An FDA independent advisory committee is set to convene Friday to weigh data related to Pfizer’s booster
Several studies published on Wednesday supporting the potential use of Pfizer’s COVID-19 vaccine booster shot met with a neutral tone from the Food and Drug Administration, according to documents posted ahead of an important meeting on Friday .
An independent advisory committee is set to convene on September 17 to weigh data related to Pfizer’s boosters, and whether sufficient evidence will support approval for people up to 16 years and six months after the initial series.
“Some observational studies have suggested a decreased efficacy of COMIRNATY [Pfizer’s approved vaccine] over time against symptomatic infections or against the delta variant, while others have not,” said an FDA briefing. document reads, noting that current vaccines still provide protection against serious COVID-19 illness and death in the US
“There are several potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their findings,” the document continues. “It must be recognized that while observational studies may be able to gauge the effectiveness of real-world, there are known and unknown biases that may affect their reliability. These biases may cause some studies to be more reliable than others. Huh.”
The agency also suggested prioritizing vaccine effectiveness studies conducted in the US to most accurately reflect the population.
a study published A report Wednesday in the New England Journal of Medicine (NEJM) stems from data from Israel’s Ministry of Health including booster shots given to adults age 60 and older. The results indicated that those who were given the additional dose faced an almost 11-fold lower risk of infection, and a 19-fold lower rate of serious illness after at least 12 days.
different conclusion published The NEJM by Pfizer-BioNTech, stemming from an ongoing multinational trial of more than 44,000 participants aged 16 and older, indicated a “gradual decline in vaccine efficacy” six months after the two-dose series. The study reported an average drop in efficacy of about 6% every two months.
Within two months of the second dose, efficacy peaked at approximately 96%, with the data slipping to about 90% by four months before falling to about 84% by the cutoff date. However the jab remained protective against severe disease at 96.7%.
Modern analysis: People who got vaccinated last year are twice as likely to get COVID-19 than those who were recently infected
additional findings On the third dose of the Pfizer vaccine, which was also published in NEJM, neutralizing antibody titers were seen to increase from five-fold to more than seven-fold, and even compared with the beta version for the first time in South Africa. Against the high level detected.
“While vaccine effectiveness against severe disease, hospitalization and death remains high, weakened immunity and viral diversification create a potential need for a third vaccine dose,” reads a research paper from Dr. Ann Falci of the University of Rochester. , Doctor. Robert Frenk of Cincinnati Children’s Hospital and others.
Debate over need for COVID-19 vaccine booster among most Americans as more than half Before the FDA meeting and shortly before September 20, when health officials expect Pfizer to begin rolling out the booster shot, the global population hasn’t been vaccinated. Top health officials have advised that more time is needed to review the modern vaccine data.
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“I think the signal right now is that we don’t need additional boosters,” said Dr. Anna Durbin, director of the Center for Immunization Research and professor in the Department of International Health at the Johns Hopkins Bloomberg School. Media advisory Wednesday, in part, “shouldn’t give us a valuable resource just because we could, it should really be indicated by the disease and the epidemiology of the disease.”
Durbin suggested that additional data may come to support the use of boosters in certain populations, such as elderly individuals and long-term care facilities. Dr. Rochelle Valensky, head of the Centers for Disease Control and Prevention (CDC), and other top health officials last month issued a plan Health care providers, nursing home residents and other senior citizens are likely to be eligible for the booster from the week of September 20.