FDA Vows Fast Pfizer Vaccine Action Amid Political Pressure

(Bloomberg) -- The U.S. Food and Drug Administration said it’s working toward rapid emergency-use authorization of Pfizer Inc.’s Covid-19 vaccine that was backed Thursday by a panel of agency advisers.

The drug regulator has “notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the FDA said Friday in a statement.

The FDA has been under tremendous political pressure from President Donald Trump and his administration to clear the vaccine, which the U.K. and Canada have already approved. Weary Americans are also eager for an end to the pandemic that has killed nearly 300,000 and dealt a crippling blow to the economy.

Trump in a Friday tweet called the FDA “a big, old, slow turtle,” and demanded Stephen Hahn, the agency’s commissioner, “get the dam vaccines out NOW.”

A formal go-ahead from the FDA would set in motion a nationwide distribution effort, starting with 2.9 million doses being made available to states. Charged with assuring the safety of the vaccine, along with its effectiveness, the agency is moving rapidly.

Allergic Reactions

One of the last things it does before clearing a product for public use is make sure the instructions for doctors and patients on the label include up-to-date information about who should use it and how. Just in the last several days there have been reports of serious allergic reactions to the vaccine in the U.K.

The FDA is seeking more information on the reactions from the U.K. drug regulator, Marion Gruber, director of the Office of Vaccines Research and Review, told the panel of agency advisers Thursday. After starting immunizations Tuesday, the U.K. said people with a significant history of allergies should not receive the vaccine.

“That’s something we’re working with Pfizer right now on is the appropriate language for the doctors, is if you have a pre-existing serious allergic reaction to anything in these vaccines or medical allergies, you should exercise caution in getting these vaccines initially,” Health and Human Services Secretary Alex Azar said Friday in an interview with Fox Business News.

Read More: Pfizer Shot Gets FDA Advisers’ Nod as Agency Decision Nears

Thursday’s FDA advisory panel discussion also touched on incidents of Bell’s palsy, a temporary facial paralysis that was experienced by four people who received Pfizer’s vaccine in clinical trials. No one in the placebo group reported the condition. FDA staff said the number of Bell’s palsy cases was consistent with the rate of the condition in the general population, and there was no reason to believe it was related to the vaccine, but some advisers were skeptical.

The FDA has asked Pfizer to conduct surveillance for Bell’s palsy cases in vaccine users in the general public. The agency may want to flag the issue on the vaccine’s label, in light of the advisory panel’s discussion.

“At this point it’s really a matter of working out some of the final details -- dotting the i’s, crossing the t’s, getting the fact sheet for the doctors,” Azar told Fox.

Clearance Coming

Azar told ABC that the FDA will soon clear the vaccine, and Americans may start getting shots as soon as Monday. He tweeted that Pfizer has already been advised that the authorization was coming.

Pfizer declined to comment. The shares fell as much as 2.5% as of 9:45 a.m. in New York. American depositary receipts of BioNTech SE, Pfizer’s partner in developing the shot, lost as much as 3.4%.

At the Thursday meeting, FDA advisers voted 17 to 4, with one abstention, in favor of authorizing the vaccine, which was shown to be 95% effective in a large clinical trial. While it often follows the panel’s recommendations, the agency itself has final say in whether to grant the authorization.

The panel also considered whether there was enough data to support the vaccine’s use in 16 and 17 year olds, leaving some members uncomfortable with voting in its favor. However, others said data from older trial participants could be extrapolated to younger people.

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