Can the Delivery of COVID-19 Vaccines Match the Speed of their Discovery?

While it may be little consolation to those who’ve lost loved ones to the COVID-19 pandemic, one positive outcome of the crisis has been the stunning pace at which the immunization process—from sequencing the virus to vaccine discovery to delivery—has been telescoped by health and economic urgency. Dr. Tim Evans, the Executive Director of Canada’s COVID-19 Immunity Task Force, explains.

In the May 2020 issue of Policy, two months into the global pandemic of COVID-19, I outlined several areas of focus to strengthen Canada’s pandemic response. These included: scaled-up testing; procurement of critical materials; the safety of care workers; attention to hot spots like long-term care; and investing in accelerated development of new technologies like vaccines. With indications the first wave was on the wane, there was optimism these measures would flatten the curve and accelerate the re-opening of the economy. Now, in the midst of a much-bigger-than-expected second wave and with a return to lockdowns, it is clear these countermeasures have fallen short. The singular exception relates to vaccine development, where rapid progress is raising hopes amid wider despair.

The world celebrated news of the first recipients of the Pfizer/BioNtech vaccine in the United Kingdom just one week after its regulatory approval. Health Canada has followed suit, approving the same vaccine this week, with a quarter of a million doses scheduled for delivery by year-end. Incredibly, the revving up of vaccine discovery and production has landed us with a 2021 public health challenge like no other in history: how can COVID-19 vaccines be delivered to the majority of the world’s 7.5 billion people?

The story of how we arrived at this grand challenge on vaccine delivery deserves some reflection. As we enter the COVID-19 vaccine era, it is important to note just how meteoric and unprecedented their development has been. In the first 12 months of the pandemic, 12 vaccines have made it to Phase III clinical trials, the final stage of evaluation prior to regulatory approval. This contrasts with the normal industry standard of 10 years for getting a single vaccine to Phase III clinical trials. Within a year of the outbreak, three vaccine candidates are likely to receive regulatory approval, two of which have pioneered a novel approach to vaccination (via messenger RNA, or mRNA). Moreover, as this accelerated vaccine development was taking place, companies were building global production capacity for billions of vaccines. Never has the world witnessed such an abundant scientific harvest on so many fronts in such a short period of time.

While there are countless factors explaining this yield, a few deserve particular attention. First, the complete genetic sequencing of the SARSCoV-2 virus and its placement in the public domain within 2 weeks of the outbreak allowed interested parties, globally, to begin working immediately on vaccine development. One would be hard pressed to imagine a stronger endorsement of the value of open science. As Jeremy Farrar, head of the Wellcome Trust in London tweeted “(this is a)…really important moment in global public health.”

Second, the novel approach common to both of the Pfizer/BioNTech and Moderna vaccines emerges from decades of research on messenger RNA (mRNA). The results from the latephase trials showing up to 95 percent success in preventing infection are rarely seen in vaccine development and the 50 percent threshold of regulatory bodies. Together with very good safety profiles, this breakthrough approach holds boundless promise for application to other infections.

Third, government treasuries took unprecedented risks in backing vaccine development with multi-billion dollar subsidies. In the face of the multi-trillion dollar cost of COVID-19 to the global economy, these subsidies represented an overwhelmingly positive return on investment. Smart

and scaled public financing not only removed financial barriers to vaccine research and development, but also guaranteed, through advance purchase agreements, global production capacity for billions of vaccines well before their regulatory approval.

The manufacturing at scale of unproven vaccines is unprecedented. The Canadian government negotiated these purchase agreements with seven vaccine manufacturers, guaranteeing procurement of more than 200 million vaccine doses for Canadians. These agreements will ensure an adequate market share of COVID-19 vaccines for Canadians in a competitive global market. Further, over-procurement hedges the risk that some of these vaccines will not meet regulatory standards.

