FDA Authorizes COVID-19 Vaccines for Children as Young as 6 Months

FDA Authorizes COVID-19 Vaccines for Children as Young as 6 Months

Following a unanimous vote of support by the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee, the FDA has authorized the emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in children as young as 6 months of age.

Specifically, the Emergency Use Authorization (EUA) for these vaccines has been amended to include the following:

For the Moderna COVID-19 Vaccine, the vaccine may be administered as a primary series to individuals 6 months through 17 years of age. The vaccine is already authorized for use in individuals 18 years of age and older.

  • For children 6 months to 5 years of age: 2 doses (25mcg each) 1 month apart.
    • Study data showed immune responses in this age group comparable to those in adults.
    • Among participants 6 months to 23 months: vaccine was 50.6% effective in preventing COVID-19.
    • Among participants 2 to 5 years: vaccine was 36.8% effective in preventing COVID-19.
    • Most common side effects: pain, redness and swelling at injection site, fever, underarm (or groin) swelling/tenderness of lymph nodes in the same arm (or thigh) as the injection.
  • For children 6 to 11 years: 2 doses (50mcg each) 1 month apart.
    • Study data showed immune responses in this age group comparable to those in adults.
    • Additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.
    • Most common side effects: pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever.
  • For adolescents 12 years of age and older: 2 doses (100mcg each) 1 month apart.
    • Study data showed immune responses in this age group comparable to those in adults.
    • Among participants 12 to 17 years of age: vaccine was 93.3% effective in preventing COVID-19 (data obtained before Omicron became predominant strain).
    • Most common side effects: pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever.
    • Myocarditis/pericarditis risk: observed to be highest in males 18 through 24 years of age.

For the Pfizer-BioNTech COVID-19 Vaccine, the vaccine may be administered as a primary series to individuals 6 months through 4 years of age. The vaccine is already authorized for use in individuals 5 years of age and older.


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  • For children 6 months to 4 years: 3 doses (3mcg each); the initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.
  • Study data showed immune responses in this age group comparable to those in older participants.
  • Additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.
  • Most common side effects: irritability, decreased appetite, fever and pain, tenderness, redness and swelling at the injection site (also fever, headache, and chills in recipients 2 to 4 years old).
  • Myocarditis/pericarditis risk: observed to be highest in males 12 through 17 years of age.

Additional information can be found in the fact sheets for the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these 2 vaccines for pediatric populations.”

Reference

Coronavirus (COVID-19) Update: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for children down to 6 months of age. News release. June 17, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

Source: Medical Bag https://www.medicalbag.com/home/news/fda-authorizes-covid-19-vaccines-for-children-as-young-as-6-months/

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