The European Commission on Monday granted a conditional marketing authorisation to Pfizer and BioNTech's coronavirus vaccine BNT162b2, which will go by the name Comirnaty, with the decision coming mere hours after the Committee for Medicinal Products for Human Use (CHMP) gave its backing for the candidate. The vaccine, which is for the prevention of COVID-19 in people ages 16 years and over, marks the first candidate cleared in the EU, having already been authorised earlier this month in the UK, where a national rollout got under way on December 8, and in Switzerland.
Emer Cooke, executive director of the European Medicines Agency (EMA), said "our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine… However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of [Comirnaty]."
The Commission said EU member states and the companies are now working toward the delivery of the first doses of Comirnaty on December 26, so that vaccination days can start on December 27, 28 and 29. "Deliveries will continue in December and on a steady weekly basis during the following months," the Commission added.
The EU signed an advance purchase agreement with Pfizer and BioNTech for the initial supply of 200 million doses of their COVID-19 vaccine, with an option to request up to a 100 million more. According to the Commission, distribution of the full 200 million doses is scheduled to be completed by September 2021, and that it is working "to activate the additional 100 million doses." Financial details of the deal are confidential, but an internal document indicates that the EU has agreed to pay €15.50 ($18.90) per dose, which is slightly lower than the $19.50 per dose agreed to by the US for a first shipment of 100 million doses.
The EMA has been conducting a rolling review of the candidate since early October and its CHMP panel was originally set to convene on December 29, but that meeting was moved forward amid pressure from some EU members to speed up the process. Germany has been particularly vocal in demanding that the EMA approve the vaccine before Christmas.
The EMA said efficacy for the mRNA-based candidate, which is given as two injections at least 21 days apart, was calculated in over 36,000 participants in a Phase III trial, including people over 75 years of age. Results showed an efficacy rate of 95% based on 170 cases of COVID-19 at the final analysis. The trial also demonstrated around 95% efficacy among participants at risk of severe COVID-19, including those with co-morbidities.
Although the most common side effects were typically mild-to-moderate and resolved within a few days, the EMA said Comirnaty "will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines." Companies are required to provide monthly safety reports over and above the regular updates required by law, and "authorities will also conduct additional studies to monitor the vaccines," the EMA said.
Shortly after the UK's rollout began, regulators there warned that anyone with a "significant history" of allergic reactions should not be vaccinated with BNT162b2 after two people experienced anaphylactoid reactions following their first dose of the vaccine. Cases of serious allergic reaction have also since cropped up in the US, which authorised the vaccine for emergency use on December 11.
Ursula von der Leyen, president of the European Commission, stated that following the authorisation of this first COVID-19 vaccine, "more…will come soon." The CHMP is next slated to discuss Moderna's mRNA-1273, with a key meeting set for January 6. The FDA authorised that mRNA-based vaccine candidate late last week for use in people ages 18 and over.
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