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The Food and Drug Administration (FDA) authorized Moderna and Pfizer COVID-19 booster shots for all adults in the US 18 and older, paving the way for expanding the eligibility of boosters in advance of the holiday season.
Previously, the FDA had only authorized booster shots for Americans 65 and older, and those who were at a high risk of contracting COVID-19 due to pre-existing conditions of their job.
“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,” acting FDA Commissioner Janet Woodcock said in a statement announcing the new guidance.
Moving forward, it is now up to the Centers for Disease Control and Prevention (CDC) to make a final decision, expected on Friday, Nov. 19, and if approved, boosters could start being administered immediately.
Under the new guidelines, anyone who is six months past the date that they reached full efficacy from their vaccination — two weeks after their second dose of Pfizer or Moderna — can get a booster shot of any of the vaccines.
“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement.
The CDC’s independent panel of vaccine experts is scheduled to meet Friday to review the new data and is expected to quickly approve the third doses.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” Dr. Peter Marks, the FDA's top vaccine regulator at the Center for Biologics Evaluation and Research said in a statement.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”
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