AstraZeneca Covid-19 vaccine.
The European Medicines Agency (EMA) safety committee which has investigated on the possible link between AstraZeneca-Oxford University COVID-19 vaccine and thrombolytic events or clots, on Thursday concluded that the vaccine is safe and effective, and its benefits of preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.
The committee also concluded that the vaccine is not associated with an increase in the overall risk of thrombolytic events or blood clots.
The Pharmacovigilance Risk Assessment Committee (PRAC) under European Medicines Agency (EMA) which is responsible for assessing and monitoring the safety of human medicines, has evaluated the available data related to all thrombolytic events reported after vaccination, following which several countries in European Union began suspending vaccination with AstraZeneca after incidents of clots among vaccinated people.
“We began to see a small number of cases of rare and unusual but very serious clotting disorders and this then triggered review based on the evidence available and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine,” said Emer Cooke, Executive Director of EMA.
“What the committee has therefore recommended is to raise awareness of these possible risks making sure that they’re included in the product information, drawing attention to these possible rare conditions and providing information to healthcare professionals and vaccinated people to help spot and mitigate any possible side effects,” Cooke said.
Cooke also said that the EMA will launch additional investigations to understand more about these rare cases.
“It remains very important that all side effects are closely monitored and reported so that we can evaluate them and see if there’s any need to update the information and warnings about possible risks,” Cooke said.
PRAC also clarified that it had found no evidence of a quality or a batch issue.
Sabine Straus, chair of EMA’s safety committee (PRAC) said till last night, seven cases of this disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis were reported out of almost 20 million vaccinated people.
The safety committee report comes as a huge relief for AstraZeneca COVID-19 vaccine, that’s under cloud in Europe for safety reasons. AstraZeneca vaccine – given its affordability, ease of storage and distribution – has become an important tool in global fight against the COVID-19 pandemic.
So far over 7 million people have been vaccinated in the EU with the AstraZeneca COVID-19 vaccine and 11 million have been vaccinated in the UK. India used 3.7 crore doses of COVID-19 vaccine, of which over 80 percent are AstraZeneca vaccine made by Serum Institute of India. The AstraZeneca vaccine has been approved by both EMA and WHO, about 50 countries, too, have given the go-ahead to the vaccine, which makes it one of most the widely used jabs in the world.
Cooke said that while the AstraZeneca vaccine demonstrated at least 60 percent efficacy in clinical trials and preventing coronavirus to disease, the real world evidence suggests that the effectiveness could be even higher than that.
“We’re very much aware that some member states have paused vaccinations waiting for EMA’s outcome of a review but given that thousands of people in the EU die every day… they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaign,” Cooke said.
