Minutes indicate review board fast-tracked Pfizer trial

WINDOW ROCK

As the COVID-19 vaccine rollout continues full bore, the minutes for the Aug. 27 Navajo Nation Human Research Review Board teleconference meeting where the Pfizer vaccine trial was approved were finally released last week.

Why it took so long to complete and share the minutes is a bit of a mystery as it was a notably short meeting, lasting less than an hour.

The minutes suggest the HRRB approval sailed through with less debate and rigor than might normally be the case, which could be tied to the nature of the COVID-19 emergency, but that justification was not documented.

The independent institutional HRRB was founded in 1996 to guarantee ethical research on the Navajo Nation, to protect Diné from “harmful, intrusive, or ill-conceived” health studies, and to establish policies, procedures and conditions for investigators, physicians, and others performing research on the Nation.

Led by former Board Chair and HRRB founder Beverly Becenti-Pigman, who had been at the helm for over 25 years, the Aug. 27 meeting included a presentation by Dr. Laura Hammitt, John Hopkins Center for American Indian Health director of infectious diseases, who oversees the Navajo Pfizer COVID-19 vaccine study, along with about 15 questions to her by the board.

In addition to Becenti-Pigman, only five board members participated in the meeting – Dr. Sonya Shin, from Gallup Indian Medical Center, Delvin Yazzie, with the Navajo Epidemiology Center, Kalvin White, Ph.D., with the Department of Diné Education, nurse Ursula Knoki-Wilson, community relations officer at the Indian Health Service’s Chinle Service Unit, and an unnamed proxy for Nanibaa’ Garrison, a Ph.D. genetics and bioethics professor at University of California Los Angeles.

As an independent review board, the HRRB was upheld for its unbiased and exhaustive multi-step approval process for research done on the Navajo Nation that normally includes buy-in from the chapter level up.

In past months President Jonathan Nez has regularly deferred to the HRRB as the official approval entity for the vaccine trial even though the review process also involved his own Navajo Department of Health, where the HRRB is housed.

The review board is supposed to be comprised of 15 board members – three appointed by the Navajo Area Health Board, three appointed by the president’s office, six by the Council’s Health, Education, and Human Services Committee, and three by the Navajo Area IHS Director.
Presently it has eight members.

‘Moving very quickly’

Questions by the board to Hammitt mostly focused on the scope, protocols and logistics of the study, including how the vaccines would be administered in coordination with IHS, recruitment for the trial, Navajo language translation for participants, side effects, and data analysis.

At this point, most of the information shared by Hammitt is common knowledge or publicly available now that the Pfizer vaccine, authorized for emergency use by the FDA, is being offered to the general population in priority phases.

The minutes can be obtained through HRRB staffer Mike Winney.

In her presentation, Hammitt stated that the pandemic was not going to end until a safe and effective vaccine was available, which would be the key to getting back to “normal life.”

She emphasized the importance of including diverse populations in the trial, including Native Americans, so that necessary vaccine safety and efficacy data could be used to help make informed decisions locally.

At the time, 15,000 participants were enrolled in the Pfizer study throughout U.S., which Hammitt said was “moving very quickly.”

She said the vaccine was already showing a “good response in people” and there was a lot of optimism that it could provide protection against COVID-19.

Notable was a motion to approve the vaccine trial protocol about halfway through the meeting by Kalvin White, who said, “Navajo Nation president requested this, and reached out (to) the federal agencies indicating Navajo Nation is interested to participate in this vaccine study, and Navajo Nation Council (is) in support of this vaccine study and to include Navajo people in this clinical trial…”

After a few more questions, White’s motion was seconded by Knoki-Wilson and the board unanimously voted 6-0 to approve the Pfizer vaccine trial on Navajo.

However, contrary to White’s statement, President Nez has publicly distanced himself from personally endorsing the approval of the HRRB vaccine trial approval, suggesting instead that was the Health, Education and Human Services Committee’s responsibility as it is the HRRB’s oversight committee.

Additionally, the Council never took steps to support the trial, which it knew little about until it was announced on Sept. 21 on during a president’s office town hall with Hammitt and special guest Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

White did not respond to a request to clarify his statement.

