December 10, 2020
I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Thank you for the opportunity to speak today.
Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania. I’ve also worked at HHS, the U.S. Congress and the White House.
Today I will focus on 2 major concerns and how to improve the data:
#1: The 2 month median follow-up is too short, so it’s essential that the randomized controlled trial be continued, to learn about long-term safety and efficacy.
#2: There’s a lack of diversity in COVID cases: There were 0 Black cases in the vaccine group, and only 7 Black cases in the placebo group.
There were 0 cases who are ages 75+ in the vaccine group, 5 in placebo group
We need more cases in these groups in order to understand the efficacy. I’m concerned that conclusions will be inappropriately drawn, as when an article in the Wall Street Journal article included a chart saying the vaccine was 100% effective in Blacks.
THERE are also too few severe cases to draw conclusions:
There were only 4 severe cases after the 2nd dose: 3 of which were in the placebo group. Not all these cases required hospitalization. In summary, there are too few severe cases to draw conclusions about whether the vaccine prevents severe COVID.
Long-term care patients were not included in the study. About 800 people ages 75 and older were in the study but only 5 were cases (all of them placebo).
We want to save their lives, but how can we ensure informed consent to nursing home patients with no data? How many frail elderly or their family members can make an informed decision based on so little information?
We need longer-term data to fully understand if benefits outweigh the risks for frail patients and all races/ethnicities, and for everyone else as well. That’s why it is essential that FDA ensure the continuation of the randomized controlled trial.
In conclusion, EUA is not approval and it should have more restrictions than approval would have:
- FDA should require continuation of the RCT while targeting EUA to priority populations, especially healthcare workers. Study participants in the placebo group should not “jump the queue.” Continuing the RCT for at least a few more months will make an important difference in knowledge.
- EUA should not allow off-label use, and celebrities and others should not be allowed to jump the queue. Off label use could occur when urgently needed under FDA’s Expanded Access program.
- FDA should delay access to vaccines by placebo group unless they are in priority populations. I am concerned about the blinded crossover proposal, because if the vaccine is effective very long-term, such as 9 months or a year, we would lose that information if placebo participants were crossed over after just 3-9 months. Blinded crossover would only provide useful information if the efficacy doesn’t last long. Let’s hope that isn’t true.