FDA

CDC Director Rochelle Walensky has signed off on updated versions of the Moderna and Pfizer-BioNTech vaccines that target the original virus and the omicron subvariants.

The new shots from Moderna and Pfizer-BioNTech target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now.

The Food and Drug Administration is planning to authorize a new generation of COVID-19 boosters this week that for the first time will target the omicron variant.

Pfizer has submitted data on its bivalent COVID-19 booster shot that specifically targets the latest omicron subvariants. If authorized, the company says the shots could be ready as soon as September.

A new FDA rule allows adults with perceived mild to moderate hearing loss to buy hearing aids over the counter. Efforts to make them more affordable and accessible have been in the works for years.

The Biden administration is allowing the shot to be given between layers of skin — a method that only requires a fifth of the full dose — in order to increase vaccinations and slow the outbreak.

The U.S. federal agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.

A committee of experts voted unanimously to recommend that the Food and Drug Administration authorize COVID-19 vaccines from Moderna and Pfizer-BioNTech for children as young as 6-months-old.

A multistate outbreak of norovirus illnesses linked to raw oysters from Canada is under investigation in 13 states by the FDA.

The BA.2 strain now accounts for more than half of all coronavirus infections nationwide, the CDC estimates. Although it's fueling a surge in Europe, the variant doesn't appear to make people sicker.