Pfizer and BioNTech said on Friday that they have filed an emergency use authorisation request with the US Food and Drug Administration for use of their Covid-19 vaccine among adolescents aged 12 to 15.
The move marks a big step towards vaccinating more of the population, especially as cases are rising among young people due to participation in extra-curricular and sport activities.
Pfizer and BioNTech say results from trials that included more than 2,000 US adolescents found those who received the vaccine "demonstrated 100 per cent efficacy and robust antibody response after vaccination".
The trial results, released in late March, also found that the vaccine was "well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age".
Pfizer-BioNTech's vaccine is currently the only Covid-19 vaccine in the US that is authorised for the vaccination of adolescents aged 16 and 17.
The other two approved vaccines in the US, from Moderna and Johnson & Johnson, are eligible for those over 18 years of age.
The company says it will also apply for authorisation for the new age group with health regulatory agencies in other countries.
Emergency use authorisation approval would be a major boost for young people, including the 12-15-year-old cohort, which in the US has faced a difficult year of remote learning and mixed returns to in-person or hybrid schooling.
Young people have also suffered anxiety, trauma and depression due to limited social interactions, fuelling a mental health crisis in children. Some regions are seeing a rise in suicide attempts.
"Pending regulatory decision, our hope is to make this vaccine available to the 12-15-year-old age group before the start of the 2021 school year," Pfizer said in a tweet.
Dr Rochelle Walensky, chief of the US Centres for Disease Control and Prevention, has said that the agency is seeing a rise in cases among unvaccinated young people who participate in team sports.
Scientists estimate that at least 80 per cent of the population of the US must be vaccinated to achieve herd immunity.
There are concerns it will be difficult to reach herd immunity in the US, influencing calls for teenagers to be included in the groups eligible to be immunised.
Studies have shown that children are less likely to develop severe symptoms of Covid-19, leading to the prioritisation of vaccines for older populations.
For an emergency use authorisation to go forward, the Food and Drug Administration must make a decision after a vaccine panel votes after reviewing information from Pfizer-BioNTech.
If both the panel and the agency chief approve, the Centres for Disease Control and Prevention will also make a decision on approval as well.
