The vaccine works, but can it be delivered?

Positive trial results for Pfizer’s Covid-19 vaccine are very welcome, but global vaccination will not be easy.

Pfizer (US), one of the world’s largest drugmakers by revenue, and its German partner, BioNTech, have released promising efficacy data on their coronavirus (Covid-19) vaccine candidate. The candidate, designated BNT162b2, showed a 90% efficacy rate over a placebo seven days after a two-dose vaccination schedule was completed.

The positive data is noteworthy for two reasons. The first is that the candidate is an mRNA-based vaccine, a so far-untested and unapproved class of gene protein-based vaccine. The fact that it has been shown to work therefore bodes well for several of the other gene protein-based vaccines currently being developed. The second is BNT162b2’s high efficacy rate; the World Health Organisation (WHO) had previously said it would be satisfied with an efficacy rate of around 50%, similar to an influenza vaccine in seasons when most viruses are well-matched. However, this was an interim analysis of 94 cases of Covid-19 among 43,358 trial participants. Safety data will come up in the next week, but Pfizer has not reported any severe effects so far.

If the safety data is positive, Pfizer’s next step, which it is already preparing for, is securing emergency use authorisation from the US Food and Drug Administration. That will require two months of safety data, which Pfizer expects to have by the end of the month. Approval should be swift if the data readouts continue to be positive, and mRNA technology has the advantage of being quick to manufacture. Pfizer has committed to producing 50m doses by end-2020 and 1.3bn within 2021.

The challenge of distribution

However, even if Pfizer achieves those targets (not a given), that will not be enough. Gavi and the WHO’s COVAX Facility aims to make 2bn doses of Covid-19 vaccines available by end-2021, which it said should be adequate for vaccinating vulnerable and high-risk individuals such as health and social care workers. Various epidemiologists and mathematicians suggest that around 60% of the world’s population will need to be vaccinated for herd immunity. That means vaccinating around 4.7bn people globally, or 9.4bn doses based on Pfizer’s two-dose schedule. Bill Gates, a global health philanthropist, has estimated that we need 7bn doses.

Transport and logistics will also pose a large roadblock to any vaccine distribution programme. Pfizer’s vaccine needs to be stored and transported at minus 70 degrees Celsius, and administered within 24 hours of being thawed. There is widespread concern about whether this will be possible in less developed parts of the world, even if they can afford the vaccine. Gavi and WHO estimate that the current cost to deliver 2bn doses in 2021 is up to US$18.1bn. Their Covid-19 accelerator programme, which aims to give poorer countries the tools to combat the pandemic, has a total funding gap of US$27.9bn as of September 2020.

Based on these estimates, adequate global vaccination will not be possible in 2021 without at least another vaccine being approved. Results from a large study of another high-potential mRNA vaccine by Moderna (US) are expected soon. Moderna’s candidate was the first to begin late-stage testing. Another vaccine candidate by AstraZeneca (UK) and the University of Oxford is already known to trigger a strong immune response in the elderly, a high-risk group. Its results are also due in a few weeks, and both are gene protein-based.

If these candidates prove effective as well, we estimate regulatory approval and production expansion to be swift. However, heavy investment in shipping and distribution will also be needed. Pfizer has already secured advance orders from Canada, Japan, the EU, UK and US for hundreds of doses, while AstraZeneca has preorders for around 1.3bn doses. A few governments are hoping that the vaccine can start being used this year, while a coordinated response by governments and industry could kickstart a full-scale rollout to the general public from mid-2021.

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