The meeting of the EMA’s human medicines committee (CHMP) to consider a conditional marketing authorisation application for Pfizer/BioNTech’s vaccine, originally scheduled for December 29, has been brought forward to December 21. A favorable opinion on Monday could see the vaccine authorized in Europe few days after.
The technology from Germany’s BioNTech, developed with US partner Pfizer, would become the first COVID-19 vaccine available in Europe.
Pfizer and BioNTech started a rolling review for its mRNA vaccine BNT162b2 with the EMA in October, allowing the regulator to start assessing available data from pre-clinical studies. It submitted its conditional marketing authorisation application on December 1. Following a request from the EMA for additional data, this information was received yesterday.
“The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” says the EMA in a statement today.
If the CHMP recommends a marketing authorization, the European Commission will fast track its decision-making process with a view to authorizing the vaccine across EU and EEA Member States ‘within days’.
The EU has made an agreement with Pfizer/BioNTech for up to 300 million doses. Deliveries are ready to start by the end of this year, if regulatory authorization is obtained. Vaccine supply for the EU will be produced by BioNTech’s manufacturing site in Germany and Pfizer’s manufacturing site in Belgium.
The Pfizer/BioNTech vaccine is gathering authorizations from regulators around the world: including the US, UK, Canada and Singapore.
EU regulatory approval for COVID-19 vaccines
In the EU, CMAs allow for the authorization of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.
CMAs are being used in the context of the COVID-19 pandemic to promptly respond to the public health threat. However, the data must show that the benefits of the medicine or vaccine outweigh any risks.
Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.
Key steps for COVID-19 vaccine applications:
- Start of rolling review
- Submission of Conditional Marketing Authorization request: which completes the rolling review process
- EMA studies the data and sends its recommendation to the European Commission
- The European Commission will then fast-track its process to validate a CMA 'within days'.
- Vaccines will be distributed to Member States on a pro-rata basis according to the number of cases. National authorities will create their own vaccination policies.
- Companies must continue to provide data, such as monthly safety reports, to the EMA according to deadlines set out by the authority.
The EMA is currently evaluating four COVID-19 vaccines: Pfizer/BioNTech and Moderna (both of which have submitted an application for conditional marketing authorisation); and Janssen and AstraZeneca’s candidates (which are under rolling reviews). Moderna's CHMP meeting is scheduled for January 12.
The EU currently has six vaccine supply agreements in place: with AstraZeneca, Sanofi/GSK, Janssen, Pfizer/BioNTech, CureVac and Moderna.