Thursday’s action, along with ok shots a day earlier by the Food and Drug Administration, marked another turning point in the pandemic and reflected the ongoing struggle to suppress disease and death two and a half years since the pandemic dawned.
“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 diminished since previous vaccination and were designed to provide broader protection against newer variants. … If you are eligible, there is no bad time to get your COVID-19 booster and I strongly 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 the potential harm of waiting for clinical data until November.
Matthew Daley, a physician at Kaiser Permanente Colorado, said the cost of waiting until the end of November to roll out the updated booster vaccine could be 9,700 deaths and an additional 137,000 hospitalizations, based on projections presented at the one-day meeting.
“I think that’s the tension I feel for sure,” 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 are going to be an effective disease prevention tool this fall and into the end of winter.”
The latest booster recommendation provides a new opportunity for the Biden administration and public health experts to launch another round of messages to a pandemic-weary public about the importance of vaccination against a virus that still kills an average of more of 500 people per day in the United States.
Doses began shipping Wednesday to pharmacies, clinics and doctors’ offices after the FDA authorized updated shots of Moderna and Pfizer and its German partner, BioNTech. Like previous coronavirus vaccines, the updated boosters will be free.
The new boosters, the first changes since the mRNA vaccines launched in December 2020, target the dominant BA.4 and BA.5 omicron subvariants in the United States. Officials say the new shots will help boost immunity because they are more compatible with the strain that is circulating.
Until now, vaccines have targeted the original version of the coronavirus, even as different variants emerged. Half of the new booster, known as a bivalent vaccine, contains the original formulation, while the other half carries 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 you account for nearly 90 percent of cases in the United States, according to the CDC.
People can get catch-up vaccinations if it has been at least two months since they completed their primary vaccination series or their most recent booster. Even if a person received boosters of the original formulation, he can get the updated booster as long as two months have passed since his last injection. The interval of at least two months is intended to extend immunity because receiving the injections too soon reduces the effectiveness of the vaccine.
A longer interval between injections also reduces the risk, especially for young adults and older adolescents, of rare side effects such as myocarditisinflammation of the heart muscle, health officials said.
The CDC estimates that about 200 million Americans over the age of 12 are eligible for the updated vaccine. While nearly 22 million adults over the age of 50 have received a second booster dose, most people over the age of 5 are at least six months from their last dose of the coronavirus vaccine, Sara Oliver, an administration official, said Thursday. from the CDC, to the advisory panel.
The Americans have been slow to get reinforcements, and experts say it’s unclear whether acceptance of the reformulated booster will be any different. The country may be moving from coronavirus as an emergency, “to becoming something that we have to learn to deal with more regularly and routinely, even through routine.” [coronavirus] immunization,” said Jen Kates, senior vice president of the Kaiser Family Foundation.
“It’s hard to see how there will be a surge, a rush to get going,” 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, referring to a recent Kaiser Family Foundation survey. “On the other hand, if people don’t perceive them as better or necessary, or if they 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.
“The poor uptake of new boosters is a real and urgent concern as we rely on vaccination to protect our communities, especially now that the use of social distancing and face masks is disappearing,” Ko said.
Panel members, echoing questions from some experts, raised concerns about the lack of human data on the efficacy of the injections (the FDA relied heavily on mouse studies), which experts say , could generate skepticism about the effectiveness of reinforcements. The data used by the FDA to authorize the injection included human studies of previous experimental bivalent injections, including one that generated virus-fighting antibodies against BA.1, the first omicron subvariant, and the overall record of injections since December 2020. .
Pablo J. Sánchez, a professor of pediatrics at Ohio State University, said he voted against it because he believes “we need the human data” on the new vaccine, which is only now being collected.
But Jeffrey Duchin, a health official for Seattle and King County, said he was comfortable with the animal data in support of the reformulated boosters. Panel members also noted that animal studies have been regularly used to adjust the composition of annual influenza vaccines.
The CDC’s Oliver presented data showing how a booster vaccination schedule in September 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. The inclusion of a variant in the vaccine amplifies the antibody response.
Interest in previous booster shots has been lukewarm, at best.
In a recent Kaiser Family Foundation SurveyNearly 6 in 10 people who are vaccinated but not boosted said they feel they have enough protection, “which we know from the data is not the case given the new and declining variants,” Kates said. Three in 10 said they are simply too busy, and 15 percent are worried about missing work, the survey found. Democrats are more likely to have been vaccinated and stimulated than Republicans.
An August CDC survey with the University of Iowa suggests more people will want the shots: 72 percent of eligible respondents said they would definitely or probably get an updated omicron booster, Oliver said.
Only half of Americans eligible for the booster: about 108 million people — received the first recommended booster dose, and only about a third of people over 50 (about 22 million people) received a second booster. CDC surveys have shown that older adults, college graduates, and people with higher incomes continue to be more likely to get vaccinated and booster shots.
Anyone who has received the primary two-shot series of mRNA or Novavax vaccinations or the single shot Johnson & Johnson Vaccine will be eligible, regardless of whether they received any booster shots.
FDA officials expect pediatric data on the new boosters in the next month or two and could license the shots for some children under 12 later this year.
The booster change is already causing confusion. Some people who signed up for the original booster formula will need to reschedule appointments to get the new version because the FDA no longer clears the original formulas for boosters.
“The last thing we need to do is tell people who signed up [for the original booster] and they are expected to get vaccinated this week which should wait,” said Michael Fraser, executive director of the Association of State and Territorial Health Officials. “We’ve seen lagging demand nationally, and this doesn’t build trust between the public and providers asking their health officer what to do next.”
The CDC recommends the coronavirus vaccination for everyone older than 6 months, and boosters for everyone older than 5 years who are eligible.
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 received a second booster had a three times lower risk of death than people who only received a booster.
Experts and officials have disagreed on whether an updated booster is needed because the original vaccines still offer 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 unclear how much additional benefit a reformulated booster will provide.
People should check with local pharmacies and providers and visit vaccines.gov before presenting for vaccinations because there will likely only be about 1.5 million doses available initially, according to information provided to state health officials. Another 10 million doses are scheduled to be delivered next week.
Laurie McGinley contributed to this report.
