The vote will now go to the FDA to issue a final decision
a U.S. Food and Drug Administration (FDA) advisory panel on Friday endorsed emergency approval for pfizer-biontech COVID-19 Vaccination Booster shots for people 65 years of age and older and those at high risk of severe COVID-19.
The vote was 18-0. The vote will now go to the FDA to issue a final decision.
The panel voted earlier Friday afternoon to reject the use of Pfizer’s booster vaccine in people 16 years and older by a vote of 2-16.
During the deliberations, panel members suggested that older, vulnerable populations may benefit from boosters, but there is insufficient data among younger groups and a potentially increased risk of heart inflammation, particularly among men aged 16-17. But mentioned the concern.
The committee was charged with voting whether safety and effectiveness data from Pfizer’s clinical trial supported the approval of the company’s booster doses among people 16 years of age and older.
The meeting was attended by members of the FDA’s Vaccines and . Biological Products Advisory Committee, (VRBPAC), as well as health ministry officials from the Centers for Disease Control and Prevention (CDC), LSRAL, vaccine experts, and Pfizer representatives.
Dr. William Gruber, senior vice president of Vaccine Clinical Research and Development at Pfizer, noted data from the Phase 3 trial, which ranged from 96% vaccine efficacy within two months to about 84% by six months after the second dose, and safety over time. It reflects. Major Delta version. While protection against infection decreased, it was effective in preventing hospitalization.
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Gruber cited evidence suggesting a decrease in efficacy due to decreased immunity over time, in contrast to the delta version that evades vaccine protection. Additional data suggested that the third dose of Pfizer would provide equal or better protection than the second dose, although concerns were raised over a possible increased risk of myocarditis. The FDA panel review included the results of Pfizer’s trial with nearly 300 participants aged 18-55 who received a booster dose approximately six months after the second dose.
To be clear, the role of the FDA and the advisory panel in this case is to determine whether an additional dose can be used, while an expert panel advising the CDC (Advisory Committee on Immunization Practices, ACIP) Will convene on Wednesday to decide who should get the vaccine and when, after the FDA’s final review. Top health officials said last month that the group would include health care workers and residents of nursing homes that were targeted in the early stages of the rollout.