San Diego doctor to cast key vote on COVID-19 vaccine

Dr. Mark Sawyer to serve on FDA advisory committee
Posted at 6:15 PM, Dec 04, 2020

SAN DIEGO (KGTV) — In just days, Pfizer’s COVID-19 vaccine will go before a key group of scientific advisers to the Food and Drug Administration, and a San Diego doctor will be part of the process to cast an important vote.

Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital, will serve as a voting member of the Vaccines and Related Biological Products Advisory Committee or VRBPAC when the body meets Dec. 10 to publicly vet Pfizer’s COVID-19 candidate.

Dr. Sawyer is also a professor of clinical pediatrics at UC San Diego. He has served before on this outside advisory committee to the FDA, but the stakes have never been so high.

“I mean this is a tough decision,” he said in an interview Friday. “We're weighing the benefit of a vaccine against the risks. And with any new product, we don't know the risks and we have to estimate based on the data we have.”

Dr. Sawyer said he received Pfizer’s full Phase 3 data Friday morning, making him one of the first Americans outside the FDA to see the full details of the company’s large-scale clinical trial. The FDA is expected to release the data to the general public by Tuesday, two days before the public meeting.

Sawyer will be one of about 20 outside vaccine experts from around the country on VRBPAC. The FDA hasn’t yet released a full roster of the doctors and scientists who will take part. The independent advisory committee will hear comments from Pfizer and the FDA and listen to public input before voting on whether to recommend emergency authorization.

The marathon meeting is expected to last up to nine hours.

“The FDA counts on this advisory committee to be an independent group of people who are looking at the same information they looked at and asking us what our concerns are, or whether we reached the same conclusion that their staff have reached,” he said.

The meeting comes on the heels of a study by Pew Research that found lingering skepticism of the vaccine. Just 60% of Americans planned to get vaccinated as of the survey released Monday.

“I do think that's going to change once this committee meets and the data is made public and we can all talk together as a community about what we know about the safety, and what we don't know, frankly,” he said.

Dr. Sawyer was a member of VRBPAC for four years and briefly served as the acting chair in 2017.

The committee meets a few times each year to make recommendations on the annual flu vaccine and other drugs.

The committee’s vote is not binding. The job of the outside advisers is to issue a recommendation and the FDA can overrule them, but the agency rarely does. From 2003 to 2019, VRBPAC made 105 recommendations. The agency fully implemented 84% of VRBPAC’s recommendations and partially implemented 10%, according to Union of Concerned Scientists.

That means when the committee votes Thursday, it’ll carry a lot of weight. The FDA is expected to announce its final decision shortly after the vote, possibly within hours.

Dr. Sawyer said the advisers will make a decision following the process they traditionally do, based on all the knowns and unknowns. “And we’re going to weigh that against what we're going through right now,” he said. “Our hospitals are getting overwhelmed. Our ICUs are getting full.”

“We really need to do something to intervene and the vaccine is the best thing we've got going,” he added.