FDA approves new vaccines from Pfizer and Moderna

The Food and Drug Administration approved updated Covid vaccines from Pfizer And Modernputting vaccines on track to reach Americans within days as U.S. hospitalizations from the virus surge.

The agency has not made a decision on an updated Covid photo of Novavax.

The new vaccines from Pfizer and Moderna are approved for people 12 years and older and are authorized for emergency use for people ages 6 months to 11 years, according to an FDA release. The agency noted that last year’s Covid boosters from both companies are no longer authorized in the United States.

The Biden administration said last month that it expects new single-strain vaccines targeting the omicron XBB.1.5 variant to be available to the public by mid-September.

Vaccines still require a recommendation from the Centers for Disease Control and Prevention, which will determine who should receive the vaccines. A CDC advisory committee is expected to meet Tuesday to vote on a vaccine recommendation.

The upcoming arrival of updated vaccines reassures Americans as the country sees an increase in Covid cases and hospitalizations. Although vaccines do not currently target the dominant variants, vaccine makers have said they will still offer protection against those strains as children return to school and the weather cools.

“We hope that this season’s vaccine will be available in the coming days, pending recommendations from public health authorities,” Pfizer CEO Albert Bourla said in a statement following the approval.

He added that people can ask their doctor about receiving an updated Covid vaccine during the same appointment as their annual flu shot, “saving time now and helping prevent serious illness later when respiratory viruses will be at their peak.”

Spokespeople for Moderna and Novavax did not immediately respond to a request for comment.

Covid cases and hospitalizations remain below the summer peak the country experienced last year. The rise is fueled by newer – but closely related to XBB.1.5 – strains of the virus like EG.5 or Eris. This omicron strain accounted for 21.5% of all cases as of September 2, according to the CDC.

Meanwhile, XBB.1.5 is in decline in the United States, the CDC said.

Pfizer, Moderna and Novavax shared early trial data indicating their new shots still provide protection against Eris.

Pfizer and Moderna also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are closely monitoring.

“The updated vaccines are expected to provide good protection against COVID-19 against currently circulating variants,” the FDA said in a statement released Monday.

The upcoming vaccine rollout will be the first since the end of the US Covid public health emergency, which expired in May.

The end of this declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated vaccines directly to health care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute them free to all Americans.

Private insurers and government payers like Medicare, which cover the vast majority of Americans, should provide vaccines for free. Federal efforts such as the Biden administration’s Bridge Access Program aim to provide free Covid shots to the uninsured.

The Biden administration will urge Americans to receive an updated Covid vaccine this fall, White House press secretary Karine Jean-Pierre said last week.

“Vaccinations against Covid-19 remain the safest protection to avoid hospitalization, long-term health problems and death,” Jean-Pierre said during a press briefing.

But it’s unclear how many Americans will roll up their sleeves for another chance in the coming months.

According to the CDC, only about 17% of the U.S. population, or about 56 million people, have received the latest booster shots from Pfizer and Moderna since they were approved last September.