Whither NACI: What’s driving the committee’s ongoing decisions on COVID?

In the 28-day period preceding May 5, 2023, the World Health Organization reported over 2,700,000 new cases of COVID-19 and 17,000 deaths worldwide. They acknowledged and expressed frustration with significant decreases in data collection and surveillance around the world while continuing to classify the pandemic as a “global health threat.” Nevertheless, the WHO declared on May 5, 2023 that COVID-19 no longer constituted a public health emergency of international concern. They cited high population-level immunity from vaccination as the primary reason to support their decision. On the surface, that makes sense in a country like Canada. After all, the Public Health Agency of Canada (PHAC) says about 80% of the Canadian population has received their primary series of the vaccine—defined as two-doses. Once you dig deeper, though, the vaccination rates show much more mixed results. For example, among children four years of age or younger, the rate is less than 6%. Moreover, PHAC and most experts acknowledge the waning nature of vaccine-induced immunity (and infection-induced immunity, too). Given the amount of time that has passed since most people received their first two doses, it’s arguable that the primary series vaccination rate doesn’t hold the relevance it once did. PHAC seems to agree, which is why they now track the number of people who've completed the primary series, or received a booster, in the past six months. On that more relevant metric, the vaccination rate is an abysmal 12.8%, with no province exceeding 18%. Even in the most vulnerable groups, like Canadians at least 80 years of age, the rate is only 30%. It appears as though much of the vaccine-induced immunity in the Canadian population has long waned. Instead, they rely on infection-induced immunity, which also wanes. For example, a recent study published in the Brazilian Journal of Microbiology found that a person with no comorbidities and three vaccine doses (primary series plus one booster) was reinfected with Omicron sub-lineages with sixteen days. The National Advisory Committee on Immunization (NACI) plays a central role in providing guidance, primarily to provinces and territories, about the use of approved vaccines in Canada. Although NACI has been in operation since 1964, it’s likely only in the past few years that most Canadians have even heard of it. In light of Canada’s low vaccination rates beyond the primary series, and given the changing nature of the pandemic and objectives of public health officials and governments, one can’t have a conversation on this topic without examining the experience, role and future of NACI. What was the experience of NACI and its physician members? Dr. Howard Njoo, deputy chief public health officer of PHAC, described the work of physicians during the COVID-19 pandemic as intense and stressful but also professionally fulfilling. The global pandemic wasn’t exactly what the physicians on NACI necessarily signed up for or expected. NACI wasn’t created or even re-constituted to deal with COVID-19. As a result, there was a “heavy lift and pull on them,” according to Dr. Njoo, as the “scale, scope and pace of work increased.” Dr. Njoo said NACI members used “real-world experience and data,” tried to make sense of “rapidly evolving science,” and worked hard to create new ways of doing business. For example, he cited the new process of receiving and assessing manufacturer data as it was being submitted to regulators, and moving to off-label recommendations regarding dosing intervals while vaccine supply was still limited. Are there too many physicians on NACI? Is NACI too heavily influenced by public health specialists? There are 16 members of NACI, including 13 physicians. Of the additional 22 liaisons and ex-officio participants on NACI, about half of those are physicians, too. It’s fair to say, physicians are heavily engaged and influential when it comes to the guidance developed by the committee. Moving past the initial phase of the pandemic and the introduction of vaccines, Dr. Njoo acknowledged that NACI struggled, as did others, with defining and communicating about full vaccination, waning immunity and unproven concepts like hybrid immunity. Diving deeper into the kinds of physicians that populate the NACI roster, more than half have public health specialty training. Many work directly for various governments in a public health capacity. Most of the non-physician and ex-officio participants have a public health background as well. The focus of public health is broad, population-level insight and data. “The population is the patient,” says Dr. Donald Vinh, an infectious diseases specialist and medical microbiologist at the McGill University Health Centre, as well as one of North America’s leading epidemiologists. Meanwhile, infectious diseases and other physicians are trained to care for the individual patient. “A public health person has never sat bedside with a patient dying of COVID,” said Dr. Vinh. What makes sense on a population level doesn’t always make sense on an individual level, according to Dr. Colin Furness, an infection control epidemiologist, and assistant professor in the Faculty of Information at the University of Toronto who also holds a status cross-appointment to the Institute of Health Policy, Management and Evaluation at the Dalla Lana School of Public Health. As the pandemic moves, at least according to government and public health officials, out of an acute phase and toward a more endemic stage, vaccine guidelines, too, could move away from broad, population-level broad guidance and toward individual, informed decision-making. Dr. Melinda Wharton, associate director for Vaccine Policy for the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention described an immunization advisory group like NACI as an “orchestra and you only have to play one instrument.” It’s possible, though, that a lot of people are playing the same instrument. After all, no one wants to go to the symphony and only hear the brass section. It could be time for NACI to consider adding experts from other fields such as sociology, behavioural economics and communications. How was/is NACI different from other jurisdictions? NACI is Canada’s national immunization technical advisory group (NITAG). Other jurisdictions have their own NITAG. In the U.S., it’s the Advisory Committee on Immunization Practices (ACIP), which is a part of the Centre for Disease Control (CDC). The chair of NACI sits on ACIP as a liaison representative. The acronyms alone are dizzying. One key difference between NACI and ACIP is the establishment of a standard of care. NACI’s guidance is non-binding. Provincial and territorial governments can choose to disregard it at their sole discretion whereas there is a “stronger expectation in the United States that ACIP recommendations will be implemented as written,” according to Dr. Wharton. One reason for this, as she noted, is that ACIP recommendations do not deviate from the guidelines from the American drug regulator—the FDA. It seems NACI has greater freedom to operate in its deliberations given the non-binding nature of its recommendations. In the COVID context, this played out with NACI and ACIP having different recommendations at different times. Dr. Wharton explained that the “approach in the United States allowed more liberal use of vaccines” because of the desire of the FDA and ACIP to provide “optimum protection.” This relates to another key difference—cost. ACIP pursued an “optimum protection” strategy with vaccine eligibility in the U.S. because the federal government there paid for vaccines and the vaccine program for children, patients within Medicare, and, in part, for patients within Medicaid (and still does). Beyond those groups, they require through legislation that private insurers pay for vaccines recommended by ACIP. When cost wasn’t an issue for public health officials, or the American states administering the vaccine program, eligibility was broader. The Canadian experience was different, particularly after the initial phase of limited supply. NACI’s role shifted in February 2022 when PHAC and the Council of Chief Medical Officers of Health officially moved “away from the crisis phase” in order to “rebalance our collective efforts towards a more sustainable approach to long term management.” One need not be a healthcare historian to know that when government officials (who report into political Ministers of Health and Premiers) use the word ‘sustainable,’ it almost always means cost—either economic, political or both. NACI explicitly stated that its recommendations from that point forward would work “to minimize serious illness and death while minimizing societal disruption as a result of the COVID-19 pandemic.” Put in context, two key matters were unfolding during that time. First, a so-called “Freedom Convoy” of people arrived at various federal and provincial government buildings and border crossings to protest, among other things, any form of COVID-19 restrictions by using parked trucks and other tactics. It was a massive and divisive political storm that created fault lines that will reverberate for years to come. Within weeks, nearly every provincial or territorial government removed all remaining public health mitigation efforts related to COVID. Second, NACI began considering economics (i.e., cost-benefit) as one of its programmatic factors. According to PHAC, it was only in 2019 that NACI’s expanded mandate was fully implemented, including the consideration of ethics, equity, feasibility, acceptability and economics. The manner in which the first of those four factors, namely ethics, equity, feasibility, acceptability, were considered by NACI was only published in August 2020. The manner in which the last factor—economics—was to be considered by NACI was published in February 2022. Why was consideration of economic factors only added in February 2022, notwithstanding NACI’s lengthy history? The answer seems to come down to cost. PHAC confirmed that, “throughout the COVID-19 pandemic, evaluation of economic evidence by NACI has not been necessary due to up front federal investments in pandemic vaccines to keep Canadians safe.” PHAC also confirmed that consideration of economic issues was added into NACI’s deliberations at the request of the provinces and territories. It also turns out economic factors were unique to NACI at that point. Dr. Wharton confirmed that ACIP has not been doing economic cost-benefit analysis throughout the COVID-19 pandemic because the information was so uncertain. It seems that as soon as the provinces and territories started to face the financial and political consequences of the COVID-19 pandemic, they were able to influence NACI’s scope and terms of reference with a view to potentially narrowing their vaccine recommendations. One of the mechanisms to exert such influence on NACI may have been a special advisory group, confirmed by Dr. Njoo, consisting of the provincial and territorial Chief Medical Officers of Health that discussed recommendation with NACI before they were formalized. Is NACI political? Dr. Njoo was clear that NACI “makes recommendations in a neutral fashion,” follows clear terms of reference, detailed programmatic factors, and “tried and true” vaccine principles. While NACI was lauded by Dr. Furness for providing “expert appraisal of emerging evidence,” there are some questions about the adequacy of that evidence, as well as the influence of government. Dr. Njoo acknowledged making