February 26, 2021
I’m Dr. Diana Zuckerman, president of the National Center for Health Research.
Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. However, I inherited J & J stock, so my criticisms today are counter to my financial interests. I have post-doc training in epidemiology, was a former faculty member and researcher at Vassar, Yale, and Harvard, former fellow in bioethics at Penn, and also worked at HHS.
I’m concerned about the hype that this vaccine is specifically effective against moderate and severe COVID. Those are PR claims. They are misleading.
Not all symptomatic cases are moderate or severe. The other two vaccine companies just counted cases and severe cases. Since Janssen reported only 4 mild cases, what the company calls moderate cases is almost identical to what the other 2 companies called “cases” – and can include mild symptoms.
All 7 deaths in the study were in the placebo arm and were in South Africa, so let’s focus on severe COVID in terms of hospitalization and medical interventions, as the FDA did on page 33 of their briefing document. 10 study participants developed severe COVID at least 2 weeks after their shots, and only 5 developed severe COVID at least 4 weeks after their shots. Most were in the placebo group, but these are very small numbers and the differences are not statistically significant. It’s misleading to tell the public that nobody who was vaccinated was hospitalized unless you also tell them that only 5 people in the placebo group were hospitalized.
The data indicate the vaccine is effective, but does not prove that the vaccine is especially effective against moderate and severe COVID.
After 28 days, there were 0 COVID cases for ages 75+ in the vaccine arm & 4 cases in placebo arm – too few to draw conclusions about efficacy in the oldest patients.
The vaccine is effective, but the median follow-up is only 8 weeks after the shot. Does human immunity last only 2 months, 4 months, a year? We won’t know unless the randomized controlled trial is continued.
In conclusion, the FDA guidance for COVID vaccine approval specified at least a year or 2 of follow-up. FDA’s Guidance for EUA drastically shortened that to a median of 2 months, and that’s exactly what the companies provided. The companies said the double blinded studies would continue after EUA, but that no longer seems likely, and FDA said today approval might be based on 6 months. As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe. A cross-over design is a reasonable compromise, but only if the placebo group has at least 6 months of data so we’ll know more about long-term efficacy. At the very least, we need to be honest with the American public about what we know and don’t know.