Pfizer Inc. (NYSE: PFE) and BioNTechSE (NASDAQ: BNTX) have submitted phase one data to the US FDA supporting the evaluation of a booster or third dose of their COVID-19 vaccine for future licensure.
Pfizer submits data booster dose study to FDA
Albert Bourla, Pfizer CEO, said, “With the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus. The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”
BioNTech CEO Ugur Sahin commented, “We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future.”
Pfizer and BioNTech evaluate booster dose
The companies submitted phase I data evaluating immunogenicity, tolerability, and safety of a third booster dose of their vaccine in US adult participants. The participants were given a 30-µg dose of the vaccine 8-9 months after the second dose. Results indicate that the booster dose elicited considerably high neutralizing antibodies against the wild-type strain of the virus as well as against the delta and beta variants.
Sahin added, “This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.”
