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According to people involved in the regulatory process, the United States will approve the BioNTech and Pfizer coronavirus vaccine for use in 12- to 15-year-olds.
Pharmaceutical companies applied for authorization for start vaccinating teens last month, after trials suggested the inoculations were 100% effective in preventing symptomatic disease in the age group.
Two people close to the trial said they hoped the Food and Drug Administration would give the green light next week, a step that could help bring the United States closer to “herd immunity” and be vital to reopening of full-time schools in the fall.
The FDA and Pfizer declined to comment.
The BioNTech / Pfizer vaccine, that was approved for those over 16 last year, it has been administered 131 million times, according to data from the U.S. Centers for Disease Control and Prevention. This has helped the U.S. vaccinate more than 50% of its adult population with a single dose, making it one of the largest Covid-19 inoculation campaigns in the world.
The push for vaccination has helped reduce cases and deaths in the United States in recent weeks. According to the latest figures compiled by the Financial Times, the country reports about 50,000 cases and 700 deaths a day, roughly the rates it experienced in October last year.
Scientists have said so to achieve the immunity of the flock – the point at which there are enough people with antibodies that the virus can no longer spread; however, the U.S. should vaccinate more than three-quarters of its population. This would be difficult if children were also vaccinated.
In March, Pfizer reported the results of Phase 3 clinical trials in people aged 12 to 15, which showed best results than for those aged 16 to 25. Of the 2,260 adolescents who participated in the trial, 18 were infected with Covid-19, all from the placebo group.
The FDA, which approves all drugs in the U.S., should not issue a new authorization for the Pfizer vaccine to be used in children under 16, avoiding the need for lengthy consultation with outside experts.
However, the CDC, which issues public health guidelines, will consult with an external group of scientists before making its own recommendations. According to a person familiar with the plans, this group was told they were waiting for a meeting to discuss vaccinating 12- to 15-year-olds with the Pfizer jab.
Anthony Fauci, the head of the U.S. National Institutes of Allergy and Infectious Diseases, had previously said he hoped high school children would start vaccinating in the fall and younger children next year.
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