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The FDA has of Pfizer/BioNTech's bivalent COVID-19 vaccine for young immunocompromised children, the agency announced on Friday.

In kids ages 6 months to 4 years with certain types of immunocompromising conditions (i.e., solid-organ transplant recipients, or those considered to have a similar level of immunocompromise), and who previously received three primary 0.2-mL doses of the companies' monovalent or bivalent vaccine, a fourth dose using the bivalent vaccine can now be administered at least 1 month following the most recent dose.

Extra doses beyond that "may be administered at the discretion of the healthcare provider, taking into consideration the individual's clinical circumstances," the agency added.

In its updated (EUA) letter, the FDA said that a fourth bivalent dose in this patient population, as well as additional doses, "may be effective in preventing serious or life-threatening disease or conditions that can be caused by SARS-CoV-2, including Omicron variant sublineages BA.4/BA.5 and other Omicron subvariants such as XBB.1.5." The agency added that the known and potential benefits "outweigh the known and potential risks."

The updated EUA closes a gap in recommendations for high-risk groups, which was a point of frustration at the recent meeting of CDC's Advisory Committee on Immunization Practices, where no specific recommendations were made for this young vulnerable group.

Recent changes in federal vaccine policy have transitioned completely to the bivalent products (which target the original strain plus Omicron BA.4/BA.5 strains), while also allowing for extra doses in high-risk groups, including adults ages 65 and over and people with immunocompromising conditions. Adults and kids 5 years and older with immunocompromising conditions can receive an additional dose starting at 2 months from their last dose, with extra doses beyond that at the discretion of their healthcare provider.

for Pfizer/BioNTech's bivalent vaccine have been updated to reflect the recent changes.

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