EU authorizes Pfizer-BioNTech COVID vaccine

Regulatory NewsRegulatory News | 21 December 2020 |  By 

The European Commission on Monday conditionally authorized Pfizer and BioNTech’s COVID-19 vaccine after receiving a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier in the day.
The fast-tracked decision shortened what is usually a two-month procedure to a matter of hours, spotlighting the dire need for a vaccine as much of Europe faces lockdowns and restrictions amid a winter resurgence of the virus. The conditional marketing authorization covers use in individuals 16 years and older paves the way for EU-wide use of the vaccine, dubbed Comirnaty (tozinameran). (RELATED: Despite data breach, CHMP set to consider Pfizer-BioNTech COVID vaccine, Regulatory Focus 15 December 2020).
“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said EMA Executive Director Emer Cooke. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.”
The EU has agreed to purchase 200 million doses of the vaccine and reportedly will exercise its option to purchase another 100 million doses, enough to vaccinate 150 million people in all. The doses are expected to be distributed to the member states later this week, with vaccinations expected to begin in some member states this weekend. In a press release, Pfizer CEO Albert Bourla welcomed the CHMP recommendation and said the company is ready to begin delivering vaccines to government-designated sites across the EU.
“I have always said, during this pandemic, that we are in this together. So vaccination can start at the same time, during the European Union vaccination days, on 27, 28 and 29 December. This is a very good way to end this difficult year, and to finally start turning the page on COVID-19,” said European Commission President Ursula von der Leyen.
Despite the rapid pace of EMA’s review—reaching a decision just 11 weeks after beginning rolling review of the vaccine—the agency has faced criticism for falling behind regulators in the UK, US and elsewhere who authorized the vaccine on a temporary or emergency basis earlier this month. (RELATED: MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline, Regulatory Focus 2 December 2020; FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020).
EMA has sought to justify and differentiate its approach to getting vaccines to market by emphasizing the fact that the vaccines it recommends will be fully licensed products as opposed to the unlicensed status vaccines will hold in other jurisdictions. So far only the EU and Switzerland have licensed the Pfizer-BioNTech vaccine through traditional pathways.
“The conditional marketing authorization is actually a full authorization. All of the emergency use authorizations or temporary use authorizations are actually for the use of unlicensed vaccines, so this does create additional obligations and requirements for us as regulatory authorities to review,” Cooke said during a press conference announcing the recommendation. Cooke also noted that EMA continued to receive data from the companies that it factored into its review. “I can assure you that we have got some information that was obviously not received by some of the other regulators because it came later,” she said, without disclosing how much additional data the agency received compared to its international counterparts.
Officials at the press conference stressed that the vaccine, which was found to be 95% effective at preventing COVID-19 across age and demographic groups, should be effective against a new strain of the virus identified in the UK that is believed to spread more quickly than other strains that have spread across Europe so far.
EMA has also committed to additional transparency measures for all COVID-19 vaccines and says it will publish its assessment report and the full risk management plan for Comirnaty in the coming days, with clinical trial data set to be published on the agency’s clinical trial database in “in due course.”
Editor’s note: this article has been updated to reflect the European Commission’s decision to issue a conditional marketing authorization for Comirnaty.
EMA, European Commission


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