The White House is moving ahead with plans to launch a COVID-19 booster campaign in September using a vaccine modified for the omicron subvariants sweeping the country, the Food and Drug Administration (FDA) said Friday.
The updated vaccine will specifically target the BA.4 and BA.5 subvariants of omicron, which are currently circulating and fueling a new increase in hospitalizations. The announcement marks an acceleration of previous plans, as the reformulated vaccine was not expected to be ready for distribution until at least October.
At the same time, the FDA said it is not considering authorizing a second booster of the original formulation of the COVID-19 mRNA vaccines for otherwise healthy individuals under the age of 50.
Currently, only people aged 50 and older as well as immunocompromised people over the age of 12 are eligible for a second booster shot.
The FDA said the accelerated time frame is possible because both Pfizer and Moderna indicated that they anticipate the modified vaccines being available as early as September. Earlier on Friday, the Biden administration announced a purchase of 66 million doses of the updated Moderna COVID-19 vaccine.
The Moderna purchase comes on top of an order placed last month for 105 million doses of Pfizer’s updated vaccine.
Combined, the two agreements with Moderna and Pfizer would make available to the U.S. approximately 171 million “bivalent” vaccine booster doses for the fall and beyond, should they be authorized and recommended, which would not be enough for every single American to receive one, officials said.
The agency told manufacturers in June that new COVID-19 booster shots should be tailored to target omicron’s BA.4 and BA.5 subvariants, as well as the original strain, in order to give people the broadest possible protection.
According to the FDA, currently available vaccines have helped reduce the most serious outcomes caused by COVID-19, but the effectiveness of primary vaccination wanes over time against certain variants, including omicron. The first booster doses helped restore that protection, but their effectiveness is also waning.
The BA.4 and BA.5 subvariants account for the majority of new infections in the U.S., according to the Centers for Disease Control and Prevention. The variant has been able to evade certain immune defenses in people who were infected previously or received the vaccine.
Still, uptake of even a first booster dose has been lagging, an indication that not everyone will want an updated booster this fall.
In announcing the September date, the FDA urged people who are eligible but haven’t yet received a booster to get one. People can get a booster now as well as a variant-specific shot in the fall.
Yet health experts have mixed opinions about the benefit of waiting until the fall when coronavirus infections are rising across the country.
Some have also expressed concern about the messaging, and that the administration is overselling what the shots will actually be able to do.
“I’d love to see the data on this bivalent vaccine’s efficacy against infections & preventing serious disease. We’re rushing toward Fall vaccines and perhaps flying blind,” tweeted Lawrence Gostin, a public health law professor at Georgetown University.
Still, Gostin said he was pleased the administration was being proactive.