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FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children


The U.S. Food and Drug Administration has amended the Emergency Use Authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 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, 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 families and public health by helping prevent severe illnesses, hospitalisations, and deaths.”

What parents and caregivers need to know:

1. 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.

2. Children 6months through 4 years of age who have not yet begun their three-dose primary series of the 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.

3. 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.

4. 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.

5. 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.

6. 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.

Related Information

COVID-19 Bivalent Vaccine Boosters

Pfizer-BioNTech COVID-19 Vaccine

Emergency Use of Authorization for Vaccines Explained

Source: FDA

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