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, asked me to speak to the staff organizing the speakers and questions. As a a member of the FDA’s Drug Safety and Risk Management Advisory Committee for the past three years, I’m familiar with 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 what I told the committee organizers what I told committee members to urge them to take the necessary time to evaluate potential vaccines.
- 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, rushing a vaccine with dangerous and life-threatening side effects to market would have decades-long repercussions. A dangerous vaccine would instill fear in the public, and all hope of gaining the trust of anti-vaxers and increasing the vaccination rate 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 all 300 million people in the US alone. Even a side effect so rare it only happened in one out of every 10,000 patients would end up impacting 30,000 people.
- It has to surpass the FDA’s (currently) low bar of success. The FDA is only requiring that the vaccine prevent disease or decrease it’s severity (by how much, we’re not sure) in 50% of people. 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. 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. But many people have comorbidities, or additional health conditions. To determine if the vaccine really works, people with multple health challenges must be included in the trials, and that almost never happens. Additionally, the trials must include people of all ages, races, and health statuses. Those who are overweight, older, Black, Hispanic, or Native American, 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. I’ve sat as a member of many FDA Drug Safety and Risk Management Committee meetings where three, four, and more individual adverse events were explained away as a result of some outside factor, not the drug being tested. When a drug is tested on 1,000 people with a single condition and (for example) five adverse events that happen are blamed on something other than the drug means that potentially a half a percent of AEs are not included in the evaluation. In the case of a vaccine that is – hopefully – being tested on people with multiple health issues, how will the researchers separate the AEs caused by the vaccine and the AEs caused by other health issues? You will need tens of thousands of people and six months to ten years of follow up.
- The manufacturer and the manufacturing process and distribution channel must be perfect. Even an ideal drug can harm or kill if something goes wrong in manufacturing. At least five Metformin manufacturers had to recall their drug in the past year because somewhere in the manufacturing process a mistake was made and it changed a lifesaving drug into one that could cause cancer. To produce COVID-19 vaccines in the quantities needed, there will have to be multiple manufacturing sites. Who will ensure that standards of safety and quality 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 theory about how long the vaccine will last, but no one will know for sure until there are actual patients who have had the vaccine and remained healthy for years and decades.
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.
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.