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Law360 (September 21, 2020, 5:00 PM EDT) -- The Navajo Nation and Johns Hopkins University are seeking a "few hundred" qualifying Navajo adults to participate in a recently announced trial for a COVID-19 vaccine candidate created by Pfizer/BioNTech, according to the Johns Hopkins Center for American Indian Health.
Navajo Nation leaders and public health experts, including Dr. Anthony Fauci, the United States' top infectious disease expert, discussed the details of the trial during a Monday town hall streamed live on Facebook. They stressed that the trial is voluntary and could provide key insights on the effectiveness of a potential vaccine for Native Americans.
Among the speakers was Dr. Laura Hammitt, director of infectious disease programs at the Center for American Indian Health.
So far, Hammitt said, "Native Americans have effectively been denied the opportunity to participate in these trials because almost all of the study sites are in large urban areas that have not done effective outreach to Native Americans."
The Pfizer/BioNTech candidate is an mRNA vaccine, made from synthetic copies of the novel coronavirus, according to Johns Hopkins. More than 25,000 Americans have already enrolled to participate in the trial, half of whom will receive a saline placebo.
"We have the same difficulty getting [trial] enrollment in other minority populations, [including] African American and Latinx," Fauci told participants in Monday's town hall. "So the fact that you're able to do a scientifically sound, ethically sound vaccine trial in this demographic is really very important."
The trial has been approved by the Navajo Nation Human Research Review Board, Navajo Nation President Jonathan Nez said during his remarks Monday.
"I think we all recognize that it's important to see the trials focus on the diversity of our population in the United States of America," Nez said Monday. "In this case, Native American people."
"It is important for everyone to recognize that as a sovereign nation we have the ability to allow our citizens, those that want to participate for the overall good of our people, to be participants in these trials," he added.
To take part, Hammitt said, Navajo Nation adults must not have had a prior COVID-19 diagnosis. Nor can they be pregnant or breastfeeding. Possible side effects include swelling or redness near the injection site, as well as fever, fatigue or soreness over the course of two days.
Volunteers will have six visits with study staff over two years, according to Johns Hopkins. Staff will collect blood samples from participants to test for COVID-19 antibodies.
"Tribal communities obviously have to be cautious about research given past research abuses," Hammitt said Monday, stressing that "participation in these studies is voluntary and follows an informed consent process."
Some participants in Monday's town hall expressed skepticism about the vaccine trial in a flurry of comments on the Navajo Nation's Facebook page, while others thanked health experts for clarification on the process.
A spokesperson for Pfizer declined to comment specifically on the Navajo Nation trial site Monday but said that diversity among participants has been a priority.
"Key considerations are to provide diverse individuals the opportunity to enroll in the study at a rate that is reflective of the diversity among those who may use the vaccine," spokesperson Sally Beatty told Law360, "and to enroll participants in areas where there is sufficient SAR-CoV-2 transmission to determine if the vaccine is effective at preventing COVID-19."
Navajo Nation has been particularly hard-hit by the coronavirus, having recently surpassed 10,000 positive cases since the pandemic began. But case rates have recently slowed, with just 12 new cases reported Sunday and no recent deaths.
Fauci praised the Navajo Nation in his remarks Monday, noting a mask mandate and strict social distancing guidelines on the reservation.
"I think this can serve almost as a model to so many other locations outside of Navajo Nation, that when you adhere to the public health measures we are talking about, you get your case positivity down very effectively," Fauci said.
--Editing by Orlando Lorenzo.
For a reprint of this article, please contact reprints@law360.com.
