FDA panel recommends Covid vaccine for XBB variant only

Why it matters: Some people remain at risk.

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

“I think that’s what the discussion today is about – how best to find out what’s going on in people’s arms to provide the best protection during a time when we think we will have waning immunity,” said Dr. Peter Marks, the FDA vaccine. chief. He added that winter could also bring “a new 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 situation has improved this year, but those who remain vulnerable include the unvaccinated, the immunocompromised and those with diabetes or chronic kidney, lung, cardiovascular or neurological disease. People 65 and older are also at risk, and this increases with age.

Background: Changes are underway regarding who gets hit and when.

The bivalent injections offered last fall included protection against the Omicron variant and a first Covid variant. About 20% of adults, or about 53 million, in the United States I got the booster shotrates are higher in the elderly.

Going forward with a targeted shot only on an XBB variant means that newborn babies and people with weakened immune systems may not be immune to early coronavirus variants. That shouldn’t be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.

And then: A vaccine can be offered alongside the shots against influenza and RSV.

The FDA is expected to make a more formal recommendation to vaccine makers soon. Manufacturers will have to study the new formulas and submit data to the agency. If the approvals are granted, the CDC will advise health providers on which age groups should receive the shot.

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

It remains unclear if or when vaccine makers or the FDA will consider the potential effects of administering several vaccines in the fall, including those for influenza and respiratory syncytial virus, or RSV, which are expected to become available. for pregnant women and the elderly. . Agency advisers also endorsed the use of a Anti-RSV vaccinated to protect infants.