Full FDA approval of Pfizer’s COVID vaccine is coming soon. What that means

Politico reports that FDA officials are speeding up the agency’s internal machinery to give Pfizer’s vaccine official approval, rather than the “emergency use authorization” under which it has been available to much of the public since December 2020, with the goal of granting the official designation by early September. Early fall had always been the agency’s milestone for full approval of the vaccine.

But that process has taken on new urgency with the rise of highly contagious coronavirus strains such as the Delta variant, combined with the enduring dilemma of American vaccine skeptics who refuse to get their shots. The more than 30% of adults who haven’t received even a single dose of the three currently authorized vaccines from Pfizer, Moderna, and Johnson & Johnson led academic physicians such as Brown University School of Public Health dean Ashish Jha and Scripps Research Translational Institute founder and director Eric Topol to criticize the FDA for dragging its feet.

1 out of 3 American adults still unvaccinated

For some, fact that vaccines still in EUA a hindrance

One thing that might help?

An FDA full approval

Pfizer initiated request on May 7

Its 6 weeks later

Data is in. Vaccines are safe and effective.

Its time for full approval— Ashish K. Jha, MD, MPH (@ashishkjha) June 22, 2021

Not all experts agree that full approval of a COVID shot will prove a panacea for vaccine skepticism, pointing out that approvals often take months even under normal circumstances, let alone with brand-new vaccines in the midst of a pandemic. And a new survey by health care think tank Kaiser Family Foundation finds that 46% of unvaccinated U.S. adults say they will “definitely not” get a COVID vaccine this year; those who say they are on the fence could very well find another reason to remain unvaccinated, such as questioning the FDA approval process.

But the need to aggressively address the Delta variant by getting as many people immunized as possible appears to have given the FDA an extra push. The delay in granting full approval has also created conflicting messaging, critics note: Public health officials have been hailing COVID vaccines as safe and highly effective on the strength of massive global clinical trials, urging Americans to get their shots, but still leaving the jabs with a lower-tier emergency designation.

The reportedly imminent Pfizer vaccine approval could also give airlines, brick-and-mortar businesses, and employers more confidence in requiring proof of vaccination in order to enter public indoor venues or receive certain services, as well as imposing other requirements such as negative COVID tests, masking, and distancing for the unvaccinated.

“It’s very difficult for us to come in and mandate a vaccine that isn’t even federally approved yet; the authorization hasn’t been final yet, so stay tuned,” as Delta CEO Ed Bastian told CNBC earlier this week about the company’s decision to not require that domestic passengers be vaccinated.

Delta’s plans may be up in the air, but a growing number of employers, governments, and public venues have already begun to impose stricter COVID protocols. That includes proof of vaccination for indoor dining, gyms, and entertainment venues either through authorized digital apps or an official paper COVID-19 vaccination card. The Biden administration and some state governments are requiring proof of vaccination or alternative safety restrictions for wide swaths of the public workforce.

Ultimately, a combination of local mandates and business owners’ discretion determines which COVID policies they believe are responsible and should be actively enforced. While full approval of the Pfizer vaccine may not persuade the biggest skeptics to change course, it may give a greater number of businesses and local officials an extra push to require vaccines amid the wave of Delta variant cases.