Pfizer and BioNTech said a booster or third dose of its COVID-19 vaccine is safe and elicits an antibody response at levels that “significantly exceed” those seen in individuals who receive two doses of the jab. The companies revealed the Phase 1 data when announcing that it had been submitted to the FDA.
“Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable,” Albert Bourla, Pfizer’s chairman and CEO, said in a news release. “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.”
The announcement comes just days after the Centers for Disease Control and Prevention (CDC) voted to recommend COVID-19 booster shots for certain immunocompromised patients. The FDA had already expanded emergency use of Pfizer-BioNTech and Moderna’s COVID-19 vaccines to authorize a booster shot for this population
Participants involved in the trial received a booster dose 8 to 9 months after receiving their second dose of vaccine. According to the news release, the booster dose remained effective against both the beta and delta variants. Pfizer-BioNTech said it expects results from a Phase 3 trial shortly and will submit the data to the FDA.
“We continuously strive to stay at least one step ahead of the virus,” Ugur Sahin, M.D., BioNTech’s co-founder and CEO said. “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.”
Sahin went on, “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.”