The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, coming alongside the seasonal flu vaccine and vaccines to protect infants and adults from RSV, a potentially deadly respiratory virus.
The Centers for Disease Control and Prevention is expected follow up on Tuesday at an advisory meeting to discuss who should get the new shots, by Pfizer-BioNTech and Moderna. After the CDC director’s final decision, millions of doses will be sent to pharmacies, clinics and health systems across the country within days.
As Covid cases rise, the containment measures could herald the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of just 20 percent of adults in the United States.
Some experts view that statistic with some alarm because the number of Covid-19 deaths has slowed 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 the more vulnerable against severe illness or death.
“We now have some very good tools,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group. “It’s just — what does it take for people to feel comfortable using them?”
Federal officials are backing away from labeling the new formulation as boosters to earlier shots, preferring to recast them as an annual vaccination effort similar to the flu shot. That change may reflect concern over the fatigue some Americans have expressed about 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. Over the years, the US government has purchased hundreds of millions of doses of the vaccine and distributed them for free. This year, private insurance and government payers like Medicare that cover most Americans are expected to provide 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 aren’t sure how big the demand will be for the latest shots.
“There could be a period here where things are a little chaotic, and that’s not a good situation,” Dr. Plescia.
Also of concern in the handoff to the private market: the nation’s 23 million seniors without health insurance. The Biden administration has made plans to cover the costs and offer the Covid vaccine through local clinics and major pharmacies, but some experts are concerned about whether people without insurance will know new shots – or where to take them.
“They don’t have an insurer sending them leaflets — they may not have a common 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, isn’t there saying, ‘There’s no charge. It’s really easy.’”
Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokeswoman for Moderna, said the company has no limit on the number of doses of the Covid vaccine it plans to provide.
The latest shots are becoming available as Covid hospitalizations and deaths are rising slightly, though not to the levels of previous years. In the week ending August 26, there were 17,400 people admitted to hospital – 6,000 more than this summer’s low point. Deaths also reached nearly 600 a week last month, though lower than the weekly average of 14,000 deaths in 2021.
Once the vaccines are approved and the CDC signs off, the Biden administration plans to encourage the public to get their Covid and flu shots at the same time, a practice that has been studied and deemed safe, an official said. of administration. It’s a messaging effort they hope to share with major vaccine makers, who will be selling Covid doses for the first time.
Walgreens and CVS said they now have updated flu and RSV shots available in stores. Once the Covid vaccine approvals are in place, Dr. Kevin Ban, chief medical officer of Walgreens, said the chain will have new shots “soon.” A CVS spokeswoman said the doses could arrive later this week. Representatives of both chains said the Covid shot will be available free of charge to all those eligible under CDC guidelines expected Tuesday.
Target populations will certainly include people 65 and older as well as those who are immunocompromised or have serious underlying medical conditions that leave them more susceptible to serious illness from the virus.
Nursing homes, some of which hosted inoculation teams from major drugstore chains when vaccines first became available, now rely on their usual long-term care pharmacies to provide most vaccines. But many homes have been caught up in booster rates: Recently Medicare data show that about 62 percent of residents are up-to-date on their shots even though the elderly are among the most vulnerable to serious illness and death from the virus.
The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began formulating and testing the new version. Although the virus has a rotating cast of variants, experts say the new Covid jab should bolster protections against severe infection.
Recent fears that a newer, highly mutated variant would escape the vaccine have been proven unfounded by credible independent labs, said Fikadu Tafesse, an associate professor of molecular microbiology and immunology at Oregon Health & Science University. The CDC has also reviewed studies on this matter and confirmed on Friday that the vaccine holds strong.
“We’re really preparing for no response, but the data is very, very promising,” said Dr. Tafesse.
As with previous shots, the updated ones are not expected to eliminate the chances of getting a mild case of Covid. Instead, they are expected to reduce the chances of serious illness, hospitalization or death. The first Covid vaccines, given in early 2021 and targeting the first form of the virus that emerged in Wuhan, have an effectiveness rate of around 95 percent, meaning fewer vaccinees get sick than the unvaccinated.
As the potency of the first vaccine waned in newer Omicron variants, a bivalent booster was approved in August 2022 targeting the initial virus and BA.5, which was dominant at the time. That shot led to fewer people with Covid being hospitalized, down within months to 25 percent from 60 percent.
The latest mRNA vaccines by Pfizer and Moderna are called monovalent because they target a variant of Omicron, XBB.1.5., and unlike previous boosters do not include protection against the original virus that caused widespread infection in China more than three years ago. . But experts and researchers say it should provide protection against many of the Omicron variants.
Pfizer and Moderna reported that their vaccines had potent responses to the latest circulating variants, although only Moderna posted it preliminary data on Thursday.
But researchers continue to discuss how well it does with new variants. The FDA primarily reviews results submitted by companies from animal or smaller human studies of immune response.
Jerica Pitts, a spokeswoman for Pfizer, said the data the company submitted to the FDA in June involved tests on animals. Tests following the people who received the shot are ongoing, he said.
Modern submitted data to the FDA on the immune response of 100 people to the new shots, which the company said in June “robustly elicit neutralizing antibodies” against XBB variants.
John Moore, a professor of virology and immunology at Weill Cornell Medicine, said he was not impressed with the latest results. He said the new shot showed an immune response similar to last fall’s booster. That means that while it’s worth getting the new shot, “it’s not remotely like a game changer.”
Regulators are also considering whether to authorize a booster dose from Novavax, which uses a different but widely used technology for its coronavirus vaccine. That shot could be approved in the coming weeks, giving some Americans who may prefer the Novavax formulation an alternative to vaccines offered by Moderna and Pfizer-BioNTech.
Dr. Daniel Griffin, an infectious disease physician at Columbia University in New York, said getting the Covid shot in late October would provide strong protection as people gather for the holidays, and help to prevent the virus from spreading to the most vulnerable, including the elderly, pregnant women and those with compromised immune systems.
And while many may be weary of the social protection argument, he says they can reduce their own chances of a more serious outcome.
“So a younger individual might say, ‘I’m not going to take a booster for public health,'” says Dr. Griffin, “‘but I’m going to take a booster because if I can reduce my chance of getting Covid, I’ll reduce chances are I’ll have a long Covid.’”
Noah Weiland and Carl Zimmer contributed to this report.