If authorized by FDA, will arrive in time for possible fall and winter surges
Pfizer and BioNTech have completed a submission to FDA requesting emergency use authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for people 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine—alongside pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine—to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has allowed us to develop, test, and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” says Albert Bourla, Pfizer’s chairman and CEO. “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."
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is found in the original Pfizer-BioNTech COVID vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste
March 24th 2025Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals. The packaging industry is meeting the moment with advances of its own, including high-performance, environmentally-friendly materials that allow life science companies meet stringent thermal requirements and ambitious CO2e reduction goals. In this episode, TemperPack’s CEO Peter Wells shares insights from working with life sciences to move to certified biobased, home compostable, and curbside recyclable shipping solutions.