This is, according to the FDA, a “small group” of people, consisting of organ transplant recipients or “those who are diagnosed with conditions that are considered to have an equivalent level of immunosuppression.”
The FDA thus amended its emergency clearances for these two vaccines, which are not yet formally approved, although they have been in use since December 2020, so that this third dose can be administered.
“After a comprehensive review of the available data, the FDA determined that this small and vulnerable group may benefit from a third dose of Pfizer-BioNTech or Moderna vaccines,” said FDA acting commissioner Janet Woodcock.
Woodcock cited the new wave of the pandemic sweeping the United States and the “particular risk of contracting a serious illness” for immunocompromised individuals, given their reduced ability to fight infection.
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For the rest of the people outside the immunocompromised group and who are vaccinated with the full course, the FDA stressed that they remain “adequately protected and do not need an additional dose of the COVID-19 vaccine at this time.”
The United States thus joins other European countries and Israel, which have announced that they will begin giving a third dose to the at-risk population in the coming weeks.
According to official data from the Centers for Disease Control and Prevention (CDC), 59.2 % of Americans have received at least one dose of the vaccines, and 50.2 % have received the full course.