Vaccines
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
In a unanimous vote, a panel of FDA advisors voted to recommend the approval of Moderna’s COVID-19 vaccine for children between the ages of six and 17 years old.
Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
Bavarian Nordic announced the U.S. Biomedical Advanced Research and Development Authority has ordered an additional 500,000 doses of its monkeypox vaccine, Jynneos.
GSK reported positive headline data from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
Takeda announced results from its Phase III clinical trial on TAK-003, its dengue fever vaccine candidate, at the Northern European Conference of Travel Medicine.
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
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