Lummi Nation to participate in Phase 3 trial of AstraZeneca’s COVID-19 vaccine
The Lummi Tribal Health Center will participate in a Phase 3 clinical trial to help determine the efficacy of a COVID-19 vaccine developed by AstraZeneca.
The Lummi Indian Business Council announced that it had unanimously approved participation in the trial for AZD1222 in a release posted to Facebook Wednesday morning, Sept. 16.
“The Lummi Nation has been a public health leader in our proactive response to the COVID-19 pandemic,” Lummi Indian Business Council Chairman Lawrence Solomon said in the release.
“This unique opportunity to partner with the University of Washington and the National Institute of Health to participate in the Phase 3 clinical trial is in furtherance of the treaty rights that our leaders fought for, namely, access to vaccines for our people.”
The vaccine trial will be led by the Lummi Tribal Health Center physicians and staff with the support of UW, according to the release.
The Lummi Nation will partner with the Nooksack Tribe for the trial, Dr. Dakota Lane said during a Facebook video broadcast Wednesday afternoon, and only members of the Lummi and Nooksack tribes are allowed to participate.
Dr. Cristina Toledo added during the broadcast that participants must:
▪ Volunteer for the trial.
▪ Be over 18 and able to consent to the trial and that elders will be allowed.
▪ Not have any other previous medical conditions that would exclude them from the trial.
Patient safety and risk have been reviewed by the Northwest Indian College Institutional Review Board and determined that the potential benefits for the Lummi Nation “were maximized and the potential risks were minimized,” the release stated.
Part of the reasoning behind the decision, according to the release, is the Centers for Disease Control and Prevention has reported that American Indian and Alaska Natives are 3.5 times more likely to contract COVID-19 compared to non-native people. Those races disproportionately suffer from chronic illnesses, which put them at higher risk for illnesses such as COVID-19, the release stated.
In Whatcom County, American Indian and Alaska Native account for 5.1% of all COVID-19 cases, according to data released Monday, Sept. 14, by the Whatcom County Health Department. That’s more than double the 2.5% of Whatcom County residents that identify as those races.
On Tuesday, Sept. 15, the Lummi Public Health Department announced via Facebook that a 60th member of the Lummi community had tested positive for the new coronavirus. It also reported that with the exception of that newest case, all 59 people to previously test positive for COVID-19 have recovered.
“Lummi Nation’s participation in this trial will create the opportunity to ensure Native people are represented in the development of this life-saving vaccine,” the release read.
UW approached all tribes in Washington state about participating in the trial, and Lummi was accepted in July, Lane said during the broadcast, adding that the Lummi and Nooksack tribes are the only Native American groups participating in the AstraZeneca trial.
“I don’t want people in our community to die from coronavirus,” Lane said. “That is why we pursued being a part of this study.”
The Lummi Public Health team will provide more information on how to volunteer to participate in the clinical trial once the trial resumes in the United States.
Approximately 5,000 people received the vaccine in earlier phases of the clinical trial, Toledo said, and the most common side effects were those similar to those associated with a flu vaccine — pain at the injection site, fever and body aches that can be relieved with acetaminophen.
One case in England did report transverse myelitis, a disorder caused by inflamation of the spinal cord, Toledo said. That report forced the vaccine trials to be put on hold to determine if the condition was related to the vaccine itself or something else.
All global trials of the AstraZeneca vaccine were stopped Sept. 6 when a standard review process triggered a “voluntary pause” to allow for a review of safety data by independent committees and international regulators, according to an AstraZeneca release.
The trial resumed in the United Kingdom on Saturday, Sept. 12, according to the release.
“AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials,” the release stated. “The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during the pandemic.”
In Phase 3 of vaccine testing, according to the CDC, vaccines are given to thousands of people to be tested for safety and efficacy.
It comes after small groups of people receive the vaccine in Phase 1, according to the CDC, and it is given to people with characteristics (such as age or physical health) similar to those the vaccine is intended to treat in Phase 2. Many vaccines undergo ongoing studies in Phase 4 after the vaccine is approved and licensed.
The AstraZeneca vaccine trial is one of three that are currently being held in the United States, Toledo said, as researchers look for a way to slow the spread of coronavirus.
“Vaccines can affect every group of people different,” Toledo said, adding that is why it’s important for Lummi to be part of this study so that researchers and the Lummi Public Health team can learn if it is both safe and effective for Native American people.
“This was a huge effort by a lot of people, and I want to thank all of you for getting us here today,” Lane said. “But we have a long ways to go.”
This story was originally published September 16, 2020 at 9:31 AM.
