EU to Acquire Extra 100M Doses of Pfizer’s COVID-19 Vaccine

Pfizer and BioNTech recently announced that an additional 100 million doses of their mRNA COVID-19 vaccine will go to 27 European Union (EU) member states this year. 

The commitment comes just after the EU exercised its option to purchase additional doses under its Advanced Purchased Agreement from November 2020. The additional doses bring the total number of doses delivered to the EU to 300 million. 

“We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to spread at an alarming rate,” Albert Bourla, chairman and chief executive officer at Pfizer said in the announcement.  

“In partnership with the European Commission, member states and healthcare providers, we will be able to reach a total of 150 million Europeans across the continent,” Bourla continued. 

Pfizer and BioNTech’s COVID-19 vaccine, known as BNT162b2 in the US, is named Comirnaty in the EU. As part of the most recent agreement, the vaccine will be produced in the company’s manufacturing sites in Europe. 

The specific number of doses delivered will be determined according to the populations identified in EU and national guidance, Pfizer noted. 

“The additional 100 million doses will be delivered in 2021 supporting the vaccination campaigns which started two days ago in all 27 member states. Our goal remains to bring a safe and effective COVID-19 vaccine to as many people as we can all around the world,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.

Pfizer and BioNTech expect to deliver a total of nearly 1.3 billion doses of Comirnaty worldwide by the end of 2021. 

In mid- December, FDA issued the first emergency use authorization for a COVID-19 vaccine to Pfizer and BioNTech for BNT162b2 based on available data that showed the vaccine met all primary efficacy endpoints in a Phase 3 study.

Specifically, the study found that the vaccine candidate elicited an efficacy rate of 95 percent in participants without prior COVID-19 infection, as well as with and without prior infection.

The first primary objective analysis was based on 170 cases of COVID-19, of which 162 cases were observed in the placebo group and eight were observed in the vaccine group.

In all, there were 10 severe cases of COVID-19 observed in the trial: nine in the placebo group and one in the vaccine group.

Notably, researchers saw 94 percent efficacy in adults over 65 years of age. 

Just a week later, the EU granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for Comirnaty, intended for active immunization to prevent COVID-19 in individuals 16 years of age and older.

Comirnaty is the first COVID-19 vaccine to receive CMA in the EU and is currently valid in all 27 member states. 

Similar to Pfizer and BioNTech’s COVID-19 vaccine, Moderna announced at the beginning of December that its mRNA COVID-19 vaccine candidate proved 94.1 percent effective in a Phase 3 clinical trial. 

The trial, known as COVE, enrolled over 30,000 participants in the US and is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of a vaccine. 

Vaccine efficiency was observed in a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group.
And a month later, FDA issued the second emergency use authorization to Moderna for mRNA-1273. Specifically, all available data proved that the vaccine may be effective in preventing coronavirus in individuals 18 years of age and older.