Will safety workgroup impede COVID-19 vaccine implementation?

Pfizer and its partner BioNTech recently announced its coronavirus vaccine is 90% effective after analyzing data from its Phase 3 trials. Despite the promising data, it could be a long time before the vaccine is made available to the general public.

The trial includes 43,538 participants from diverse backgrounds. Only 94 study participants went on to develop COVID-19 and none experienced serious side effects. Pfizer is expected to submit the vaccine to the U.S. Food and Drug Administration for approval for emergency use later this month.

 

 

“Today is a great day for science and humanity,” Dr. Dr. Albert Bourla, Pfizer Chairman and CEO, said in   a statement. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”

While data is promising, further testing still needs to be done before the vaccine is ready to be made public. A Western states COVID Vaccine Scientific Safety Review Workgroup was recently formed to vet the safety of all vaccines before they are offered to the public.

The consortium consists of representatives from California, Nevada, Oregon and Washington who will evaluate and ensure the safety of the vaccine. On Monday, Washington Governor Jay Inslee announced that Dr. Ed Marcuse and Dr. John Dunn will represent Washington on the workgroup.

“Together, their experience and expertise represent the best of our state and I know they will add a tremendous amount of knowledge to this very important workgroup,” Inslee said of his new appointees.

Vaccines generally take years to develop. The FDA can fast track this timeline by granting an Emergency Use Authorization. Even after that happens, the consortium adds a new layer of safety checks, which raises the question of whether or not this will delay its release to the public.

“The work group is already meeting, their recommendations will be timely and will not cause delays in the allocation and distribution of vaccine,” said the California Department of Public Health when asked about the subject.

“We expect there to be very minimal time delay,” stated Dr. Arthur Reingold, Chairman of California’s Scientific Safety Review Workgroup, when asked about their timeline.

Dr. Reingold, Division Head of Epidemiology and Biostatistics at the UC Berkeley, School of Public Health, asserted that the workgroup is well aware of the time-sensitive nature of this process and that he does not anticipate any significant postponements.