Pfizer and BioNTech have announced a new $3.2bn vaccine supply agreement with the US government for 105 million doses of their COVID-19 vaccine, which may include adult Omicron-adapted COVID-19 vaccines, subject to authorisation from the US Food and Drug Administration (FDA).
The doses could be delivered as early as late summer 2022 and will continue into the fourth quarter of the year. Under the agreement, the US government also has the option to purchase up to an additional 195 million doses, which would bring the total of potential doses up to 300 million.
In June, the companies shared positive results from a phase 2/3 trial of two Omicron-adapted vaccine candidates, demonstrating the safety, tolerability and immunogenicity of the two candidates, and plan to request a US Emergency Use Authorisation (EUA). In order to begin deliveries rapidly upon authorisation or approval, the companies have already begun the manufacturing process.
One vaccine is monovalent and the other is bivalent, made up from a combination of the Pfizer/BioNTech COVID-19 vaccine and a vaccine candidate designed to target the spike protein of the Omicron BA.1 variant.
Albert Bourla, Pfizer’s chairman and chief executive officer, said: “As the virus evolves, this new agreement will help ensure people across the country have access to vaccines that may provide protection against current and future variants.
“Vaccines have been and will remain critical to protecting people of all ages against COVID-19. We remain proud of our long-term partnership with the US government in helping to address this pandemic, and of the ongoing impact of vaccination efforts in the US and around the world.”
The Pfizer/BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, is authorised by the FDA under EUA for active immunisation in individuals aged six months and older.
The FDA granted Pfizer and BioNTech EUA for the vaccination of children aged six months through to four years old in June following positive results from a phase 2/3 trial. Participants aged six months to four years old were given a third 3µg dose of the vaccine at least two months after the second dose, which elicited a strong immune response comparable to people aged 16 to 25 years, who had received two doses of the vaccine.