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Moderna and Pfizer vaccine trial results are milestones - distribution poses new challenges

A staff member sets up an antibody production line at the Ibex building of Lonza, where part of the Moderna mRNA Covid-19 vaccine will be produced, in Visp, Switzerland, October 6, 2020. Credit: Keystone/ Olivier Maire

News that vaccine candidates of both Moderna and Pfizer were 95 per cent effective in protecting people against Covid-19 is a huge milestone, but the logistics and fair distribution of vaccines to the world’s population remains an equally huge challenge.

Just this week, both Moderna and Pfizer have unveiled results from massive clinical trials indicating that their Covid-19 vaccine candidates is not only safe - but also 94-95 per cent effective in preventing the disease. Almost as important has been news that the Pfizer vaccine, developed jointly with BioNTech was 94 % effective in preventing Covid infections among older people, who are much more vulnerable to the disease. Both companies are now poised to ask the United States Food and Drug Administration for emergency use authorizations, meaning vaccines could begin distribution as early as next month. But this is only the beginning of a long road to actually getting the vaccine into the hands of people around the world. And due to the huge logistics and financial challenges involved, vaccine rollout could very well prove to be even more challenging than the research. Here are some of the brighter signs and more difficult ones on the horizon.

Moderna’s vaccine is particularly good news for low and middle-income countries. The vaccine can be stored at 2 ° to 8 ° C (36 ° to 46 ° F) for up to 30 days, for longer at around -20 C ° (-4 F °). This, in comparison to Pfizer's vaccines which needs ultra-cold storage temperatures of -70 C ° or below. That makes Moderna’s vaccine much more accessible to developing countries with limited cold-chain capacity - and even to rural regions of high-income countries.

‘No patents enforcement’. Another bright spot is the fact that Moderna has already pledged “not to enforce our patents” on its Covid-19 vaccine for the duration of the pandemic - meaning that generic vaccine manufacturers could also step in very soon after the vaccine is approved by regulatory authorities to support massive production. The company also has said that it is on track to manufacture 1 billion vaccine doses in 2021 in collaboration with the Swiss-based manfacturing firm Lonza, at sites in the USA and Visp, Switzerland.

The hurdle of fair distribution. Even so, the world still faces huge challenges ensuring a fair allocation of the first vaccines to the most vulnerable groups around the world - particularly health care workers.

Adding to the anxiety of low and middle income countries is the fact that rich countries have already snapped up huge quantities, if not the lions share, of next year’s projected vaccine supply from Moderna and Pfizer, as well as other companies with front-running vaccine candidates in final stage trials.

In the case of Moderna’s vaccine, for instance, high income countries have already made pre-orders for some 300.5 million doses, and have options to purchase another 480 million more - for a total of 780.5 milion out of the 1 billion doses to be produced in 2021. Countries with large pre-orders and options include the United States, the European Union, Canada, Switzerland and Japan.

That would mean up to 78 per cent of Moderna's available vaccine supply would go to countries representing just 12 per cent of the world's population, as a coalition of NGOs recently pointed out.

What about COVAX? The WHO co-sponsored COVAX facility procurement network facility that now includes 186 countries, aims to secure and distribute sufficient doses to immunize health workers and at-risk populations globally by pooling large vaccine purchase orders to pharma.

Speaking at a WHO press conference on Monday, WHO officials would only say that Moderna had been in discussions with COVAX about channeling supplies to the procurement pool. Charlie Weller, head of vaccines at The Wellcome Trust, indicated that the company had gone further.

“Moderna's vaccine is part of the COVAX Facility, which will be instrumental to ensuring any effective vaccines are prioritized for those most in need globally,” said Weller.

The fact Moderna has already pledged “not to enforce” its patented mRNA vaccine technology, might offer an opportunity to generic vaccine manufactures to quickly jump into the act and ramp up vaccine supplies even further. But in contrast to most drugs, vaccines are technically much more complex to produce; it remains to be seen if the pharma company would expedite the development of copycat versions by actually licensing its technology and trade secrets to generic manufacturers.

And this has led civil society groups such as the UK-based STOPAIDs, to call upon Moderna to do even more. On Monday, the coalition called on the company to:

"Openly share their vaccine technology so doses can be produced at needed scale, at the lowest possible price."

The coalition also noted that Moderna received some US$ 2.48 billion in United States government public subsidies, and yet its reported price tag for the two-dose vaccine at $US 50-60 per course is the "highest cited for a potential vaccine so far."

Logistics the other hurdle. And once the manufacturing bottleneck is resolved somehow, there is remains yet another, equally big concern. That is logistics. That is the challenge of getting any vaccine rolled out at the high levels of coverage required to generate “herd immunity” - from the steppes of central Asia, to rural Africa and Latin America, as well as conflict zones in the Middle East and elsewhere. Additionally, since most of the world’s vaccine campaigns are aimed at children, working with adults in hard-to-reach communities, including ones that are vaccine-skeptic, will be a whole new experience even for experienced vaccine campaigners. Said Weller:

“It is critical that we urgently and decisively work on the wider issues of Covid-19 vaccine allocation and delivery. Overcoming the logistical hurdles ahead will take unparalleled levels of global collaboration.”

… And a “One Dose” vaccine would still be a lot better. Due in part to the logistics challenges, as well as the limits of manufacturing capacity and associated costs, neither the Moderna nor the Pfizer vaccines are really ideal - because they require two doses to induce immunity. So, even if generic copies of the Moderna vaccine quickly do become available, opening up the feasibility of worldwide distribution in low- and middle income countries, other vaccine candidates, still in the pipeline, could yet prove to be a better bet for much of the world’s population. As Katherine O’Brien, head of WHO’s department of immunization, vaccines and biologicals, put it bluntly:

“This is a two-dose vaccine, and certainly any vaccine that achieves [immunity] at one-dose is going to be easier to deliver than a two-dose vaccine.”

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An earlier version of this article was first published on Health Policy Watch

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