The European Medicines Agency (EMA) said on Wednesday that a particular combination of unusual blood clots with a low platelet count should be listed as a side effect of the vaccine, but stopped recommending that its use be limited. The benefits of the shot outweigh the risks and Covid-19 is a “very serious disease,” he added.
UK regulators have taken a more cautious approach, saying healthy adults under 30 should be offered other vaccines. Officials described the move as a “course correction” that would not derail the country’s rapid immunization 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 that drain blood from the brain and 24 cases of coagulation in the abdomen. The cases were reported to an EU safety database from European countries, including the UK, where a total of around 25 million people had received the AstraZeneca vaccine.
“First of all, I want to start by stating that our safety committee (the Pharmacovigilance and Risk Assessment Committee or PRAC) … has confirmed that the benefits of the AstraZeneca vaccine in the prevention of Covid-19 Overall outweigh the risks of side effects, “EMA executive director Emer Cooke said at a press conference.
PRAC President Sabine Straus reiterated that cases of severe coagulation with a low platelet count were extremely rare, but admitted, when challenged by journalists, that the EMA did not have the data necessary to understand to what extent the benefits might still outweigh the risks for particular groups, by age or sex, for example.
“At the moment it’s very difficult to answer because the clinical trials … we don’t have all the age-stratified data available,” Straus said, adding that the agency planned to get that data and d ‘undertake a more in-depth analysis.
Cooke said there was no clear risk profile found when the safety committee looked at the age and gender of those reporting these rare side effects, although a statement released by the EMA earlier said clearly that most of the reported cases “have occurred in women under 60 years of age within 2 weeks of vaccination.”
The EMA statement called on healthcare professionals and those receiving the vaccine “to remain aware of the possibility of very rare cases of blood clots associated with low blood platelet levels occurring within 2 weeks of vaccination” .
The UK authorities also concluded that the benefits outweighed the risks in most age groups, but presented data showing that the benefits for people under 30 only slightly outweighed the risks. in scenarios where exposure to the virus is limited. Those who had already received the first blow from AstraZeneca should be offered the second, however, they said.
After reviewing data from the EMA and the UK, the World Health Organization said in a statement on Wednesday that “based on current information, a cause-and-effect relationship between the vaccine and the onset low platelet count blood clots is considered plausible but not confirmed. Specialized. Studies are needed to fully understand the potential relationship between vaccination and possible risk factors. “
What does the data say?
UK Deputy Chief Medical Officer Jonathan Van-Tam on Wednesday presented charts showing the balance of risks and benefits for each age group in getting the AstraZeneca vaccine in the UK.
He showed that the vaccine offered only slightly greater benefits than the risks for people under the age of 30, in scenarios where people are not at high risk – such as those who work from home. The analysis considered the probability of being admitted to intensive care as its main measure.
People who have reached the recommended age limit should make “their own decision” whether or not to accept an AstraZeneca vaccine, said UK Joint Committee on Vaccination and Immunization chairman Wei Shen Lim.
“For someone who is 31 and 32 years old, I think they have to make their own decision as to what they want to do with the vaccination,” he said. “We would still say that the balance is in favor of being vaccinated because of the risks of Covid-19 and the protection the vaccine offers.”
The University of Oxford said on Wednesday that “the identification of rare cases of blood clots, which could be associated with the vaccine, shows that the safety system is working.”
“Safety has been our priority throughout vaccine development at the University of Oxford in 2020, and we are reassured to see that safety oversight continues under the careful scrutiny of regulators and public health authorities. as the vaccine is rolled out globally, “Andrew Pollard, professor of pediatric infection and immunity, said in a statement.
AstraZeneca said on Wednesday it was “working with regulators” to update its product information regarding possible side effects following announcements from UK and EU regulators.
“Updates to vaccine labels in the UK and EU have been requested by regulators. Neither agency has identified risk factors, such as age or gender, nor a specific cause of these extremely rare events, the events were possibly related to the vaccine and requested that they be listed as an extremely rare potential side effect, ”he said.
“Overall, these two reviews reaffirmed that the vaccine offers a high level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks,” the statement added.
Safety concerns around the vaccine are the latest headache for pharmaceutical company AstraZeneca, which has been at the center of a public war of words between the European Union and the UK as it has lost dozens millions of doses below its delivery targets to the EU, while appearing to be doing good on UK supplies.
The company has also come under close scrutiny by drug regulatory authorities, including the United States Food and Drug Authority, for submitting outdated clinical trial data and, previously, for commingling trial data. separated which were conducted differently.
CNN’s Richard Allen Greene, Schams Elwazer, Ivana Kottasová, Chloe Adams and Zahid Mahmood contributed to this report.