Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios for Omicron neutralizing antibody response consistent with regulatory requirement of superiority … [Read more…]

Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA

In the EPIC-SR study of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, as previously reported Data from standard-risk patients, both vaccinated and unvaccinated, while not all statistically significant, are supportive of efficacy data observed in EPIC-HR study … [Read more…]

Immunome Announces Data Demonstrating COVID-19 Antibody Cocktail Potently Clears Omicron BA.1 Variant in Hamster Model and Retains Activity Against BA.2 Subvariant

– Data show that combination of two antibodies in Immunome’s cocktail successfully neutralized the Omicron variant in vivo in hamsters – – IMM20253 antibody also retained activity against BA.2 subvariant in pseudovirus testing in vitro, with additional testing underway – EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B … [Read more…]