Asked by the Times about the approval, Delegate Carl Slater, vice chairman of the HEHS Committee, indicated he did not understand why Nez didn’t just take ownership of supporting the trial if he believed that was the right direction to go in instead of deflecting responsibility to the Council, which was largely left out of the discussions.

“Neither the HEHSC Committee nor the Navajo Nation Council took any sort of formal action to approve Navajo people’s participation in the Pfizer trials,” said Slater. “It was my understanding that the president had initiated this with IHS and said they were going through the formal process of going to the review board which has the authority to approve it and they approved it.”

In response to a request for clarification from the president’s office on the matter, Communications Director Jared Touchin said that they needed more time to respond.
Of course, at this point Nez himself has received a COVID-19 vaccine and is promoting vaccination events across the Nation.

Genetic mRNA technology

It was only after the HRRB approval that the HEHSC received a report from Hammitt and Navajo Nation Department of Health Director Jill Jim on the vaccine trial (Sept. 16), where many questions came up, including concerns raised by Chairman Daniel Tso regarding the use of the new “messenger RNA” technology in the Pfizer vaccine.

At that time, none of the board members who participated in the HRRB vaccine trial approval meeting, except Becenti-Pigman, would speak to the Navajo Times, which was especially curious to know if the synthetic m-RNA technology was discussed or debated.

According to the minutes, it was not.

The only reference to mRNA in the minutes is in the title of Hammitt’s presentation on the agenda: “A Phase 1/2/3 Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARs-COV 2 RNA Vaccine Candidates Against COVID-19 in Healthy Adults (Pfizer COVID-19 Vaccine Study).”

Prior to the vaccine studies and now the massive mobilization of the vaccination effort across the country, the mRNA vaccine technology, used to mount an antibody response to COVID-19, was never tested in humans.

There is also a moratorium on genetic research on the Navajo Nation and the Navajo Times wondered if the use of man-made mRNA, that stimulates production of the COVID-19 “spike protein” in the body, in any way conflicted with that.

Reached by phone on Sept. 22, Becenti-Pigman indicated she was not aware that genetic material was being used in the trial vaccine, despite the fact that Hammitt had distributed reports with the information in the Aug. 27 approval meeting, although she did not bring it up in her oral presentation.

Hammitt did respond to the Navajo Times on Oct. 2 with clarification saying that the full packet of materials she submitted to the HRRB, including sponsor protocols, consent forms, recruitment materials and a one page abstract “clearly identified the vaccine as an RNA vaccine.”

“I presented the study to the board members, describing the vaccine and how it works, the available safety and immunogenicity data, the consenting process and the study activities,” she said.

Hammitt claimed that board members asked many questions about all aspects of the study and there was a “robust discussion.”

She further explained that the Navajo Nation’s moratorium against genetic research is to “prevent the misuse of tribal members’ genetic material.”

“The NNHRRB does not allow researchers to do any projects that collect or sequence human DNA,” said Hammitt. “The vaccine trial does not involve any genetic research on participants – no DNA is collected – and the board did not raise any concerns about this.”

‘Yes and no’

In the meantime, Becenti-Pigman, who has for decades served as a stalwart career community health advocate for the Nation, was quietly replaced with Rebecca Izzo?Manymules, Ph.D., as chair of the HRRB. Manymules has been a member of the review board for 13 years.

Manymules refused a request for a short bio, including her credentials, where she currently works, and when she was elected chair. None of this information is on the HRRB website.
“With all due respects, I chose not to provide my credentials,” Manymules told the Navajo Times on Tuesday. “I am unaware of the information you are providing and to whom you are providing it too. Your intentions have not been shared with me or the Navajo Nation HRRB.”

Reached by phone, 76-year-old Becenti-Pigman said Manymules was elected by the board on Jan. 9.

When asked if she wanted to pass the baton to Manymules, Becenti-Pigman said “yes and no.”

“It’s good because we have many pressing issues and research that have to be taken care of,” she said. “Rebecca just finished her degree at UNM so she was the one that another board member recommended to be the chair.”

Becenti-Pigman will remain on the board as a regular member.

Hammitt did not respond to a request for an update on the Navajo Pfizer vaccine trial.

---