Bruce L. Davidson MD, MPH

On Friday March 19, 2021, the FDA released new data with a breakdown of location for the 18 American Indians and Alaska Natives in whom the Johnson & Johnson single-dose vaccine failed to protect against COVID-19.

Only one of these 18 patients was in the United States, 17 were in South America or Mexico. By independent statistical analysis, the protection from COVID-19 by the Johnson & Johnson vaccine is not different from and protects as well as the Pfizer and Moderna vaccines in US American Indians and Alaska Natives.

All three vaccines are quite safe.

On March 10, Indian Country Today published my Op-Ed explaining that the single-shot Johnson & Johnson vaccine failed to protect 18 American Indians/Alaska Natives among 1628 injected.

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Compared to all others combined in the large study, it had half the efficacy, with a 4 in 1000 chance this result happened by accident. After conveying my concern to FDA which had authorized all three vaccines for all Americans, Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, promised to look into the exact data to identify how many of those 18 active vaccine failure COVID-19 cases occurred in the United States.

Compared to all others combined in the large study, it had half the efficacy, with a 4 in 1000 chance this result happened by accident. After conveying my concern to FDA which had authorized all three vaccines for all Americans, Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, promised to look into the exact data to identify how many of those 18 active vaccine failure COVID-19 cases occurred in the United States.

His colleagues re-reviewed the study results and reported the new information today. One failure only among about 95 US American Indian/Alaska Natives given active vaccine is no different in vaccine statistics from the zero failures in 104 Pfizer and 107 Moderna US American Indian/Alaska Natives.

Why? Because the exposure to virus is different, the nasal swab result accuracy isn't perfect, and the next subjects in the Pfizer and Moderna studies might have been the ones to have vaccine failures.

With only about 100 persons in each study, zero cases equals one and one equals zero.

This new result is very good news. It is also heartening that FDA's top physician leading this division takes external concerns about the American Indian and Alaska Natives so very seriously and personally that he runs the matter to ground with his colleagues to obtain and rapidly provide the answer.

Why was this concern important to address?

If you have high fever from a severe bacterial infection, you want a doctor who will choose the best antibiotics for that bacterium, not just any antibiotic.

When there is a choice in vaccines to prevent a serious illness, you want your public health leaders to behave the same.

All three vaccines are similarly safe and effective against COVID-19 in all US populations, including American Indians and Alaska Natives. Get your arm jabbed as soon as you can.

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Bruce L. Davidson MD, MPH co-led 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.