Speaking at the press briefing, EMA’s executive director, Emer Cooke said, “The committee has come to a clear scientific conclusion, this is a safe and effective vaccine. It benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks. The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
EMA began the review after some countries suspended the use of the vaccine over fears of a link to blood clots rising in people vaccinated by the AstraZeneca’s Covid-19 Vaccine.
The committee assessed and discussed preclinical and clinical trial data, published literature and adverse events related to the blood clots that have occurred during the vaccination campaign reported by vaccinees and healthcare professionals.
Emer Cooke stated that during the investigation and review, a small number of cases of rare and unusual but very serious clotting disorders were seen which then triggered a more focused preview based on the evidence available.
Dr Sabine Straus, chair of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) also present at the press briefing said, “PRAC noticed that the number of thromboembolic events reported after vaccination is lower than expected in the general population.”
As of last night, seven cases of this disseminated intravascular coagulation (DIC) and 18 cases of cerebral venous sinus thrombosis (CVST) were reported out of almost 20 million vaccinated people, noted EMA committee.
Sharing the finding of rare cases, Dr Sabine Straus said, “We have seen some very rare case reports describing specific unusual events of a combination of thrombosis and thrombocytopenia, and bleeding. In a few cases, tiny clots developed in multiple blood vessels in the first seven to 14 days after vaccination, a condition called disseminated intravascular coagulation. Also in a few cases, we saw clots developing in blood vessels, draining blood from the brain – a condition known as cerebral venous sinus thrombosis. These conditions are linked to low levels of blood platelets, also known as thrombocytopenia.”
According to Dr Sabine Straus the evidence, at the moment is not sufficient to conclude with certainty whether these adverse events are indeed caused by the vaccine or not.
She reinstated that the AstraZeneca vaccine is safe and effective in preventing Covid-19 and its benefits continue to be far greater than its risks.
Based on the occurrence of rare events, EMA has strongly recommended measures to raise awareness of the possible risks among healthcare people and vaccinated people.
EMA safety committee PRAC has recommended adding a warning to the SmPC (Summary of product characteristics) under patient leaflets and a description of these cases.
It remains very important that all side effects are closely monitored and reported to update information warning of possible risks.
The committee came to the conclusion 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,” Cooke said.
EMA also announced that it is launching additional investigations to understand more about these rare cases and conducting targeted observational studies, said the agency’s executive director.
Furthering the safety assurance, the WHO‘s global advisory committee on vaccine safety issued a statement on Friday saying, “The AstraZeneca Covid-19 vaccine continues to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world.”