FDA advisory committee approves booster for individuals 65 and older and others at high risk for COVID-19
Vote does not go far enough in addressing boosters for healthcare workers, some committee members say.
Photo: Kathrin Ziegler/Getty Images
A Food and Drug Administration advisory committee voted unanimously on Friday to approve emergency use authorization for a Pfizer vaccine booster shot for individuals 65 years and older and for individuals of any age at high risk of severe COVID-19.
The booster would be given six months after the last regular dose.
The 18-member FDA Vaccines and Related Biological Products Advisory Committee overwhelmingly rejected a question on the safety and effectiveness of the clinical trial to approve the booster shot for all individuals 16 years and older.
Some members felt the question fell short because it did not directly address a booster shot for healthcare workers.
WHY THIS MATTERS
Advisory member Dr. Stanley Perlman said the group he worried about, other than the ones addressed in the question, were healthcare workers.
Committee member Dr. Steven Pergam said he was concerned about a healthcare system that was already overstressed and workers being exposed as antibodies waned.
"We have not addressed that," he said.
Panel Chair Dr. Arnold Monto said the Advisory Committee on Immunization Practices would need to fine-tune some of these recommendations.
Commitee member Dr. Mark Sawyer said he was among the minority voting yes to the first question to approve the booster for all over the age of 16.
"I voted yes on the first question because I thought it was the quickest, most efficient way, and most flexible way for providers to be able target certain populations," Sawyer said.
He said he would be comfortable if ACIP would take up the issue and provide additional guidance.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said the FDA is not bound by the members' vote and can tweak the results.
He suggested a poll for members to see if healthcare workers should be included. This would also include other front-line groups such as teachers, he said.
The question of whether healthcare workers and others at high risk for occupational exposure should be included in the emergency use authorization for a booster passed unanimously, as a poll question.
THE LARGER TREND
The question of whether a booster dose of the COVID-19 vaccine would provide added protection has been ongoing.
The Pfizer, Moderna and the Johnson & Johnson vaccines have received FDA emergency use authorization for use in the United States. In August, the FDA granted full approval for the Pfizer vaccine.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
