So far, federal health authorities have only given the green light to Pfizer/BioNTech and Moderna boosters to be used by adults 65 years of age or older or any adult at high risk for Covid- 19 severe or live or work in long-term care. facility or high-risk facility that completed their second dose at least six months ago. All adults who received the Johnson & Johnson vaccine at least two months ago are eligible for the booster shot.
But that could soon change.
As the United States waits for the FDA to approve the booster for all adults, frustration has grown in some communities and among some public health experts, who argue that there is a need to move quickly to get more boosters.
For some states, “the reason they go ahead and do this is they’re really concerned about experiencing another wave in their transmission state, and we’ve seen in a few states where Unfortunately, many of them, Hemi Tewarson, executive director of the National Academy of State Health Policy, told CNN on Tuesday.
“According to the public perception, there are some people who really want boosters. They are worried about the ability to deliver breakthroughs,” Tewarson said. “So I think this is where the governors – at least some of the governors – are trying to work out the tension here of some who really want to take that extra step even though we don’t know all of them yet. All the data tells us.”
‘Disappointed’ and waiting
Overall, some states have moved forward in deciding to expand eligibility for boosters, Tewarson said, adding that the move is similar to how initially during the pandemic, some states required masks. in public spaces despite the absence of a federal mask policy.
Most states that have expanded eligibility for the booster dose to all adults have seen an increase in Covid-19 cases and hospitalizations – and the state’s public health agency has “The final decision” on how to respond to such public health concerns, Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University and a former FDA commissioner, told CNN on Tuesday. Those increased cases are happening as winter approaches.
“I think the higher risk assessment now is responsible for some of those decisions,” McClellan said.
“But I know that all states are waiting for further guidance from the FDA and CDC based on whatever new evidence comes out,” he said. “I hope the FDA goes ahead this time with more widespread licensing of boosters and then CDC confirms that and then you’ll see all the states go further.”
“I was very frustrated with the complicated messaging of the CDC and FDA,” Polis told Brennan.
“Everybody should get a booster shot after six months,” says Polis. “The data is incredibly clear that it increases your level of personal protection – that’s why my parents got it, I got it. , my family members got it”. “But it can also help improve the epidemiology of a particular state or of an entire country, because you have people who are willing to roll up their sleeves and add that extra protection, to move going from 70% or 80% protection back to 90% to 95% protection can really have an impact in stopping the spread of the virus.”
FDA authorization can come at any time
Pfizer and BioNTech were the first vaccine manufacturers to request that eligibility for their Covid-19 booster shot be expanded to all adults.
Last week, Pfizer and BioNTech asked the FDA to amend the emergency use authorization for their vaccine so that all adults are eligible for a booster shot. Currently, boosters are authorized for a more limited group of adults.
When such requests are made to change an emergency use authorization, the FDA’s Vaccines and Related Biologicals Products Advisory Committee (VRBPAC) will typically meet to discuss the request and submit it. make recommendations on how the FDA should proceed.
But this time, the FDA has no plans to convene VRBPAC to discuss expanding eligibility for the Pfizer/BioNTech Covid-19 booster shots, FDA spokesman Alison Hunt confirmed to CNN in an email on Tuesday. The FDA concluded that the Pfizer/BioNTech request did not raise questions for further discussion by the advisory committee, which included outside experts.
In the absence of a committee meeting, the FDA’s authorization decision can be made at any time.
“While the FDA cannot predict how long it will take to evaluate their data and information, the agency will review the request as quickly as possible,” Hunt noted.
CDC spokesman Jason McDonald said a separate panel of CDC vaccine advisers will meet on Friday to discuss expanding eligibility for Pfizer’s Covid-19 vaccine, spokesman of CDC Jason McDonald said Tuesday. The CDC’s Advisory Committee on Immunization Practices typically only meets after a vaccine has been approved by the FDA – another sign that FDA approval could come any time this week.
Reviewing Pfizer’s request to authorize the Covid-19 booster vaccine for all adults is “the highest priority” for the FDA, the agency’s top official told CNN on Monday.
“At this point, consideration of the Extended Booster claim is the highest priority at the Center for Biological Evaluation at FDA,” said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research. to CNN in an email.
“While we cannot give an exact date for the completion of this process, we are working to review the request and evaluate data at the fastest pace in the event of a medical emergency,” Marks wrote. current public health”.
He added: “The FDA is moving as quickly as possible to address the recently filed information regarding the expansion of the population of individuals eligible for booster use. “As is evident from previous public discussions of boosters, the thinking of experts in the field regarding booster support for all individuals over the age of 18 has evolved very fast.”
Recent studies show that although vaccination still provides strong protection against severe illness and death many months later, immunity may begin to wane and the ability to protect against Milder and asymptomatic disease may subside with time. Studies have also shown that enhanced doses restore that immunity.
Public health officials in the Biden administration are on the same “page” when it comes to the benefits of booster shots, Dr. Vivek Murthy, US Surgeon General, said Sunday.
Murthy said that Fauci, Walensky, and he all believe that vaccines’ immunity against Covid-19 can weaken over time, and they want the FDA and CDC to consider both the efficacy and safety of the vaccines. booster injection.
“While we currently have millions of people eligible for booster shots, we are going through an FDA process and we will be doing the CDC process to see if it should be expanded,” Murthy said. the case or not”. “But the bottom line is we’re all on the same page about the powerful protection that vaccines offer, and we know that boosters are specified that they’ll be useful in expanding the ability people’s ability to protect against Covid-19.”
CNN’s John Bonifield, Naomi Thomas, Virginia Langmaid and Amanda Sealy contributed to this report.
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