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Capitol Correspondence - 10.26.21

FDA and CDC Approve Moderna and Johnson & Johnson Boosters, As Well As Mix-and-Match Approach to Boosters

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On Wednesday, the Food and Drug Administration (FDA) announced it was amending its emergency use authorization for COVID-19 vaccines and approved the use of Moderna and Johnson & Johnson COVID-19 boosters, as well as approving a mix-and-match approach to boosters, meaning anyone who is eligible to receive a booster can get a different brand than their original vaccination.

FDA authorized a half-dose of the Moderna COVID-19 vaccine as a booster for certain populations after six months from their last vaccine and authorized the Johnson & Johnson’s booster for all individuals, regardless of age or risk status, at least two months following their initial vaccination.

Moderna and Johnson & Johnson now join Pfizer as FDA-approved COVID-19 boosters. However, eligibility for each booster differs:

Pfizer & Moderna: A single booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines may be administered at least six months after completion of the primary series to individuals:

  • 65 years of age and older.
  • 18-64 years of age at high risk of severe COVID-19.
  • 18-64 years of age with frequent institutional or occupational exposure.

Johnson & Johnson: A single booster dose of the Johnson & Johnson COVID-19 Vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.

Mix-and-match: The use of each of the available COVID-19 vaccines as a heterologous booster dose is authorized for any eligible individual following completion of primary vaccination with a different available COVID-19 vaccine.

The day after the FDA’s approval, the Centers for Disease Control and Prevention (CDC) advisory panel met to vote on the use of COVID-19 boosters and echoed the recommendations made by the FDA. The CDC panel unanimously recommended the half-dose Moderna booster for those 65 and up, those who live in long-term care settings, those who have underlying medical conditions, and those who work or live in high-risk settings. The panel also recommended the use of Johnson & Johnson boosters and granted approval for a mix-and-match approach; however, it directed the CDC to provide further guidance to consumers and clinicians about mix-and-match boosters. CDC Director Rochelle Walensky later endorsed the panel’s recommendations.