefits in most age groups outweigh the risks, but they have presented data showing that the benefits for people under 30 outweigh the risks slightly than in scenarios where exposure to the virus is limited is. Those who have already received the first AstraZeneca shot should be offered the second time, they said.
Following a review of data from the EMA and the United Kingdom, the World Health Organization said in a statement on Wednesday that ‘based on current information, a causal link between the vaccine and the incidence of low blood platelet counts is considered plausible, but it is not confirmed. studies are needed to fully understand the potential link between vaccination and possible risk factors. ‘
What does the data say?
British Deputy Chief Medical Officer Jonathan Van-Tam on Wednesday presented charts showing the balance between risks and benefits for each age group in getting the AstraZeneca vaccine in the UK.
This has shown that the vaccine offers only fewer benefits than the risks for people under 30, in scenarios where people are not very exposed – such as those who work from home. The analysis considered the probability of being admitted to intensive care to be the most important criterion.
People who are outside the age recommendation must make their own decision on whether to accept a vaccine against AstraZeneca, said the chairman of the British Vaccine and Immunization Committee of the United Kingdom, Wei Shen Lim.
“For someone who is 31 and 32, I think they have to decide for themselves what they want to do about vaccination,” he said. “We would still say that the balance is in favor of vaccination because of the risks of Covid-19 and the protection that the vaccine provides.”
Vaccine safety concerns are the latest headache for pharmaceutical company AstraZeneca, which was in the midst of a civil war between the European Union and the UK as it fell short of tens of millions of doses on its EU delivery targets, while it looks as if it were good with its stock to the UK.
The company has also been scrutinized by drug regulators, including the U.S. Food and Drug Administration, for presenting outdated clinical trial data and earlier for mixing data from separate trials done differently.
AstraZeneca did not immediately respond to CNN’s questions regarding Wednesday’s announcements by EMA and the MHRA.
CNN’s Richard Allen Greene, Schams Elwazer, Ivana Kottasová, Chloe Adams and Zahid Mahmood contributed to this report.