Bruce L. Davidson, MD, MPH
The study results for the third COVID-19 vaccine, a single-dose vaccine from Johnson & Johnson was good news for nearly everyone—but not for American Indians, nor Alaska Natives.
The results are conclusive for lack of protection by 28 days after a dose for these two groups, who should avoid this vaccine for now and stick to the other two-dose (first and booster) vaccines.
Why is that true? Why haven't the US FDA and others said so?
The first question is easy to answer. The second question's answer remains a mystery.
First, understand that much of science depends on calculating numbers.
"Vaccine efficacy" takes the failure percentage in the placebos minus that in the vaccinees and divides it by the failure percentage in the placebo recipients. According to FDA, page 27 of FDA's briefing document, Table 12, shows that 28 days after that single dose, the efficacy of the Johnson & Johnson vaccine in the American Indian/Alaska Native population was only 32 percent, with a "95 percent confidence interval" (more on that below) indicating a 2.5 percent chance the actual efficacy was high as 64 percent, and a 2.5 percent chance that being vaccinated actually caused COVID-19 in 29 percent who received an active blinded vaccine.
Looking at this another way, 18 of 1628, 1.1 percent of the American Indian/Alaska Native group who received the active vaccine developed COVID-19 anyhow starting a month after being vaccinated. Comparing that to all the non-American Indians/Alaska Natives who received the active vaccine, 95 of 17,674 who received the active vaccine, 0.5 percent developed COVID-19.
(Related opinion: 'Call for Native people to reject Johnson & Johnson vaccine alarming')
(Related news story: Vaccine hesitancy is as old as vaccines themselves)
The relative risk of getting COVID-19 after being vaccinated was 2.1 times, 210 percent higher, in the American Indian/Alaska Native populations compared to persons of all the other groups in the study who received the active vaccine.
Statisticians use a term called the "p-value," the probability value, to calculate the possibility of that happening by accident.
In medicine, if there is less than 5 percent probability, a p-value less than 0.05 (5 in 100), that the result happened just by accident, the result is considered significant and real.
American Indians/Alaska Natives having 2.1 times the probability of vaccine failure by 28 days compared to everyone else had a p-value of 0.004, meaning 4 chances in 1000.
This result is as true a result as we get in medical studies.
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Why didn't FDA and its committee and CDC's committee disclose what is written just above?
There would be no reason for panic. There would be no delay in vaccinating American Indians and Alaska Natives with either of the two COVID-19 vaccines that many have already received.
There were no sites in Alaska to recruit any persons for any of the three vaccines but the Moderna vaccine study had two sites on American Indian reservations, one in Arizona and one in New Mexico.
There are several excuses given to suppress this information. One is "the confidence intervals for the efficacy results are wide and include 64 percent efficacy."
Some "experts" honestly do not know that the likelihood of that 64 percent being a real result is only 2.5 percent. Another is "but it's so important to vaccinate as many people as possible." Yes, it is, but there are two other vaccines to use in this group.
Another excuse given is "it is possible the other two vaccines might also fail in this group if they enrolled higher numbers of American Indians/Alaska Natives."
One can fantasize a dozen possibilities but we deal with the evidence we have, which is zero vaccine failures in any active vaccine recipients for both the Pfizer and Moderna vaccines in American Indian/Alaska Natives in those two studies.
The last excuse is "It is possible those failures occurred entirely in South American Indians, with no vaccine failures in USA American Indians/Alaska Natives at all." Well, that is possible but there were only 18 vaccine failures in this Johnson & Johnson study in the American Indian/Alaska Native group. So why do we have to assume they lived in South America? Why didn't FDA just count up to 18 and tell us if that were the explanation?
Vaccination is wise as part of COVID-19 protection. There are two quite safe vaccines with no failures in American Indians/Alaska Natives.
Make sure to tell your doctor and health administrators that you want one of those two.
Bruce L. Davidson MD, MPH co-led the development of the NIH oral rotavirus vaccine, is past President of the National Tuberculosis Controllers Association, and is a public health and pulmonary physician in the Seattle area.