Just days after Australia's deputy chief medical officer, Michael Kidd, acknowledged that there was likely a connection between rare blood clots and the COVID vaccine developed by AstraZeneca and Oxford, officials from the EMA, Europe's top pharmaceutical regulator, have finally acknowledged the link, even if the agency's official stance - that there's no evidence of a link, but no evidence to rule it out - remains unchanged.
The EMA declared at the conclusion of a hasty "safety review" last month that the benefits of the AstraZeneca jab (which is expected to to be the workhorse of the global vaccination rollout as Covax, the WHO/Gates Foundation program to vaccination developing countries, expects to heavily rely on the 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 insisted they had found evidence of a connection. And after the UK acknowledged more than 2 dozen new cases of the rare clots - 9 of them fatal - it seems the dam has finally broken.
New findings from the EMA show that there is indeed a link between the "very rare" blood clots in the brain and the AstraZeneca vaccine, but the exact possible causes are still unknown, according to a senior EMA official, who made the comments in an interview with the Italian newspaper Il Messagero. Here's a Reuters summary of that report.
"In my opinion, we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine. However, we still do not know what causes this reaction," Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily Il Messagero.
Cavaleri provided no evidence to support his comment.
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.
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.
In response to Cavaleri’s comments, the Amsterdam-based EMA said in a statement on Tuesday: "EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has not yet reached a conclusion and the review (of any possible link) is currently ongoing."
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 from the UK's drugs watchdog, the Medicines and Healthcare products Regulatory Agency, before giving any further vaccinations to children or teenagers in the pediatric trial.
As WSJ reported in a critical piece about AstraZeneca's vaccine rollout published last month that the company's various battles with regulators have damaged its reputation among consumers in the US, its biggest market. 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.
We imagine the suspension of trials in the UK won't exactly help change this perception.