The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) showed its support, on Thursday 15 April, for a draft delegated regulation to accelerate regulatory approval of Covid-19 vaccines when they need to be “updated”.
Vaccines that are already authorised could become less effective in the face of virus mutations and will then have to be “modified in ways that involve changing their composition so as to protect against new or multiple variant strains”, says the draft delegated regulation, unveiled by the Commission at the end of March.
The amendments would clarify which provisions are affected by the modification of the active substance of vaccines, allowing companies to focus on collecting only the necessary evidence and for the European Medicines Agency to proceed with the authorisation of modified vaccines with a more limited data set. And thus save time.
“Nothing revolutionary”, insisted Pierre Delsaux, Deputy Director-General for Health at the European Commission, to MEPs. “All we are doing is applying to Covid-19 vaccines what we are already doing for human influenza vaccines”, he said.
Citing the delegated regulation, he also recalled that changes can only be accepted “if the benefit-risk balance of the medicinal product is favourable”.
More transparency, more information
The Commission is not expected to meet much resistance in the European Parliament. The coordinators of the political groups all expressed their support for the Commission’s initiative.
“I think it is the right thing to do”, said Peter Liese (EPP, Germany), calling for the procedure to be accelerated “as much as possible”. Nicolás González Casares (S&D, Spain) also considered it very important to adapt, but called for this to be done transparently.
Although she assured the Commission of her group’s support, ID coordinator Joëlle Mélin (France) said it would be “rather illusory” to deal with mutations without more information on the origins of the virus.
Similarly, Greens/EFA coordinator Michèle Rivasi (France) recommended that upstream studies be carried out, notably on the potential influence of mRNA vaccines on DNA or on the context of the appearance of variants.
“All these remarks are important, I am obviously not neglecting them”, reacted Mr Delsaux. “But that’s not exactly what we’re talking about here”, he said, reiterating that these are only proven provisions for vaccines that have already been approved.
As of Friday 16 April, a recommendation to give an early green light to this draft delegated regulation will be put to a vote in the ENVI Committee. The latter is expected then confirm that it has no objection to the proposal.
To consult the delegated regulation: https://bit.ly/3sn1QvW (Original version in French by Agathe Cherki)