FDA approves new COVID vaccines

The Food and Drug Administration (FDA) approved newly updated COVID-19 shots on Monday in an effort to give Americans some added protection ahead of a potential winter uptick in infections.

Outside advisors for the Centers for Disease Control and Prevention (CDC) on Tuesday will recommend who should get the shots, which are manufactured by Moderna and Pfizer-BioNTech. Once the CDC director signs off, the shots will be available to the public. 

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, on Monday. “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.”

The updated shots were designed to target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. That variant is no longer dominant, though experts and administration officials have said the vaccines should still be effective at preventing severe infection against other variants that are circulating because they're closely related.

It's not yet clear which populations health officials will consider for the shots. Last year, the CDC's advisory panel recommended only older and at-risk populations get the omicron-specific booster, but the agency decided instead to recommend everyone get the shots.

COVID-19 cases are rising, but the numbers are far below where they were at the height of the pandemic. Infections are not surging, and hospitals are far from being overwhelmed like they were at the height of the pandemic.

Over 95 percent of the U.S. population already has some level of COVID immunity, whether it's from vaccination, infection, or both. The new vaccine should provide the best protection for a few months before starting to wane, and will likely have the biggest impact on people who are older with underlying conditions, as well as some people who are immunocompromised.   

The risks of serious illness for healthy younger people are low, though any infection carries a risk of turning into "long COVID," when symptoms linger for months or even years later. 

The Biden administration is refraining from calling the updated shots a booster, likely reflecting a concern that much of the public is vaccine-fatigued and has moved on from pandemic worries. Instead, it is being marketed as an annual shot, just like the flu vaccine.

"Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine," the agency said Monday.

More than a year after the omicron boosters were rolled out, only about 17 percent of the public received a shot, and only about 43 percent of people over age 65.

The rollout of the newest shots is also complicated by the fact that they are no longer bought and distributed by the federal government, because the public health emergency expired in May. 

That puts the burden of ordering shots on hospitals, physician offices and pharmacies, and on the public for paying for it. 

Pfizer and Moderna have decided to charge up to $130 a shot, compared with $30 last year for the booster, which was produced under government contract.

People who have Medicare or private insurance likely won't face any out-of-pocket costs, unless they see a provider who is out of network. 

Uninsured or underinsured Americans will have access to free shots as part of the Biden administration’s “Bridge to Access” program, which will keep a limited supply of vaccines and therapeutics on hand to distribute free through state and local health departments, as well as pharmacies. But, they may not be available at pharmacies until mid-October at the earliest.

Some people without insurance may be able to get boosters free from safety net providers, but others may have to pay the full cost. 

--Developing