The Biden administration is planning to offer the next generation of COVID-19 boosters to Americans 12 and up some time after Labor Day in an effort to protect against an expected winter surge of the virus.
Dr. Peter Marks, the head vaccine regulator for the Food and Drug Administration (FDA), said Tuesday that his team is close to authorizing updated doses meant to target the latest version of the virus. Marks said that he is "extremely confident" that the shots are safe and will be effective since the FDA has "extremely good" data, even though these versions of the vaccines have not been tested in humans, according to The New York Times.
Both Pfizer-BioNTech and Moderna finalized their submissions to the FDA this week asking for emergency authorization of booster shots aimed at BA.5 and another subvariant of Omicron, which together account for the most COVID-19 cases in the country, the Times adds.
President Biden's chief medical adviser, Dr. Anthony Fauci, said Tuesday that "we have really got to do better to protect the American public. We are in the middle of a BA.5 outbreak here, and we are nowhere near where we want to be."
Some scientists believe that the government is moving too fast to approve new shots, since existing vaccines already strongly protect against severe cases. John P. Moore, a virologist at Weill Cornell Medicine, said that "deaths are concentrated in unvaccinated people and people with serious health conditions," and that protection from new shots could be "weak to nonexistent."
Jeremy Kamil, a virologist at Louisiana State University Health Shreveport, supports new boosters but believes that enough people already have immunity for it not to matter, saying "even if we get this out in the next 10 days, how many people are left who haven't gotten Omicron?"
However, Dr. Marks believes that the plan makes sense, since the virus has changed and immunity may wane over time, saying that if regulators wait for more data, the virus may mutate more and "we may have lost a bunch of individuals who could otherwise be sitting around at the dinner table together."
The Center for Disease Control (CDC) has scheduled a two-day meeting of its advisory panel of experts on the matter for September 1 and 2, after which CDC director Rochelle Walensky would make a final decision on introducing the new doses. The plan is to offer the new Pfizer shots to everyone 12 and older, while offering the Moderna version to adults only.
The new shots combine the original vaccine with components aimed at Omicron's recent subvariants, BA.4 and BA.5. These shots, unlike the earlier ones, have not been tested widely on humans, and have only been subjected to mice trials, the Times notes. Moderna only began human trials of the new vaccines this month, while Pfizer plans to do so later in the month, with initial data from the trails expected to be available later this year.