On May 17, the U.S. Food and Drug Administration (FDA) extended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 shots for children ages 5 through 11 to include a third dose. In a move that would have been unusual prior to 2020, but has become increasingly common, members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) heard the news at the same time as the general public.

FDA typically convenes VRBPAC when considering a pharmaceutical company’s biological license application (BLA) or request for EUA. However, at several critical points over the past 18 months, FDA has rendered its decision without advice from the panel of experts appointed to VRBPAC. Notably, these decisions have involved extending the Pfizer EUA to include children ages 12 through 15 (May 10, 2021), to include boosters for everyone age 18 and older (Nov. 19, 2021), and for everyone age 12 and older (Jan. 3, 2022).

Longtime VRBPAC member Dr. Paul Offit, who is also the director of the Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP) and is the co-inventor of the Rotateq vaccine, tells the Press that these “unilateral decisions” by FDA are problematic, citing both the lack of transparency and the lack of clear program goals.

Critical of FDA’s acting on its own, Dr. Offit says, “Frankly it’s upsetting to me that these proclamations are made by the FDA without consulting the [VRBPAC] committee.” He points out that no evidence supporting greater efficacy in preventing death in 5- through 11-year-olds with three doses as compared with two has been discussed in a public forum.

“I think we’re seeing COVID exceptionalism,” he says, also voicing his view that “we’re just being pushed along here without clearly defining what is the goal of this vaccine.”

However, he doesn’t believe the unusual situation of VRBPAC-less FDA approvals and EUAs will become business as usual. He even suggests, “You could argue that as we move from pandemic to endemic, then nothing should be an EUA at that point.”

Offering his view on when COVID will no longer be regarded as a “pandemic,” he says, “A pandemic, by definition, changes the way you live, work, or play; an endemic disease doesn’t.” Noting that there were more than 60,000 deaths attributed to influenza in the winter of 2017–2018, he points out, “We chose to accept it.”

“SARS-CoV-2 will be with us forever,” Dr. Offit says. “The question becomes, How do we decide to live with it?”