Comment Unlock This article is free to access. Why; The Centers for Disease Control and Prevention on Thursday recommended that millions of eligible Americans, including those age 12, get an updated Omicron booster shot to boost defenses against serious illness and death during a possible fall or winter surge in cases of covid-19. CDC Director Rochelle Walensky approved an advisory committee recommendation, clearing the way for some clinicians, pharmacies and other providers to begin administering the vaccines as early as this weekend. The Advisory Committee on Immunization Practices voted 13-1 to recommend updated vaccines from Moderna, for people over 18, and from Pfizer-BioNTech, for people 12 and older. Thursday’s action, along with approval of the shots a day earlier by the Food and Drug Administration, marked another turning point in the pandemic and reflected the dogged fight to combat disease and death 2½ years since the pandemic began. “Updated COVID-19 boosters are designed to better protect against the latest circulating variant of COVID-19,” Walensky said in a statement. “They can help restore protection that has been weakened by previous vaccination and were designed to provide broader protection against newer variants. … If you qualify, there’s no bad time to get your COVID-19 reminder, and I strongly encourage you to get it.” Several members of the advisory group 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 later in November to release the updated booster vaccine could be an additional 9,700 deaths and 137,000 hospitalizations, based on projections presented at the day’s meeting. “I think that’s the tension I feel for sure,” Daley said. But with the FDA’s decision, “we are now in the position where we have millions of doses of bivalent vaccines that are ready and available. And I think it will be an effective tool for disease prevention this fall and through the end of winter.” The latest recommendation for boosters 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 vaccinating against a virus that still kills an average of more than 500 people per day in the United States. Doses began shipping Wednesday to pharmacies, clinics and doctor’s offices after the FDA approved the updated vaccines from Moderna and from Pfizer and its German partner, BioNTech. Like previous coronavirus vaccines, the updated boosters will be free. The new boosters — the first changes since mRNA vaccines were released in December 2020 — target the BA.4 and BA.5 omicron subvariants that predominate in the United States. Officials say the new shots will help broaden immunity because they more closely match the strain in circulation. Until now, vaccines have targeted the original version of the coronavirus, even as different variants emerged. Half of the new booster, known as the bivalent vaccine, contains the original formulation, while the other half contains a formulation 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. People can get the updated vaccines if it has been at least two months since they completed their main vaccine series or their most recent booster. Even if a person received the original formula boosters, they can receive the updated booster as long as two months have passed since their last dose. The interval of at least two months is intended to broaden immunity, because receiving vaccines too soon reduces the effectiveness of the vaccine. A longer interval between shots also reduces the risk, especially for young adults and older teenagers, of rare side effects such as myocarditis, an inflammation of the heart muscle, health officials said. The CDC estimates that about 200 million Americans age 12 and older are eligible for the updated shot. 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 since their last dose of the coronavirus vaccine, CDC spokeswoman Sarah Oliver told the advisory panel on Thursday. Americans have been slow to get boosters, and experts say it’s unclear whether uptake of the redesigned booster will be any different. The country may be transitioning from the coronavirus as an emergency, “to becoming something that we have 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 see how there will be a rush, a rush to push,” Cates said in an email. Some people — about 20 percent of people who have been vaccinated — are “waiting for updated vaccines that can target variants,” Cates said, citing recent research by the Kaiser Family Foundation. “On the other hand, if people don’t perceive them as better or necessary, or if they have other reasons for not wanting to get a booster, it’s hard to see how that’s going to change things.” Albert Ko, an infectious disease specialist and epidemiologist at the Yale School of Public Health, said he is concerned about what Americans will face this winter, noting that the country is dealing with more than 500 deaths from Covid-19 a day. “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 among some experts, raised concerns about the lack of human data on the shots’ effectiveness — the FDA has relied heavily on mouse studies — which experts said could fuel skepticism about with the effectiveness of reinforcers. The data the FDA used to approve the shot included human studies of previous experimental bivalent shots, including one that produced antiviral antibodies against BA.1 — the first micron subvariant — and the overall record of shots since December 2020. Pablo J. Sanchez, a professor of pediatrics at Ohio State University, said he voted no because he believes “we need the human data” on the new vaccine, which is just now being collected. But Jeffrey Duchin, health officer for Seattle and King County, said he’s comfortable with the animal data to support the reformulated boosters. Panel members also noted that animal studies have been routinely used to adjust the formulation of annual flu vaccines. The CDC’s Oliver 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 evolved, the effectiveness of vaccines declined faster. Including a variant in the vaccine broadens the antibody response. Interest in earlier booster shots has proven tepid at best. In a recent Kaiser Family Foundation survey, nearly 6 in 10 people who have been vaccinated but not boosted said they had enough protection, “which we know from the data is not the case given the decline and the new variants,” Cates said. Three in 10 said they are too busy and 15 percent are worried about a lack of work, the survey found. Democrats are more likely to be inoculated and boosted than Republicans. A CDC survey conducted in August with the University of Iowa shows more people will want the shots — 72 percent of eligible respondents said they would definitely or probably get an updated booster against omicron, Oliver said. Only half of Americans eligible for a booster — about 108 million people — got the first recommended booster dose, and only about a third of those 50 and older — about 22 million people — got a second booster. CDC surveys have shown that older adults, college graduates, and people with higher incomes remain more likely to get vaccinated and boosted. Anyone who has received the main two-shot series of the mRNA or Novavax vaccines or the Johnson & Johnson one-shot vaccine will be appropriate, regardless of whether they have received booster shots. FDA officials expect pediatric data on the new boosters in the next month or two and could approve the shots for some children under 12 later this year. What you need to know about the updated Covid booster shots for autumn Changing the amp is already confusing. Some people who signed up to receive the original booster formulation will need to reschedule appointments to receive the new version because the original formulations are no longer FDA-cleared for use as boosters. “The last thing we have to do is tell the people who signed up [for the original booster] and they are expected to be vaccinated this week they have to wait,” said Michael Fraser, Chief Executive of the Association of State and Territory Health Officers. “We’ve seen lagging demand nationally, and that’s not creating confidence among the public and providers who are asking their health care provider what to do now.” The CDC recommends the coronavirus vaccine for everyone 6 months of age and older and booster shots for everyone 5 years of age and older who are eligible. CDC data at Thursday’s meeting showed that adults who had an initial series and two boosters had a 14 times lower risk of dying from covid-19 than the unvaccinated. People who had a second recall had three times the risk of death than people who had only one recall. Experts and officials have disagreed over whether an updated recall is needed because the original vaccines still offer strong protection against serious illness and death for…
