GSK aims to get the company’s respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly watched late-stage study involving older adults.
A look at some of the latest COVID-19 news includes the U.S. Food and Drug Administration’s plans to review changes to Novavax’s manufacturing process before the regulatory agency authorizes the company’s vaccine. Moderna expects to submit data to regulators soon with expectations of the company’s bivalent COVID-19 vaccine—consisting of the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine—becoming available in late summer.
Moderna announced that the company’s Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study. The booster contains the original COVID-19 vaccine, Spikevax, as well as a vaccine targeting the Omicron variant.
Moderna Inc. said on Wednesday a new version of its coronavirus vaccine produced a better immune response against Omicron than the original shot, as the drugmaker pursues a booster against a surge in infections in the fall season.
Moderna Inc. is testing potential vaccines against monkeypox in preclinical trials as the disease spreads in the United States and Europe.
The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
White House COVID-19 response coordinator Dr. Ashish Jha said on May 22 he expects a U.S. Food and Drug Administration decision on authorizing Moderna’s vaccine for children under age five within the next few weeks.