FDA approves Omicron booster for children as young as 5
The vaccines provide better protection against the Omicron variants, amid warnings of increased infections during the fall and winter months.
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The U.S. Food and Drug Administration has amended the emergency use authorizations of the Moderna and Pfizer COVID-19 vaccines to allow their use as a single booster dose in children.
The Moderna COVID-19 vaccine bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children at least six years of age.
The Pfizer-BioNTech COVID-19 vaccine bivalent is authorized for administration at least two months following the completion of primary or booster vaccination in children at least five years of age.
WHY THIS MATTERS
The vaccines provide better protection against the Omicron variants, amid warnings of increases in infections during the colder fall and winter months.
These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the Omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the variant, the FDA said.
The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive "spike" protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.
"Since children have gone back to school in person and people are resuming prepandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19," said Dr. Peter Marks of the FDA. "Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death. While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible."
THE LARGER TREND
While data shows that COVID-19 vaccines are safe and effective, only about one-third of adults are getting booster shots so far this fall, according to statistics released by the HHS Assistant Secretary for Planning and Evaluation.
The booster is aimed at the Omicron variant, which remains highly transmissible.
Twitter: @SusanJMorse
Email the writer: SMorse@himss.org
