FDA approves new COVID vaccines

The Food and Drug Administration (FDA) on Monday approved newly updated COVID-19 vaccinations to give Americans additional protection from a possible winter surge in infections.

Outside advisers to the Centers for Disease Control and Prevention (CDC) will recommend Tuesday who should receive the shots made by Moderna and Pfizer-BioNTech. Once the CDC director gives his approval, the shots will be released to the public.

“Vaccinations remain critical to public health and continued protection against serious outcomes of COVID-19, including hospitalizations and deaths,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday. “The public can be assured that these updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We strongly encourage those who are eligible to consider vaccination.”

The updated vaccinations targeted the XBB.1.5 variant that was dominant when vaccine makers began formulating and testing a new version. That variant is no longer dominant, although experts and administration officials have said the vaccines should still be effective in preventing severe infections against other circulating variants because they are closely related.

It is not yet clear which populations health authorities will consider for vaccinations. Last year, the CDC’s advisory panel recommended that only older and at-risk populations be given the Omicron-specific booster shot, but the agency decided instead to recommend vaccination to everyone.

The number of COVID-19 cases is increasing, but the numbers are far below what they were at the height of the pandemic. Infections are not increasing and hospitals are nowhere near as overwhelmed as they were at the height of the pandemic.

Over 95 percent of the U.S. population already has some level of COVID immunity, whether through vaccination, infection, or both. The new vaccine should provide the best protection for a few months before it wears off and is likely to have the greatest effect on older people with underlying medical conditions as well as some people with weakened immune systems.

The risk of serious illness for healthy younger people is low, but any infection carries the risk of turning into “long COVID” if symptoms persist months or even years later.

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

“Unless a significantly more virulent variant emerges, the FDA anticipates that the composition of the COVID-19 vaccines may need to be updated annually, as is the case for the seasonal influenza vaccine,” the agency said Monday.

More than a year after the introduction of the Omicron boosters, only about 17 percent of the population received a vaccination and only about 43 percent of those over 65 years old.

The rollout of the latest vaccinations is also complicated by the fact that they are no longer being purchased and distributed by the federal government since the public health emergency expired in May.

That means hospitals, doctor’s offices and pharmacies will have to bear the burden of ordering vaccinations and the public to do so.

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

People who have Medicare or private insurance likely won’t have to pay out-of-pocket costs unless they see an out-of-network provider.

Uninsured or underinsured Americans will have access to free vaccinations under the Biden administration’s Bridge to Access program, which provides a limited supply of vaccines and therapeutics to be distributed free of charge through state and local health departments and pharmacies. However, they may not be available in pharmacies until mid-October at the earliest.

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

-Development