For Kids, Benefits of COVID Vaccine ‘Don’t Outweigh Risks,’ Experts Tell FDA


Published 11 June 2021, The Defender 

During an FDA meeting Thursday to discuss granting Emergency Use Authorization for COVID vaccines for children under 12, several experts spoke out against the plan, saying the benefits don't outweigh the risks for young children. 

The following issues were discussed during the meeting:

  1. What's needed in terms of data - including safety data, database size and duration follow-up - to support EUA and licensure for COVID vaccines for pediatric age groups 6 to 12 years, 2 to 6 years and 6 months to 2 years of age.
  2. Provided there is sufficient evidence of effectiveness to support the benefit of a COVID preventive vaccine for adolescents 12 to 18 years old, safety data, including database size and duration of follow-up, would be needed to support licensure of the vaccine.
  3. Studies following licensure and/or issuance of an EUA needed to further evaluate safety and effectiveness of COVID vaccines in different pediatric age groups.