EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. 
The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide. 
The European Commission approved a sixth contract under the EU Vaccines Strategy, this time with the pharmaceutical company Moderna. The contract provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19.