The announcement comes amid a late summer uptick in Covid-19. The CDC tracks the disease through hospitalizations and emergency room visits, as well as wastewater monitoring and testing of travelers at some airports. More than 12,600 Americans are hospitalized with Covid-19, and that number is rising, jumping 22% in the most recent week.
Still, the officials said, those are levels that are about one-third of where they were a year ago, largely thanks to immunity from vaccinations and prior infections.
But antibodies against Covid-19 wane over time, and many Americans are due for a tuneup. Only about 17% of those eligible got the bivalent vaccines last fall, the last time the immunizations were updated. Three vaccines are expected to be available this year. Two are mRNA vaccines, from Pfizer and Moderna, and a third protein subunit vaccine from Novavax. The Novavax vaccine uses an older type of technology that contains the spike protein of the virus that causes Covid-19, plus an ingredient that revs up the immune system to crank out antibodies against it.
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Both vaccine technologies are well-understood and safe, and they have been proven in the real world and in clinical studies to reduce the risk of hospitalization and deaths from Covid-19, the officials said.
The FDA plans to grant full licensure for the Pfizer and Moderna vaccines for people 12 and older. Vaccines for children 11 and under, as well as the Novavax vaccine, will be available under an emergency use authorization, the officials said.
The vaccines have been updated to teach the body to fight the XBB.1.5 coronavirus subvariant. They are also expected to retain potency against closely related strains. All three vaccine manufacturers say testing shows that their vaccines are effective against EG.5, the currently dominant strain in the US.
While vaccines were previously provided for free by the government, this is the first time vaccines will be provided through the commercial market. Under the Affordable Care Act, most insurance plans are required to cover the full cost of vaccines, without co-pays.