The study results for the third Covid-19 vaccine, a single-dose vaccine from Johnson & Johnson, were good news for nearly everyone—but not for Alaska Natives, nor American Indians. 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 by the failure percentage in the placebo recipients. According to FDA, page 27 of FDA’s briefing document, Table 12, 28 days after that single dose, the efficacy of the Johnson & Johnson vaccine in the Alaska Native/American Indian population was only 32%, with a “95% confidence interval” (more on that below) indicating a 2.5% chance the actual efficacy was high as 64%, and a 2.5% chance being vaccinated actually caused Covid-19 in 29% who received active blinded vaccine. Looking at this another way, 18 of 1628, 1.1% of the Alaska Native/American Indian group who received active vaccine developed Covid-19 anyhow starting a month after being vaccinated. Comparing that to all the non-Alaska Native/American Indians who received active vaccine, 95 of 17,674 who received active vaccine, 0.5% developed Covid-19. The relative risk of getting Covid-19 after being vaccinated was 2.1 times, 210% higher, in the Alaska Native/American Indian populations compared to persons of all the other groups in the study who received active vaccine. Statisticians use a term called the “p-value”, the probability value, to calculate the possibility that happened by accident. In medicine, if there is less than 5% 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. Alaska Natives/American Indians having 2.1 times the probability of vaccine failure by 28 days compared to everyone else had a p-value of 0.004: 4 chances in 1000. This result is as true a result as we get in medical studies.
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 Alaska Natives and American Indians with either of the two Covid-19 vaccines that many other Americans have received. There were no sites in Alaska to recruit any persons for any of the three vaccines but the Moderna vaccine 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% efficacy”. Some “experts” honestly do not know that the likelihood of that 64% being a real result is only 2.5%. 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 Alaska Natives/American Indians”. 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 Alaska Native/American Indians in those two studies. A last excuse is “It is possible those failures occurred entirely in South American Indians, with no vaccine failures in Alaska Native/USA American Indians at all”. Well, that is possible but there were only 18 vaccine failures in this Johnson & Johnson study in the Alaska Native/American Indian 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 prevention. There are two quite safe vaccines with no failures in Alaska Natives/American Indians. Make sure to tell your doctor and health administrators that you want one of those two.
Bruce L Davidson MD MPH
Tel (+1) 206 799 4513