Why it matters: Some people remain at risk.
Pfizer, Moderna and Novavax have made it clear they need time to make hundreds of millions of doses of the shots to be available in the fall.
“I think that’s what the discussion is about today – how best to come up with what goes into people’s arms, how to best provide protection during a period when we think we’ll have waning immunity, “FDA’s Vaccines Dr. Peter Marks said pres. He added that winter could also bring “further evolution of the virus”.
Since the start of the pandemic, 6.2 million hospitalizations and 1.1 million deaths in the United States have been attributed to the virus, according to data presented by Natalie Thornberg, a vaccine expert at the Centers for Disease Control and Prevention.
He said the picture has improved this year, but those who remain vulnerable include the non-vaccinated, the immunocompromised and those with diabetes or chronic kidney, lung, heart or neurological diseases. People 65 and older are also at risk, and it increases with age.
Background: Changes are afoot in who gets the shots and when.
The bivalent shots offered last fall included protection against the Omicron version and the early Covid version. about 20 percent of adults in the United States, or about 53 million got a booster shotwith higher rates among older adults.
Proceeding with a shot targeted at only one XBB variant means that newborns and people with compromised immune systems may not have immunity against early coronavirus variants. That shouldn’t be a problem, according to a briefing given by a World Health Organization official, who said those versions were no longer in circulation.
What happens next: A vaccine may be given along with the flu and RSV jabs.
The FDA is expected to make a more official recommendation to vaccine makers soon. Manufacturers will be expected to study the new formula and submit data to the agency. If approval is granted, CDC will advise health providers about which age groups should receive the vaccine.
An FDA spokeswoman said it expected an updated vaccine would be available by the end of September, assuming data support safe and effective vaccines.
It is unclear if or when vaccine makers or the FDA will examine the potential effects of administering several vaccines in the fall, including those for flu and respiratory syncytial virus, or RSV, which are expected to be available to pregnant people and older adults. Is. , The agency’s advisories have also supported the use of the RSV antibody shot to protect infants.