BioNTech/Pfizer Covid vaccine to be approved for 12- to 15-year-olds

The US is set to approve BioNTech and Pfizer’s coronavirus vaccine for use in 12- to 15-year-olds in the coming days, according to people involved in the regulatory process.

The pharmaceutical companies applied for authorisation to begin vaccinating adolescents last month after trials suggested the inoculations were 100 per cent effective at preventing symptomatic disease among the age group.

Two people close to the process said they expected the Food and Drug Administration to give its green light next week, a move that could help bring the US closer to “herd immunity” and prove vital for reopening schools full-time in the autumn.

The FDA and Pfizer declined to comment.

The BioNTech/Pfizer vaccine, which was approved for those aged 16 and over last year, has been administered 131m times, according to data from the US Centers for Disease Control and Prevention. This has helped the US vaccinate more than 50 per cent of its adult population with one dose, making it one of the largest Covid-19 inoculation campaigns in the world.

The vaccination drive has helped reduce cases and deaths in the US in recent weeks. According to the latest figures compiled by the Financial Times, the country is reporting about 50,000 cases and 700 deaths per day — roughly the rates it experienced in October last year.

Scientists have said that to reach herd immunity — the point at which enough people have antibodies that the virus can no longer spread — however, the US would need to vaccinate more than three-quarters of its population. That would be difficult unless children were vaccinated as well.

In March, Pfizer reported the results of phase 3 clinical trials in people aged 12-15, which showed better results than for those aged 16-25. Out of 2,260 adolescents who took part in the trial, 18 were infected with Covid-19 — all in the placebo group.

The FDA, which approves all drugs in the US, does not have to issue a new authorisation for Pfizer’s vaccine to be used in under-16s, avoiding the need for lengthy consultation with outside experts.

However, the CDC, which issues public health guidance, will consult an external panel of scientists before giving its own recommendations. That panel has been told to expect a meeting to discuss vaccinating 12- to 15-year-olds with the Pfizer jab next week, according to a person aware of the plans.

Anthony Fauci, the head of the US National Institutes for Allergy and Infectious Diseases, had previously said he expected secondary school-aged children to begin being vaccinated in the autumn, and younger children next year.