FDA okays new coronavirus vaccine as Best Respiratory illness variant season nears

The Food and Drug Administration on Monday approved a reformulated coronavirus vaccine in a bid to provide increased protection ahead of cooler weather — even as the nation experiences a late-summer uptick variant of covid-19 cases and hospitalizations.

The shots, which target an omicron sub variant and were cleared for everyone 6 months and older, this variant are manufactured by Moderna and by Pfizer and its German partner, BioNTech. If the Centers for Disease Control and Prevention signs off Tuesday, injections could be available in pharmacies, clinics and doctor’s offices by the end of the week.

The FDA decides who can get a shot, but it’s the CDC that recommends who should get it. That question has been vigorously debated by agency officials and its outside experts in recent days.

The CDC is leaning toward a broad recommendation that this variant covers almost all ages, mirroring the FDA approach, according to federal officials who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly.

But it is possible that some on the agency’s panel of outside experts, the Advisory Committee on Immunization Practices, will push for a targeted recommendation focused on those at greatest risk — older Americans or people with weakened immune systems or other illnesses.

The committee is scheduled to meet Tuesday on the matter and CDC Director Mandy Cohen is expected to weigh in shortly afterward, the final step in allowing the new shot to be administered.

The big question is whether health authorities should try to sell the vaccine to a covid-fatigued public “by calling attention to the groups for whom the vaccines provide the strongest potential benefit.

While many people are referring to the updated shots as boosters, they actually represent a new vaccine formula, health officials said.

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”

This is the first time the federal government is not buying all the coronavirus shots, meaning doctors, hospitals and pharmacies must order them directly.

The shots will still be free for most Americans with private health insurance or coverage through Medicare or Medicaid, said Jennifer Kates, senior vice president and director of global health and HIV policy at KFF, a health policy nonprofit. The Biden administration also is taking steps to provide the shots without cost to people who don’t have insurance.

The updated vaccines are part of a revamped arsenal of protections designed to counter an expected increase in covid, influenza and respiratory syncytial virus — known as RSV — as the weather turns cooler. Flu shots and RSV immunizations for infants and adults 60 and older are already available.

Experts interviewed by The Washington Post said they would get the coronavirus shot as soon as possible; one said he is telling his elderly parents to get their coronavirus, flu and RSV vaccinations by Halloween.

Some doctors say healthy young people who opt for the vaccine might want to wait until a bit closer to the winter holidays, when cases are expected to proliferate. It takes about two weeks for the shot to reach full effect.

But experts emphasize that covid cases, while increasing since July, remain sharply lower than in past peaks. While new covid-related hospital admissions rose to more than 17,000 for the week ending Aug. 26, the total was nearly 37,000 for the same period a year ago, the CDC says.

And the 658 weekly deaths, while higher than earlier in the summer, were far below the nearly 3,000 of a year ago. Even with the coronavirus’s ability to cause serious illness, many Americans now see it as little more than a nuisance and express scant appetite for isolating and donning masks.

Only 20 percent of eligible people received the previous booster, and many experts don’t expect the proportion to go much higher for the new version, no matter what the government recommends.