EU authorises Pfizer/BioNTech vaccine Comirnaty switch from conditional to standard marketing authorisation

The EU’s European Commission has authorised the conversion of the conditional marketing authorisation for Comirnaty to standard marketing authorisation, as reported on Tuesday, October 11.

As mentioned on the European Medical Agency’s website, Comirnaty received a conditional marketing authorisation valid throughout the EU on December 21, 2020, which was switched to a standard marketing authorisation on October 10, 2022.

On September 16, EMA’s human medicines committee (CHMP) recommended converting the conditional marketing authorisations of the COVID-19 vaccine Comirnaty (BioNTech/Pfizer’s vaccine) into standard marketing authorisations.

“Comirnaty was granted a conditional marketing authorisation at the time of its authorisation,” the EMA wrote at the time.

“This imposed obligations on the companies to submit results from the ongoing clinical trials and to provide additional data on the pharmaceutical quality of the vaccine in light of the planned manufacturing scale-up.”

It added: “These trials and additional studies, including observational studies, have provided reassuring data on key aspects such as how well the vaccine prevents severe COVID-19. In addition, the companies have provided all requested additional data on the pharmaceutical quality of the vaccine.

“Taking into account the totality of the available efficacy and safety data resulting from the large utilisation of the vaccine, the specific obligations are no longer considered key to the benefit-risk (of the product), which has cleared the way to move from a conditional to a standard marketing authorisation.”

“The CHMP recommended their conversion to standard marketing authorisations as an outcome of the second annual renewal procedure,” it continued.

“This recommendation covers all existing and upcoming adapted Comirnaty vaccines, including the recently-approved adapted Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4/5.”

“As for any medicine, Comirnaty continues to be closely monitored,” it concluded at the time.

No official statement has been aside from the switch on the website.

What is conditional marketing authorisation?

The approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.

What is standard marketing authorisation?

The approval to market a medicine in one, several or all European Union Member States.

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