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Opinion Why the FDA’s full approval of the Pfizer-BioNTech vaccine could be a turning point

Syringes filled with a doses of Pfizer's coronavirus vaccine at a vaccination site in Valley Stream, N.Y., on Feb. 23. (Brendan Mcdermid/Reuters)
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The Food and Drug Administration on Monday granted full approval of the Pfizer-BioNTech coronavirus vaccine for those 16 years old and above. This long-anticipated regulatory change marks a crucial turning point in the effort to increase vaccine uptake.

There are five reasons. First, though many employers, universities and government entities have already implemented vaccine mandates, others have been waiting for this official stamp of approval. United Airlines, the Pentagon and universities from Louisiana to Minnesota have all said they will institute vaccine requirements after full approval. A school district in Culver City, Calif., has already mandated inoculation of eligible students. I expect more schools to follow given the full approval, adding the coronavirus vaccine to the long list of childhood vaccinations that are already required for students to enroll.

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Second, some who have not yet been vaccinated cite lack of full FDA approval as a major reason for their hesitancy. Even though more than 200 million Pfizer doses have been safely administered in the United States and hundreds of millions more worldwide, anti-vaccine activists have adopted a narrative that the vaccine was somehow “experimental” because it was still under emergency use authorization (EUA). A poll from the Kaiser Family Foundation found that 3 in 10 of the unvaccinated say they would be more likely to get the shot if it were fully approved.

Third, full approval will allow Pfizer to market the vaccine, which is prohibited for products under an EUA. Though some of these holdouts might seek the vaccine on their own initiative following the FDA’s announcement, far more will need active outreach to persuade them. Pharmaceutical companies have extensive experience with and budgets for direct-to-consumer marketing. In 2019, Pfizer spent $1.9 billion on advertising its products. Some have criticized drug companies for the amount directed to promotional efforts, but there can be little doubt that allowing their marketing expertise and advertising dollars will aid in the public health effort to ramp up vaccinations.

Fourth, physicians will be able to prescribe booster doses to patients who may not meet the official criteria — something not permitted under the EUA. At the moment, only about 3 percent of Americans who are considered to be moderately or severely immunocompromised are eligible for a third shot. The Biden administration has announced that, beginning Sept. 20, federal officials will likely recommend that most Americans receive boosters eight months after their initial shots.

There are patients who may not want to wait until then. Eight months is a somewhat arbitrary cutoff, and there may be circumstances that warrant an earlier inoculation. Let’s say that a medically frail, elderly patient first received the coronavirus vaccine in mid-January. Even a mild breakthrough infection could land them in the hospital, and a booster could reduce that likelihood. That person could try to reduce their risk, but what if they live with a family member who refuses to get vaccinated and won’t wear masks in public? It wouldn’t be unreasonable for this patient to have a discussion with their physician and decide they would benefit from a booster now.

Similarly, someone who received the Johnson & Johnson one-dose vaccine could make a personal determination to receive a Pfizer booster dose. This is not yet recommended by federal health officials, but because the Pfizer vaccine now has full approval, it could technically be prescribed “off-label” like other medications or therapeutics. (It’s important to note that vaccine providers are still supposed to follow official recommendations, but it’s hard to imagine the federal government rebuking a physician for using their best clinical judgment.)

Finally, the coronavirus vaccine can be regarded as no different from any other vaccine that Americans are used to getting throughout our lives. To me, this is the most important impact of the full approval. All 50 states require childhood immunizations to attend school. Physicians speak to patients every year about the flu vaccine and routinely counsel patients to get vaccinated to protect against pneumonia, tetanus and shingles. We need to adopt the same language when it comes to the covid-19 shot: Like any other vaccine, it is safe and effective, and can save lives.

The FDA’s announcement should be impetus for many more efforts to increase vaccinations. The federal government can and should do more. I hope that the Biden administration announces vaccine requirements to board planes and trains and to enter airports and federal buildings. Administration officials should nudge private employers through financial incentives to implement mandates to protect their workers and customers. State and local governments should also require vaccines; there should be no excuse for those who work with patients, nursing home residents and young children to remain unvaccinated. More locales should follow the lead of San Francisco to verify vaccine status to access restaurants, gyms and concerts. The covid-19 pandemic is raging because we have let it; now is the time to finally stem the surge.

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