COVID-19 vaccine trial to include hundreds of members of the Navajo Nation

The final phase of study for a coronavirus vaccine will include volunteers from the Navajo Nation.

Since coronavirus first arrived in the United States in the late winter of 2020, a race among pharmaceutical companies to find a vaccine for the virus has been underway.

Now three companies and their vaccines have reached phase three of the trial, including Moderna, AstraZeneca and Pfizer.

In phase three, thousands of people will receive the vaccine. Pfizer and Biontech plan to enroll 30,000 people throughout the US in their trial, including a few hundred members of the Navajo Nation.

The clinical trial is completely voluntary and will be administered by the Johns Hopkins Center for American Indian Health.

Beginning this month, healthy adults who have not had a prior COVID-19 infection will be able to volunteer for the study. 

Those interested in being a part of the trial will go through an informed consent process where they will be taught the benefits and risks of participating in the study, as well as have questions answered.

Those who wish to move ahead will then meet with a doctor who will perform an exam to determine eligibility. 

Those who consent and are eligible will then be given either the trial vaccine or a placebo. Half of the participants will receive the trial dose and the other half will receive a saline solution to act as a control group. Participants will get another dose three weeks later.

Volunteers for the study will receive a total of six visits over a two-year period from local Johns Hopkins study staff, who will collect blood samples to test for antibodies to COVID-19.

The announcement of the study has produced mixed reactions among members of the Navajo Nation. Some residents expressed excitement about the vaccine while others are far more suspicious of the trial.

In a Facebook Live town hall meeting with Navajo Nation President Johnathen Nez on Monday, September 21, members of the nation heard from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Fauci congratulated the Navajo Nation on their work to dramatically reduce the number of COVID-19 cases in the nation. He also explained how vaccine trials are kept safe.

“One of the assurances that you’re dealing with something that is safe is that each vaccine that is tested has what’s called a data and safety monitoring board,” said Fauci.

Fauci explains the independent board views all data from trials to ensure that a vaccine is effective. Whenever there is an ill-effect that could possibly be related to the vaccine, the board sees that and has the power to pause the study. 

He mentioned the example of a different vaccine in Great Britain that was put on hold when a single person showed adverse reaction to the trial vaccine. 

Fauci also says the data is scrutinized by the Food and Drug Administration (FDA), in addition to the safety monitoring board.

Additionally, the decision to allow the trial to be conducted on the Navajo Nation was made by the Navajo Nation Human Research Review Board, which reviews all submitted research proposals.

At the same town hall, Dr. Laura Hammitt was invited to speak. Hammitt is the Director of Infectious Disease Programs of the Johns Hopkins American Indian Center and is conducting the trial on the Navajo Nation.

Hammitt says that early phases of coronavirus vaccine trials have not looked at how effective the vaccine will be among Native American populations.  This is because of focus on testing in urban areas, coupled with poor outreach to Native American populations. 

“What that means is that we’ll have little data to understand if vaccines will work as well in Navajo populations as they do in other populations to prevent this disease,” said Hammitt.

Hammitt says the trial offers an opportunity to ensure the vaccine is just as effective among Native American populations as it has been among earlier study participants.