Navajo Nation to participate in Pfizer-BioNTech COVID-19 vaccine trial
Navajo health care centers to offer trial vaccine on volunteer basis
WINDOW ROCK, Ariz. —Navajo Nation announces participation in Pfizer-BioTech COVID-19 vaccine trail on a patient-volunteer basis — the study will be led by the John Hopkins Center for American Indian Health.
Navajo Nation President Jonathan Nez and Vice President Myron Lizer recently received a report from the Navajo Department of Health, indicating that the Navajo Nation Human Research Review Board approved the Pfizer COVID-19 Vaccine Study, to be conducted at several health care centers on the Navajo Nation on a patient-volunteer basis.
“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,” Nez said. “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.”
Nez said the Nation has many people whose family members are in hospitals fighting to recover from COVID-19 and they may want to participate in the vaccine trial.
“Please remember that the vaccine trials have been conducted on many people outside of our Nation already, so this is now the third phase of the trial. A vaccine is needed to end the pandemic,” Nez said.
Currently, there are no licensed vaccines to prevent COVID-19, however, several are in development.
The Pfizer COVID-19 Vaccine Study will be the first COVID-19 vaccine study on the Navajo Nation and will be administered by the John Hopkins Center for American Indian Health.
Enrollment participation will include individuals between the age of 18 to 85 years, who are healthy or have stable underlying health conditions. Enrollment will begin mid-September and participation is voluntary.
Participants will receive two doses of approved vaccine and will be monitored over a two- year period. To be eligible to join the study, a person cannot have had a prior COVID-19 infection, because those people who have recovered from a prior COVID-19 infection likely will already have antibodies.
“If this study finds that the vaccine is effective against COVID-19, then American Indian and Alaska Native individuals and indigenous people around the world would benefit,” Nez said. “We want to do everything we can to keep our elders and people healthy and to prevent another spike in COVID-19 cases. Without a safe vaccine, our numbers of cases will continue to fluctuate and we will continue to face substantial risk of infection.”
The administration said state and federal efforts to include tribal communities in decision making throughout the pandemic is a federal responsibility.
The Nez-Lizer administration has worked closely with health care experts across the country to learn more about vaccine trials.
Recently, Nez and Navajo Department of Health Executive Director Dr. Jill Jim spoke with officials with the National Institute of Allergy and Infectious Diseases regarding vaccine trials.
On Sept. 21, NIAID Director Dr. Anthony S. Fauci is scheduled to join Nez and Lizer during a live online town hall to discuss the COVID-19 response efforts and trial vaccines.
“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,” Jim said. “Supporting national strategies to develop a vaccine addresses health equity to guide local decision making about vaccine selection and vaccine use.”
As the federal government seeks to deliver 300 million COVID-19 vaccine doses by January 2021, Operation Warp Speed comprised of several federal agencies are partnering to deliver a vaccine and other countermeasures safely and with efficacy.
In response to distribution needs of the vaccine, U.S. Department of Health and Human Services agreed with Pfizer to produce several million doses. Pfizer partnered with BioNTech to enroll more than 20,000 people around the U.S. with less than 0.5% American Indian and Alaska Native participants.
“With our participation in the vaccine trial, we can reduce disparities and increase representation to ensure the vaccine works safely among the Navajo population,” Lizer said. “We will directly contribute to vaccine use in tribal communities instead of being left in the dark.”
The administration said The Johns Hopkins Center for American Indian Health is a trusted partner with expertise in clinical trials on the Navajo Nation for the past 30 years.
“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 Dr. Laura Hammitt with John Hopkins Center for American Indian Health. “We are honored to have to opportunity to contribute to combating COVID-19 with the Navajo Nation.”
Patient volunteer information:
People interested in participating in the study through the Johns Hopkins Center for American Indian Health may contact the Site Manager at the following locations:
Chinle, Arizona: (928) 674-5051
Shiprock, New Mexico: (505) 368-4030
Gallup, New Mexico: (505) 722-6372
Or by email: email@example.com