Some states do not wait for the FDA and extend the eligibility of Covid-19 boosters to all adults

“From the general public, some people really want boosters. They’re worried about a breakthrough infection,” Tewerson said. “So this is trying to deal with the public tension that the governor (at least some governors) really wants to take that extra step, even though he still doesn’t know what all the data shows. I think we are here. “

Waiting for “frustration”

Overall, some states are making decisions to expand booster eligibility, Tewerson said, and the move was in the early days of the pandemic, even without the federal mask policy. He added that it was similar to needing a mask in.

In most states that have expanded their eligibility for booster doses to all adults, the number of cases and hospitalizations for Covid-19 has recently increased, and state public health authorities have addressed such public health issues. Has made a “final decision” about. McClellan, director of the Duke Margolis Health Policy Center at Duke University and former FDA Commissioner, told CNN on Tuesday. The increase in these cases is occurring as the winter season approaches.

“I think the assessment of being at higher risk now drives some of these decisions,” McClellan said.

“But based on the new evidence coming in, I know that all states are waiting for further guidance from the FDA and CDC,” he said. “This time we look forward to the FDA approving the booster more broadly and the CDC confirming it to move forward, and we can see that all states will go further.”

“I’m very dissatisfied with the complex messages from the CDC and the FDA,” Police told Brennan.

“Everyone needs to get a booster after 6 months. The data makes it incredibly clear that it enhances your personal level of protection-that’s what my parents get it. That’s why I got it, my family got it, “Police said. “But it also helps to improve the epidemiological condition of a particular state or country as a whole, because to get it back from 70% or 80% protection, roll up the sleeves and add that additional protection. Because some people are ready to do it. 90% to 95% level of protection. This can actually affect the prevention of virus spread. “

FDA approval may come at any time

Pfizer and BioNTech were the first vaccine makers to demand increased eligibility for Covid-19 booster shots for all adults.

Last week, Pfizer and BioNTech requested the FDA to revise the emergency use authorization for the vaccine so that all adults are eligible for booster shots. Boosters are currently allowed for a more limited group of adults.

When such a request is made to change an emergency use authorization, the FDA’s Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) usually meets to discuss the request and recommend how the FDA should proceed. to hold.

But this time, the FDA has no plans to convene a VR BPAC to discuss the eligibility expansion of the Pfizer / BioNTech Covid-19 booster shot, FDA spokesperson Allison Hunt confirmed to CNN by email on Tuesday. The FDA has concluded that Pfizer / BioNTech’s request does not raise questions that require additional discussion by an advisory board consisting of outside experts.

Without a committee meeting, the FDA’s approval decision may be made at any time.

“The FDA cannot predict how long it will take to evaluate data and information, but the FDA will consider the request as quickly as possible,” Hunt said.

CDC spokesperson Jason Mcdonald said Tuesday that another panel of CDC vaccine advisors would meet on Friday to discuss expanding Pfizer’s Covid-19 vaccine booster eligibility. The CDC’s Immunization Implementation Advisory Board usually meets only if the vaccine is approved by the FDA. This is a further sign that FDA approval may occur at any time this week.

Considering Pfizer’s request to allow Covid-19 booster shots for all adults is a “top priority” for the FDA, the FDA’s chief vaccine official told CNN on Monday.

“At this time, the review of expanded booster requirements is a top priority at the FDA’s Biopharmaceutical Evaluation Center,” Dr. Peter Marks, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, emailed CNN.

“We cannot give an exact date of completion of this process, but we are working to review the requirements and evaluate the data at an appropriate rate, given the current public health emergencies,” Marks said. He writes.

“The FDA is moving as quickly as possible to address recently submitted information related to the growing population of individuals targeted for boosters,” he added. “As evidenced by previous public discussions on boosters, the thinking of experts in this field related to the support of boosters for all individuals over the age of 18 has evolved very rapidly.”

Recent studies show that vaccination provides strong protection against serious illness and death months later, but immunity begins to weaken and protection against mild asymptomatic diseases over time. It may decrease. Studies have also shown that booster doses restore that immunity.

Biden’s public health officials are on the same page when it comes to the benefits of booster shots, said US Surgeon General Vivek Murthy on Sunday.

Mercy believes that Fauci, Warensky, and he all believe that vaccine immunity to Covid-19 can decline over time, and the FDA and CDC to examine both the efficacy and safety of booster shots. Said he likes.

“Millions of people are currently on booster shots, but we’re going through the FDA process and we’ll see if we need to expand their eligibility through the CDC process,” Mercy said. Says. “But the bottom line is that we’re all on the same page about the powerful defenses that vaccines offer. Where boosters are shown, we’ve found that they help expand people’s defenses against Covid-19. I am. “