In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle.
As booster shots become increasingly available and COVID-19 vaccines for young children are introduced into pediatric offices, several potential therapeutics to battle the SARS-CoV-2 virus are lining up for regulatory authorizations.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Bicycle, Endo, Eli Lilly, Galecto, Inovio, Medimmune, Roche, Queensland University of Technology, Theoremrx, Quoin, Valirx, Venatorx, Zealand.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 7 Hills, Aldeyra, Astrazeneca, Aurinia, Axon, Clene, Compass, Equillium, Huyabio, Hyloris, Metacrine, Oncoresponse, Primmune, Rhythm, Uniqure, Vicore.
An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men.
The FDA has granted emergency use authorization (EUA) to the COVID-19 vaccine created by Pfizer Inc.-Biontech SE for use in children ages 5 through 11. This is the first EUA for a COVID-19 vaccine to be awarded for this group of roughly 28 million children in the U.S. and it comes after weeks of lengthy debate among experts about the wisdom of targeting the young demographic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Detect, Renovia.
On target with last year, a total of 87% of funds recorded in 2021 through biopharma collaborations with nonprofit entities by the end of October are focused on COVID-19 pandemic efforts. The pandemic accounts for 54% of the money collected through grants, which is still a sturdy amount but down from 76% in 2020.
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