FDA Politics Delays Vaccines in U.S.

The United Kingdom just approved the Pfizer/BioNTeach vaccine for immediate use. They’re already distributing the vaccine over there. You’re probably wondering why it hasn’t been approved yet in the United States.

President Trump’s Operation Warp Speed made it possible for pharmaceutical companies to greatly shorten the time for development and approval of a new vaccine. Four companies entered Phrase III clinical trials of their vaccines by late summer. (see Vaccine Hope on the Way) Pfizer/BioNTech submitted their application to the FDA for Emergency Use Authorization (EUA) two weeks ago after they reported 95% efficacy. Moderna submitted their application one week later after similar results.

According to The Wall Street Journal editorial board, the FDA has scheduled an online public meeting December 10 with outside experts to discuss the authorization for Pfizer/BioNTech and allowed the public to submit comments. FDA Commissioner Stephen Hahn tweeted Dec. 3rd, “Send your comments in before this group of outside experts meets to discuss a potential emergency use authorization for a Covid-19 vaccine.”

Who is in charge here, the FDA or some outside experts? The WSJ editorial board asks a similar question: “This is a nice gesture, but isn’t this supposed to be a scientific review?” They point out 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.

But it seems that Commissioner Hahn committed to this process in the fall as Democrats like Kamala Harris and New York Governor Andrew Cuomo warned the Trump Administration was rushing approval. The conclusions should be obvious, but the WSJ editorial board says what you’re thinking: “In other words, this regulatory rigamarole 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.”

Naturally, Dr. Anthony Fauci, defender of all things political in this pandemic, defends the FDA’s slower review. He says, “We have the gold standard of a regulatory approach with the FDA and the U.K. did not do it as carefully and they got a couple of days ahead.” This is unnecessarily conservative, but consistent with the FDA approach before Operation Warp Speed. Vaccine makers have no incentive to conceal safety problems given their reputation is at risk and their liability is enormous. There is no evidence they cut corners.

This unnecessary delay comes at an inopportune moment. The number of Covid positive tests is rising steadily and hospitalizations are up. The editorial board stresses the importance of vaccine approval as soon as possible: “Hospitals are strained by this surge of cases and staffing problems are likely to get worse. Nursing home residents, who would be prioritized for the vaccine, make up 40% or more of U.S. deaths. Delaying vaccine approval even a couple of weeks could lead to thousands, if not tens of thousands, of more deaths.”

Governor Cuomo has been credited with causing thousands of deaths in nursing homes in New York when he mandated nursing homes accept newly discharged Covid patients from the hospital. It looks like his efforts to “ensure the vaccine is safe” may cost thousands of more lives. This is the same guy who bemoaned the approval of a vaccine had come too soon because it would not be distributed by the Biden administration.You would think his failures in the past would make him humbler.

No comments yet. You should be kind and add one!