The Biden administration is aiming for a mid-September rollout for reformulated Pfizer and Moderna COVID-19 booster shots, after both companies promised they would be able to deliver doses by then, according to the New York Times, citing people familiar with the deliberations.
The new versions are expected to perform better against then now-dominant (yet far more mild than Delta) BA.5 Omicron subvariant, though the Times notes that data on the reformulated shots is still preliminary.
As such, federal officials have decided not to expand eligibility for the next round of existing boosters this summer - which have only been approved for Americans over 50, or those over the age of 12 who have immune deficiencies.
Dr Fauci, interestingly enough, apparently didn't get his way, as the Times reports that he was pushing for more of the current vaccine to go into arms before the reformulated version is ready.
In internal deliberations, some senior health officials argued that eligibility for a second booster should be broadened before the reformulated version is ready because coronavirus infections are on the rise again. Dr. Anthony S. Fauci, the president’s chief medical adviser, and Dr. Ashish K. Jha, the White House pandemic response coordinator, both advocated that position. -NYT
"I think there should be flexibility and permissiveness in at least allowing" a second booster for younger Americans, Fauci told the Times earlier this month.
Another alternative under discussion was offering the shots only to a subset of younger, at-risk individuals - such as pregnant women (who don't have periods to disrupt!).
The FDA and the CDC, however, said the government should concentrate on a fall campaign for the reformulated doses, as long as they were ready for 'prime time' (disregarding the typical decade of so development and safety testing for most vaccinations, of course). Both Pfizer and Moderna said millions of doses would be ready by mid-September, so regulators made the call to wait for those shots.
All adults are expected to be eligible for the updated boosters, while Children could be eligible as well according to insiders.
According to the Biden administration, anyone who is eligible for shots now should just get them as opposed to waiting for the fall - despite its reduced efficacy against Omicron vs. the original strains it was developed for.
The Times notes that "Deaths from Covid-19 are still heavily concentrated among older age groups, while hospitalizations remain well below the peak of the Omicron wave last winter."
One concern was assuring that people did not get a booster now followed by another with the updated formulation too soon after. Officials worried that, especially for young men, two boosters in close succession might elevate the risk of a rare heart-related side effect, myocarditis, that has been linked to both Pfizer’s and Moderna’s vaccines.
For other reasons, immunologists warn against receiving booster shots in short intervals. -NYT
"You can’t get a vaccine shot Aug. 1 and get another vaccine shot Sept. 15 and expect the second shot to do anything," said La Jolla Institute of Immunology virologist, Shane Crotty. "You’ve got so much antibody around, if you get another dose, it won’t do anything."
"The antibodies stop that next dose from working" if the next dose is administered too early, he continued.
It will be interesting to see how many people actually get booster shots, given that federal officials are already concerned over the 'public's patience with additional shots,' according to the Times, which notes that the number of people getting the jab has been dropping more with each new one offered - to the point where fewer than 30% of eligible Americans have elected to receive a second booster, which would be their fourth total shot.
To accomplish the rollout, the Department of Health and Human Services made an advance purchase of 105 million doses of Pfizer's reformulated offering for $3.2 billion, with a possible fall deployment in mind. A similar agreement with Moderna is expected soon.