The US Department of Health and Human Services (HHS) and the Department of Defense reached an agreement with Pfizer and BioNTech to receive the first 100 million doses of their coronavirus disease 2019 (COVID-19) vaccine candidate, BNT162, following emergency use authorization (EUA) or approval from the Food and Drug Administration (FDA).
Pfizer and BioNTech will be paid $1.95 billion by the US government upon receipt of the 100 million doses and Americans will receive the vaccine for free. The US government also has the option to acquire a further 500 million doses. “Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar.
The Companies are developing 4 vaccines as part of their BNT162 development program. Two of these vaccine candidates, BTN162b1 and BTN162b2, have been granted Fast Track status by the FDA. Both vaccines are nucleoside-modified messenger RNA (modRNA) vaccines. The Companies recently announced positive preliminary results from a phase 1/2 study evaluating BNT162b1. Findings showed the vaccine produced neutralizing antibody responses similar to those seen in convalescent human serology samples obtained from patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Based on these positive findings, a phase 2b/3 trial, which may include upwards of 30,000 individuals, is anticipated to begin later this month. The Companies hope to have enough data to seek EUA or some form of regulatory approval by October 2020.
“We are pleased to have signed this important agreement with the US government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech. “We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon.”
The BNT162 program is based on BioNTech’s proprietary mRNA technology and is supported by Pfizer’s vaccine development and manufacturing capabilities. BioNTech is the market authorization holder and will hold all trademarks for the potential product. Both Companies have expressed interest in supplying to the COVAX Facility, a mechanism that aims to provide governments with early access to COVID-19 candidate vaccines.
According to the Companies, manufacturing efforts are already increasing to keep up with potential demand. If a vaccine is approved, the Companies expect to produce up to 100 million doses by the end of 2020 and possibly more than 1.3 billion doses by the end of 2021.