Pfizer Chairman and CEO Albert Bourla
Xinhua News Agency via Getty Images
On Monday, Pfizer and BioNTech announced they have asked the FDA to grant an emergency use authorization for their new version of a Covid-19 vaccine that’s been adapted to be specific to the BA.4/BA.5 versions of the omicron variant.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” Pfizer CEO Albert Bourla said in a statement.
The new version of the vaccine is “bivalent” — meaning that it contains both materials from the original Covid vaccine, which is already FDA approved, as well as mRNA matching the spike protein of the BA.4/BA.5 variant of omicron, which is the most rapidly-spreading version of Covid around the world.
According to Pfizer, preclinical data of the new version of the vaccine provided a strong neutralizing antibody response against both the original strain of the coronavirus as well as the circulating omicron variants. In June, the companies announced strong safety data from a clinical trial of a bivalent version of its vaccine targeted towards the original omicron variant.
Covid-19 cases have been on a slight decline over the past few days in the U.S., but the CDC reports that it’s still seeing an average of over 90,000 new cases per day, over 5,500 new hospitalizations per day, and nearly 400 deaths per day. All of these numbers are expected to rise again during the fall and winter, a concern that led the FDA in June to encourage vaccine manufacturers to develop omicron-specific booster shots in an attempt to forestall that rise.
Pfizer’s rivals are also working on omicron-specific boosters. Last week, Moderna’s bivalent omicron-booster was the first to get any type of regulatory approval when it was authorized in the U.K. Novavax has also been working on an omicron-booster, and in July signed an agreement with SK Biosciences for its manufacture.
“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” BioNTech CEO Ugur Sahin said in a statement.
