EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines

02 December 2020

The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.

After a historically fast development process and the biggest clinical trials in world history with participation of tens of thousands of trial subjects globally, the European Medicines Agency, EMA, has now received two applications for conditional marketing authorisation of COVID-19 vaccines from the vaccine manufacturers Pfizer/BioNTech and Moderna.

In just a few weeks, the EMA expects to be able to deliver its recommendation to the European Commission on whether conditional marketing authorisations can be granted to the vaccines so that Europe, including Denmark, can start using them.

However, this will only happen if the EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses that there is solid evidence on the vaccines’ efficacy, safety and quality, and that the benefits of the vaccines, i.e. the extent to which the vaccines work on COVID-19, outweigh the possible side effects.  

The CHMP under the EMA consists of independent experts from the EU member states, including Denmark.

Extra resources to ensure a fast and thorough expert assessment

It normally takes the EMA several months to review the comprehensive documentation from the companies’ clinical trials. The fast review process is made possible only because the EMA has deployed more resources than normal to ensure a fast review without compromising its thoroughness, and because the agency already in early October for the BioNTech/Pfizer vaccine and in mid-November for the Moderna vaccine began reviewing the comprehensive documentation and started a so-called rolling review, a regulatory tool of the EMA’s emergency procedure.

Under this emergency procedure, the pharmaceutical companies submit their data to the EMA as they become available. This is different from the normal authorisation procedure according to which the companies submit all data at once at the end.

Vaccine manufacturers must submit ongoing documentation

If the European Commission issues a conditional marketing authorisation, it means that data will still be collected and that further trials will still be conducted. The vaccines will also be subjected to a particularly close monitoring of efficacy and safety after the vaccines have been authorised and are in use.

A conditional marketing authorisation means that medicines can be authorised before long-term data on efficacy and possible side effects become available, which would normally take two to three years, but only if the benefits of the medicine's immediate availability outweigh the risks of not having the normally required long-term data.

After a conditional marketing authorisation has been granted, the vaccine manufacturer must submit ongoing data to the EMA. A conditional marketing authorisation is granted for one year and may be renewed. When the authorities have received all the requested documentation, the conditional marketing authorisation may be converted into a standard marketing authorisation.

Further reading:

EMA’s press release: EMA receives applications for two COVID-19 vaccines

6 October: News from the Danish Medicines Agency: A rolling review of one more potential COVID-19 vaccine has started (BioNTech/Pfizer)

16 November (17 November in English): News from the Danish Medicines Agency: EMA starts rolling review of corona vaccine from Moderna

19 November: News from the Danish Medicines Agency: Fourth contract ensuring access to a potential COVID-19 vaccine

Danish Medicines Agency’s COVID-19 theme page: Vaccines and medicines against COVID-19.