The European Medicines Agency (EMA) will today announce their decision on the AstraZeneca COVID-19 vaccine following a suspension on at least 11 EU states, including Ireland.
On 29 January, the organisation originally gave the green light to the vaccine developed by British-Swedish firm AstraZeneca and Oxford University.
However, earlier this week the AstraZeneca coronavirus jab was suspended in 11 EU states following a number of cases of blood clotting.
A regulator for all human and animal medicines in the 27 nations of the European Union plus the European Economic Area countries of Norway, Iceland and Liechtenstein, the EMA acts like a watchdog and tester for everything for safety and efficacy.
Since the vaccine was pulled, the EMA has remained steadfast in their 'benefits outweigh the risks' belief and that numbers of blood clot cases are no more than it would expect to normally find in the general population.
Professor of Immunology and Director of the Kathleen Lonsdale Institute for Human Health Paul Moynagh told Newstalk Breakfast:
"I'm expecting to hear the EMA continue to recommend what they have been recommending which is that the benefits are much greater than the risk.
"Having said that, what triggered this latest review is there have been some unusual cases of cerebral clotting in the vein that drains blood from the face and head towards the heart. The incidence of that, especially in Germany, has been higher than expected – but it will be difficult to come to one singular conclusion."
Professor Moynagh continued by referencing how EU member states aren't working in tandem to assess risk, choosing a 'better safe than sorry' principle overall:
"I've found the response of individual countries puzzling because if you look at the pharmacovigilance risk assessment group within the EMA, each member state has representation from its own national regulatory agency, so there's a collective judgement there and yet, we don't seem to be relying on this. So, obviously individual countries seem to have decided to apply the precaution's principle.
"I think it's alright to be ultra-cautious, but in this case, it's arguable that there's higher risk."
Furthermore, Professor Moynagh highlighted the implications of COVID-19 reinfection within the over-65s cohort:
"In Denmark, it's free to get a PCR test, you don't need a referral – so up to 10 million PCRs have been taken. In terms of reinfection, the over 65s [who have gotten their vaccine] stand at a 50% reinfection rate.
"Now there are other studies that would contradict that, and certainly, I wouldn't like to create concern – but the way our immune system works, immunity may wain but we may still have residual immunity which stops us being very sick which I think needs to be said.
"Certainly, the vaccine should give us protection in terms of preventing us from getting very sick."
Main image: A member of NHS staff holds the Oxford-AstraZeneca Covid-19 vaccine. (Photo by Dinendra Haria / SOPA Images/Sipa USA)
