I would really like to have 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 full confidence in the top scientists at the US FDA who will ultimately determine whether or not to grant emergency approval for a vaccine. Still, I’m very worried about what might happen then.

Clint Hermes has advised various universities, teaching hospitals and life science companies on global health problems. Among other things, he was involved in setting up vaccination, therapy and control projects against infectious diseases in North and South America, Africa, Asia and the Middle East. The views expressed in this article are his personal and not those of any organization to which he belongs, including his employer. The information is not to be understood as legal advice.

The pace of vaccine research against Covid – 19 is impressive: there are now there are more than 200 candidates at different stages of development, several of which are already in phase 3 clinical trials – just months after the virus had one triggered global crisis. For the FDA to approve 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 manufacturing 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 considering criteria for several months to make a vaccine usable with an emergency approval until all information is available for a regular approval are available. Some of the manufacturers with candidates in phase 3 studies have already publicly announced their intention to apply for such approval. According to the remarkable preliminary results on its vaccine, Pfizer plans to address them in November.

Risk of slowing down the 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, is on 22. October came together for the first time to discuss corona vaccinations. Some of its members questioned whether the agency had made the requirements for emergency approval strict enough. There were also generally significant concerns about such a procedure for a vaccine.

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

“But in my opinion the most important point is the trust of the public” Vaccines alone do not offer any protection, warn health experts – that is what it takes Vaccinations. If the public does not trust a vaccine, even if it is highly effective, it will have limited pandemic control.

But Pew data Research centers show declining trust in a Covid – – vaccine across all genders, ethnicities, age groups and educational levels. Information from the Reagan-Udall Foundation was also presented to the advisory panel indicating considerable suspicion about the pace of vaccine development. It is likely to have been compounded by recent political interference with the FDA and the US Centers for Disease Control and Prevention, as well as claims by some politicians that vaccinations will be available before the end of the year. Individuals of color have raised additional research concerns on this.

According to written and oral submissions for the FDA advisors, major manufacturers have identified the potential problems for later clinical studies aware. These are difficult to solve, but I suspect that it would be possible together with the authorities. But that doesn’t change the public distrust of emergency approvals – especially since most citizens first heard about it in connection with the hydroxychloroquine debacle and later the controversy over convalescent plasma.

Experimental therapy without an alternative? In fact it is like this: If the study data are good enough to To allow the early use of a Covid vaccine in some people, the FDA should use a mechanism called “expanded access”. She usually uses it to make experimental therapies available to patients without alternatives. But it has already been used for vaccines, and that would be possible now, so as not to disrupt ongoing studies and not fuel public fears that a vaccine is being approved too quickly because of an “emergency”. In addition, such programs have ethics council oversight, and patients have to give consent statements that go further than emergency approvals.

And the public doesn’t just have to have enough confidence to support them for the first time Winning wave of approved vaccines: This trust must also be stable enough to withstand possible setbacks – a protection rate below 100 percent (and maybe under 50 percent), serious side effects (or rumors about it) and possible recalls. It takes time for that much trust to be rebuilt once it has been destroyed. And it’s not just the slowing down of the pandemic at stake.

Former senior health official Andy Slavitt recently put it this way: “If you do it right, vaccines stop pandemics. But if you get it wrong, pandemics are the end of vaccines. ” (sma)