Peter Doshi, an associate editor at British Medical Journal, is not favorably impressed with the recent vaccine trial announcements. “90% effective.” “95% effective!”
Coronavirus guru Anthony Fauci assures us that a coronavirus vaccine will only be FDA-approved if it’s “safe and effective.”
From Doshi:
But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
Yet the current phase III trials are not actually set up to prove either. None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.
Will COVID-19 vaccines save lives? Current trials aren’t designed to tell us.
Switching gears to the flu vaccine for a minute. The flu vaccine’s been a godsend in preventing influenza death among the frail elderly, right? Not so fast there, pardner. Doshi again:
But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.
Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths.
Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality.
The Moderna and Pfizer trials enrolled 30,000 and 44,000 participants, respectively. That sounds like a lot of people to be vaccinated. But they only vaccinate half the folks. The other have serve as a control group. Next, the investigators track the occurrence of coronavirus events over time, then compare the two groups. An “event” may be anything from a cough plus positive COVID-19 PCR test, to hospitalization or death. Of course, they also look at potential adverse effect of vaccination, comparing the two groups.
The trials aren’t going to give us good information on COVID-19 hospitalizations and death rates because those outcomes are so infrequent. Most people with symptomatic COVID-19 experience only mild symptoms; there are relatively few cases of serious disease in a general population of 30,000.
Who needs a safe and effective vaccine the most?
- Those over 60-65
- Anybody seriously immunocompromised (i.e., a poor immune system too weak to fight infection).
Immunocompromised people are excluded from the seven ongoing trials. So these trials focus on those over 60, right? Wrong. The Moderna trial eligibility started at age 18. Pfizer’s accepted 12-year-olds.
Surely the vaccine trials will have some participants over 60-years-old. There just may not be enough to generate clinically meaningful data on serious disease outcomes and adverse effects in the elderly.
Steven Novella says Moderna developed their vaccine with a grant from the U.S. government, and Pfizer funded themselves. Each vaccine has cost over two billion dollars to develop. They will be the first ever mRNA vaccines approved by the FDA. Our other vaccines are based on different technology. Both vaccines require two shots, 28 days apart.
Steve Parker, M.D.
PS: I am not generally anti-vaccination.
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