The FDA amended its Emergency Use Authorization (EUA) for Pfizer and Moderna vaccines, allowing for a third booster dose “in certain immunocompromised individuals.”
The US Food and Drug Administration (FDA) amended its Emergency Use Authorization (EUA) for Pfizer and Moderna vaccines, allowing the Biden administration to administer a third 'booster' dose "in certain immunocompromised individuals." The amendment applies specifically to solid organ transplant recipients and those diagnosed with conditions that are considered to have an "equivalent level of immunocompromise."
The decision followed the CDC's Advisory Committee on Immunization Practices vote in favour of recommending the additional doses, with acting FDA commissioner Dr. Janet Woodcock signing off on the recommendation on Friday. The FDA commissioner took to Twitter to stress that this decision does not apply to the fully immunized members of the general public.
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View on XThe announcements comes amid a World Health Organization (WHO) call for a moratorium on COVID-19 vaccine boosters until the end of September 2021 to ensure an equitable, global vaccination campaign, while Dr. Anthony Fauci had "strongly urged" the FDA to expedite its approval process.
The FDA's announcement does not apply to immunocompromised patients who received the Johnson & Johnson vaccine due to a lack of data.
"We think that at least this is a solution for the vast majority of immunocompromised individuals, and we believe that we'll probably have a solution for the remainder in the not-too-distant future," FDA official Peter Marks told the CDC panel.
The panel is expected to meet again in a few weeks to discuss options for other immunocompromised individuals.
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