[Epoch Times September 18, 2021](Epoch Times reporter Li Xin comprehensive report) A vaccine advisory committee of the U.S. Food and Drug Administration (FDA) voted at 16:2 on Friday (September 17) to recommend The FDA does not approve the Pfizer-BioNTech booster injection for the general population of 16 years and older. But in another vote, the committee supported the booster vaccine for people 65 years and older and people vulnerable to COVID-19.
The result of the vote is not binding, but it may be an unexpected obstacle to the US government’s plan to start extensive injections of boosters as early as next week.
Pfizer is seeking FDA approval to provide booster injections for people 16 years and older, and Moderna has applied for authorization to inject booster injections for people 18 years and older.
The committee unexpectedly voted against it after hours of debate. Its debate focused on concerns about the quantity and quality of available data, which were used to weigh the long-term effectiveness and safety of enhanced injections for young people.
However, in a later vote, the committee unanimously passed 18:0 to support booster vaccines for seniors 65 years of age and above and those who are at high risk of contracting COVID-19 or causing serious diseases. However, the result of this vote approved an emergency use authorization, not a supplementary approval for a vaccine that has been fully licensed.
Lena Wen, a visiting professor at the George Washington University Milken Institute School of Public Health, told the Yahoo Finance website that the vote was balanced.
“This is a reasonable’middle ground’ solution, allowing doctors and patients to decide for themselves who is at high risk. The level of individual decision-making is the key.” Wen said.
The FDA’s leading vaccine expert Peter Marks also stated that the agency encourages discussion of different points of view. He also added that the meeting focused on near real-time analysis and the goal is still to slow the spread of COVID-19, which causes nearly 2,000 Americans to die every day.
At this meeting to vote, scientists are arguing whether there is evidence to support the Biden administration’s extensive third-dose vaccination plan. Although the vote of the FDA advisory panel is not binding, the FDA usually follows the recommendations of its advisory committee.
After the FDA approves the above recommendations, a panel of experts from the Centers for Disease Control and Prevention (CDC) will meet next week to further determine who is eligible for booster injections and when to receive booster injections and other specific details.
Editor in charge: Ye Ziwei#
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