The Food and Drug Administration (FDA), said Friday, that the White House is pressing ahead with its plans to launch a booster campaign for COVID-19 in September using a modified vaccine for the omicron sub-variants sweeping the country.
The updated vaccine will specifically target the BA.4 and BA.5 sub variants of omicron, which are currently in circulation and fueling a new surge in hospitals. The announcement represents an acceleration of earlier plans, as the reformulated vaccine was not expected to be ready for distribution until at least October.
At the same time, the US Food and Drug Administration said it is not considering allowing a second batch of the original formulation of the COVID-19 mRNA vaccines for healthy individuals under 50 years old.
Currently, only people 50 years of age or older as well as immunocompromised people over 12 years of age are entitled to a second booster dose.
The FDA said the accelerated timeframe is possible because both Pfizer and Moderna have indicated they expect modified vaccines to be available as early as September. Earlier on Friday, the Biden administration Announced the purchase of 66 million doses Moderna’s updated COVID-19 vaccine.
Moderna’s purchase comes on top of an order placed last month for 105 million doses of Pfizer’s updated vaccine.
Combined, the agreements with Moderna and Pfizer will provide the United States with nearly 171 million booster doses of the “bivalent” vaccine in the fall and beyond, if authorized and recommended, which would not be enough for every American to get one, officials said.
The agency told manufacturers in June that the new COVID-19 booster shots should be designed to target the BA.4 and BA.5 sub-variants of the omicron, as well as the original strain, in order to give people the broadest possible protection.
According to the U.S. Food and Drug Administration, currently available vaccines have helped reduce the most severe outcomes from COVID-19, but the effectiveness of primary vaccination wanes over time against some variants, including Omicron. The first booster doses helped restore that protection, but their effectiveness is also waning.
Subvariants BA.4 and BA.5 account for the majority of new infections in the United States, according to the Centers for Disease Control and Prevention. The variant was able to evade some of the immune defenses in people who had previously been infected or had received the vaccine.
However, my first booster dose was late, which is an indication that not everyone will want an updated booster dose this fall.
When the September date was announced, the Food and Drug Administration urged people who qualify but have not yet received a booster to get one. People can get a booster dose now as well as a different injection in the fall.
However, health experts have mixed opinions about the benefit of waiting until fall when coronavirus infections rise across the country.
Some have also expressed concern about the messages, and that management is exaggerating what the footage can actually do.
“I would like to see data on the efficacy of this bivalent vaccine against infection and preventing serious disease,” Lawrence Justin, professor of public health law at Georgetown University, tweeted.
However, Justin said he was glad the management was proactive.