Pfizer and BioNTech announced this week that they have reached an agreement with the European Commission to supply 200 million doses of their mRNA-based vaccine candidate against SARS-CoV-2 (BNT162b2), to the EU Member States.
EC strikes agreement to supply 200 million Pfizer/BioNTech COVID-19 vaccine doses to EU Member States
The agreement also provides an option for the European Commission to order an additional 100 million doses of the vaccine. Deliveries are expected to start by the end of 2020, subject to successful clinical trials and regulatory approval.
Pfizer and BioNTech anticipated to produce up to 1.3 billion doses globally in 2021
The vaccine supply for the European Union will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. According to current projections, it is anticipated that the companies will produce up to 1.3 billion doses globally in 2021. Deliveries are expected to start by the end of 2020, subject to successful clinical trials and regulatory approval.
Should the COVID-19 vaccine candidate be approved by the European Medicines Agency (EMA), providing the achievement of successful results from the ongoing Pfizer/BioNTech Phase 3 study, the doses will be ordered by the EU Member States who have elected to receive the vaccine as part of this agreement. According to the Phase 3 study data so far, the vaccine candidate appears to be more than 90% effective.
Albert Bourla, Chairman and CEO, Pfizer stated:
“Since the onset of the pandemic, Pfizer’s priority has been to develop a safe and effective vaccine, while simultaneously scaling up our manufacturing to deliver doses before the end of the year. This is an ambitious goal but critical to halting this global pandemic. Today’s finalized supply agreement with the European Commission represents the largest initial order of vaccine doses for Pfizer and BioNTech to date and a major step toward our shared goal of making a COVID-19 vaccine available to vulnerable populations.”
Ugur Sahin, M.D., CEO and Co-founder of BioNTech commended:
“As a company founded in the heart of Europe, we are looking forward to supplying millions of people upon regulatory approval. We would like to thank the Commission and the Member States for their support and trust in our COVID-19 vaccine candidate. Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end. Only through joint efforts will we be able to do so,”
Promising initial interim efficacy data of the vaccine
Based on the initial interim efficacy analysis conducted on November 8, 2020 by the Data Monitoring Committee (DMC) from the Phase 3 clinical study, Pfizer and BioNTech announced that their mRNA-based vaccine candidate against SARS-CoV-2 has shown evidence of efficacy against COVID-19 in trial participants without prior evidence of SARS-CoV-2 infection.
The DMC has reviewed a total of 94 cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, one week after the second dose. This shows that protection is achieved 28 days after the first vaccination, which consists of a 2-dose schedule. But as the study is still ongoing the final vaccine efficacy rate may be different. To date, the DMC has not reported any serious safety concerns and the study continues as planned. The trial data will be discussed with regulatory authorities globally. Pfizer and BioNTech aim to submit data from the full Phase 3 trial for scientific peer-review publication.