CHMP Recommends Standard Marketing Authorisation for COVID-19 Vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna)

Both COVID-19 mRNA vaccines were granted conditional authorisation at the time of their approval. This imposed obligations on the companies to submit results from ongoing clinical trials and to provide additional data on the pharmaceutical quality of the respective vaccine product in view of the planned huge increase in production.

These data, as well as additional studies, including independent studies coordinated by the EU authorities, have provided data on important aspects, such as how well the vaccines prevent severe COVID-19 disease. Furthermore, the companies have provided all requested additional data on the pharmaceutical quality of the respective vaccine product.

Overall, extensive data has been generated since the introduction of these vaccines with hundreds of millions of doses administered. In view of the totality of the available data, the specific obligations are no longer considered to be decisive for the benefit-risk ratio of the vaccine products, so that the way is clear for the transition from a conditional authorisation to a standard authorisation.

The recommendation of conversion to a standard marketing authorisation applies to all existing and future adapted Comirnaty and Spikevax vaccine products, including the recently approved COVID-19 vaccine products adapted to the Omicron variant of SARS-CoV-2, Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4-5 and Spikevax bivalent Original/Omicron BA.1.

As with all medicines, Comirnaty and Spikevax continue to be closely monitored. The Paul-Ehrlich-Institut and the Pharmacovigilance Risk Assessment Committee (PRAC) at the EMA will continue to promptly assess any new data and, if necessary, take measures to protect patients.

Background - Conditional Marketing Authorisation and Conversion to Standard Authorisation

Conditional marketing authorisations are subject to conditions and are reviewed annually.

Conditional marketing authorisations were granted for the COVID-19 vaccines for the following reasons:

• There was a positive risk-benefit balance according to the available trial data.
• The vaccines targeted an unmet medical need.
• It was expected that the applicants would be able to provide more comprehensive clinical and quality data after authorisation, which was considered necessary given the novel mode of action of the vaccines and their expected very extensive use.

The CHMP now recommended conversion to a standard marketing authorisation as a result of the second annual renewal procedure. The EU Commission followed this recommendation for the vaccine Spikevax on 03 October 2022 and for the vaccine Cormirnaty on 10 October 2022.