Niall Conroy: Vaccine rollout will be a once-in-a-lifetime endeavour – we must get it right

Vaccinating the population is no straightforward task – we need logistics-heavy taskforces and must value public health expertise and convince sceptics

The EU has made a deal to procure 1.4 billion doses of vaccine, but low-income countries must have access to the vaccine for ethical reasons, as well as the self-interest of richer nations. Picture: Getty

We are less than one year into a global pandemic. There have been 60 million cases and 1.5 million deaths. Millions more have been hospitalised, with many of these patients spending time in intensive care units. The global economy has taken a battering and society has ceased to function with any sort of normality.

This pandemic is the real deal. Its march has been relentless. But if the ability of this novel coronavirus to penetrate every corner of the globe in a matter of months was impressive, our response has been extraordinary.

Since we saw the first cases in February, there has been an unprecedented mobilisation of scientific expertise. Global collaborations have given us three solid vaccine candidates, with many more in the pipeline and a number of proven treatments for hospitalised Covid-19 patients.

The ability to cut through red tape and perform large-scale clinical trials over a period of months is in stark contrast to the meandering bureaucracy that normally characterises the scientific process. Years became months and months became days. Hydroxychloroquine didn’t work. Remdesevir did. Steroids helped a subset of very ill patients. This wasn’t esoteric academia. Lives were saved because scientists, clinicians and regulators have been focused and flexible in a way that we have never seen before.

Perhaps the biggest scientific breakthrough of the pandemic has been the news that three vaccines have shown good efficacy in clinical trials, and will likely be rolled out in the coming weeks. Of course, we are yet to see the raw data. Science by press-release has been a feature of this outbreak, and we are yet to receive anything more formal than a media statement from any of the vaccine manufacturers.

If the information being provided is accurate, however, we could be on the receiving end of a vaccine that is anywhere between 70 and 95 per cent efficacious in the New Year. Vaccine rollout is likely to be the biggest story of 2021 and will take an enormous amount of collaboration to make it work. This will be a once-in-a-lifetime endeavour.

The light at the end of this particular tunnel is a population that will be immune to Covid-19. We’ve been hearing lots of reports describing “vaccine efficacy” of 70 to 95 per cent. That is a very attractive proposition. In reality, this could mean that up to 95 per cent of those people who are vaccinated would be protected from Covid-19. The small number of people who weren’t protected would be surrounded by a community of immune people, which would keep them safe. This would facilitate a return to at least a near-normal and would allow our most vulnerable citizens to get on with their lives.

But, however tantalising this prospect might be, it’s not a world we’ll be inhabiting anytime soon. The logistic obstacles and the supply bottle-necks are likely to mean that we’ll see a tiered response, with the elderly, vulnerable and essential workers at the top of the queue.

While vaccinating the population might seem like a straightforward task, it is anything but. Vaccine transport and storage is difficult at the best of times. Governance is strict and refrigeration rules are tight. The first challenge, however, will be lack of vaccine. Vials will be drip-fed to us in stages. The fact that a country might start a rollout programme in December or January doesn’t mean that vaccines will be accessible to most people in the near future.

The European Union has made a deal to procure 1.4 billion doses of vaccine from various manufacturers. That means Ireland should have more than enough to vaccinate the entire population several times over. The problem with those numbers is that most of these vaccines only exist on paper. Vaccine manufacturing is slow, complex and costly. It’s difficult to imagine most of the Irish population being vaccinated before late 2021. Vaccinating the most vulnerable in society, however, as well as those most likely to infect them, should allow many aspects of life to return to normal before then.

From a technical perspective, how normal our lives might become and how soon that happens will depend on more than the efficacy of the vaccines. A big unanswered question for those of us who manage outbreaks for a living is how effective these vaccines are at preventing transmission.

In an ideal world, a vaccine would not only stop people from becoming unwell with Covid-19, it would completely protect them from infection. If a vaccinated healthcare worker, for example, can still carry the virus in their nose and throat, then they could potentially pass it on to others, though they may not become unwell themselves. Ultimately, when enough people are vaccinated, this would not be a huge issue, as passing the virus on to others who have also had the vaccine is unlikely to cause harm. But in the early stages of any vaccine rollout, transmission chains may persist if vaccinated patients can become asymptomatic carriers. This will be an important piece of the puzzle to unravel.

Efficacy and effectiveness at stopping disease or transmission become less relevant if enough people decline vaccination. Most public health professionals have some concerns around vaccine uptake. Protecting 90 per cent of the population is an attractive proposition. Protecting 90 per cent of the 50 per cent who opt to take the shot is less appealing.

Managing communications and public education around vaccine rollout will be a big task, and one that’s filled with potential potholes. Many people will have concerns that these new vaccines have been “rushed through” or that they’re based on new vaccine technology.

It’s true that vaccines have never been produced in such a short timeframe before. It usually takes ten years or more. But those ten years are not spent examining the vaccine in fine detail. The norm is not a decade-long deep-dive into the efficacy and safety of a new product. Much of this time is usually spent caught up in bureaucratic wrangling with oversight groups, which may meet only a handful of times each year. It’s spent trying to organise recruitment of volunteers, which is no small task when your vaccine candidate doesn’t have the profile that Covid-19 does. Vaccine trials are split into different phases, which further delays them. After each phase, a decision is made on whether to continue to the next phase. Only when each phase is complete do we even start producing vaccine and planning for the next.

