The FDA’s Political Inoculation

Why the U.K. has approved a vaccine faster than the U.S.

 WSJ editorial.

"The U.K. on Wednesday approved Pfizer -BioNTech’s vaccine, and no doubt many Americans are wondering as thousands die each day why the U.S. Food and Drug Administration wasn’t first. Blame politicians who promoted public skepticism of a vaccine that U.S. regulators now feel they must remedy.

Two weeks ago Pfizer and BioNTech applied to the FDA for emergency use authorization of their vaccine, which they reported was 95% effective. The FDA then scheduled an online public meeting on Dec. 10 with outside experts to discuss the authorization and allowed the public to submit comments.

FDA Commissioner Stephen Hahn tweeted Thursday: “Send your comments in before this group of outside experts meets to discuss a potential emergency use authorization for a #COVID19 vaccine.” This is a nice gesture toward transparency and democracy, but isn’t this supposed to be a scientific review?

These outside “experts” will also have less knowledge than FDA scientists who have been working alongside vaccine makers over the last nine or so months providing real-time feedback on their clinical trials. Mr. Hahn, however, committed to this process in the fall as Democrats like Kamala Harris and New York Gov. Andrew Cuomo warned the Trump Administration was rushing approval.

In other words, this regulatory rigmarole is essentially a placebo to reassure the public it will be safe to get inoculated. There’s no evidence that a three-week review is needed. The U.K.’s Medicines and Healthcare products Regulatory Agency with 1,320 employees scrutinized Pfizer’s data on a rolling basis, and the FDA with 17,000 staff could do the same.

Defending the FDA’s slower review, Anthony Fauci of the National Institutes of Health explained “we have the gold standard of a regulatory approach with the F.D.A.” and “the U.K. did not do it as carefully and they got a couple of days ahead.” But vaccine makers have no incentive to conceal safety problems given their reputation risk, and there’s no evidence Pfizer cut corners.

Inoculating health-care workers is becoming increasingly urgent as many get sick or have to quarantine after being exposed to the virus. Hospitals are strained by surging cases, and staffing problems are likely to worsen. Nursing home residents who would be prioritized for Pfizer’s vaccine make up 40% or so of U.S. deaths. Delaying vaccine approval even a couple of weeks could lead to thousands, if not tens of thousands, of more deaths.

The FDA has long been cautious when approving new medicines, which has resulted in delayed treatments for life-threatening diseases like cancer. But its self-protective instinct and desire to compensate for reckless politicians endanger public health."