Tweaks of approved vaccines will not have to be fully assessed, commissioner reportedly says
The EU will allow approved vaccines to be enhanced to tackle new coronavirus variants without having to go through a full approval process again before they can be used, according to reports.
The German German newspaper Augsburger Allgemeine reported on 14 February that EU health commissioner Stella Kyriakides told it: “We have now decided that a vaccine that has been improved by the manufacturer on the basis of the previous vaccine to combat new mutations no longer has to go through the entire approval process…So it will be quicker to have appropriate vaccines available without compromising on safety.”
The European Commission directed Research Professional News to a press conference at which it was asked about the remarks, and at which a spokeswoman said: “Now that we have the variants coming up, there will definitely be no need to go back to square one to adapt the vaccines…We can see what is being done currently for the flu vaccine; we see that the adaptations are faster and we will be building on these experiences.”
She added: “It is clear that there needs to be a new system for accelerated regulatory approval of Covid-19 vaccines”, and that this would be the main aim of a biodefence preparedness programme the Commission will present on Wednesday.
The EU has so far approved three Covid-19 vaccines based on the recommendation of its healthcare treatment regulator, the European Medicines Agency. Data from clinical trials indicate that some of the approved vaccines and others in development are less effective against variants of the virus that have arisen around the world in recent months.
The EMA said on 10 February that it was developing guidance for companies planning changes to vaccines to tackle new variants, and that it will soon publish a reflection paper on the data needed to support adaptations. It also said it had asked all vaccine developers to investigate whether their vaccine can offer protection against any new variants.