FDA, CDC Clear 3rd Dose of Pfizer and Moderna COVID-19 Vaccine for All Adults

The CDC advisory panel voted unanimously to recommend a third COVID-19 shot to all adults.

A woman receives her booster vaccination with the Biontech/Pfizer vaccine against the corona virus at the vaccination center. Sven Hoppe/picture alliance via Getty Images

The Food and Drug Administration and the Centers for Disease Control and Prevention on Friday authorized a third booster shot of the Pfizer (PFE)-BioNTech and Moderna (MRNA) COVID-19 vaccines for all American adults.

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The agencies recommend a 30-microgram Pfizer-BioNTech BNT162b2 shot or a 50-microgram mRNA-1273 Moderna for everyone 18 and older at least six months after their primary mRNA series or two months after receiving the Johnson & Johnson vaccine.

The FDA cleared the shots for all adults on an emergency basis early Friday after reviewing new trial data submitted by Pfizer-BioNTech and Moderna. A third Pfizer booster had already been authorized for people over 65 and younger adults with underlying medical conditions or facing high risk of infection.

The CDC’s Advisory Committee on Immunization Practices met on Friday and voted unanimously to recommend the third booster under the FDA’s emergency use authorization. CDC Director Dr. Rochelle Walensky is expected to sign off on the advisory panel’s decision later Friday.

Under the CDC’s recommendation:

  • Adults 50 and older who received an mRNA-based vaccine should receive a booster dose.
  • Adults between 18 and 49 who live in long-term care facilities should receive a booster dose.
  • Other adults between 18 and 49 who received an mRNA-based vaccine may receive a booster dose.
  • All adults who received a Johnson & Johnson vaccine should receive a booster shot.

“COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement on Friday. “Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death.”

“I think it’ll be especially important going into the holiday season and the winter season,” Jamie Loehr, a member of the CDC’s immunization advisory panel, said in a statement after Friday’s vote. “I look forward to having more data in the future about whether this is actually a booster dose or actually a third dose of the primary series. That will take months, if not years, to figure out.”

More than 31 million people in the U.S., about 16 percent of those who are fully vaccinated, have received an extra booster dose of the COVID-19 vaccine, according to CDC data.

FDA, CDC Clear 3rd Dose of Pfizer and Moderna COVID-19 Vaccine for All Adults