FDA, CDC Sign Off on Omicron Vaccines for Children as Young as 6 Months Old

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U.S. federal regulators have authorized updated Omicron COVID vaccines for children as young as 6 months old, allowing pharmacies and health care providers to start administering the shots.

The Centers for Disease Control and Prevention (CDC) on Friday signed off on updated mRNA vaccines developed by Pfizer (NYSE: PFE)-BioNTech (NASDAQ: BNTX) and Moderna (NASDAQ: MRNA), a day after the Food and Drug Administration (FDA) authorized the shots.

"Vaccines remain the best defence against the most devastating consequences of disease caused by the currently circulating Omicron variant, such as hospitalization and death," said Dr. Peter Marks, head of the FDA's vaccine segment, in a statement on Thursday. "Parents and caregivers can be assured that the FDA has taken a great deal of care in our review."

The eligibility criteria for the Omicron vaccines depend on whether the child has received Mondera's or Pfizer's original vaccines--developed to target the initial SARS-CoV-2 virus that emerged from Wuhan, China--as their primary series.

Here are the FDA's authorization rules for the vaccines:

  • Children aged 6 months through 5-years-old who received Moderna's vaccine as their two-dose primary series are eligible for an omicron boosters two months after their second dose.
  • Children 6 months through 4-years-old who have not received a third dose of Pfizer's primary series will now receive the updated vaccine as their third dose. Children in the same age range who have already completed Pfizer's third-dose series are not eligible for the Omicron vaccine at this time.
The FDA said in a statement it is still waiting on data for children who have received Pfizer's three-dose primary series on whether or not a booster Omicron dose is beneficial. The agency expects data in January, and will review it as quickly as possible, FDA said.

According to CDC data, the vast majority of children under the age of 5 have not received a single dose of COVID vaccine, with 95% of young children being either unvaccinated or have yet to complete their primary vaccine series. The CDC said in a statement Friday that it is working with parents to improve confidence in the vaccines, especially as COVID infections and hospitalizations begin to rise again as people hold more gatherings indoors during the colder months of the year.

The updated Omicron vaccines target both the highly infectious Omicron BA.5 subvariant as well as the original SARS-CoV-2 strain.