FDA Authorizes Bivalent COVID-19 Vaccines for Children Down to 6 Months of Age

Today, the FDA announced it had amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.

“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, MD, said in a statement.

According to the FDA, parents and caregivers should know the following about the vaccines:

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 two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.

• 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 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant. The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.
  
  
• The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
  
  
• Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines.
  
  
• The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.

The respiratory virus season has been extremely challenging in recent months and concerns of the tripledemic (RSV, influenza, and COVID-19) have been front of mind for clinicians, parents and public health officials. There have been reports of RSV overwhelming pediatric units in hospitals, and influenza incidence rates increasing dramatically.

Without the benefit of an RSV vaccine available yet, vaccine uptake for both influenza and COVID-19 remains vital to

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the same statement.