For Kids, Benefits of COVID Vaccine ‘Don’t Outweigh Risks,’ Experts Tell FDA
14/06/2021
Published 11 June 2021, The Defender
The following issues were discussed during the meeting:
- 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.
- 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.
- Studies following licensure and/or issuance of an EUA needed to further evaluate safety and effectiveness of COVID vaccines in different pediatric age groups.