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COVID-19 vaccine trials starting this week on Navajo

WINDOW ROCK

Volunteer vaccine trials with Pfizer-BioNTech for COVID-19 will be starting this week on Navajo, President Jonathan Nez announced last Friday on Facebook.

“A vaccine is needed to end the pandemic,” Nez said, adding that trials are occurring across the U.S. and “it’s important that the Navajo people have an opportunity to participate in a Phase 3 trial.” The post drew immediate backlash and suspicion.

The common sentiment among many people who responded to the post was that they don’t want to be used as “lab rats” or “guinea pigs.” “Hell no!” read several responses.

Laura Hammitt, director of infectious disease programs at the Johns Hopkins Center for American Indian Health, who is overseeing the COVID-19 vaccine trials on Navajo, said the choice to go with the Pfizer trial was vetted by health professionals who serve the Navajo Nation. These include the Navajo Department of Health, the Indian Health Service and tribal health providers.

Hammitt has been working with the Navajo Nation since 2011 and is part of the COVID-19 testing coordination team at the Navajo Health Operations Command Center. “There were a number of people who came together to look through the trials that are ongoing,” she said. “There was good support for the Pfizer vaccine based on the preliminary data they had on the safety and the antibody response.”

Hammitt said Pfizer has done clinical trials in collaboration with the Navajo Nation before. Pfizer’s goal is to enroll 30,000 people from across the U.S. in the Phase 3 vaccine trials. So far they have enrolled approximately 23,000. Hammitt hopes that several hundred Navajo will choose to participate in the study, which has also been approved by the Navajo Nation’s Human Research Review Board.

She said the review board was established in 1996 to critically and carefully review all research to ensure that it offers potential benefit to the Navajo Nation and is conducted in an ethical manner and protects the rights of participants.

“The trials that are being done are not dissimilar to trials that have been done before, which have led to the licensure of medications that we use every day and vaccines that we give to our children that protect them from terrible diseases,” she said.

Area that needs it most

Hammitt believes that if a vaccine gets licensed for use nationally, it is important to make sure it will work in the populations that need it the most, which is one of the reasons testing the vaccine on Navajo will be beneficial.

“Right now, with COVID-19, we know that tribal communities, especially those in the Southwest, have been among the most hard-hit in the United States,” she said. “It’s largely about health equity, but also helps give the Navajo Nation the data it needs to be able to make decisions about vaccine use.”

The president’s office said the Nez- Lizer administration has worked closely with health care experts to learn more about vaccine trials, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who will be joining a live virtual town hall on Monday.

“With our participation in the vaccine trial, we can reduce disparities and increase representation to ensure the vaccine works safely among the Navajo population,” said Vice President Myron Lizer.

Hammitt said that while the Navajo Nation has done an amazing job of flattening the curve of COVID-19 cases by adhering to public health orders and safety measures, the virus has not gone away. “If we continue to do all these things to limit its opportunity to spread, I think that’s a way to contain it, but I don’t think that’s sustainable,” she said. “People need to be able spend time with loved ones, to gather, and kids need to be able to go to school.”

She said in order for us to get back to a more normal way of life, we need a vaccine. “That is going to be the way out of this pandemic,” said Hammitt. Earlier on in the pandemic, a lot of people were hoping that COVID-19 would just go away on its own, she said, but unfortunately that isn’t happening.

“I think that’s proven over time not to be the case with this virus,” she said. “Every time you see the restrictions lifted there’s a resurgence of cases, which means that it’s there, and given the opportunity, it will do what viruses do, which is spread to other people.” Nez concurs. “Without a safe vaccine, our (COVID-19) numbers will continue to fluctuate and we will continue to face substantial risk of infection,” he said.

Phase 3

Hammitt explained that the Pfizer vaccine has already been evaluated in thousands of people outside of the Navajo Nation in the Phase 1 and Phase 2 trials, which focus on proper dosage and minimizing side effects.

“Phase 3 is where we really establish the efficacy of the vaccine and measure whether the vaccine can reduce the severity of the disease or prevent the disease altogether,” said Hammitt. She clarified that COVID-19 vaccine trials that are going on around the world right now are efficacy studies that compare the amount of disease that occurs in people randomly selected to receive the vaccine versus those who have been randomly selected to receive a placebo. A placebo, often used in testing, contains no active ingredients.

“Normally, what you would expect in a clinical trial is good levels of antibody in people who got the vaccine and less cases of COVID disease,” said Hammitt. “We measure the amount of antibodies that are generated. That type of data is really helpful.”

These are some of the key factors that the Food and Drug Administration will look at when considering how soon to license the vaccine, she said. Hammitt is optimistic that over the coming year, multiple vaccines will be licensed and recommended for use by the FDA and Centers for Disease Control.

“Some of them might work better in certain populations and unless the Navajo Nation participates in the studies, those decisions will have to be made in the dark,” she said. Hammitt emphasized that many harmful diseases have been eradicated because of vaccines, which people sometimes forget. “It’s always important to look at the facts and look at the success that vaccines had in terms of reducing infectious disease and deaths,” said Hammitt. “I think vaccines have been a really incredible tool in improving the health and well being of societies around the world.”

What to expect

Participants who volunteer for the vaccine trial can expect six study visits over the course of two years. They are administered two doses of the vaccine or placebo in the first two visits three weeks apart. It is up to the FDA to determine at what point within the two-year study a vaccine can be licensed. “Normally, a Phase 3 clinical trial will often last one to two years and the FDA won’t review it for licensure until that process is complete,” said Hammitt.

However, because of the pandemic, there is a possibility the vaccine would be available earlier for emergency use, which would be based on the initial efficacy, antibody response and safety data, she said. “Because of the situation we’re in now, there is the thought that if there is a vaccine that is safe and effective that we should make that available for people,” said Hammitt.

Hammitt said that if the vaccine is approved prior to the term of the study, what researchers wouldn’t know from the early data is how long the vaccine protection will last. Participants will continue to be followed to assess durability of the protection and if the antibody levels start to wane, she said.

Eligibility requirements

If someone wants to participate in the vaccine trials, they must first go through a lengthy informed consent process that helps them understand everything they need to know about the vaccine and what the risks and benefits are. “We want to make sure people have all of their questions answered,” said Hammitt. “If they agree that they want to participate in the study, they go through an eligibility check to make sure they meet the criteria.”

Hammitt said the vaccine study is enrolling people ages 18 to 85, who are healthy or have stable underlying medical conditions. Those who have had the COVID-19 infection or have tested positive cannot participate in the study, because people who have recovered from COVID-19 are likely already to have antibodies to the disease.

Participants will be required to go through a complete physical exam and evaluation. If they are deemed eligible, they will receive two doses of vaccine or placebo, administered by a nurse, and will be monitored for two years. There is compensation for participants for their “time and effort,” said Hammitt.

Over the course of the entire study, people can be compensated up to $710. “It’s important for people to know they will be followed for two years and any side effects will be investigated,” said Hammitt. “Participants in the study are monitored very carefully for safety.”

Hamitt stands by the professionals, including researchers, nurses and physicians like herself who will be administering the trials at the Johns Hopkins Center for American Indian Health locations in Gallup, Shiprock and Chinle.

“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 studies that meet strict FDA requirements,” said Hammitt. “Many of our team members are Navajo and speak the language,” she said, “which helps to ensure that this work can be done in a culturally informed way.”

Information: Chinle, 928-674-5051; Shiprock, 505-368-4030; Gallup, 505-722-6372; or johnshopkinscaih@gmail.com


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