The Food and Drug Administration (FDA) announced on March 14 that children aged 6 months through 4 years old who completed primary COVID-19 vaccination with three monovalent vaccines now can receive a bivalent Pfizer-BioNTech COVID-19 vaccine booster.
Bivalent vaccines protect not only against the original variant of SARS-CoV-2, the virus that causes COVID-19, but against BA.4 and BA.5 omicron subvariants as well.
The decision comes following a clinical study in which 60 children who had completed primary vaccination received a bivalent booster dose and demonstrated a clear immune response to both the original SARS-CoV-2 virus strain and the BA.4 and BA.5 subvariants one month after vaccination.
Children in this age group who received the first two doses of the monovalent vaccine and a third dose of the bivalent vaccine are not eligible for a booster dose of a bivalent vaccine. These children are expected to have protection against the most serious COVID-19 outcomes.
FDA Advisers Vote in Support of Paxlovid Approval
FDA advisers on March 16 voted 16-1 in support of full approval of Paxlovid, an oral medication used to treat COVID-19, to treat adult patients who are at high risk for progression to severe illness.
The advisory committee states that clinical trial data shows the benefits of the medication outweigh risks and confirmed low rates of rebound infections, in which patients test positive or have symptoms days after a course of the drug is completed.
If Paxlovid receives agency approval, it would become the first FDA-approved COVID-19 oral treatment.
HHS Secretary Amends EUA Declaration
Health and Human Services (HHS) Secretary Xavier Becerra amended on March 15 the determination of a public health emergency (PHE) established in February 2020 to account for the “significant potential for a public health emergency.” This amendment will allow the continued use of emergency use authorizations (EUAs) for certain in vitro diagnostics, personal respiratory protective devices and other medical devices, and drug and biological products.
The move serves to protect these available services despite the upcoming termination of the national PHE on May 11. The previous declaration only allowed EUAs regarding COVID-19 if HHS declared a current PHE.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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