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The U.S. Food and Drug Administration (FDA) has formally approved the BioNTech/Pfizer new crown vaccine, which may encourage groups who do not want to be vaccinated.
Since December last year, due to the urgent need for a vaccine to combat the new crown epidemic, the two-dose vaccine required by BioNTech/Pfizer has been vaccinated in accordance with emergency use approval.
On Monday, the FDA decided to officially approve the messenger ribonucleic acid (mRNA) vaccine for people over 16 years old, making it the first new coronavirus vaccine to be officially approved. The vaccine will continue to be approved for emergency use in children aged 12 to 15 years and will be used as a booster vaccination for people with weakened immune systems.
FDA Acting Commissioner Janet Woodcock (Janet Woodcock) said in a statement on Monday: “As the first new coronavirus vaccine approved by the FDA, the public can fully believe that the vaccine meets the FDA’s requirements on the safety, effectiveness, and safety of approved products. High standards of production quality.
“Although many people have been vaccinated against the new coronavirus, we realize that for some people, the approval of a vaccine by the FDA may now give them more confidence in the vaccination.”
At the time of this official approval, employers are increasingly asking their employees and customers to show proof that they have completed the entire vaccination process.
Recently, the lagging vaccination rate in some states has improved. The reason is that the highly contagious Delta variant has caused a surge in the number of infections and hospitalizations in these states-mainly in people who have not been vaccinated.
The FDA stated that the evaluation of the vaccine’s effectiveness comes from data of 20,000 subjects in the vaccine group and 20,000 subjects in the placebo group, and the analysis of safety comes from 22,000 subjects in the vaccine group and placebo group. The data of the participant.
Translator/He Li