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  • Writer's pictureThe San Juan Daily Star

FDA approves new COVID shots

A vaccine drive in Lynwood, Calif., last autumn. This year’s campaign will be the first since the end of the public health emergency, which expired in May.

By Christina Jewett and Noah Weiland

The Food and Drug Administration approved a new round of COVID boosters Monday that will arrive alongside the seasonal flu vaccine and shots to protect infants and older adults from RSV, a potentially lethal respiratory virus.

The Centers for Disease Control and Prevention was expected to follow up Tuesday with an advisory meeting to discuss who should get the new shots, by Pfizer-BioNTech and Moderna. After a final decision by the CDC’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days.

As COVID cases creep up, the trifecta of prevention measures could portend the first winter of the decade without a crush of patients overwhelming some hospitals. But a healthy winter is far from a lock: In the past year, the updated COVID vaccine made it into the arms of only 20% of adults in the United States.

Some experts view that statistic with little alarm because the number of COVID deaths slowed considerably over the past year, thanks to an increasingly immune population and higher vaccine rates among older Americans. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, the FDA’s top vaccine expert.

The FDA granted full approval for the new formulas for people who are 12 and older and authorized them to protect infants 6 months and older through age 11. The Pfizer shot was authorized in the European Union for ages 6 months and older on Aug. 31.

COVID vaccines are just rolling out in the United Kingdom this week, with the first doses going to the highest risk people in care homes, ages 65 and older as well as health and social care staff members.

Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine. That shift may reflect concern over the fatigue that some Americans have expressed about yet another round of shots against the virus.

The vaccine campaign will also be the first since the end of the public health emergency, which expired in May. In previous years, the U.S. government bought hundreds of millions of vaccine doses and distributed them for free. This year, private insurance and government payers like Medicare that cover the vast majority of Americans are expected to provide the vaccines to people for free.

But the question remains whether the private market of hospitals, clinics and pharmacies will be able to calibrate their vaccine orders to stock a realistic supply. Experts are uncertain how much demand there will be for the latest shots.

“There could be a period in here where things are a little bit chaotic, and that’s never a good situation,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group.

Also of concern in the handoff to the private market: the nation’s 23 million adults with no health insurance. The Biden administration has made plans to cover costs and offer the COVID vaccine through local clinics and major pharmacies, but some experts are worried about whether people who lack insurance will be aware of the new shots — or where to get them.

“They don’t have an insurer sending them leaflets — they may not have a usual source of care,” said Anthony Wright, executive director of Health Access, a California advocacy group. “And so the trusted messenger of their health plan, their doctor, their clinic, is not there saying, ‘It’s no cost. It’s really easy.’”

Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokesperson for Moderna, said the company had no cap on the number.

The latest shots are becoming available as COVID hospitalizations and deaths are rising slightly, albeit not to the levels of past years. In the week ended Aug. 26, there were 17,400 people admitted to the hospital — more than about 6,000 at a low point this summer. Deaths were also up to about 600 a week last month, though far lower than the weekly average of 14,000 deaths of 2021.

Once the CDC signs off, the Biden administration plans to urge the public to get their COVID and flu shots at the same time, a practice that has been studied and considered by some experts to be safe. It’s a messaging effort they expect to share with major vaccine makers, which will be marketing the COVID doses commercially for the first time.

Walgreens and CVS said they both already have the updated flu and RSV shots available in stores. Dr. Kevin Ban, Walgreens’ chief medical officer, said the chain would have the new COVID shots on hand “as soon as possible.” A CVS spokesperson said doses could be arriving later this week. Representatives of both chains said the COVID shot would be available at no cost to all who are eligible under the CDC guidelines expected Tuesday.

Targeted populations most certainly will include people 65 and older as well as those who are immunocompromised or have serious underlying medical conditions that leave them more susceptible to severe illness from the virus.

Nursing homes, which inoculated nearly all of their residents in the first waves of the pandemic, have fallen behind on booster rates: Recent Medicare data shows that about 62% of residents are up-to-date on their shots even though older adults are among the most vulnerable to severe disease and death from the virus.

The new COVID vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. They are monovalent because, unlike the earlier boosters, they do not include protection against the original virus that caused widespread infections in China more than three years ago. Although the virus has had a rotating cast of variants, experts say the new COVID jab should fortify protections against severe infection.

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