2 billion vials. Public acceptance. The obstacles to vaccine delivery
While global focus is on the race to develop a COVID-19 vaccine, little attention has been paid to the obstacles that may come after.
Previous research on other coronavirus vaccines such as SARS and MERS has helped accelerate the development of a COVID-19 vaccine and early promising results from clinical trials have raised hopes that we can return to normal life in the near future.
However, while speed in laboratory research and clinical trials has drawn most of the media and the public’s attention, the infrastructure to manufacture and distribute the vaccine, its costs and availability and the need to educate the public require planning and organization from all levels of government.
Something as simple as glass vials may be a significant hurdle to delivering the vaccine. Given that the vials are a critical component of vaccine delivery, alarms have been raised of a potential shortage, especially if distribution coincides with flu vaccine delivery. Manufacturers have estimated that worldwide demand will rise by 1 billion to 2 billion glass vials over the next two years.
European glass manufacturers Stevanato Group, Gerresheimer and Schott issued a statement in June to assure the public that global demand will be met.
The federal government has ordered more than 75 million syringes, alcohol swabs and bandages to be delivered by the end of November so it can inoculate Canadians as soon as a vaccine becomes available. Procurement Minister Anita Anand says Ottawa intends to stockpile enough supplies to give at least two doses to every Canadian.
“We are working to procure supplies, including those syringes, and other supplies that would be needed for the eventual discovery of a vaccine and its administration throughout Canada,” Anand said recently.
Ottawa will ship 80 per cent of what it buys to the provinces as needed, it says. The other 20 per cent will be part of the National Emergency Strategic Stockpile, stored in warehouses across Canada.
Dr. Allison McGeer, infectious disease specialist at Sinai Health System and member of Canada’s National Advisory Committee on Immunization, says Canada does not have the required vaccine manufacturing capability for all of its final finishing. “Although this could be of concern, it’s probably better for us to be part the global partnership making and using vaccine than its for us to rapidly construct a vaccine manufacturing facility that is expensive and quite difficult to do,” says McGeer. “In terms of vials and syringes, it should not be an issue to ramp up production.”
According to the World Health Organization records, in total 165 vaccine candidates have started some form of trials, with 33 of them in clinical trials. Several clinical vaccine trials supported by Health Canada are currently underway across Canada.
McGeer says vaccination probably will be a staged process starting with the elderly in long-term care units and frontline workers.
Defining appropriate risk groups, evidence-based interventions and the importance of local context are factors that will help have to be taken into account. Studies within Canada and worldwide have consistently shown ethnic and racial disparities in vaccination coverage, the ethnic or racial groups at risk may vary depending on the social and epidemiologic contexts at a particular time and place.
Dr. Vinita Dubey, an associate medical officer of health for Toronto Public Health, says the city will have to take a different approach for its flu vaccination delivery this year. Combined with COVID-19 and dangers of transmission, delivery will be more complicated. The agency typically holds clinics at places such as shelters and pharmacies also provide flu shots. This year, it is considering smaller clinics and even drive-thru or at-home vaccinations.
Health Canada has not yet announced plans for delivery. McGeer says it will be hard to draw up detailed plans until we know when and under what circumstances the vaccine will be available.
ACCESSIBILITY AND AFFORDABILITY
More than 5.7 billion doses already have been pre-ordered globally even though none of the vaccines under development has proved its efficacy in clinical trials.
Canada has agreements with four biotech companies for vaccine doses. The federal government announced this week that it has signed deals with Novavax for 76 million doses and Johnson & Johnson for up to 38 million doses of their vaccine candidates.
“Our strategy is to secure agreements with numerous developers of vaccine candidates so that Canadians are well positioned as clinical trials advance among these developers,” Anand said. “Diversification in our vaccine contracts and in our supply is crucial.”
Ottawa previously had reached deals with Moderna Inc. for up to 56 million doses and Pfizer Inc. will deliver at least 20 million doses. In total, Canada has secured a minimum of 88 million doses with options for an additional 102 million doses, Anand said.
The U.S. has provided $9.4 billion in funding to seven vaccine developers and signed manufacturing contracts with five of them to provide at least 700 million doses. It has reached deals worth $1.95 billion with Pfizer and BioNTech to purchase 100 million doses of coronavirus vaccine, among others. The Trump administration’s Operation Warp Speed allows it to acquire an additional 500 million doses from Pfizer provided it has proved effective and secures regulatory approval.
Meanwhile, the European Union already has purchased or is in negotiations to purchase 700 million doses from two developers; the United Kingdom is negotiating it own order for 250 million doses from four developers; and Japan is purchasing 490 million doses from three suppliers.
