Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…
Pfizer and BioNTech launch Phase 1 study of next-gen BNT162b4 COVID-19 vaccine
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have begun a Phase 1 study to investigate the next-generation BNT162b4 COVID-19 vaccine candidate that could potentially result in a stronger and more durable immune response. Known as BNT162b4, the vaccine candidate has a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are conserved across various variants. The…
Pfizer shares preliminary findings on omicron-adapted bivalent COVID-19 booster
Early data from a Pfizer-BioNTech (NYSE:PFE/Nasdaq:BNTX) Phase 2/3 study (NCT05472038) indicate that their updated omicron BA.4/BA.5-adapted bivalent COVID-19 booster works as intended. After drawing sera from booster recipients seven days after administration, investigators concluded that a single 30-µg booster dose increased omicron BA.4/BA.5 neutralizing antibody levels. In addition, they note that the updated vaccine potentially…
Moderna says Pfizer-BioNTech COVID vaccine infringed its patents
Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…
FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said…