Pfizer and Moderna apply for European COVID-19 vaccine authorization
The EMA says opinions on both mRNA vaccines could be issued 'within weeks', depending on whether it considers the data submitted robust enough to conclude on the quality, safety and effectiveness of the vaccine.
It has pledged to continue working on assessments over the Christmas period: setting out dates 'at the latest' for extraordinary meetings of the scientific committee for human medicines (CHMP) as follows: Pfizer on December 29 and Moderna on January 12.
Pfizer and BioNTech started submitting data – such as non-clinical data and ingredients and manufacturing information – in a rolling review at the beginning of October. This has been followed with clinical data: such as from a Phase 3 study which reported 95% efficacy and no safety concerns.
Going by today's timeline set out by the EU, the UK and US can be expected to decide on authorization of the Pfizer vaccine before the EU. Authorization in the UK is reported to be a matter of days away: with distribution potentially starting next week. In the US, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet with Pfizer on December 10 as it considers its request for Emergency Use Authorization.
BioNTech suggests the vaccine could potentially be in use in Europe by the end of 2020.
Rolling submissions are also under way in Australia, Canada and Japan; with plans to submit applications to other regulatory agencies around the world.
Conditional Marketing Authorization
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 mRNA vaccine has been developed by US giant Pfizer and Germany’s BioNTech.
“As a company located in the heart of Europe, today’s milestone [of submitting an application for conditional marketing authorization in the EU] is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech.
“We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”
Earlier this month, the European Union agreed a deal with Pfizer and BioNTech for up to 300 million doses of the vaccine.
While Pfizer started its rolling review with the EMA at the beginning of October, Moderna's started on November 17. Its CHMP meeting is set for January 12 'at the latest'.
Moderna's mRNA vaccine candidate, mRNA-1273, targets the virus' spike (S) sportein and was co-developed by Moderna and investigators from the US NIAID Vaccine Research Center.
Moderna's primary efficacy analysis of the Phase 3 COVE study was conducted on 196 cases: 185 cases of which were observed in the placebo group compared to 11 cases in the mRNA-1273 group. Moderna says this confirms the high efficacy observed at the first interim analysis earlier this month with a vaccine efficacy of 94.1%.
Moderna submitted its request for Emergency Use Authorization to the US FDA yesterday. A meeting with the VRBPAC is scheduled for December 17, one week after Pfizer.
Moderna and the European Union have reached a deal for the supply of 160 million doses.