Pfizer and BioNTech are seeking supplementary approval for a booster shot of their SARS-CoV-2 vaccine from the US Food and Drug Administration, the New York Times reports.
FDA earlier this week approved their SARS-CoV-2 vaccine, dubbed Comirnaty, which had been available under an emergency use authorization. The companies previously reported that a third shot given six months after the two initial vaccine doses vaccine increased antibodies against SARS-CoV-2 and said a booster could combat waning immunity. While US officials initially said there was limited evidence supporting the need for a booster dose, the Biden Administration recently announced that adults who received either the Pfizer-BioNTech vaccine or the Moderna vaccine could soon be eligible for a booster.
According to the Times, Pfizer and BioNTech have now released initial findings from Phase 3 clinical trial of more than 300 people who received such a booster shot. The companies report that neutralizing antibody titers after this third dose were about three times higher than they were after the second dose. The companies say they plan to submit their findings to a peer-reviewed journal.
The Times notes, though, that some public health experts think booster shots are premature, as vaccines continue to provide protection against severe disease and hospitalization. The World Health Organization has also called for a moratorium on booster shots until more people around the world have received their first doses.