The latest coronavirus booster, expected to be approved by the Food and Drug Administration as early as Monday, is expected to be approved by the Food and Drug Administration as early as Monday, along with seasonal influenza vaccines and prophylaxis to protect infants and the elderly from RSV, a potentially deadly respiratory virus. It is scheduled to appear along with the vaccination.
The Centers for Disease Control and Prevention is expected to: follow up On Tuesday, an advisory meeting will be held by Pfizer-BioNTech and Moderna to discuss who should receive the new vaccine. Once finalized by the CDC director, millions of doses will be shipped to pharmacies, clinics, and health systems across the country within days.
As coronavirus cases rise, if precautions are taken, we could see the first winter in a decade without an influx of patients that overwhelms hospital capacity. However, a healthy winter is far from harsh. Last year, only 20% of U.S. adults received coronavirus vaccines.
Some experts view this statistic with little alarm, as deaths from the coronavirus have declined in the last year thanks to a growing immune population among older Americans and rising vaccination rates. There are some too. Some see this year as an opportunity to protect more vulnerable populations from serious illness and death.
“We have some really good tools now,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group. “It’s: What does it take to make people feel comfortable using them?”
Federal officials want to back away from labeling the new formulation as a booster shot to previous vaccines and reframe it as an annual immunization effort similar to the flu vaccine. The change may reflect concerns about fatigue that some Americans are expressing about further attacks on the virus.
The vaccination campaign will be the first since the end of the public health emergency, which expired in May. Over the past few years, the U.S. government has purchased hundreds of millions of doses of vaccines and distributed them for free. This year, private insurance that covers the majority of Americans and government payers such as Medicare will provide the vaccine for free to the public.
But questions remain about whether the private market of hospitals, clinics and pharmacies can adjust vaccine orders to ensure a realistic supply. Experts are unsure how much demand there will be for the latest shot.
“There may come a time when things get a little chaotic here, and that’s never a good situation,” Dr. Plescia said.
Another concern with the handover to the private market is that 23 million adults in the country do not have health insurance. The Biden administration plans to pay for the coronavirus vaccine and make it available through local clinics and big-box pharmacies, but some experts say it will be difficult for people without insurance to learn about new vaccinations. They are concerned about whether or where they can get the vaccine.
“They don’t have an insurance company that will send them leaflets. They may not be able to get regular care,” said Anthony Wright, executive director of California advocacy group Health Access. “And their doctors and clinics, who are the trusted messengers of their health plans, don’t say, ‘It costs nothing.'” It’s that simple, really. ”
Vaccine manufacturers are expected to donate vaccines for the uninsured. Moderna spokeswoman Kelly Cunningham said there is no limit to the number of coronavirus vaccine doses the company plans to donate.
The latest vaccines are becoming available as hospitalizations and deaths from COVID-19 are increasing slightly, although not at the levels of past years. In the week ending Aug. 26, 17,400 people were hospitalized, compared with about 6,000 at the lowest point this summer. The number of deaths last month also reached around 600 per week, far lower than the average weekly death toll of 14,000 in 2021.
Once a vaccine is approved and approved by the CDC, the Biden administration will encourage people to get both the coronavirus and flu shots at the same time, which administration officials said have been studied and determined to be safe. . It’s a messaging effort the company hopes to share with major vaccine makers, who are set to sell their first coronavirus doses commercially.
Walgreens and CVS said both companies already have the latest flu and respiratory syncytial virus shots available in their stores. Dr. Kevin Bunn, Walgreens’ chief medical officer, said the chain will have a new coronavirus vaccine ready “as soon as possible” once a coronavirus vaccine is approved. A CVS spokesperson said doses could arrive later this week. Representatives from both chains said the coronavirus vaccine will be available for free to everyone who is eligible under CDC guidelines, scheduled for Tuesday.
The targeted population mostly includes people over 65, as well as people with weakened immune systems or serious underlying health conditions that make them more susceptible to severe illness from the virus. It’s certain.
When vaccines first became available, some nursing homes hosted vaccination teams from major drugstore chains, but now they rely on regular long-term care pharmacies for most vaccine supplies.But many homes are behind on booster fees: Recently medicare data Although older people are most at risk of severe illness and death from the virus, about 62 per cent of residents have been shown to be up to date with vaccinations.
The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers started formulating and testing new versions. As variants of the virus emerge, experts say new COVID-19 drugs should provide better protection against severe infection.
Fikadou Tafesse, associate professor of molecular microbiology and immunology at Oregon Health & Science University, said recent concerns that new highly mutated variants could leak from vaccines have been substantiated by reliable independent research. It has been proven that there is no such thing. The CDC also looked at research on this issue and confirmed on Friday This showed that the effectiveness of the vaccine was sustained.
“We were prepared for no response at all, but the data is very, very promising,” Dr. Tafesse said.
Like previous shots, the updated shot is not expected to eliminate the possibility of mild coronavirus infection. Rather, it is expected to reduce the chance of severe illness, hospitalization, and death. The first coronavirus vaccines, which were given in early 2021 and targeted the early version of the virus that emerged in Wuhan, had an efficacy rate of about 95%, which is a lower percentage of those who became ill than those who were not vaccinated. This means that the number was much smaller.
As the efficacy of the first vaccine was weakened by new Omicron variants, a bivalent booster shot targeting the first virus and the then-predominant BA.5 was approved in August 2022. The shot has reduced the number of people hospitalized with the coronavirus, dropping from 60% to 25% in just a few months.
The latest mRNA vaccines from Pfizer and Moderna target one of the Omicron variants, XBB.1.5, and unlike previous boosters, they target the original one that caused widespread infections in China more than three years ago. They are called monovalent vaccines because they do not contain any protection against viruses. . But experts and researchers say it should offer protection against many of Omicron’s variants.
Pfizer and Moderna reported that their vaccines showed strong responses against the latest circulating variants, but only Moderna Posted Initial data for Thursday.
But researchers continue to debate how well it holds up against new variants. The FDA has primarily reviewed results from animal or small human studies of immune responses submitted by companies.
Pfizer spokeswoman Jerica Pitts said the data the company submitted to the FDA in June included animal testing. Trials tracking people who have been vaccinated are continuing, she said.
moderna Submitted data Reporting to the FDA about 100 people’s immune responses to the new vaccine shot, the company announced in June that it “strongly induced neutralizing antibodies” against the XBB variant.
John Moore, a professor of virology and immunology at Weill Cornell Medical College, said he was not impressed with the latest results. He said the new vaccine produced a similar immune response to last fall’s booster shot. In other words, while the new shot is worth getting, it’s “not a game-changer.”
Regulators are also considering whether to authorize a booster shot from Novavax, which uses a different but widely used technology from coronavirus vaccines. The vaccine could be approved in the coming weeks, and some Americans may prefer Novavax’s formulation as 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 vaccinated against the coronavirus in late October would provide strong protection during the holiday season and protect the most vulnerable, including: He said it would help stop the spread of the virus to people. Elderly people, pregnant women, and people with weakened immune systems.
And while many people may be tired of the social protection debate, he said they can reduce their own chances of suffering more serious consequences.
“So a young person might say, ‘I’m not going to get the booster shot in the interest of public health,'” Dr. Griffin said. , can reduce the chance of lingering Covid. ”
Noah Weiland and Carl Zimmer contributed to this report.
