FDA panel advises vaccine makers to aim for only one Covid variant

Why it matters: Some people remain at risk.

Pfizer, Moderna and Novavax have made it clear that they need time to make tens of millions of doses of the shots that would be available in the fall.

“I think that’s what today’s discussion is about – how best to figure out what goes into people’s arms to provide the best protection at a time when we think we’re going to have waning immunity,” said Dr. . Peter Marks, the FDA’s vaccine. chief. 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 have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.

She said the picture has improved this year, but those who remain vulnerable include the unvaccinated, those with weakened immune systems and those with diabetes or chronic kidney, lung, cardiovascular or neurological conditions. People over 65 are also at risk, and this increases with age.

Background: Changes are underway in who gets the injections and when.

The bivalent shots offered last fall include protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shotwith higher rates among older adults.

Continuing a shot aimed only at an XBB variant means newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That shouldn’t be a problem, according to a briefing from a World Health Organization official, who said those variants were no longer in circulation.

What’s next: a vaccine can be offered in addition to flu and RSV shots.

The FDA is expected to issue a more official recommendation to vaccine makers soon. The manufacturers are expected to study the new formulas and submit data to the agency. If approvals are granted, the CDC will advise health care providers on which age groups should get the shot.

An FDA spokesperson said it expects an updated vaccine to be available by the end of September, assuming the data supports safe and effective vaccines.

It remains unclear if and when vaccine makers or the FDA will investigate the potential effects of administering multiple vaccines in the fall, including those for influenza and respiratory syncytial virus, or RSV, which are expected to be available to pregnant people and older adults . . Agency advisers have also approved the use of an RSV antibody shot to protect babies.