In a briefing document issued ahead of a two-day meeting by its vaccines advisory committee that begins today, the FDA indicated its support for Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children age six months through four years. Read More

The companies are aiming to make the booster available later this year. Read More

AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed it reduced the risk of progression to severe disease or death by 50 percent in a group of unvaccinated patients at high risk of poor outcomes. Read More

The agency said it will carefully review the new information from Novavax before it authorizes the vaccine for emergency use. Read More

Merck’s COVID-19 pill Lagevrio (molnupiravir) not only reduced the risk of hospitalization or death in patients with mild-to-moderate COVID-19 by 32.1 percent, it also reduced the chance of needing acute care visits for weeks after treatment ended, researchers reported in the Annals of Internal Medicine. Read More

Sabizabulin demonstrated a 55.2 percent reduction in deaths relative to the untreated cohort. Read More

Moderna anticipates that the Omicron-specific booster will be available in the late summer. Read More

The FDA’s Vaccines and Related Biological Products Advisory Committee voted almost unanimously yesterday for Emergency Use Authorization (EUA) of a two-dose primary series of the Novavax COVID-19 vaccine. Read More

Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Read More

The test uses anterior nasal swab samples rather than the more invasive nasopharangeal swabs. Read More

The portable eLab system provides “results comparable in quality to those provided by central lab testing,” the company said. Read More

Novavax goes before FDA’s Vaccines and Related Biologics Advisory Committee this week, seeking Emergency Use Authorization of its COVID-19 vaccine. Read More