Some states won’t wait for FDA, extend Covid-19 booster eligibility to all adults – Community News
Covid-19

Some states won’t wait for FDA, extend Covid-19 booster eligibility to all adults

So far, federal health authorities have only given the green light for the administration of Pfizer/BioNTech and Moderna boosters to adults 65 and older or adults at high risk for severe Covid-19 or who live or work in long-term care settings. or high-risk institutions that completed their second dose at least six months ago. All adults who have received the Johnson & Johnson vaccine at least two months ago are eligible for boosters.

But that could soon change.

As the US waits for the FDA to approve boosters for all adults, frustration has increased within some communities and among some public health experts who argue that there is an urgent need to act quickly to get boosters into more arms.

For some states, “the reason they’ve done this is that they’re really concerned about experiencing a new wave in their broadcasting state and we’ve seen an increase in Covid-19 cases in some states. Unfortunately, many are of those are driven by those who have not been vaccinated, but there are some breakthrough infections among those who have been vaccinated,” Hemi Tewarson, executive director of the National Academy for State Health Policy, told CNN on Tuesday.

“From a public perception, there are some who really want the boosters, they’re concerned about breakthrough transmission,” Tewarson said. “So I think this is where governors — at least some governors — are trying to address the tension here from some in the public who really want to take that extra step, even though we don’t know what all the data tells us yet.”

‘Frustrated’ and waiting

Overall, some states have moved ahead with the decision to expand booster eligibility, Tewarson said, adding that the move is similar to how early in the pandemic some states required masks in public areas, even though there were none. federal mask policy.

The Covid-19 numbers seem to be stuck.  That doesn't bode well for the winter, experts say

Most states that have expanded booster eligibility to all adults have seen recent increases in Covid-19 cases and hospitalizations — and the state’s public health authorities have the “final decision” on how to respond to such public health issues, Dr. . Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University and a former FDA commissioner, told CNN Tuesday. Those increases in cases occur as the winter season approaches.

“I think assessing that you’re at higher risk now drives some of those decisions,” McClellan said.

“But I do know that all states are waiting for further guidance from the FDA and the CDC based on new evidence that comes in,” he said. “I would expect the FDA to continue to authorize boosters more broadly this time and CDC to confirm that and then you’ll see all the states move forward.”

In Colorado, for example, about 81% of people hospitalized for Covid-19 have not been vaccinated, but for the 19% who have been vaccinated, booster doses can help lower their cases, Governor Jared Polis told CBS’ Margaret Brennan on Face The Nation on Sunday.

“I am very frustrated with the complicated messages from the CDC and the FDA,” Polis told Brennan.

“Everyone should get the booster after six months. The data is incredibly clear that it increases your personal protection level — that’s why my parents got it, I got it, my relatives got it,” Polis said. “But it can also help improve the epidemiological state of a particular state or the entire country, because you have people who are ready to roll up their sleeves and add that extra protection, up to 70% or 80% protection going back to that level. 90% to 95% protection level, which can really have an impact on preventing the spread of the virus.”

His state announced last week that there is a “significant wave of disease spread” and that an estimated 1 in 48 Coloradans is contagious.

FDA authorization could be coming anytime

Pfizer and BioNTech were the first vaccine makers to request the extension of eligibility for their Covid-19 booster injection to all adults.

Last week, Pfizer and BioNTech asked the FDA to change the emergency use authorization for their vaccine so that all adults are eligible for a booster shot. Boosters are currently authorized for a more limited group of adults.

Pfizer and BioNTech seek FDA authorization for Covid-19 vaccine booster for all adults

Typically, when such requests are made to change an emergency use authorization, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the request and make a recommendation on how the FDA should proceed. have to go.

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 Pfizer/BioNTech’s request does not raise questions that would require additional discussion by the advisory committee, which is composed of outside experts.

Without a committee meeting, the FDA’s approval decision could come any moment.

“While the FDA cannot predict how long the evaluation of the data and information will take, the agency will review the request as soon as possible,” Hunt noted.

A separate panel of CDC vaccine advisors is scheduled to meet Friday to discuss expanding the eligibility of boosters for Pfizer’s Covid-19 vaccine, CDC spokesman Jason McDonald said Tuesday. CDC’s Advisory Committee on Immunization Practices usually doesn’t meet until a vaccine has been approved by the FDA — a further sign that FDA authorization could be coming any time this week.

Source: FDA likely to make booster decision without consideration of an outside advisory committee

Reviewing Pfizer’s request to approve Covid-19 booster injections for all adults is the “top priority” for the FDA, the agency’s top vaccine official told CNN on Monday.

“At this time, the review of the expanded Booster request has the highest priority at the Center for Biologics Evaluation at FDA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an email to CNN.

“While we cannot provide an exact date for the completion of this process, we are working to review the request and evaluate the data with appropriate speed given the current public health emergency,” Marks wrote.

“FDA will act as soon as possible to address recently submitted information related to expanding the population of individuals eligible for boosters,” he added. “As evidenced by the past public discussions of boosters, the thinking of experts in this field regarding supporting boosters for all individuals over the age of 18 has evolved very rapidly.”

Recent studies suggest that while vaccination may still provide strong protection against serious illness and death months later, immunity may begin to wane and protection against milder and asymptomatic illness may decline over time. Studies also show that booster 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, said U.S. Surgeon General Dr. Vivek Murthy Sunday.

“The reality is there’s a lot more agreement here than I think people appreciate,” Murthy . said at the request of Fox News’ Chris Wallace whether there was a split between experts like Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and CDC director Dr. Rochelle Walensky.

Murthy said Fauci, Walensky and he all believe vaccine immunity to Covid-19 may decline over time and they prefer the FDA and CDC review both the efficacy and safety of booster shots.

“While we now have millions of people who are eligible for booster shots, we are going through an FDA process and we will be going through a CDC process to see if that eligibility needs to be expanded,” Murthy said. “But the bottom line is that we are all on the same page about the strong protection that vaccines provide and we know that where boosters are indicated they will be helpful in extending people’s protection from Covid-19.”

CNN’s John Bonifield, Naomi Thomas, Virginia Langmaid and Amanda Sealy contributed to this report.