COVID-19 Vaccination Now Available for Infants and Young Children

Strategic Insights -

Parents of children under five years old now have the option to vaccinate their infants and young children against COVID-19, following the Food and Drug Administration's (FDA) emergency authorization of Pfizer-BioNTech and Moderna mRNA-based COVID-19 vaccines for young children in June. The Centers for Disease Control and Prevention (CDC) has accepted CDC advisory committee recommendations for vaccination of infants and other children.

The vaccination protocol for Moderna calls for two vaccinations, each one-quarter of Moderna's adult vaccine dose, spaced four weeks apart. Pfizer-BioNTech's original protocol included two vaccinations, each one-tenth of the adult dose and spaced three weeks apart, but it failed to meet FDA criteria for authorization and was withdrawn. Pfizer later added a third dose, administered eight weeks after the second, and collected additional data for FDA submission before the three-dose protocol was authorized.

The FDA approvals were granted primarily based on antibody immune responses generated by the vaccines, which mustered responses comparable to those measured in earlier COVID-19 vaccine trials of adults, despite the lower dosages.

We spoke to Lee Atkinson-McEvoy, MD, a professor of pediatrics at UC San Francisco, for more on what parents should know about COVID-19 vaccines for young children.

Key Takeaways:

  • Parents of children under five years old now have the option to vaccinate their infants and young children against COVID-19, following FDA emergency authorization of Pfizer-BioNTech and Moderna mRNA-based COVID-19 vaccines for young children in June.
  • Moderna's vaccination protocol calls for two vaccinations, each one-quarter of Moderna's adult vaccine dose, spaced four weeks apart.
  • Pfizer-BioNTech's original protocol included two vaccinations, each one-tenth of the adult dose and spaced three weeks apart, but it failed to meet FDA criteria for authorization.
  • Pfizer later added a third dose, administered eight weeks after the second, and collected additional data for FDA submission before the three-dose protocol was authorized.
  • The FDA approvals were granted primarily based on antibody immune responses generated by the vaccines, which mustered responses comparable to those measured in earlier COVID-19 vaccine trials of adults, despite the lower dosages.
  • Side effects from the vaccine are similar to those from being ill, including fever, fatigue, and aches, and are usually short-lived, lasting just a day or two.
  • Parents should monitor their child's side effects and seek medical attention if they last longer than one-to-two days, if fever is greater than 104°F (39.5°C), if their child is not acting well, or for other serious concerns.
  • Vaccination decreases the risks of COVID-19 in children, including severe COVID and Multisystem Inflammatory Syndrome in Children (MIS-C).
  • With the emergence of Omicron and its subvariants, hospitalization rates among young children have overtaken rates seen in older children.
  • Parents should contact their child's physician's office if their child has a high fever greater than 104°F (39.5°C), appears sick, or is urinating less than three times per day.
  • It is safe for children to receive COVID-19 and other vaccines during the same clinic visit.
  • COVID-19 vaccination decreases risk for serious COVID illness and allows children to be well enough to attend routine appointments for important screenings and vaccinations against other major illnesses.

Statistics:

  • The FDA granted emergency authorization for Pfizer-BioNTech and Moderna mRNA-based COVID-19 vaccines for young children in June, nearly 18 months after vaccines were first approved for adults.
  • The vaccination protocol for Moderna calls for two vaccinations, each one-quarter of Moderna's adult vaccine dose, spaced four weeks apart.
  • Pfizer-BioNTech's original protocol included two vaccinations, each one-tenth of the adult dose and spaced three weeks apart, but it failed to meet FDA criteria for authorization.
  • Pfizer later added a third dose, administered eight weeks after the second, and collected additional data for FDA submission before the three-dose protocol was authorized.
  • The FDA approvals were granted primarily based on antibody immune responses generated by the vaccines, which mustered responses comparable to those measured in earlier COVID-19 vaccine trials of adults, despite the lower dosages.
  • Only a minority of children ages 5 to 11 have been fully vaccinated since they became eligible last November.
  • With the emergence of Omicron and its subvariants, hospitalization rates among young children have overtaken rates seen in older children.
  • More than half of young children hospitalized for COVID in this age group have had no pre-existing medical conditions.

Sources:

  • UCSF Medical Center
  • Food and Drug Administration (FDA)
  • Centers for Disease Control and Prevention (CDC)
  • Lee Atkinson-McEvoy, MD, professor of pediatrics at UC San Francisco.