The U.S. Food and Drug Administration authorized Moderna and Pfizer-BioNTech COVID-19 vaccines for children as young as 6 months old.
The decision comes as COVID-19 infections and hospitalizations are increasing nationally. Eligibility rules vary depending on whether children received Moderna’s or Pfizer’s original vaccines as their primary series.
What parents and caregivers need to know:
- Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine if it has been two months since their last shot.
- Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
- Children in the same age group who completed the three-dose series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine.
According to the FDA, those who recieved the three doses of Pfizer's vaccine are not authorized for the omicron shots because they are waiting on supporting data for the booster dose.The data to support giving an updated bivalent booster dose for these children are expected in January.
The Centers for Disease Control and Prevention needs to sign off on the shots before pharmacies and physicians can start administering them.
“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert M. Califf, M.D. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”
In a statement, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said vaccines “remain the best defense against disease caused by the currently circulating omicron variant”.
“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing,” Marks said.