• Posted September 11, 2023

FDA Approves New COVID Booster Shots

The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days.

The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID vaccines are each fully approved for those 12 and older and are authorized under emergency use for individuals 6 months through 11 years of age.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,"Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

One infectious diseases expert said the approvals matter most to vulnerable Americans.

"Having an updated booster that more closely matches circulating strains is an important tool for high-risk individuals, who still remain at risk for severe disease, hospitalization and death," said Dr. Amesh Adalja, a senior scholar with Johns Hopkins' Center for Health Security in Baltimore.

Next up? The Advisory Committee on Immunization Practices is set to meet Tuesday to make recommendations on who should get the new booster shots. Dr. Mandy Cohen, director of the U.S. Centers for Disease Control and Prevention, could sign off soon after, allowing vaccinations to begin.

In its approval, the FDA recommended the following eligibilities for Americans:

• Those aged 5 and older, regardless of previous vaccination, can receive a single dose of an updated COVID vaccine at least two months since the last dose of any COVID vaccine.
• Individuals aged 6 months through 4 years who have been vaccinated against COVID can receive one or two doses of an updated COVID vaccine (depending on the previous COVID vaccine received).
• Unvaccinated individuals 6 months through 4 years can receive three doses of the updated Pfizer COVID vaccine or two doses of the updated Moderna COVID vaccine.

The boosters target the XBB.1.5 Omicron subvariant. That's no longer the dominant variant circulating, but those that are spreading widely are closely related, and health experts say this booster will still offer some protection.

"This decision comes at a time when COVID-19 cases are once again climbing. Now, most people 6 months or older in the U.S. are eligible to receive this season's COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,"Albert Bourla, Pfizer Chairman and CEO, said in a company news release.

"We expect this season's vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,"Bourla added.

"As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," Moderna CEO Stéphane Bancel said in a company news release. "We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."

Although protection against COVID-19 wanes over time, about 97% of adults have some immunity from past COVID infections, vaccinations or both. These updated shots are expected to boost that coverage.

They will, however, come at a price. For the first time, the federal government is not covering costs of the shots.

Most people with private and public health insurance should still be able to receive them for free. Those who are uninsured may be able to get them at community health centers.

Others may have to pay. The full price is expected to be $110 to $130 per dose, according to NBC News.

Whether someone can get their shots covered, and when they can get them, will depend on their insurance, Jennifer Kates, director of the Global Health & HIV Policy Program at KFF, a nonprofit health policy organization, told NBC News.

The Biden administration has also announced a "bridge"program to offer uninsured people access to free boosters through 2024.

More information

The U.S. Centers for Disease Control and Prevention has a new risk assessment of a currently circulating strain of COVID-19.

SOURCES: U.S. Food and Drug Administration, news release, Sept. 11, 2023; Pfizer Inc., news release, Sept. 11, 2023; Moderna Inc., news release, Sept. 11, 2023; Amesh Adalja, senior scholar, Center for Health Security, Johns Hopkins University, Baltimore; NBC News