During Covid-19 vaccine development, governments supported manufacturers by funding advance production of vaccine. Because of this, they could start working to generate a supply while still in the early stages of trials. This, along with being put to the top of the queue for regulatory review, has taken years off the production process.

People are also concerned that these vaccines are new, and that we haven’t had a chance to assess any long-term side-effects. This is true, but people can be reassured by the fact that the vast majority of vaccine side-effects happen very quickly. So far, the information we have suggests there have been low numbers of adverse events in these trials, which is very reassuring.

But we can’t say that these vaccines won’t be risk-free. Public health interventions like this a involve a balance of risks. There is a choice between taking a very small calculated risk with vaccination and trying to co-exist with a virus that has no interest in co-existing peacefully with us for the foreseeable future.

As vials of vaccine arrive into the country, the real challenge will be equitable distribution. Some of these vaccines need to be stored and transported in conditions that are colder than winter in the Arctic. Normal vaccine fridges are designed to keep vaccines somewhere between 2-8⁰C. This means there will be difficulties in vaccinating people through their GP surgeries. This is a particular issue with the Pfizer vaccine. The Oxford/Astra Zeneca candidate is more stable in normal temperatures, but might be less effective. The Moderna vaccine occupies the middle ground, needing very low temperatures for transport but it can be stored in a normal fridge for 30 days.

In healthcare, we make decisions about trade-offs all the time. But availability will dictate vaccine choice initially, and we will need to be ready to distribute whichever one arrives. In all likelihood, we will receive a mixture of all three vaccines, with the Pfizer one arriving first. Others will be added to that mix in the coming months as they are approved.

The US has been working for many months on an impressive logistics plan to deliver vaccine to all corners of its nation quickly and efficiently. Theirs is the one to beat. The Irish vaccine taskforce is finalising its rollout plan, with a view to being ready to begin vaccination shortly after the first vaccine is approved by the European Medicines Agency.

It is unclear at the moment how much public health and general practice, the two reservoirs of expertise in this field, will be involved in the project. But government would be well advised not to push experience and practical knowledge aside in the search for efficiency. Transport, refrigeration and delivery are important, but so is communication, safety and education. Our public health teams excel in the latter three areas. Lorries, couriers and fridges are important. But they don’t talk to the public, they can’t monitor vaccine safety, and they won’t reassure the vaccine-hesitant.

The very quiet elephant in the room for those looking at the big picture is the question around global access to vaccines. Simply inventing a vaccine against a particular disease is no guarantee that it will make its way to some of the most deprived regions of the globe. Having spent a considerable amount of my career working in low-income countries, I have witnessed more children die from vaccine-preventable diseases than I care to recall. Tetanus and measles stick in my mind as two truly awful diseases, and children are still dying from both with alarming regularity in poorer regions.

Considering that the tetanus vaccine was first used during World War II and that the measles vaccine has been available since the 1960s, my concerns about the likelihood of people in rural Sierra Leone or Somalia accessing Covid-19 immunisation are understandable. Many low-income countries report that, with the vaccine deals currently in place, they will struggle to vaccinate 5 per cent of their population. The vaccines that the European Union has pre-ordered for its members would be sufficient to give the first dose of vaccine to every man, woman and child in the EU and Sub-Saharan Africa.

This issue transcends simple ethics. Even if you don’t agree that high-income countries have a responsibility to help those less fortunate in the world, self-interest must surely push us to ensure some level of equitable distribution of vaccines. When you think about viral mutations, it’s hard to argue against the need to have the entire planet immunised. The SARS CoV2 virus has been thankfully stable so far. There are about 30,000 parts to its genome, and any two random viruses isolated from Covid-19 cases around the world are likely to differ by just a handful. This is important, because any mutations in the virus’s genetics could make vaccines less effective against it, or could make it more lethal.

Why is this relevant to the question of vaccines in low-income countries? Well, one of the ways that viruses mutate is by jumping species, such as when human-to-animal or animal-to-human transmission occurs. This is much more likely to happen in poorer parts of the world, where live animal markets are common, and people are more likely to live in close proximity to animals than they are in the west. This virus is less likely to mutate than others, but we do know that SARS CoV2 has infected several animals already. We’ve seen it in domestic cats and dogs, and even in a tiger. There was a close-call when it infected mink in Denmark.

Allowing Covid-19 infections to burn through communities in remote corners of the globe could plausibly lead to mutations that might stall some of the progress we’ve made in fighting this virus so far. Ensuring that every person in every country has access to the vaccine is the best way to protect smaller countries like Ireland in the long-term.

For many people, Christmas is the most exciting time of the year. But this time around it might just be the curtain-opener. I, for one, am filled with optimism about the prospect of vaccination in early 2021. It would take some real pessimism to focus on the potholes in front of us, instead of the new road ahead. A cautious sense of hope is what’s needed now.

Vaccination provides our best chance of returning to some sense of normality. But the only real way forward is to work together. Yes, we need the logistics-heavy taskforces, but we must value the public health expertise. Make vaccination quick and easy for those who want it. Give time, space and support to those who have concerns. Make sure everyone gets the opportunity to be vaccinated, and extend that opportunity to the global community.

By taking small steps together rather than leaping as individuals, we will realise the real value of vaccines: safety in unity.

Dr Niall Conroy is an Irish consultant public health medicine physician working in Queensland, Australia