The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26
meeting of the Vaccine and Related Biological Products Advisory Committee.
Biontech SE is piggybacking on the U.K.’s lead in implementing cancer genomics in routine health care to set up a national clinical trial of personalized mRNA cancer vaccines that are based on the mutational landscape of individual tumors.
Ryvu Therapeutics SA is banking €40 million (US$41.3 million) as an initial payment from a two-pronged alliance with Biontech SE, which involves a multitarget small-molecule research collaboration in immunotherapy and a license agreement for Ryvu’s portfolio of Sting agonists.
Pfizer Inc. and Biontech SE have initiated a phase I study to evaluate the safety, tolerability and immunogenicity of BNT-162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T-cell responses and potentially broaden protection against COVID-19.
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
