December 17, 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 3 major concerns:
#1: The 2 month median follow-up is too short, so Moderna’s proposal to immediately unblind and offer to vaccinate the entire placebo group should be rejected.
#2: Moderna made a good effort to include a diverse group of participants, but only 4 COVID cases were in Black patients, and there were even fewer in other racial groups. We can’t assume that the vaccine was highly effective in demographic groups with so few cases because just 1 Covid case in the vaccinated group would have greatly reduced the efficacy rate.
The data on cases for participants with co-morbidities was slightly more substantial, with 24 placebo cases and only 1 vaccinated case
#3 I’m glad to see that unlike Pfizer, Moderna provided info on the total number of participants who reported 1 or more adverse events. That’s important. Unfortunately, the total of severe systemic adverse events after the 2nd dose was over 17% for vaccinated group compared to 2% for the placebo group.
There are also too few severe cases to draw conclusions:
There were 30 severe cases after the 2nd dose, and none were in the vaccine group. This is a strong finding. However, only 9 of the severe cases required hospitalization; 12 involved the questionable criteria of at least slightly low blood oxygen saturation.
Long-term care patients were not included in the study. About 1300 people ages 75 and older were in the study, almost half of them vaccinated, but only 3 were cases (all of them placebo). Only 15 cases were in patients over 65.
We want to save their lives, but with no data it’s not possible to provide useful informed consent to nursing home patients. That puts a tremendous burden on those patients and their family members to decide whether or not to be vaccinated.
We need longer-term data to fully understand the benefits and risks for different types of patients. The vaccine is clearly effective, but does that last 2 months, 4 months, or a year? We need to know that, and that’s why it is essential that the blinded randomized controlled trial is continued.
In conclusion, EUA is not approval, and it should have more restrictions than approval would have. The EUA should be targeted to priority populations, because if the EUA applies to all adults, celebrities and others who are well-connected will cut in line. We’ve already seen that this week.
Other people could apply for the vaccine under FDA’s Expanded Access program.
We need at least 1 year of blinded, randomized, controlled data. We agree with Dr. Goodman’s proposal that FDA should delay access to vaccines by members of the placebo group unless they are in priority populations. Blinded crossover has limitations because it can’t control changes in the community spread of the virus, but it is better than not continuing a blinded controlled study, if continuing the current study is not possible.