Pfizer, BioNTech Report 90% Effectiveness for COVID-19 VaccineBy
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have reported positive interim efficacy data of their COVID-19 vaccine candidate, BNT162b2, from a Phase III study, which found the vaccine to be more than 90% effective in preventing COVID-19.
The data, which was reviewed by an external, independent data monitoring committee, was based on 94 confirmed cases of COVID-19 in trial participants. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90% at seven days after the second dose of the vaccine. The companies say that this means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.
The Phase III clinical trial of BNT162b2, a mRNA-based vaccine, 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 candidate as of November 8, 2020. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, the virus that causes COVID-19, as well as vaccine prevention against severe COVID-19 disease.
Pfizer and BioNTech report that the independent data monitoring committee has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The companies say they are continuing to accumulate safety data, and submission for emergency use authorization to the US Food and Drug Administration is planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November (November 2020). Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Supply pact with the EU
In a separate development, Pfizer and BioNTech have reached an agreement with the European Commission to supply 200 million doses of BNT162b2 to European Union (EU) member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.
Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency, then the European Commission will lead the process for allocation of the vaccine doses among the EU member states that have elected to receive the vaccine as part of this agreement. Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) last month (October 2020) and say they will continue regular and open dialogue with the EMA on results from their ongoing Phase III study.
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization, which aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers globally.