Dear USET/USET SPF Family,
On Friday, June 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the mRNA COVID-19 vaccines made by Moderna and Pfizer-BioNTech to allow children 6 months and older to be vaccinated to protect against COVID-19. The FDA independently reviewed data submitted by both companies and deemed the vaccines both safe and effective, based on clinical trials in several thousand children.
This approval followed a unanimous decision by the FDA’s independent advisory committee to recommend amendments of Moderna’s EUA to allow adolescents 12 to 17 to be given the adult dose (100 mcg) of the vaccine, children 6 to 11 to be given a 50-mcg dose version of the vaccine, and children 6 months through 5 years to be given a 25-mcg dose of vaccine. All of the Moderna vaccine preparations are given as a 2 dose primary series 4 weeks apart.
While the Pfizer-BioNTech EUA already allowed for children 5 years and above to be vaccinated, the new EUA amendment is for a 3-mcg dose vaccine given to children aged 6 months through 4 years of age. The vaccine is administered as a 3 dose primary series, with 3 weeks between doses 1 and 2, and the 3rd dose given at least 2 months after the 2nd dose.
Now that the FDA has amended the EUAs for these vaccines, the Advisory Committee on Immunization Practices (ACIP), an advisory committee to the Centers for Disease Control and Prevention (CDC) met June 17 and 18 and endorsed all these decisions from the FDA. The CDC officially recommended the vaccines Saturday, June 18, 2022, allowing for their administration to the general public.
It is important to note that there are differences in vaccine administration intervals, volumes, reconstitution, and age groups. It is imperative that vaccine administrators give the appropriate vaccine to the appropriate pediatric patient. For more information on this, please see the CDC website: [COVID-19 Vaccination for Children | CDC ]. It is anticipated that booster doses may become necessary for these vaccines in the future to maintain high levels of protection, but more research will need to be conducted to determine an appropriate time interval for booster doses (if needed).
After reviewing the data presented to the FDA and CDC, the USET Tribal Epidemiology Center endorses the use of these vaccines to protect children 6 months and older against COVID-19. We urge parents to consult with their child’s medical provider for individual questions or concerns. In addition, a question and answer session with USET’s own Dr. Harry Brown will be forthcoming. Be on the lookout for an invitation. As always, do not hesitate to contact the TEC should you have any questions at email@example.com.