Navajo Nation officials announce participation in COVID-19 vaccine trials – The Arizona Republic

Coronavirus 2019-nCoV vials(Photo: solarseven, Getty Images/iStockphoto)

Navajo Nation officials said Friday they will participate in the Pfizer-BioNTech COVID-19 vaccine trials. Trials will be conducted at various health care centers across the Navajo Nation on a volunteer basis.

The vaccine trials come after theNavajo Nation, which once held the highest COVID-19 infection rate in the country,has seen a decline in its numbers. On Sept. 8, officials reported zero new cases for the first time since the pandemic started.

The total number of COVID-19 cases reported from the Navajo Nation is 9,933 as of Sept. 10.

"Several COVID-19 vaccine clinical trials are making progress across the U.S. and it's important that the Navajo people have an opportunity to participate in a Phase 3 trial," Navajo Nation President Jonathan Nez said in a press release.

"The clinical trials will be done on a patient-volunteer basis, meaning that no one will be forced to participate unless they are fully willing to do so."

The Navajo Nation Human Research Review Board approved the Pfizer-COVID-19 Vaccine Study on Aug.27, according to Jared Touchin, communications director for the Navajo Nation Office of the President and Vice President.

The study will be led by theJohn Hopkins Center for American Indian Health and is the first COVID-19 vaccine study on the Navajo Nation.

"COVID-19 has disproportionately affected tribal communities. In the Southwest, tribal members have experienced some of the highest rates of the COVID-19 disease in the country," said Navajo Department of Health Executive Director Dr. Jill Jim in a press release.

"Supporting national strategies to develop a vaccine addresses health equality to guide local decision making about vaccine selection and vaccine use," she added.

Enrollment for the study will begin in mid-September and participation will include individuals between the ages of 19 to 85who are healthy or have a stable underlying health condition.

Participants will be given two doses of approved vaccine and will be monitored over a two-year period. Eligible participants who join the study must not have had a prior COVID-19 infection.

"This is because people who have recovered from COVID-19 will likely have antibodies," the press release states.

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There are no approvedvaccines against COVID-19, but there many under development. The federal government announced a goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021 in a plan called Operation Warp Speed.

For COVID-19 vaccine trials, the FDA has issued guidance that "strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities," and has encouraged the inclusion of other high-risk groups such as those with underlying diseases in late-stage vaccine trials as well as pregnant women or women of child-bearing age.

The inclusion of these groups can have important implications for understanding how treatment may affect various groups differently since genetics or other factors influence how well a treatment works.

Before signing up for any COVID-19 study, Jason Robert, an Arizona State University bioethicist who focuses on how to practice safe and ethical science, said people should fully understand the risks and shouldn't volunteer for the wrong reasons.

"Scientists are doing this for the good of the whole, not the individual," he said. "It might be our civic duty to participate in these studies, but don't do it because you think you're going to get better."

Navajo people who are interested in participating in the Pfizer COVID-19 Vaccine Study through the John Hopkins Center for American Indian Health can contact site managers in Chinle;Shiprock, New Mexico;and Gallup, New Mexico.

"We have overseen numerous phase 3 clinical trials with an experienced, dedicated staff who have specialized training in research ethics, Good Clinical Practice, HIPAA compliance, specimen collection, and who are able to conduct high-quality studiesthat meet strict FDA requirements," Dr. Laura Hammitt with John Hopkins Center for American Indian health stated in the press release.

The Chinle site can be reached at 928-674-5051, Shiprock at 505-368-4030, and Gallup at 505-722-6372.

The Navajo Nation is hosting a live online town hall meeting on Sept. 21.Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious DiseasesDirectorwill joinNez and Vice President Myron Lizer to discuss the COVID-19 response efforts and trial vaccines.

Republic bioscience reporter Amanda Morris contributed to this report.

Reporter Shondiin Silversmith covers Indigenous people and communities in Arizona. Reach her at ssilversmi@arizonarepublic.comand follow her Twitter @DiinSilversmith.

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Navajo Nation officials announce participation in COVID-19 vaccine trials - The Arizona Republic