FDA OKs new coronavirus vaccine as respiratory illness 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 of COVID-19 cases and hospitalizations.

The shots, which target an omicron subvariant and were cleared for everyone 6 months and older, 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 week’s end.

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 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 – or by saying this (shot) provides some benefit to everyone, but a bigger one to some people,” said Jason L. Schwartz, an associate professor at the Yale School of Public Health.

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.

Spokane County health officer Dr. Francisco Velázquez said last week that the public should reframe the COVID vaccine in their mind to that of an annual flu shot – part of the general precaution against respiratory illness in the fall and winter. To that end, the new COVID vaccine can be co-administered in one arm with the flu shot in the other arm.

“My advice is you make sure to have this conversation with your provider between Labor Day and Halloween, and have gotten at least the flu shot and the COVID vaccine if it is available,” he said.

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. Protection against infection fades within several months but offers a longer-lasting shield against serious illness, studies show.

The new coronavirus shots are arriving as the virus is popping up again, stirring concern. Nearly everyone knows someone who has COVID. Schools in Kentucky and Texas canceled classes because of widespread absences, and debates resumed about mask-wearing.

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.

“We are seeing more people with COVID, especially mild COVID, but I would not call it a surge,” said Shira I. Doron, chief of infection control at Tufts Health and hospital epidemiologist at Tufts Medical Center in Boston.

Doron said six patients were in her hospital with COVID last week, about double the average number from earlier in the summer. “That’s a far cry from the over 90 patients we were seeing during peaks,” she added.

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% 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.

“People are going to walk, not run, for this one, unfortunately,” said Peter Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine.

Hotez recommends that people of all ages get the shot. “All the COVID numbers are climbing, and it is a big unknown: Is this going to turn into a significant wave as we progress into the fall or not?” he said.

That’s similar to the FDA position, which argues the coronavirus vaccine should be treated like the flu shot, with an updated product recommended yearly for everyone 6 months and older. A study published in February showed that COVID remains deadlier in severe cases than the flu.

“Why should COVID be different from flu? Everyone is recommended to get the flu shot,” said Katelyn Jetelina, an epidemiologist who consults for the CDC and publishes a public health newsletter, Your Local Epidemiologist, that monitors COVID and other diseases. “COVID is more deadly, more contagious than flu.” Some experts think older people might need a booster of the retooled vaccine sometime during the year to protect against COVID.

Other experts say the injection should be targeted to high-risk groups, including older people, immunocompromised individuals and patients with chronic illnesses such as diabetes and heart disease. Other people probably have built up enough immunity to ward off severe illness, they say.

Tufts Medical Center’s Doron noted, for example, that males ages 16 to 30 who have had several shots or experienced covid possess enough immunity to avoid severe illness even if reinfected. But they should consider that if they get the vaccine, they face a small risk of contracting a rare but serious heart inflammation called myocarditis, she said.

Other experts note, however, that covid itself can cause myocarditis that is more serious and harder to treat than the inflammation potentially triggered by the vaccine.

The newly formulated vaccine is a monovalent, with a single component designed to target an omicron variant called XBB.1.5. Previous boosters, which were bivalents, aimed to counter the original coronavirus strain and the BA.4 and BA.5 variants – all long gone.

The XBB.1.5 variant accounts for a small proportion of the cases in the United States, but it is closely related to the other XBB variants making up most cases now. That includes EG.5, the most prevalent variant at the moment and responsible for more than 21 percent of cases, according to the CDC. Tests show the new shot will protect against EG.5 and similar variants, health officials said.

In addition, new data from Pfizer and Moderna and independent scientists suggests the shot will protect against the closely watched BA.2.86, a highly mutated variant that some scientists initially worried could evade protections from vaccines or earlier infections. New studies indicate the variant is not as dangerous as feared.

BA.2.86 “appears to be a nothingburger,” said John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine. “It has been showing a very slow rate of increase, not an explosive event. If it were going to have a huge impact, we would know it by now.”

In its weekly update on respiratory viruses, the CDC said Friday that “early research data from multiple labs are reassuring and show that existing antibodies work against the new BA.2.86 variant.” It noted that current increases in covid cases and hospitalizations in the United States “are not being driven by BA.2.86 and instead are being caused by other predominantly circulating viruses.” These data are encouraging, the CDC said, because the updated vaccine is tailored to the circulating variants.

“We expect this season’s vaccine to be available in the coming weeks, 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,” said Albert Bourla, chairman and CEO of Pfizer.

Stéphane Bancel, CEO of Moderna, said that with the continued evolution of the virus “updated vaccines will be critical to protecting the population this season.”

The pharmaceutical firm Novavax has also applied for FDA clearance for an updated vaccine, but that review is ongoing. That shot might be available in coming weeks. Unlike the Pfizer-BioNTech and Moderna mRNA vaccines, Novavax’s is a more traditional protein-based shot.

The FDA said everyone 5 and older is eligible to receive a single dose of the updated coronavirus vaccine regardless of whether they have gotten a vaccine before. Children 6 months through 4 years who have been vaccinated are eligible to receive one or two doses of an updated shot, but the timing and number of doses depends on the previous vaccine received. Children 6 months through 4 years who have not been vaccinated against COVID are eligible to receive three doses of the updated vaccines.

The FDA approved the updated mRNA vaccines for individuals 12 and older, and authorized them for emergency use for those 6 months through 11 years. The bivalent Moderna and Pfizer-BioNTech vaccines are no longer authorized for use in the United States, the agency said.

Fenit Nirappil contributed to this report.