For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem.

For context, last week the President issued a tweet stating that people were operating within FDA to slow progress on a vaccine without supplying any evidence, credible or otherwise, to support that. Subsequently in a speech on Thursday the President stated a pledge that there would be an approved vaccine by end of year “or even sooner” signaling urgency to the effort. But later in contradiction to that sense of urgency, the President has also re-tweeted a message that the number of deaths due to coronavirus has been greatly exaggerated – a tweet later deleted by Twitter.

More importantly, there have been new developments involving the FDA and CDC that are noteworthy.

  • First, FDA’s Commissioner appeared to walk back some of the statements made during the announcement of the Emergency Use Authorization (EUA) for convalescent plasma.
  • Second, he also apologized for the characterization.
  • Third, FDA let go of staff and a consultant reportedly involved in both the announcement and apology.
  • Fourth, FDA announced that there would be an October 22 meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the developments and study around research related to a vaccine for COVID-19, without specificity to a particular company’s effort. Typically these announcements include a docket number so that the public can submit commentary into the docket, however this author found no such link in the announcement.
  • Fifth, the Centers for Disease Control issued recommendations regarding testing saying that people who were asymptomatic need not be tested, later changing it to “may be considered” – generating headlines about creating confusion.
  • Sixth, in turn, the former head of NIH expressed the sentiment in an opinion piece in the New York Times entitled “It Has Come to This: Ignore the CDC“. Just let that one sit there for a moment.

That is a lot to unpack. And those are just a few of the highlights.

There are so many moving parts, it is difficult to put it together into a coherent picture. As noted last week, the credibility of these agencies would seem to be vital to the end goal – an uptake of vaccine once one is approved. There needs to be confidence in the process and for that there needs to be confidence in the agencies involved.

Regarding the meeting of an FDA Advisory Committee, one has to ask oneself what exactly it is in the way of data that will be examined and discussed? The study subjects in vaccine trials are still getting the investigative vaccines administered to them (some require two doses – spreading out the inoculation to even greater periods of time). Subsequent to that, they have to be followed for their exposure to the virus and then assessed as to whether or not they were protected. Meanwhile, effects – both safety and efficacy will likely be sketchy at best and the effects on outliers would likely be yet non-emergent. Will people be willing to take a vaccine that has been granted authorization before the clinical trial data has been fully collected, must less examined?

In last week’s posting, I cited two surveys of people related to willingness to take a COVID vaccine. Since then, STAT published a survey that revealed that three-fourths of Americans believed the process for vaccine approval was driven by politics and not science. There may be some who say that there is a crisis of confidence in science – a high degree of skepticism, but it is far more likely that there is an even higher skepticism of politics. All that being said, the survey also found that most people would take a vaccine, even if authorized prior to the election. There were many critics of the Russian approach to approval, but the door is at least open for a very rushed process here as well.

Two questions stand out among the many that remain. First, is there actual political benefit to rushing an approval? That is not immediately clear. Will the shortcomings in managing the pandemic so far in the United States evaporate as an issue because of the early use authorization of a candidate vaccine? And second – and more importantly, what are the long-term effects of an erosion of public confidence in the gold standard set by FDA for the approval of new medicines. How will it impact confidence in future approvals – not just of these vaccines, but of all drugs? And if there is growing doubt about the integrity of FDA, will people begin to look to European regulatory authorities more readily than those in the U.S? The next few weeks will be critical in providing the answers.

Photo by Glen Carrie on Unsplash

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