The Food and Drug Administration decision opens the newest shots from Moderna and Pfizer and its partner BioNTech to most Americans even if they've never had a coronavirus vaccination. It's part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot.
There's still another step: The Centers for Disease Control and Prevention must sign off. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. Vaccinations could begin later this week, and both the COVID-19 and flu shot can be given at the same visit.
COVID-19 hospitalizations have been rising since late summer although — thanks to some lasting immunity from prior vaccinations and infections — not nearly as much as this time last year.
But protection wanes over time and the coronavirus continually churns out new variants that can dodge prior immunity. It's been a year since the last time the vaccines were tweaked.
Just like earlier vaccinations, the fall round is cleared for adults and children as young as age 6 months. FDA said starting at age 5, most people can get a single dose even if they've never had a prior COVID-19 shot.
Younger children might need additional doses depending on their history of COVID-19 infections and vaccinations.
The newest shots target an omicron variant named XBB.1.5. That specific strain is no longer dominant but it's close enough to coronavirus strains causing most COVID-19 illnesses today that FDA determined it would offer good cross-protection.
These newest shots replace combination vaccines that mixed protection against the original coronavirus strain and even older omicron variants.
Like earlier versions, they're expected to be most protective against severe illness, hospitalization and death, rather than mild infection.