The latest novel coronavirus booster, which is expected to be approved by the Food and Drug Administration as early as Monday, is a seasonal flu vaccine 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, Pfizer BioNtech and Moderna will hold an advisory meeting to discuss who should be vaccinated with the new vaccine. Millions of doses are expected to be shipped to pharmacies, clinics and healthcare systems across the country within days after the final decision by the CDC Director.
With the number of coronavirus cases on the rise, if precautions are taken, the first winter in a decade could arrive without a flood of patients overwhelming hospital capacity. But a healthy winter is far from harsh. Last year, only 20% of adults in the United States were vaccinated against the novel coronavirus.
Some experts view this statistic with little alarm, as the number of deaths from the novel coronavirus fell last year, thanks to a growing immune population and rising vaccination rates among older Americans. There are some too. Some see this year as an opportunity to protect more vulnerable populations from serious illness and death.
“We have some very good tools now,” said Dr. Marcus Prescia, chief medical officer for the Association of State and Territory Health Officials, a public health group. “It’s: What does it take to make people feel comfortable using them?”
Federal officials want to step back from labeling the new formulation as a booster to previous vaccines and reset it as an annual vaccination effort similar to the flu vaccine. The change may reflect concerns about fatigue some Americans have expressed against further attacks on the virus.
The vaccine 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 the vaccine 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 the question remains whether the private market of hospitals, clinics and pharmacies will be able to adjust vaccine orders to ensure a realistic supply. Experts aren’t sure how much demand there will be for the latest shot.
“There may come a time when things get a little messy here. It’s never a good situation,” Dr Precia 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 and provide coronavirus vaccines through local clinics and big-box pharmacies, but some experts say it’s 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 to send leaflets to,” said Anthony Wright, executive director of California advocacy group Health Access. “And doctors and clinics who are trusted messengers in their health plan don’t say ‘it doesn’t cost’.” ”
Vaccine manufacturers are expected to donate vaccines for the uninsured. Moderna spokeswoman Kelly Cunningham said there is no limit to the number of Covid-19 vaccines the company plans to donate.
A modest increase in the number of hospitalizations and deaths from COVID-19, albeit below the levels of previous years, is making the latest vaccines available. 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 the vaccine is approved and approved by the CDC, the Biden administration will encourage the public to get the coronavirus and flu vaccines at the same time, which has been studied and determined to be safe, administration officials said. . It’s a message effort that it hopes to share with major vaccine makers who plan to commercially market their first dose of the novel coronavirus.
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 target population includes people over the age of 65, as well as those with weakened immune systems or severe underlying medical conditions that make them more susceptible to severe illness from the virus. It’s certain.
When the vaccine first became available, some nursing homes hosted inoculation teams from major drugstore chains, but now rely on regular long-term care pharmacies for most vaccine supplies.But many homes are behind on booster rates: Recently Medicare data About 62 percent of the population has been shown to have up-to-date immunizations, although older people are most at risk of severe illness and death from the virus.
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 The CDC also looked at research on this issue and confirmed on Friday showed that the efficacy of the vaccine persisted.
“We were expecting no response at all, but the data are very, very encouraging,” Dr. Tafesse said.
As with previous shots, the updated shot is not expected to rule out the possibility of mild coronavirus infections. Rather, it is expected to reduce the chance of severe illness, hospitalization, and death. The first COVID-19 vaccine, given in early 2021 and targeting the early form of the virus that emerged in Wuhan, has an efficacy rate of about 95 percent, which means more people who get sick compared to those who were not vaccinated. This means that the number was much smaller.
A bivalent booster against the original virus and then-dominant BA.5 was approved in August 2022, as the efficacy of the first vaccine was weakened by the new Omicron variants. The injection reduced the number of people hospitalized with the new coronavirus, from 60% to 25% in 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. It is called a monovalent vaccine because it does not contain protection against viruses. . But experts and researchers argue that it should offer protection against many of Omicron’s variants.
Pfizer and Moderna reported that their vaccines showed strong responses to 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 Jerika 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 After reporting to the FDA about immune responses in 100 people to the new vaccine, the company announced in June that it “strongly induces 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.
Daniel Griffin, M.D., an infectious disease physician at Columbia University in New York, believes that getting the COVID-19 vaccine in late October will provide strong protection during the holiday season, with the most vulnerable being: 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 may be fed up with the social protection debate, he said, you can help yourself reduce the chances of more serious consequences.
“So young people might say, ‘I’m not going to get a booster for public health,'” Dr. Griffin said. , can reduce the likelihood of lingering on Covid. ”
Noah Weiland and Carl Zimmer contributed to this report.