What are the FDA's biggest mistakes

Comment: Emergency FDA approval for Covid vaccines is a mistake

I really would like a vaccine against Covid-19. Like many other Americans, I have family members and neighbors who contracted the novel coronavirus and died from it. My sister works as a nurse in a Covid ward and I want her to be safe while doing it. As a healthcare attorney, I have complete confidence in the top scientists at the US FDA who will ultimately decide whether to grant emergency vaccine approval. Still, I am very worried about what might happen then.

The pace of vaccine research against Covid-19 is impressive: there are now more than 200 candidates in various stages of development, several of which are already in phase 3 clinical trials - just months after the virus triggered a global crisis. For the FDA to approve a vaccination, it is not just the studies that have to be completed - usually with tens of thousands of participants and over at least six months. The agency must also inspect production facilities, review detailed plans for manufacturing and stability data, and analyze masses of study data. This process can easily take a year or more.

For this reason, the FDA has been thinking for several months about criteria for making a vaccine usable with an emergency approval until all information is available for regular approval. Some of the manufacturers with candidates in phase 3 studies have already publicly stated their intention to apply for such approval. Following the remarkable preliminary results on its vaccine, Pfizer plans to address them in November.

Risk of slowing down science

In this way, the FDA can make products that have not yet been approved available in public emergency situations. So far there have been a few such cases with diagnoses or therapies for other infectious diseases such as H1N1 or Zika virus; but vaccines have never been among them. They differ from other medicinal agents in that they are widely used and used in healthy people. So the hurdles for approval are high.

The FDA's Vaccines and Related Biological Products Advisory Committee, an advisory group of external experts, met for the first time on October 22nd to discuss corona vaccinations. Some of its members questioned whether the agency has made the requirements for emergency approval strict enough. There have also generally been significant concerns about such a vaccine practice.

Among other things, it is feared that - for ethical and practical reasons - it could become difficult to complete clinical studies with the vaccine (in order to collect more detailed data). It could also affect the ability of scientists to research other candidates who might be better suited in different ways but were not up and running as quickly.

"In my opinion, the most important point is the public's trust"

Vaccines alone do not offer protection, health experts warn - this also requires vaccinations. If the public does not trust a vaccine, it will do little to control the pandemic, even if it is highly effective.

But data from the Pew Research Center shows declining confidence in a Covid-19 vaccine across all genders, races, ages and levels of education. Information from the Reagan-Udall Foundation was also presented to the Advisory Board indicating considerable suspicion about the pace of vaccine development. Recent political swaying of the FDA and the US Centers for Disease Control and Prevention, as well as claims by some politicians that vaccination will be available before the end of the year, is likely to have compounded it. Ethnic minorities have raised additional concerns about research on it.