A committee of the European Medicines Agency (EMA) recommended converting the conditional marketing authorizations (CMA) of Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) Comirnaty and Moderna's (NASDAQ:MRNA) Spikevax COVID-19 vaccines into standard marketing authorizations.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said this recommendation covers all existing and upcoming adapted Comirnaty and Spikevax vaccines, including the recently-approved adapted Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4/5 and Spikevax bivalent Original/Omicron BA.1.
The authorizations no longer need to be renewed annually but all other obligations for the companies remain in place, the agency noted.
During the CMA certain obligations were imposed on the companies to submit results from ongoing trials and provide additional data on the pharmaceutical quality of the vaccines.
The CHMP said that trials and additional studies provided reassuring data on key aspects, such as how well the vaccines prevent severe COVID-19, and the companies also provided all requested additional data on the pharmaceutical quality of the vaccines.
CHMP added that taking into account the totality of the available efficacy and safety data from the large utilization of these vaccines, the specific obligations were no longer considered key to the benefit-risk of the products. Thus clearing way for standard marketing authorization.