This is the first Covid-19 vaccine in the United States authorized for use in young adolescents and adolescents; the vaccine had previously been authorized for people aged 16 and over. Moderna and Johnson & Johnson’s Covid-19 vaccines are approved for people 18 years of age and older.
To support prolonged use, the FDA has reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 young people aged 12 to 15 showed the vaccine to be 100% effective and well tolerated.
The FDA’s independent advisory committee on vaccines and related biologics did not meet to vote on whether to recommend EUA expansion to children 12 to 15 years old.
But the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet on Wednesday to advise the CDC on whether to recommend the vaccine for use in this age group. CDC director Dr Rochelle Walensky will then decide whether the agency will recommend the use of the vaccine in the new group.
The extension of the authorization to people aged 12 to 15 opens up the Covid-19 vaccination to 5% of the American population, or nearly 17 million additional people. The expanded authorization means that 85% of the US population is eligible to receive a Covid-19 vaccine.
Pfizer said last week that it plans to submit an emergency use authorization for its Covid-19 vaccine for children aged 2 to 11 in September. His study on the safety and effectiveness of vaccines in children aged 6 months to 11 years is underway.
The FDA has also scheduled a meeting of its Vaccines and Related Biologics Advisory Committee on June 10 to discuss the potential extension of the EUA to children under 12.
“During the meeting, the agency will provide an update on our approach to Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in people 12 to 17 years old.” the FDA said in a statement on Monday.
“The committee will also discuss the data needed to support an EUA and a Biologics License (BLA) application for a COVID-19 vaccine intended for use in children under 12 years of age. The committee will not discuss specific products, ”he added.
Vaccines manufactured by Moderna and Johnson & Johnson are currently approved for people 18 years of age and older.
“We recognize that the next critical step is to have vaccines available for use in the entire pediatric population,” Dr. Peter Marks, chief of the FDA division in charge of vaccines, said in a statement.
“As with the initial COVID-19 vaccine authorizations, we want to ensure that the public clearly understands our expectations regarding the data and information needed to support emergency use authorization requests and product license applications. biologics for vaccines intended to prevent COVID-19 in this pediatric age group. ”