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UPDATED: EU authorises Pfizer/BioNTech's COVID-19 vaccine

Authorisation closely follows CHMP recommendation

The European Commission has granted Pfizer/BioNTech's COVID-19 vaccine a conditional market authorisation (CMA) on the same day that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of the vaccine.

Earlier this month, the EMA announced that it had scheduled an ‘exceptional meeting’ of the CHMP on 21 December to review additional data for the Pfizer/BioNTech vaccine.

Originally, a meeting had been planned for 29 December, but was brought forward as the vaccine gained emergency approvals in the US, UK and other countries.

After reviewing the available data, the CHMP adopted a positive opinion of the vaccine, which will now be market as Comirnaty in the EU following the EC authorisation.

The vaccine is indicated for active immunisation to prevent COVID-19, caused by the SARS-CoV-2 virus, in individuals aged 16 years and older, in line with US and UK regulators.

Last week, Reuters reported that Germany is set to begin administering doses of the Pfizer/BioNTech vaccine on 27 December.

“The conditional marketing authorisation by the European Commission is an historic achievement. It is the first vaccine which has been developed in a large-scale trial with more than 44,000 participants and approved in less than a year to address this pandemic. This is based on the decade-long pioneering work by many scientists from all over the world. This achievement is also a testament to the successful collaboration with our partner, Pfizer,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.

“As a company founded and headquartered in the heart of Europe, we are looking forward to delivering the vaccine to Europeans in the coming days. We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalised. Moving forward, we will continue to collect efficacy and safety data in participants for an additional two years and test the vaccine against additional mutations that might occur," he added.

Last month, the EC signed a contract with Pfizer/BioNTech for the initial purchase of 200 million doses on behalf of all EU member states. This includes an option to secure an additional 100 million doses, set to be supplied when the vaccine has been proven to be ‘safe and effective’ against COVID-19.

As part of that contract, EU member states can donate doses of the vaccine to lower and middle-income countries or redirect them to other EU countries.

Following the authorisation, Pfizer/BioNTech will begin delivering the first doses of the vaccine immediately across the EU based on a distribution plan defined by the EC and contract terms.

Under the CMA process, the companies will also be required to continue to provide results from the main phase 3 trial of their vaccine, which will continue for two years.

In addition to this study, further trials will provide information on how long protection against COVID-19 lasts in vaccinated individuals, how well the vaccine is able to prevent severe COVID-19, its efficacy in protecting immunocompromised people, children and pregnant women and whether it prevents asymptomatic cases.

Article by
Lucy Parsons

21st December 2020

From: Regulatory



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