Now comes the challenge of figuring out how to vaccinate the majority of Canadians as quickly as possible. The government of Canada has set the ambitious targets of vaccinating three million Canadians by March 2021 and the rest of Canadians by the end of the 2021. This 12-month delivery challenge is no less daunting than discovering and producing COVID-19 vaccines at scale within a year.

Encouragingly, the Public Health Agency of Canada has just issued a COVID-19 immunization plan. Grounded in clear principles with multi-jurisdictional engagement, the plan identifies seven action elements with the overall objective of enabling rapid immunization of Canadians with priority to high-risk populations. Several of these elements are already well underway, such as procurement arrangements for vaccines and their regulatory approval, and the prioritization of the elderly and care workers as the first to receive the vaccines. The recent announcement of “Operation Vector”, enlists the military through a National Operations Centre to ensure timely and efficient distribution of vaccines to the provincial-territorial front lines. All of these elements to strengthen the delivery of vaccines hinge on the choice of individual Canadians to take them.

With politicians eschewing mandatory vaccination, this choice boils down to persuading and enabling those whose lives are on the line “to get in line” for vaccines. While surveys suggest about two thirds of Canadians are willing to get in line, vaccine hesitancy—the reluctance or refusal to be vaccinated—is widespread enough to require pro-active management. Hesitancy is actively fueled by anti-vaccine crusaders who are rampant on social media. Moreover, for informed and misinformed publics alike, hesitancy is refractory to old-style public health messaging of “these are the facts” or “don’t listen to them”. Tailored communication engaging diverse communities with trusted agents deploying an array of media is the way forward. However, generating these strategies rapidly and deploying them at scale requires tapping the best strategic communications minds, social media and community micro-influencers all at the same time.

Beyond effective communication and engagement strategies, the choice to be vaccinated relies on an individual’s confidence that a vaccine is safe and effective. Even with rigorous regulatory approval, safety and effectiveness remain an ongoing concern as vaccines roll out. The early reports of allergic reactions to the vaccine in the UK underline the imperative for ongoing vigilance. Many questions require further study. For example, how long will vaccine protection last? Does vaccinating persons previously infected with COVID-19 pose any risks? Does vaccination prevent transmission of infection? And what about subgroups like infirm elderly, children and pregnant women on whom the vaccines have not been tested?

Answering these and other questions central to vaccine safety and efficacy requires a fit-for-purpose vaccine surveillance system. Ideally, a pan-Canadian vaccine registry in which every person vaccinated is followed-up over time would provide the best and simplest system. Unfortunately, with the delegated responsibility of health to provinces/territories, there is no such unified system in Canada. Instead, monitoring vaccine safety and effectiveness across the country will require aggregating across P/T systems and pulling together a diverse array of purpose-built networks— largely found within the Canadian Immunization Research Network. Repurposing, aligning and mobilizing this patchwork vaccine surveillance system to match the speed and scale of the vaccine roll-out is a tall order but must garner the requisite political and technical attention to sustain vaccine confidence.

The delivery challenge, however, goes well beyond securing public confidence in vaccine safety and effectiveness. COVID-19 vaccines are unlikely to have a significant impact on the trendline of SARS-CoV-2 cases and deaths for at least several months after roll-out begins. As such, good public behaviors such as physical distancing and mask wearing will need to be sustained in order to counter expectations that immunization permits an immediate return to “normal life”. Without active management of these expectations with clear data, new COVID-19 cases during the roll-out may be misinterpreted as a failure of vaccines.

As we look forward to the COVID-19 New Year, therefore, the response must not only seize the opportunity of vaccine delivery but also surmount the second wave! On both of these fronts, the battle’s most valuable resource will remain an informed and engaged public supported to make the best choices for their own and the nation’s health.

Dr. Tim Grant Evans is the Executive Director of the COVID-19 Immunity Task Force and Director and Associate Dean of the School of Population and Global Health at McGill University. He is former Senior Director, Health, Nutrition & Population at the World Bank.