An Omicron-specific monovalent vaccine for a primary series is not recommended, the advisory group said. Read More

On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years. Read More

Enrollment is set to begin in September, with as many as 700 participants expected. Read More

The companies also plan to begin submitting data supporting a variant-adapted vaccine to the FDA in the coming weeks. Read More

An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021, primarily due to COVID-related restrictions. Read More

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 21-0, yesterday in favor of FDA emergency authorization for Moderna’s two-dose COVID-19 vaccine series in children between age six months and five years and Pfizer’s three-dose COVID-19 vaccine series in children between age six months and four years. Read More

Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to end enrollment in the study. Read More

Genedrive previously received a CE mark for the test. Read More

Results are not to be used as the sole basis for treatment or other patient management decisions, the FDA said. Read More

The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 22-0, yesterday to recommend FDA authorization of Moderna’s two-dose primary series of its COVID-19 vaccine for children between the ages of 12 and 17 and between six and 11. Read More

The FDA’s Center for Drug Evaluation and Research (CDER) is looking past the pandemic in its current goals for 2022, says Director Patrizia Cavazzoni, focusing on initiatives on rare diseases, real-world data (RWD), supply chain surveillance and increased patient engagement in drug development. Read More