CDC Panel Outlines Who Should Get Pfizer-BioNTech COVID-19 Booster Shots…

cdc-panel-outlines-who-should-get-pfizer-biontech-covid-19-booster-shots,…




A CDC committee today recommended booster shots of Pfizer-COVID-19 BioNTech’s vaccine for persons 65 and older, as well as anyone over 50 with certain underlying medical problems, in a four-part decision.

The group also suggested that those aged 18 to 49 who had underlying medical issues be allowed to obtain a booster if they so wished, depending on individualized decisions regarding the advantages and dangers.

However, the committee voted not to suggest booster injections for adults working in high-risk environments such as health care and school systems in one of its four votes.

That vote went against the Food and Drug Administration’s (FDA) decision on Sept. 22 to authorize a booster dose of the Pfizer-BioNTech vaccine for people over 65, those ages 18 to 64 who are at higher risk of getting the disease, such as people with immune system conditions, health-care, front-line and emergency workers, and teachers, among others who are at higher risk of getting the disease.

All of those categories should obtain the booster at least six months after receiving the second of the two-dose immunization, according to the FDA.

However, it was up to the CDC committee that convened today to figure out how that authorisation should be communicated to the groups who were eligible. While the CDC’s Advisory Committee on Immunization Practices (ACIP) frequently follows the FDA’s recommendations, it isn’t required to do so—the CDC’s mandate, which is more focused on public health goals than the FDA’s, which is more focused on evaluating safety and efficacy, differs slightly from the FDA’s.

Dr. Beth Bell, professor of global health at the University of Washington, reminded the committee, “What we need to be doing is looking at the totality of evidence and thinking about what makes the most sense using the tools we have to protect as many people as possible, and how to operationalize this considering other things like feasibility.”

While the members were generally in agreement regarding the need for a booster for those over 65, they were split on whether it was necessary for younger people, even those who were at increased risk of COVID-19 exposure due to their jobs or other circumstances.

In the United States, 220 million doses of Pfizer-BioNTech vaccine have been delivered, with 27 million persons over 65 receiving both doses. They were among the first to be vaccinated when Pfizer-vaccine BioNTech’s was licensed, and they are now showing signs of diminishing immunity, which is why the committee decided to give them a booster dosage to improve their immunity.

When discussing whether boosters should be extended to people with underlying medical conditions and those whose jobs put them at higher risk of exposure, some members expressed concerns about health care equity, arguing that extending the booster to these populations would widen coverage gaps as those without access to care who remain unvaccinated continue to miss shots.

Finally, the committee agreed to strongly suggest the booster to anyone over the age of 50 who has underlying medical conditions, but to give it a less enthusiastic recommendation to those aged 18 to 49 who have such conditions. The ACIP recommends that consumers decide for themselves whether or not they desire a booster shot.

When it came to people like health care workers under 65 whose jobs might put them at increased risk of exposure and infection, the CDC committee deviated from the FDA, noting that there isn’t strong evidence to suggest that they are experiencing higher rates of severe disease if they are vaccinated.

The data suggest that the two Pfizer-BioNTech doses that are currently licensed continue to offer good protection against COVID-19, particularly against severe illness, hospitalization, and death. While Pfizer-BioNTech did give the FDA and CDC with data indicating that a booster shot increased antibody levels in young people, the data only followed those individuals for a few months. Members of the committee also brought up the fact that, while it appears to be uncommon, certain young guys can suffer a rare inflammation of the heart tissue as a side effect of the vaccine.

As a result, some members stressed that their support for the booster today was just temporary, limited to a small group of people, and based on the information provided. “A lot of activity around booster doses is just getting started,” Bell added. “At this time, given the lack of evidence for a marginal benefit of boosters in people in certain groups who have received the Pfizer-BioNTech primary series—too it’s narrow, and too soon, and given the potential risks or adverse outcomes, it’s worth waiting until we know a little more about what we’re doing, and we can better assess the opportunity costs and unintended consequences.”

Because the FDA only assessed data on that cohort, the CDC committee was told that its booster decision would only apply to people who had previously been injected with the Pfizer-BioNTech vaccine. Some committee members, however, contended that, in order to be fair and equal, the ruling should also apply to persons who received Moderna or Johnson&Johnson-Janssen shots in the first place. (Moderna has also applied to the FDA for permission to use a booster dosage of its vaccine, but the agency has yet to analyze the data.) However, the data currently available does not support such dose mixing and matching.

Some committee members, such as Maine Center for Disease Control and Prevention Director Dr. Nirav Shah, claimed that allowing boosters to be mixed and matched will help more people get vaccinated. He emphasized the difficulty of expecting people to keep track of their immunization records and of requesting vaccine providers to verify those information.

Limiting the booster to only those who received the Pfizer shot would be especially unfair to those living in long-term-care facilities who received an initial series of Moderna vaccine and would be unable to get a booster while their neighbors who received the Pfizer shot would be vaccinated again, according to Dr. Sarah Long, professor of pediatrics at Drexel University College of Medicine. “I don’t understand how, later this afternoon, we’ll tell individuals over 65 that they’re at risk of serious disease and death, but only half of them can protect themselves right now,” she said.

“There is currently no data available to guide interchangeability of authorized COVID vaccines, either for completing the [two-dose] primary series or for use as a booster dose,” Dr. Doran Fink of the FDA’s office of vaccines research and review told the committee.

Due to the absence of data, the CDC panel ultimately ruled that only those who had previously gotten two doses of the Pfizer-BioNTech vaccine should receive a booster dose. However, today’s proposal may not be the final word in this area: study results on such mix-and-match tactics are due soon; researchers claimed the experiment was completed and the data had been submitted to a journal for publication.

The committee emphasized that the existing two-dose vaccine still provides significant protection against SARS-CoV-2, including the Delta form, for the vast majority of patients who have been vaccinated.

Dr. Matthew Daley, senior investigator at Kaiser Permanente Colorado, said, “Our conclusion today is not about who deserves a booster, but who needs a booster.” “If you are in a category for which a booster is not recommended today, it is because the vaccine efficacy against serious outcomes for individuals who have received the primary series is already high.”




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