Today the House Oversight Committee will hold a briefing on the FDA’s process for approving a safe and effective COVID-19 vaccine. The Chair of the Oversight Committee, Carolyn Maloney, called to ask me to speak to the professional staff organizing the speakers and questions. I’ve been a member of the FDA’s Drug Safety and Risk Management Advisory Committee for the past three years, so I know about the FDA approval process.
Watch the House Oversight Committee‘s live briefing below:
I thought deeply about the development process for the vaccine — a process that is undoubtedly being hurried. Here is a summation of what I told the committee organizers.
- A faulty vaccine is more dangerous than COVID-19. An effective vaccine would save millions of lives and end the deeply damaging social separation we’re suffering. However, rush a vaccine that brings about dangerous and life-threatening side effects to market, and the repercussions would be felt for decades. A hazardous vaccine would instill fear in the public, and all hope of turning anti-vaxxers would be lost. If you think COVID-19 is dangerous — which it very much is — a public distrust in vaccines would be an international disaster.
- Safety is the most important consideration. A vaccine like this could be given to 150 – 300 million people in the US alone. Even rare side effects causing deaths or damaged patients will multiply to 15,000 people or more. I’ve sat as a member of many FDA Drug Safety and Risk Management Committee meetings where three, four, and more adverse events were explained away as a result of some outside factor, not the drug tested. Explaining away adverse events among a test population that includes people with underlying health conditions will be too easy.
- It has to surpass the FDA’s (currently) low bar of success. The FDA is only requiring that the vaccine prevent disease or decrease its severity (by how much, we’re not sure) in 50% of people. If we settle for 50% we cannot get to herd immunity. If only half the people vaccinated benefit from the vaccination, we have to realize that 100% of the people vaccinated will have the risk of side effects. (I return to safety.) The vaccine must be engineered so that those who get no benefit from the vaccination aren’t also risking a lot of harm.
- It must be tested on “real” people. Drugs that perform well in clinical trials sometimes disappoint when in “the real world.” In clinical trials, doctors recruit people who have only one condition — the condition the drug is being developed for. However, people often have co-morbidities, which is more than one health condition. To determine if the vaccine really works, people with multiple health challenges must be in the trials, and that almost never happens. The trials must include people of all ages, races, and health. Those who are overweight, older, and have heart and lung disease are most likely to die from COVID-19, so they are who we should focus on protecting first and the testing should reflect that.
- The manufacturer must be trustworthy. Even a perfect drug can harm or kill if something goes wrong in manufacturing. At least five Metformin manufacturers had to recall their drug because somewhere in the manufacturing process a mistake was made and it changed a lifesaving drug into one that could also cause cancer. To produce COVID-19 in the quantities needed, there will have to be multiple manufacturing sites. Who will make sure that standards are met?
- The effects must be prolonged. Here’s a question we won’t know the answer to if we stick to the January 2021 goal: how long will the immunity from a vaccination last? Scientists will have a good idea, but until people have had the vaccine in their body for a period of time, we won’t know for sure if it will last for a year, five years, or a lifetime.
Just like you, I want a vaccination for COVID-19. But I only want it if it is safe and effective. To create the vaccine, pharmaceutical companies will need tens of thousands of volunteers. Several vaccines are in development and most of them will probably not pass the clinical trials. Still, consider being a volunteer for testing the vaccine. Volunteers in trials are watched carefully to minimize any potential adverse effects and their body’s response adds to information scientists need in order to save millions of people. We need to know what works and what doesn’t. Human trials are the only way to find out.
In the rush to get a vaccine, let’s give the FDA enough time and staff to conduct the reviews of drug trials properly. If the FDA has to go back to the pharmaceutical companies to continue trials or to do the trials better, know that they are doing it for your safety.