This raises the question of who the vaccine will belong to among nations or will countries that produce vaccines keep them for their own citizens.
“It would be sad if, for the vaccine for COVID-19, priority were to be given to the richest,” said Pope Francis during a live from his private Vatican library in mid-August. “It would be sad if this vaccine were to become the property of this nation or another, rather than universal and for all.”
Prime Minister Justin Trudeau and other leaders have raised similar concerns. “We cannot allow access to vaccines to increase inequalities within or between countries – whether low-, middle- or high-income,” the letter signed by the leaders states. “A future COVID-19 vaccine can be instrumental in our commitment to achieve one of the key elements in the United Nations’ sustainable development goals: ensuring healthy lives and promoting well-being for all at all ages.”
Under-resourced nations remember the struggle for affordable access to antiretrovirals in the AIDS pandemic. India successfully challenged patents to manufacture antiretroviral generics and the Treatment Action Campaign in South Africa fought for free antiretrovirals. Will time allow for this kind of activism before again?
Most infectious disease experts agree that at least 80 per cent to 90 per cent of the population needs to be vaccinated for herd immunity to occur.
“It depends what level of control we hope to achieve with the vaccination, whether we want to eliminate this versus reduce rate of infection, and also how effective the vaccination is,” says McGeer. “In an ideal world as many people as possible, because that will give the best chance to drive levels down so we can go back to normal life.
“Even if 60 per cent to 70 per cent of the population get vaccinated, we will see a noticeable reduction in transmission. Herd immunity is not an on-and-off phenomenon, it’s a phased progress.”
Efficiency is essential if there is to be public acceptance. The public needs to be reassured that the vaccine is safe and effective and that there is value to being vaccinated.
Infectious disease specialist Dr. Zain Chagla, Associate Professor at McMaster University, stresses that even if the vaccine is only 60 per cent effective, people should think of it as something that reduces the risk of a deadly disease by more than half.
“That’s how people should think of the vaccine,” he emphasizes. “That should be the message we deliver.”
One major concern is the speed of vaccine development. However, McGeer says lab experiments and clinical trials are happening in 24/7 shifts and no safety rules are broken. Some modifications, however, have been made. For example, normally since the efficacy of the vaccine is still unknown, only enough is made for the in Phase 1 trials. But, given the current situation, enough doses are made to include Phase 3 trials. Though it is definitely not cost effective, clearly speed is of the essence.
Dr. Theresa Tam, Canada’s chief public health officer, says Canada will not cut corners to get a vaccine for COVID-19 approved and that safety will not be compromised.
This may be the most important element.
Let’s take a step back and look at the H1N1 pandemic in 2009. Vaccination was available for all Canadians but only an estimated 41 per cent of us aged 12 or older had an H1N1 flu shot. The lowest percentage was in Ontario at 32 per cent. The most frequent reason given, at 74 per cent, was “I did not think it was necessary.”
According to McGeer, the timing of vaccine availability is important as people tend to stop worrying about infectious disease as soon as infection rates start to diminish. Given the impact of COVID and its continued spread, health experts expect a higher acceptance rate this time around.
However, a Gallup poll in the U.S. between July 20 and Aug. 2 indicated only 65 per cent of respondents would take a coronavirus vaccine.
Another factor is that it takes very little to shift demand in the short term. For example, McGeer pointed to 2009 when a child in Toronto died of the flu the day before a vaccine became available. The publicity from the case drove huge demand for a vaccine that the week before had not drawn much interest. At the same time, a rumour spread in Taiwan that the daughter of a high-profile politician had died of the side effect of the vaccine the day before it was offered to the public and demand plummeted.
Health communication experts say they need to lay the groundwork for acceptance now because the flood of misinformation from antivaccine activists has surged. It is estimated that in recent months, 10 per cent of Facebook pages run by people asking questions about vaccines have already switched to antivaccine views.
Keeping in mind the current opposition to wearing masks and social distancing, the baseline hesitancy toward vaccines should prompt early planning.
To that end, the Johns Hopkins Bloomberg School of Public Health in the U.S. has released a lengthy paper on acceptance of COVID vaccinations. Among its recommendations: “Communicate in meaningful, relevant, and personal terms, crowding out misinformation.”
Education and gaining trust of the public will need time and effort. Focus on close coordination with health systems for vaccine availability, accessibility, and affordability further increase chance of public acceptance. This will promote sense of confidence and ownership in public health intervention.
“Doctors are probably not the best people to send messages, giving statistics that are not very familiar to people,” says infectious disease specialist Dr. Sumontra Chakrabarti at Trillium Health Hospital. “We need the help of marketing people who know how to get messages across.”