FDA to Authorize COVID-19 Vaccine for Adolescents Early Next Week

FDA to Authorize COVID-19 Vaccine for Adolescents Early Next Week

Ayden Nguyen, Writer

The US Food and Drug Administration (FDA) is expected to authorize Pfizer/BioNTech’s COVID-19 vaccine for teens ages 12-15. Currently, the FDA is reviewing data from the vaccine trials for adolescents. The trials run by Pfizer showed that the vaccine is 100% effective in adolescents. 


Previously, the FDA held meetings with their Vaccines and Related Biological products Advisory Committee (VRBPAC) to look over the data and vote on whether or not to grant emergency use authorization (EUA). This will not happen with the vaccine for adolescents. “While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” says the FDA, “Based on an initial evaluation of the information submitted, at this time, the agency does not plan to hold a meeting of the VRBPAC on this request to amend the EUA for the Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended for authorization at the VRBPAC meeting in December 2020. As with all FDA-authorized COVID-19 vaccines, we are committed to transparency with this EUA review process.”


The US Centers for Disease Control and Prevention (CDC) advisory committee known as the Advisory Committee on Immunization Practices (ACIP) will host a meeting after any FDA decision. In this meeting, the ACIP will look into the vaccine and advise the CDC on what age groups the vaccine should be recommended for. This information will be relayed to CDC director Dr. Rochelle Walensky who will ultimately decide if the agency will recommend the vaccine to this new age group.


Pfizer expects to submit the vaccine for 6 month – 11 year olds for EUA in September. The vaccine safety and efficacy for this age group is still being studied. “We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,” says Pfizer CEO Albert Bourla. The EUA submission for 6 months – 2 year olds is expected to be in the last quarter of 2021.


Moderna is also testing its vaccine in children as young as 6 months old. They are expected to ask for EUA later this year. 


Source: https://www.cnn.com/2021/05/03/health/pfizer-covid-vaccine-teens-fda/index.html