BioNTech and Pfizer announce data transfer to US FDA to support third dose of vaccine

BioNTech and Pfizer sent preliminary data to the U.S. Food and Drug Administration (FDA) in support of the third dose of the coronavirus vaccine. The company said in a press release issued Monday.

“Data obtained to date suggest that antibody levels of the third dose of our vaccine are significantly higher than levels observed after the initial two-step regimen. We are pleased to provide this data to the FDA as we continue to work together to address emerging pandemic concerns,” said Pfizer CEO Albert Burla.

As noted, adult participants in the U.S. study received a booster dose of the vaccine eight to nine months after receiving a second dose. According to the results, subjects who received the third round of vaccination had higher concentrations of neutralizing antibodies against the original SARS-CoV-2 virus (not the mutant type) and against the beta and delta strains compared to those who received the two-stage vaccination.