Doran Fink, a deputy director in the Food and Drug Administration’s (FDA) vaccine regulation division, made the assessment during a Centers for Disease Control and Prevention (CDC) vaccine advisory panel on whether or not the agency should recommend an additional dose of the Pfizer-BioNTech vaccine.
“Data are not available to inform the interchangeability of a booster dose of one vaccine with the primary series of another vaccine,” Fink said at a meeting of the CDC’s Advisory Committee on Immunization Practices on Wednesday.
Ultimately, the FDA on Wednesday authorized Pfizer booster shots for individuals aged 65 and older as well as for those at a high risk of COVID-19, coming after an advisory panel last week voted overwhelmingly against recommending the third Pfizer dose for the general public.
The FDA, meanwhile, has said it needs more time to review whether booster doses for J&J and Moderna vaccines are needed.
“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers, and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” acting FDA Commissioner Janet Woodcock said during the meeting on Wednesday.
Johnson & Johnson this week said that second doses of its vaccine boosted its efficacy to 94 percent against COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. in the United States. J&J’s shot uses an adenovirus, whereas Moderna and Pfizer use mRNA technology in their vaccines.
Moderna said it has applied for permission to market third doses of the vaccine. The FDA, however, hasn’t provided a timeline on when it may make a decision, while Fink on Wednesday said his department is working as quickly as possible on the firm’s submission.
During last week’s FDA advisory panel meeting on booster doses, some experts expressed concern that a third dose of Pfizer’s shot could cause significant side effects, including myocarditis, in younger recipients.
“I honestly don’t think there is enough good quality data at this point to make an informed decision,” Brittany Kmush, an epidemiologist at Syracuse University, said of an Israeli study that Pfizer cited to claim that third doses are needed in the United States, noting the 12-day follow-up period and the variability of the authors’ estimates.
And Dr. James Hildreth, a voting member on the FDA expert panel, added that he “[has] a serious concern of myocarditis in young people.”
The Epoch Times has contacted Pfizer for comment.
From The Epoch Times