FDA Expands Updated COVID-19 Vaccines EUA to Children


The bivalent vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 and a component of omicron lineage BA.1.

The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children starting at six months old.

The decision means that children six months through five 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, FDA said in a news release.

In addition, children six months through four 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.

However, children six months through four 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 currently, FDA said.

“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 agency said. The data to support giving an updated bivalent booster dose for these children are expected in January and the FDA “is committed to evaluating those data as quickly as possible.”

Robert M. Califf, M.D.

Robert M. Califf, M.D.

“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,” FDA Commissioner Robert M. Califf, M.D., said in a press release. “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 mid-October, the FDA issued an EUA for both the Moderna and Pfizer updated COVID-19 vaccine boosters in children. These bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 and a component of omicron lineage BA.1.

Moderna’s updated booster is authorized for children six years of age and older. In August, the FDA had authorized Moderna’s updated booster for those 18 years and older.

The BioNTech/Pfizer updated booster is authorized for children five years and older. In August, the agency had authorized the BioNTech/Pfizer updated booster for those 12 years and older.

In its new EUA amendment, the FDA said that 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. As a result, the fact sheets for both bivalent COVID-19 vaccines include information about the potential side effects, as well as the risks of myocarditis and pericarditis.

The monovalent Moderna COVID-19 vaccine is authorized as a two-dose primary series in individuals six months of age and older and as a third primary series dose for individuals six months of age and older who have been determined to have certain kinds of immunocompromise.

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