IHS: Data Doesn't Support Physician's Claim Johnson & Johnson Vaccine Doesn't Work in AI/AN Populations
- By Jenna Kunze
Indian Health Service’s (IHS) chief medical officer Michael Toedt on Thursday dispelled misconceptions spread by a Seattle doctor column that the Johnson & Johnson vaccine is less effective in American Indian/Alaska Native (AI/AN) populations.
“I'm sure that many of you have seen recent opinions that have been published expressing concern about the Johnson and Johnson vaccine in the American Indian and Alaska Native population,” Toedt said in a regularly scheduled press briefing. “The problem with that opinion is that there is no data to support it. The issues with interpreting the results for subgroups within a study with populations that are too small are well documented.”
The editorial column, penned by Seattle-based physician, Dr. Bruce L. Davidson, and republished by Indian Country Today, looked at the FDA’s briefing document for the newly approved, single shot vaccine. In clinical trials of more than 30,000 volunteers for the vaccine, only a small percentage of participants were Native Americans, thus skewing statistics, Toedt said.
The study showed that 1,628 Natives in clinical trials appeared to be 2.1 times more likely to get Covid after being vaccinated, compared to 0.5 percent of 17,674 people in other racial groups.
“The bottom line is that the number of American Indians and Alaska Natives in the study was not large enough to make the conclusion that the op-ed made,” IHS team lead on the vaccine task force, Matthew Clark, wrote in response to Native News Online earlier this week.
“The FDA Briefing Document for the Johnson & Johnson vaccine cautions against interpreting the vaccine efficacy results for subgroups with small numbers of participants, such as certain racial subgroups,” Clark wrote. “The data on American Indians and Alaska Natives was included in the briefing to provide additional information on the study, but was not intended to be used to draw conclusions regarding specific subgroups.”
On Thursday, Dr. Toedt added that there are three safe and effective vaccines that “have been properly vetted in clinical trials and should be utilized in our patient population.”
“The best Covid-19 vaccine is the first vaccine that is available to you,” he said.
President of the Association of American Indian Physicians, Dr. Mary Owen (Tlingit), wrote to Native News Online that that column’s inaccuracies about the efficacy of the Johnson & Johnson vaccine’s efficacy “could do more harm to our communities.”
“Essentially, the message to take home is that the numbers of Natives in the vaccine trial were far too small—and not all Native Americans, but some South American Indigenous people as well— and therefore conclusions cannot be drawn,” she wrote. “Most importantly, in our vulnerable community, we need to get people vaccinated now.”
Covid-19 vaccine rollout updates
This week, Congress passed a historic bill appropriating $31.2 billion in relief funding—the largest one-time investment in history for Indigenous communities— dedicated to stabilizing Native communities impacted by the pandemic.
The American Rescue Plan Act includes $6.1 billion in funding to IHS. “These much needed funds will support a variety of activities, including additional sources for Covid-19 testing, and vaccination administration,” Toedt said in Thursday’s media briefing.
IHS Office of Finance and Accounting Jillian Curtis said the money provides $1.5 billion for testing activities, $600 million for vaccine related activities, $240 million for public health workforce activities, and $10 million to support the delivery of potable water across Indian Country. Notably, the bill also includes “an unprecedented level of investment” in behavioral health services, with an additional $420 million for mental health and substance abuse prevention and treatment across Indian Country. “This new funding is an addition to the $366 million that the IHS received for behavioral health activity, and its annual appropriation for FY 2021,” Curtis said.
Curtis said IHS will begin distributing the funds “immediately” based on consultation with Tribal leaders.
As of this week, IHS has administered more than 684,000 doses of Covid-19 vaccines so far, according to chief medical office Toedt. “We've established a goal of administering 1 million doses of Covid-19 vaccine by the end of March, and we are on pace to reach that milestone,” he said.
Additionally on the call was Dr.Loretta Christensen, IHS’ Navajo Area chief medical officer. Christensen said that 70 percent of all eligible Navajo Tribal members 16 and older have been vaccinated.
In the Oklahoma area—another Tribal region still seeing the greatest impact of Covid-19, along with the Navajo Nation—IHS chief medical officer for the area, Greggory Woitte said, of the 400,000 Native people who receive health care at one of the local IHS facilities, that have administered over 170,000 vaccine doses.
“To support community immunity, some of our sites have even begun to offer vaccinations to all members of the community and intend to routine daily vaccination efforts,” Woitte said.
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