Thursday’s action, along with the approval of the shots a day earlier by the Food and Drug Administration, marked another turning point in the pandemic and reflected the ongoing battle to address illness and death 2½ years since the pandemic began.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Walensky said in a statement. “They can help restore protection that has declined since previous vaccination and are designed to provide broader protection against newer variants. …If you qualify, there’s not a bad time to get your COVID-19 booster and I highly encourage you to get it.
Several members of the advisory panel expressed concern about the lack of clinical data on the reformulated boosters, but also noted that waiting for clinical data until November may be harmful.
Matthew Daley, a physician at Kaiser Permanente Colorado, said the cost of waiting until later November to roll out the updated booster injection could be 9,700 additional deaths and 137,000 hospitalizations, based on forecasts released at the one-day meeting. were presented.
“I think that’s the tension I definitely feel,” Daley said. But with the FDA decision, “We are now in a position where we have millions of doses of bivalent vaccines ready and available. And I think they will be an effective disease prevention tool this fall and through the end of winter.
The latest booster recommendation offers the Biden administration and public health experts another chance to launch a new round of messages to a pandemic-weary public about the importance of vaccination against a virus that still kills an average of more than 500 people a day. in the United States.
Doses began shipping to pharmacies, clinics and doctor’s offices on Wednesday after the FDA approved updated shots from Moderna and from Pfizer and its German partner, BioNTech. Like previous coronavirus vaccines, the updated boosters are free.
The new boosters — the first changes since the mRNA vaccines were rolled out in December 2020 — target the BA.4 and BA.5 omicron subvariants that are dominant in the United States. Officials say the new injections will help boost immunity because they better match the species circulating.
Until now, vaccines have focused on the original version of the coronavirus, even though several variants have emerged. Half of the new booster, known as a bivalent vaccine, contains the original formulation, while the other half contains a prescription against BA.4 and BA.5, by far the most contagious versions of the virus since the coronavirus swept the world in 2020. . BA.5 now accounts for nearly 90 percent of cases in the United States, according to the CDC.
The updated booster is for people who have had their primary vaccinations, using the original vaccines, or who are eligible for a booster at least two months after their last. Even if a person has been given boosters of the original formulation, they can get the updated booster as long as it has been two months since their last injection. The interval of at least two months is intended to boost immunity, as getting it too early reduces the effectiveness of the vaccine.
A longer interval between shots also reduces the risk, especially for young adults and older teens, of rare side effects such as myocarditis — inflammation of the heart muscle, health officials said.
CDC estimates that approximately 200 million Americans ages 12 and older are eligible for the updated admission. While nearly 22 million adults age 50 and older have received a second booster dose, most people age 5 and older are at least six months away from their last coronavirus vaccine dose, CDC official Sara Oliver told the advisory panel on Thursday.
Americans have been slow to get boosters, and experts say it’s unclear whether booster reformulation will be any different. The country may be moving from the coronavirus as an emergency, “to something we need to learn to manage on a more regular, routine basis, including through routine [coronavirus] vaccination,” said Jen Kates, senior vice president at the Kaiser Family Foundation.
“It’s hard to imagine how there will be a tidal wave, a rush to get a boost,” Kates said in an email. Some people — about 20 percent of people who have been vaccinated — are “waiting for updated vaccines that can target variants,” Kates said, citing a recent study from the Kaiser Family Foundation. “On the other hand, if people don’t see these as better or necessary, or have other reasons for not wanting a booster, it’s hard to see how this will change things.”
Albert Ko, an infectious disease physician and epidemiologist at the Yale School of Public Health, said he was concerned about what Americans will face this winter, noting that the country is experiencing more than 500 Covid-19 deaths a day.
“Mistake of the new boosters is a real and urgent concern as we depend on vaccination to protect our communities, especially as the use of social distancing and face masks is on the decline,” Ko said.
Panelists, following questions from some experts, expressed concern about the lack of human data on the effectiveness of the injections — the FDA relied heavily on mouse studies — which experts have said could raise skepticism about the boosters’ effectiveness. The data used by the FDA to approve the shot includes human studies of previous experimental bivalent shots, including one that generated virus-fighting antibodies to BA.1, the first omicron subvariant, and the overall record of the shots since December 2020. .
Pablo J. Sanchez, a professor of pediatrics at Ohio State University, said he voted no because “I really feel we need the human data” about the new vaccine, which is only now being collected.
But Jeffrey Duchin, health officer for Seattle and King County, said he was pleased with the animal data in support of the reformulated boosters. Panelists also noted that regular animal studies are used to adjust the composition of annual flu vaccines.
Oliver, of the CDC, presented data showing how a September booster vaccination program could prevent significant deaths, hospitalizations, infections and direct medical costs. Oliver noted that as the virus has evolved, the effectiveness of vaccines has declined more rapidly. Inclusion of a variant in the vaccine broadens the antibody response.
Interest in previous booster shots proved tepid at best.
Experts said this may be a reflection of people lacking the right information about vaccines, party differences and practical challenges. In a recent survey by the Kaiser Family Foundation, nearly 6 in 10 people who have been vaccinated but not boosted said they feel they have adequate protection, “which we know from the data that this is not the case given the decreasing and new variants,” said Kates. Three in 10 said they are just too busy and 15 percent are concerned about missing work, the survey found. Democrats have been vaccinated and boosted more often than Republicans.
A CDC poll conducted in August with the University of Iowa suggests that more people want the photos — 72 percent of eligible respondents said they will definitely or probably get an updated booster against omicron, Oliver said.
Only half of booster-qualified Americans — about 108 million people — received the first recommended booster dose, and only about a third of those 50 and older — about 22 million people — received a second booster. CDC surveys have shown that older adults, college graduates, and those with higher incomes are most likely to be vaccinated and boosted.
Anyone who has received the two-shot primary series of the mRNA or Novavax vaccines or the single-shot Johnson & Johnson vaccine is eligible whether or not they have been given booster shots.
FDA officials expect pediatric data on the new boosters in the next two months and could authorize the injections for some children under the age of 12 later this year.
What you need to know about the updated covid booster shots for fall
The booster change already causes confusion. Some people who signed up to receive the original booster formulation have to reschedule appointments to get the new version because the original formulations are no longer authorized by the FDA to be used as boosters.
“The last thing we need to do is tell people who signed up [for the original booster] and are expected to be vaccinated this week, they will have to wait,” said Michael Fraser, chief executive of the Association of State and Territorial Health Officials. “We have seen lagging demand nationwide and this is not instilling confidence in the public and providers asking their health officer what to do next.”
CDC recommends coronavirus vaccination for everyone 6 months and older, and boosters for everyone 5 years and older who qualify.
CDC data at Thursday’s meeting showed that adults who had a primary series and two boosters had a 14-fold lower risk of death from Covid-19 than unvaccinated people. People who had a second booster had a three times lower risk of death than people who had only one booster.
Experts and officials differed on whether an updated booster is needed, as the original vaccines still provide strong protection against serious illness and death for generally healthy people, especially if they received the first booster dose. Some experts have said it’s not clear how much additional benefit a reformulated booster will provide.
People should contact local pharmacies and suppliers and visit vaccines.gov before showing up to receive shots, as only about 1.5 million doses are likely to be available initially, according to information provided to state health officials . Another 10 million doses are scheduled for next week.
Laurie McGinley contributed to this report.