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FDA’s Pfizer Vaccine Approval Adds Fuel to Biden Booster Plan

Aug. 25, 2021, 9:26 AM

Full FDA approval of Pfizer’s Covid-19 vaccine may ease the path to booster shots in the U.S., a plan that’s received mixed reactions amid spiking infections from the delta variant and global inequity in immunization access.

Sept. 20 is the day the Biden administration plans to open the doors for most Americans to begin getting third doses of Covid-19 vaccines, pending sign-off from the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. The plan has been on a bumpy road as policy experts debate the need for a booster—the CDC has already pushed back by one week a meeting of outside advisers on the issue.

The FDA’s action on Aug. 23 now makes it easier for the CDC to recommend a booster because it would be endorsing an extra dose of a vaccine that’s already approved, said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.

The Pfizer vaccine’s former emergency use status meant that patients who had gotten the jab were “signing a consent form saying it’s experimental,” making it “very hard to offer a third dose to the entire U.S. population,” Gostin said.

“But if it’s fully licensed, we don’t call it experimental,” he said. “This is an entrée to facilitate population-wide boosters this fall and winter.”

The vaccine’s approval marks a critical step in the U.S. immunization efforts. Health policy experts expect it to assuage fears of those who are hesitant and encourage more pubic and private organizations to mandate staff inoculations.

When it comes to boosters, the agency question “as always will be whether we have good safety and efficacy data,” said Robin Feldman, a University of Hastings College of Law professor focusing on health-care law. “The next question will be timing and supply. How do we find the optimal balance between waning efficacy and sufficient shots.”

Pfizer said it plans to seek FDA approval of a third-dose via a biologics license application for people 16 and older.

The administration will likely want to move “quickly and decisively” to greenlight the additional shot as the delta variant drives up infection rates among the population, Feldman said. The U.S. has seen about 38 million confirmed cases of Covid-19 and almost 630,000 deaths, according to the Bloomberg virus tracker.

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‘Grease the Skids’

The FDA on Aug. 12 extended the emergency use authorization on Pfizer and Moderna Inc.'s Covid-19 vaccine to allow a third shot for immunocompromised individuals. The CDC’s Advisory Committee on Immunization Practices voted unanimously the next day in favor of a third-dose recommendation.

FDA Acting Commissioner Janet Woodcock said at a briefing Monday that the agency still needs to evaluate additional data before clearing a third dose for people who aren’t immunocompromised.

Still, the FDA’s full approval of Pfizer’s initial two jabs “does help grease the skids” for greenlighting boosters, said Kurt Karst, a Hyman Phelps & McNamara PC attorney who works with pharmaceutical manufacturers.

When changing the dosing on a drug or its method of administration, companies will submit a supplement with additional data, health-care attorneys say.

“You don’t start from ground zero,” said John Serio, a Withers partner experienced in FDA regulatory issues. Getting the OK on boosters is now “easier to do, because you have an approved product where the safety and efficacy has been approved by the FDA.”

There’s “a large body of data” pointing to Covid vaccine safety in general that “paves the way, especially from a statistical viewpoint,” for a quick authorization on booster shots, Serio said. What’s more, boosters are “part and parcel to any vaccine program.”

“All the booster is doing is adding one more administration. And like any vaccine, having a subsequent administration is well known in the art,” he said. “Maybe it won’t be Sept. 20, but I don’t think it will be far past that date.”

Road Ahead

There still remains “a lot of pitfalls” for the FDA and CDC in giving their blessings to boosters, Gostin said. Agency advisory committees composed of independent scientists might complicate efforts if there’s “a large outcry against the boosters,” especially over whether they’re actually needed.

If so, the FDA and CDC could find themselves “on a very rocky road publicly, and that could delay it,” he said. “We’re in uncertain territory, and I don’t think the American public should take this as set in stone.”

The FDA approval also makes it easier to prescribe Pfizer’s vaccine for “off label” uses like boosters, spurring concerns that individuals would try to get ahead of the Biden administration’s plans to roll out third doses. But the use of boosters “will not significantly increase” until the agency gives its OK, according to Julie Swann, a North Carolina State professor who aided the CDC during the H1N1 pandemic.

“Off-label use leaves a lot in the subjective opinion of an individual physician,” as doctors may be reluctant to go around the EUA, Swann said.

But while delays to the Sept. 20 target date remain a possibility, health policy experts largely agree that the FDA approval signals boosters will be broadly available sooner rather than later.

The vaccine’s approval gives “a strong indication that boosters are going to be the next thing that are either going to be approved or authorized under an EUA,” Serio said.

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

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