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Clincial Trial For COVID-19 Vaccine Seeks Navajo Volunteers – KNAU Arizona Public Radio

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The pharmaceutical company Pfizer is recruiting tens of thousands of volunteers to test a possible new vaccine for the coronavirus disease. Some will be from the Navajo Nation. A legacy of systematic racism and unethical research has left many Navajos wary of participating in clinical trials. But health experts say it’s critical for Indigenous people to be involved for an equitable and scientifically sound process. KNAU’s Melissa Sevigny spoke about this dilemma with Laura Hammitt, of Johns Hopkins’ Center for American Indian Health, who is overseeing the trial on Navajo.

Tell me about the vaccine that’s being tested on the Navajo Nation and how it works.

This an mRNA vaccine…. So it’s actually a laboratory-made synthetic code that codes for the virus’ spike proteins. It’s not any part of the virus at all… It tells our body’s cells how to make—it’s sort of the instruction book or code book for how to make spike protein. Then by making that spike protein, our bodies recognize that and make antibodies against it…. And that way once when exposed to the coronavirus virus we’ll have antibodies and be prepared to fight the real thing.

Why is it important to do these Phase Three trials on the Navajo Nation?

Right now Native Americans have one of the largest burdens of COVID-19 disease, but they’ve largely, effectively, been denied the opportunity to participate in these clinical trials, given that the vast majority of the study sites are in urban areas…. If we get to the end of all these vaccine trials and prove we have a vaccine that can protect white people, we’ve really missed the point, and that’s a real injustice. So providing opportunities for people to participate should they choose to do so is the right thing to do from a health equity standpoint. But we also know that…there may be differences in our physiology and how we response to the vaccines that may make one of these vaccines that are in clinical trials right now, may make one of them preferable, that might have better characteristic for this population. Being involves in clinical trials allows communities to have that information to make informed decisions.

On the flip side I know some Navajos feel concerns about in essence being experimented on. What would you respond to those concerns?  

There is unfortunately an egregious history of research abuses in tribal communities. Tribal communities should be cautious about research given these past harms that have been experienced. One of the key things for people to understand is that these are voluntary clinical trials, they are in later stages—these are Phase Three clinical trials—and they are ongoing around the world, with tens of thousands of Americans having participated in them so far. The Navajo Nation actually has one of the largest standing tribal research regulatory bodies in the country, the Navajo Nation Human Research Review Board, which is a model for Indian County. All of our research involves two layers of consent, there is community consent and approval by the Navajo Nation Research Review Board, as well as individual participant consent.   

How will you know if the vaccine is a success, what determines that?

These trials are randomized controlled trials, meaning that… half the people will get the study vaccine and half the people will get a placebo, which is a saline injection…. We’re looking to see if the number of cases of COVID-19 that occur in people who received the vaccine is substantially lower than people who didn’t receive the vaccine. We’d like to see the vaccine is at least 60 percent effective at preventing COVID 19 disease.

Laura Hammitt, thank you so much for speaking with me.

Thank you.

More information on the clinical trial: https://caih.jhu.edu/news/pfizer-covid-19-vaccine-clinical-trial

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