Earlier in the week Michael Kidd, acknowledged that there was likely a connection between rare blood clots and the COVID vaccine developed by AstraZeneca and Oxford. Now officials from the EMA, Europe’s top pharmaceutical regulator, acknowledge the link even though the agency’s official stance remains there is no evidence of such a connection.
The EMA declared at the conclusion of a hasty “safety review” last month that the benefits of the AstraZeneca jab far outweighed any risks, while saying it couldn’t definitively rule out the possibility that the blood clots and the vaccine might be connected. But researchers from Norway, Germany and elsewhere insist that they can show a connection. Britain reported 30+ cases of blood clots nine of them fatal .
“In my opinion, we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaluation team at the EMA
Cavaleri said the EMA would say in its review that there is a link but was not likely to give an indication this week regarding the age of individuals to whom the AstraZeneca shot should be given.reuters
In a separate interview, Armando Genazzani, a member of the EMA’s Committee for Medicinal Products for Human Use, told another Italian newspaper, La Stampa, that a connection between the jab and the clots was “plausible.”
The EMA is officially investigating 44 cases of the brain blood clots, an ailment known as a cerebral venous thrombosis (or CVST). More than 9.2M people in the EU have received the vaccine in total.
While the EMA refused to confirm the comments made by individual officials, WSJ reported Tuesday that the University of Oxford had decided to pause trials of the vaccine in the UK that involved children between the ages of 12 and 15.
An Oxford spokesman said Tuesday that while no safety issues have arisen in the trial, broader concerns about rare clotting problems in adults have triggered further regulatory reviews in the UK and Europe to investigate any potential link with the vaccine. Oxford is waiting for more information before proceeding with vaccinations to children (in trials).
The fight has heightened doubts among senior US medical officials about the company’s analysis, threatening to prolong the regulatory review, which is already months behind schedule after a separate standoff with the FDA in the fall over disclosures about the vaccine’s UK trials.