THE HEAD OF the European Medicines Agency (EMA) has said vaccine developers would not have to go through a full three phase regulatory process if they had to adapt their vaccine to a new strain.
Pfizer/BioNTech have already said they are confident their vaccine will be effective against mutations that originated in the UK and South Africa. The companies have also said that one of the key advantages of an mRNA vaccine is that it can be quickly adapted.
Pfizer/BioNTech have said they could change the sequence and deliver a new vaccine within six weeks if it transpires that a new variant is resistant to it.
Speaking at a webinar for the Institute of International and European Affairs (IIEA), Executive Director of the EMA Emer Cooke said the agency has been working with both Pfizer and Moderna (which has also developed an mRNA vaccine) on how their vaccines would work in the context of new strains.
“We’re asking them to study it but we hope we’ll be able to do a very adaptive process,” she said.
“They wouldn’t have to go back to the full package. We’d be able to use a lot of what we had already.”
Cooke also addressed the decision by some governments to delay the second dose of the vaccine to accelerate their roll-out. She said this has been discussed widely in European and international circles, but the EMA authorisation is based on evidence around a 21 day scheduled for the Pfizer vaccine and a 28 day schedule for the Modern vaccine.
“Now there is a bit of leeway around that that we’ve seen in the clinical trials, but how much leeway has not been studied,” she explained.
“So there’s still a lot of work to do to really be able to say definitively whether this will work or not. And we can only go on the basis of the trials that have been done and the evidence in those trials.”
This week the EMA received an application for authorisation from Oxford/AstraZeneca and started its official review. Cooke said she is “hopeful” a decision will be made by the end of January, but cautioned that these timeframes are not set in stone.
“We’re receiving new information all the time. There are there are two big trials ongoing. We know for one of them we won’t have all that information by the end of January.
But we do hope that we have sufficient [data] to be able to come to a scientific conclusion by then. I have to say, being at the same time pragmatic but quite conservative, things can go wrong and these dates depend on everything going right and us all reacting and working together to make this happen. It’s challenging, but I’m hopeful.
Cooke rejected the suggestion that the EMA has been under political pressure to expedite its regulatory process, stating that the agency is under pressure but it is pressure to “service European citizens”.
“We’re constantly thinking about how we can do better, how we can be more reactive, how we can speed up our processes,” she said.
“Since the start of this pandemic, and I can speak from the start of my tenure at EMA, we have been looking at ways to take out the more bureaucratic aspects of our processes, to try and make sure that we have a robust scientific process at the same time as eliminating things that might be unnecessary.
“So I can firmly confirm that the pressure that we have been under his pressure or responsibility towards European citizens, not political pressure.”
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