decision based on “rapidly evolving science.” Dr. Wharton was more blunt. She said, “decisions have repeatedly been made with very limited evidence.” While that was inevitable during the initial phases of the pandemic, the flow of research and real-world data now available to NACI is vast. Nevertheless, NACI’s focus has only been on the acute respiratory issues associated with COVID-19, according to Dr. Vinh. He opined that if NACI’s focus was and is only on acute respiratory illness, it missed, and will continue to miss, information about long COVID sequalae, blood clots, strokes and heart attacks. Dr. Furness agreed with this assessment, stating, “if you see COVID as a respiratory disease, you’ve lost the plot.” Rather, said Dr. Furness, COVID is a multi-system, vascular disease that only begins with an acute respiratory illness. The result of the influence of the cost of vaccine programs may have resulted in a problematic blend of politics, economics and science, according to Dr. Furness. He worries that the accountability of NACI members to government could subtly undermine their oath to their patients and their professional identity. One example is that NACI won’t recommend children ages five to 11 receive a bivalent booster dose if that child has already had a monovalent booster over six months ago (unless that child has underlying medical conditions that place them at high risk of severe illness due to COVID-19). Meanwhile, that same child could drive down to the U.S. and obtain that bivalent booster even if they had a monovalent booster two months ago. Dr. Vinh is perplexed by that situation, calling it the “epitome of ridiculousness” and lamented barriers to public health being placed by public health themselves. Dr. Vinh would like to see a model consistent with other vaccine programs now that vaccine supply is no longer an issue. He believes NACI restricting eligibility no longer makes any sense—unless “perhaps they are incorporating more politics than they should.” Dr. Vinh favours getting vaccines out of vaccine centres and instead into medical provider’s offices in a more traditional model. Medical providers should be educated by NACI and others to provide accurate, reliable information to patients who can make their own informed decisions. In that model, NACI could make recommendations to the public on who should be immunized instead of using the current model that, in conjunction with the provinces and territories, ends up, de facto, excluding people from eligibility. What about long COVID? The focus of NACI on preventing serious illness and death while minimizing societal disruption is too narrow, according to Dr. Vinh, and it’s presenting a huge problem. Long COVID is a complication of disease and nothing is being done to prevent it, which astounds Dr. Vinh. “Prevent complication of disease—that is the core of being a physician,” he said. There is undeniable and mounting evidence of the symptoms of long COVID. Just recently, a CAMH study confirmed ongoing brain inflammation associated with long COVID. Moreover, Canada’s chief science advisor, Dr. Mona Nemer, said long COVID has the potential to be a “mass disabling event,” and it already affects about 10% to 20% of those who get COVID-19. "Some patients have not recovered two to three years after the initial infection, and it is uncertain whether a proportion may ever fully recover,” said Dr. Nemer. She noted that common symptoms include memory loss, blurred vision, mood disorders and potentially irreversible cellular changes observed in aging or in some neurodegenerative disorders. Dr. Njoo agreed that the current vaccines are good at slowing down, containing and reducing transmission, as well as reducing morbidity and mortality, while acknowledging there is, “a lot we don’t know about Long COVID.” He also acknowledged long COVID as an area where there is a difference between individual care and population health. Likewise in the U.S., “long COVID has not been a major part of our deliberative process. It just hasn’t,” said Dr. Wharton. Dr. Vinh raised concerns about this approach, or lack thereof, to long COVID. “It is across the age groups and a high frequency of people. It is a consequence of infection. The only way to prevent it is to prevent infection. NACI needs to play a role.” “You can’t prevent long COVID if you’re only trying to prevent serious illness and death,” said Dr. Furness. He reiterated that an exclusionary, restrictive vaccine policy with a narrow understanding of COVID and a narrow focus on preventing only serious illness and death, will lead to greater transmission and greater rates of long COVID. Dr. Furness wants NACI to avoid the sentiment now popular among politicians, and the public health officials that report to them, that it’s time to simply stop talking about COVID. Such a directive is political in nature. “Not talking about COVID is the best way to get re-elected,” said Dr. Furness. “We’re not vaccinating enough.” Instead, Dr. Furness would like to see NACI use their knowledge and data not to be an activist themselves but rather to enable activists. Note: We sought comment from the Council of the Federation—the committee of all the Canadian provincial and territorial premiers—for this article but they declined. We also sought comment from the Ontario Ministry of Health, who referred the inquiry to Public Health Ontario, who, in turn, referred the matter to the Ministry. Inquiries to NACI and its members were referred to PHAC. Matt Maruca is a lawyer, communications expert and consultant. He is also an expert in physician compensation and spent a decade as a senior executive of a major medical association.

Whither NACI: What’s driving the committee’s ongoing decisions on COVID?

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