‘Let this be the milestone that gets you there’: Why the Pfizer vaccine’s approval matters

On Monday, the Pfizer-BioNTech COVID-19 vaccine became the first to move beyond emergency-use status to receive full approval from the Food and Drug Administration — a step that polling suggests might encourage a subset of the unvaccinated public to get their shots.

With case rates in Sacramento and other local counties ascending in recent weeks in large part due to the delta variant, what does Pfizer’s FDA approval really mean? Here’s what you need to know.

Emergency use vs. full approval

Until Monday, all three vaccines available in the U.S. — Pfizer, Moderna, and Johnson & Johnson — were each granted the FDA’s emergency-use authorization, which is when the agency allows unapproved medical treatments to be used during public health emergencies. The FDA can grant the emergency authorization when the benefits of a medical product outweigh the risks. The Pfizer vaccine has been available under emergency-use authorization since December 2020.

FDA combed through hundreds of thousands of pages of data and followed subjects for longer periods of time to track the vaccine’s safety in order to grant full approval of the Pfizer shot, which will now be marketed as Comirnaty, according to the FDA’s announcement.

Though the full approval only applies for individuals ages 16 and up, the Pfizer vaccine is still available under the emergency designation for people ages 12 through 15. The Pfizer shot is still also covered by the emergency use designation when it’s prescribed as a third dose booster shot for certain immunocompromised individuals, according to the FDA.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement.

Why does full authorization matter?

In short: vaccine hesitancy. The biggest impediment to beating back the coronavirus has been the reluctance in some sects of the population to get vaccinated. It’s also what has made space for the development of new strains of the disease like the delta variant.

In a poll released in May, two in five people in the Sacramento region reported they were unlikely to get inoculated against COVID. While that poll was conducted prior to the rise of the delta variant, hesitancy fueled by skepticism or mistrust of the vaccine is what has allowed the virus to mutate and become more dangerous, according to public health experts.

But the Kaiser Family Foundation found through polling that 31% of the unvaccinated population would be more likely to get the vaccine if the FDA granted its full approval. So the Monday announcement may make more people amenable to public health leaders’ messaging around the importance of getting vaccinated.

Dr. Tomás J. Aragón, CDPH director and state public health officer, capitalized on the news this morning, saying in a statement the FDA approval comes at a “critical juncture” as case counts rise due to the delta variant.

“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected, especially against severe and long-term illness,” Aragón said. “We know the vaccines work. We know vaccines are safe. We know they save lives. If you are not vaccinated, let this be the milestone that gets you there. Get vaccinated to protect yourself and help put an end to this deadly pandemic.”

It’s not a certainty that FDA approval will have the effect for which public health officials are hoping, though. KFF made it clear in its analysis of the polling data that respondents used FDA approval as a “proxy” to cover for other concerns about the vaccines.

In Sacramento County, 50.8% of the population is fully vaccinated, trailing the statewide average of 56.45% and the national average of 52.04%. Of all the COVID-19 cases in the county, 122,791 have occurred in individuals who were not fully vaccinated, whereas fewer than 4,000 occurred in fully vaccinated individuals.

Vaccine mandates

Full approval may mean a proliferation of vaccine mandates as well. Following the Pfizer approval, Pentagon spokesperson John Kirby said the Defense Department is preparing new guidance that would require all U.S. service personnel to be vaccinated.

In California, school teachers and staff are required to either be fully vaccinated or submit to weekly testing. When asked, Gov. Gavin Newsom left the door open on the possibility of a vaccine requirement for students. A multitude of California universities — including both the University of California and California State University systems — already instituted vaccine mandates over the summer.

When asked about a potential vaccine mandate for students, the California Department of Public Health referred The Sacramento Bee to Aragón’s statement urging people to get vaccinated.

Sacramento Mayor Darrell Steinberg is considering issuing a vaccine mandate for indoor activities, but a spokesperson for the mayor said Monday there’s no further news on such a mandate. The city is working with the business community on a potential mandate.

This story was originally published August 24, 2021 at 5:00 AM.