COVID-19 vaccines: Safe and effective for American Indian and Alaskan Native communities

Editor's note: Joseph R. Betancourt, MD, MPH, contributed to this post.

When the Johnson and Johnson single-dose COVID-19 vaccine joined the ranks of the Moderna and Pfizer/BioNTech two-dose vaccines, many Indigenous Peoples were excited about its potential.

American Indians and Alaska Natives (AI/ANs) have the highest COVID-19 hospitalization and death rates in the US. And given that 46% of adult Natives lack access to a vehicle, a single-dose vaccine looked like an especially appealing option to protect Indigenous communities. Yet even before the recent pause on the Johnson and Johnson vaccine raised concerns about safety that have since been resolved, its effectiveness for AI/AN peoples was in the spotlight.

A challenge: How effective is the Johnson and Johnson vaccine for AI/AN communities?

Efficacy is the measure of how well a vaccine protects against illness under the ideal conditions of a scientific study. In March, a physician wrote an opinion challenging the efficacy of this vaccine in protecting Indigenous recipients. This appeared in Indian Country Today, the most prominent Indigenous-centered news source in the US.

After analyzing data from the FDA briefing document on the Johnson and Johnson vaccine, the author claimed that the risk of getting COVID-19 after being vaccinated was over two times higher in Indigenous people compared with people from all other racial groups. He strongly encouraged Natives to choose the Moderna or Pfizer/BioNTech vaccines instead.

An upswell in response

A group of Indigenous health scholars including Abigail Echo Hawk, director of the Urban Indian Health Institute, penned a response in Indian Country Today. They expressed confidence in the efficacy of all three available vaccines, and encouraged Native people to take the first one available to them.

The chief medical officer of the Indian Health Services (IHS), Dr. Michael Toedt, also disagreed. No data support the claim that the Johnson and Johnson vaccine is less effective for Natives, he stated.

Even in large, well-powered studies, it's not possible to interpret results for small subgroups, such as people over age 75 or racial subgroups represented only in small numbers as participants in a trial. And in fact, the FDA report also makes this point. Subgroup results are provided for completeness, although their interpretability is limited.

How well does this vaccine protect against COVID-19?

So, how well does the Johnson and Johnson vaccine protect AI/AN peoples from COVID-19? Let's tease apart the available numbers.

In the trial, about 19,300 participants received the Johnson and Johnson vaccine. Only 1,628 of those participants were Indigenous. Just 95 were AI/AN from US tribes (the rest were from Latin American countries). Only 18 of all the Indigenous participants got COVID 19 after being vaccinated — and just one of them was AI/AN from the US. Not a single hospitalization or death occurred among the Indigenous participants. It's worth adding that no genetic or scientific factors explain why this vaccine would offer less protection against COVID-19 for AI/ANs compared with all other racial groups.

What about the two-dose COVID-19 vaccines? No cases of COVID-19 were recorded among AI/AN study participants who received these vaccines: that's zero out of 107 (Moderna) and 104 (Pfizer/BioNTech).

How safe are the three vaccines?

All three vaccines were rigorously studied in tens of thousands of clinical trial volunteer participants. Given the reassuring results of those studies, the FDA deemed them safe and effective in protecting people from hospitalizations and deaths due to COVID-19 infection. By late April, more than 230 million doses of COVID-19 vaccines had been given to people across the US.

Some people have no side effects after getting the vaccine. Others have common, temporary side effects, such as pain at the injection site, muscle aches, fever, and feeling tired.

Two extremely rare side effects have been noted:

• Severe allergic reactions, which may occur with any vaccine. Medical providers and vaccine staff keep medicine available to treat this right away. This happens at a rate of two to five people per million people vaccinated.
• Blood clots and low blood platelets (the blood cells that help stop bleeding) have been reported with the Johnson and Johnson vaccine. According to the CDC, risk is higher in women younger than 50 than in older women or men. It occurs in about seven per million vaccinated women ages 18 to 49, and about one per million vaccinated women 50 or older. After investigation showed that this side effect is rare, the temporary pause on using this vaccine was lifted. According to the FDA, the known benefits outweigh known risks for the Johnson and Johnson vaccine in all adults, including Native Americans.

The bottom line

Because COVID-19 is a danger to every racial and ethnic group, free and accessible vaccination is important for everyone. American Indian and Alaskan Native communities face some of the highest rates of diabetes, cardiovascular diseases, and cancer, making COVID-19 deadlier to them. They are exposed to pollution, have less access to health care, are less wealthy, live without clean water, and experience food insecurity at levels greater than non-Indigenous people. As a result of centuries of neglect, many Native Americans also have well-earned mistrust of the US medical system.

This is a time when trust could save lives. Claims that the Johnson and Johnson vaccine fails to protect Native Americans may needlessly work against community trust. Currently, no evidence shows that the Johnson and Johnson vaccine is less effective or less safe for AI/AN communities than the Moderna and Pfizer/BioNTech vaccines.