Contract Pharma Staff11.11.20
Pfizer and BioNTech SE have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to EU Member States, with an option to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.
The vaccine doses will be produced at BioNTech’s German manufacturing sites, as well as Pfizer’s manufacturing site in Belgium. If the vaccine candidate is approved by the EMA, then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.
The first interim efficacy analysis from the Phase 3 study indicates a vaccine efficacy rate above 90% at 7 days after the second dose. This means that protection may be achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
The BNT162 program is based on BioNTech’s mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. Two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. FDA, with Phase 1/2 studies currently ongoing in the U.S. and Germany.
The Phase 3 trial of BNT162b2 began on July 27, 2020 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine. The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will also include, with the approval of the U.S. FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose.
The vaccine doses will be produced at BioNTech’s German manufacturing sites, as well as Pfizer’s manufacturing site in Belgium. If the vaccine candidate is approved by the EMA, then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.
The first interim efficacy analysis from the Phase 3 study indicates a vaccine efficacy rate above 90% at 7 days after the second dose. This means that protection may be achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
The BNT162 program is based on BioNTech’s mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. Two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. FDA, with Phase 1/2 studies currently ongoing in the U.S. and Germany.
The Phase 3 trial of BNT162b2 began on July 27, 2020 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine. The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will also include, with the approval of the U.S. FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose.
