Vaccine Development and Approval in a Time of Pandemic

Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. Usually prior to an FDA Advisory Committee meeting where a product is being considered for approval, the posting of the FDA Reviewer comments is greatly anticipated for what it will say about the potential shortcomings of the investigative compound under consideration. The review that was posted regarding the vaccine candidate was extremely positive. Three other countries (United Kingdom, Bahrain and Canada) have already approved the vaccine for emergency use.

We are at a point in time in the United States where this could not come soon enough. We are running out of intensive care beds in hospitals across the nation. Yesterday the U.S. set a world record with over 3000 deaths, nearly as many people dying daily as died in the 9/11 attack. And there were approximately 220,000 new cases reported yesterday and the day before alone. Worse, there is complacency among some about these numbers and their impact on individual human lives. It is as if the lives, and the process for the development of a solution, have been taken for granted. Experience has taught us well that should not be the case.

It is not even a year ago that this virus emerged to threaten pandemic, lives and livelihoods. Within that short amount of time, research identified the virus, routes of transmission and began exploring therapeutics to treat and pathways to prevention. Phase 1 trials of vaccine candidates were designed and executed while plans were underway to engage in Phase 3 trials involving tens of thousands of people around the world. Study subjects had to be administered vaccine or placebo in huge numbers, wait and receive a second dose, and then to wait and see if it worked to prevent illness. All of this has brought us to this day to a VRBAC meeting to consider an EUA for a candidate vaccine for the first of at least two applications, with more to follow.

By contrast, looking back to the AIDS epidemic, the first really effective therapeutic took a decade and a half, an extremely painful and bleak time for people who were infected and their care partners. There has been criticism of the governmental response in COVID-19, but the AIDS epidemic began in 1981 and it was not until 1985 that President Reagan referred publicly to the epidemic. By the end of 1985, there had been a cumulative total of over 44,000 cases diagnosed in the United States with over 24,000 dead. After nearly 40 years, a vaccine still eludes us.

It is not simply the speed of the COVID-19 research response that has been breathtaking, but there has been a dogged determination in overcoming substantial obstacles that were in the way to get us to this point – practical, political, bureaucratic and even financial barriers – that frankly merit our admiration at the accomplishment.

While the speed and process for approval have been a point of concern and criticism for many, there is also the prospect of what weighs against those concerns. As of yesterday over 286,000 people have died from COVID-19. Many others suffer lingering illness. Economies are strained. The global pandemic out of control, but particularly in the U.S. These things are a heavy counterweight. We should not lose sight of it. FDA will likely make its decision in very short order after the conclusion of the meeting.

In the coming days and weeks, as people are considering their personal decisions about whether to vaccinate, other people will be getting this jab and will experience adverse events and reactions. Many of these will be reported on in the media and exploited by some with political agendas as well as vaccine deniers, all of which will be discouraging to those who are fence sitting about whether to take a vaccine. There will be problems in distribution, in uptake and in administration. In some respects, all of these are good problems to have because they come to us solely as a result of the fact that we have viable choices. And there is much for an individual to weigh – from their own health status to that of those with whom they live, among other things.

Speaking for myself, roll up a van to my front door right now. My sleeve is pulled up and my arm is out there and I’m waiting. And as I do so, I’m thanking my lucky stars that this time, it was not a fifteen-year wait.

Photo by Elena Mozhvilo on Unsplash

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in COVID19, FDA, FDA Image and tagged . Bookmark the permalink.