The European Medicines Agency (EMA) announced on Friday 16 September, following the meeting of its Committee for Medicinal Products for Human Use (CHMP) (12-15 September), that it recommended converting the conditional marketing authorisations granted to the Covid-19 messenger RNA vaccines Comirnaty, developed by Pfizer and BioNTech, and Spikevax, developed by Moderna, into a standard marketing authorisation. This decision is taken during the second annual renewal procedure of this authorisation.
A conditional marketing authorisation is an accelerated procedure for placing medicines on the market that can be activated in the event of a health emergency for a medicine meeting several criteria. Such an authorisation is issued on an annual renewable basis. In return, the authorisation is subject to the obligation for the companies concerned to provide the results of ongoing clinical trials and additional data relating to the pharmacological quality of the medicine.
The EMA considers that the results of the clinical trials and the additional studies required under the conditional authorisation for both vaccines have provided reassurance on the efficacy of both vaccines. The companies have provided all relevant data on the pharmaceutical qualities of the vaccine. The obligations related to the conditional marketing authorisation are therefore no longer considered crucial for the benefit-risk assessment of the product. The other obligations on medicines companies remain unchanged.
The CHMP also recommended that Comirnaty be used as a booster dose in children aged 5-11 years.
The EMA has approved a new production site for the Valneva Covid-19 vaccine in Dessau-Rosslau, Germany.
Finally, the CHMP recommends the extension of the use of AstraZeneca’s medicine Evusheld for the treatment of adults and adolescents with Covid-19 who do not require supplemental oxygen and the extension of the use of Gilead’s Veklury (remdesivir) for the treatment of Covid-19 in two paediatric populations. (Original version in French by Émilie Vanderhulst)