Hopes of a coronavirus vaccine are over-optimistic

A group of Israeli scientists working at MIGAL, the Galilee Research Institute, will be able to develop a vaccine for coronavirus in weeks – and have it pass safety tests in just 90 days, it was claimed today. According to Dr. Chen Katz, MIGAL’s biotechnology group leader, the team had been working on a related disease and their breakthrough on the strain of coronavirus behind the current epidemic, COVID-19, was pure luck.

Even allowing for a lucky break this timeframe seems incredible. It took 20 years for the Meningitis B vaccine to be researched, developed, and approved. Even with thirty to forty groups worldwide currently working on a vaccine for COVID-19 experts have been estimating that development and deployment of a vaccine will probably take a year to a year and a half, which would already be a breakneck pace in the world of vaccine development. Finally, even if the Israeli team does successfully develop a vaccine in a few weeks it could be a long time before it becomes publicly available on a mass scale.

Before any new vaccine is released it has to undergo rigorous testing. The first tests are conducted on animals followed by clinical trials on humans, which have three phases. Phase one involves a small number of adults, a maximum of 100, who are administered the vaccine to check there are no serious safety issues and to work out the most effective dose. Phase two sees the test group expanded to a few hundred people and is used to establish if the vaccine functions consistently, as well as any potential side effects. Phase three involves several thousand test subjects to allow for proper statistical analysis of its efficacy. Lastly, with clinical trials over, regulatory boards conduct an expert review of all the available evidence before approving the vaccine.

Once a vaccine has been approved then comes the issue of mass production. While recent breakthroughs mean that viral proteins central to the vaccines can now be produced considerably faster than previously producing vaccines can still be a finickity process. Indeed, the high levels of difficulty, cost, and risk means that many pharmaceutical companies pay little attention to developing and producing vaccines.

Furthermore, the pharmaceutical industry that produces vaccines is no more immune to supply chain disruptions caused by coronavirus than any other industry. Just like any other industry pharmaceutical companies have increasingly outsourced production of vital component parts to companies in China. Now, just like car companies struggling to get the necessary parts from China to assemble their vehicles, biomedical companies may struggle to obtain vital parts for the vaccines. (Other vital medical supplies may also be affected).

Research by the US Food and Drug Administration in August 2019 found that 13% of active pharmaceutical ingredients (APIs), vital for the manufacture of medicines, are produced in China. Wuhan the epicentre of the epidemic, is a burgeoning centre of pharmaceutical manufacturing. While there are other major centres manufacturing APIs– 28% are produced in the USA, 26% in the European Union, and 18% in India – this is still a substantial supply shock at a time of increased demand.

In addition, as the virus spreads globally other manufacturing centres may be affected by quarantines. Countries capable of manufacturing the vaccines may even deliberately prevent their export until they are sure there is a sufficient domestic stockpile, as Australia did in 2009 in reaction to H1N1. The UK, with its large pharmaceuticals sector, may be somewhat less vulnerable but the issue remains deeply worrying.

As the vaccine moves through all these stages of testing, approval, and production, the odds grow that the virus will mutate. Multiple mutations, with different strains emerging in different parts of the world, is also possible.

Professor Neil Ferguson, a disease outbreak scientist at Imperial College London, has stated that the virus’ genetic code shows a slow rate of mutation. Whatever the odds if a mutation does occur it would be a major setback requiring the development of a new vaccine.

Even if and when these hurdles are cleared there is the issue of administering the vaccine. Even the most cursory consideration of the amount of resources needed for a mass inoculation of an entire country’s population, let alone most of the world, gives a sense of the staggering scale of the challenge. The challenge only grows when one realises vaccines are difficult to transport. They have to be kept at consistently low temperatures when transported in order to be effective.

This does not mean that efforts to develop a vaccine are pointless. In an interview with The Evening Standard on Tuesday Professor Peter Piot, Director of London School of Hygiene & Tropical Medicine, expressed scepticism at suggestions that we will have a vaccine before the end of the epidemic. But he did say that a vaccine would be useful “if this becomes a seasonal thing and every year we have a wave (of COVID-19)”.

What it does mean is that, as coronavirus spreads across the globe with 83,307 confirmed infections and 2,858 confirmed deaths, we must be wary of our need for “silver bullets” or magic fixes. Even the most optimistic estimate now puts such a vaccine months away with a substantially longer timeframe seeming likely. A mass inoculation campaign would also be a vast logistical exercise. In the meantime, we can only do our best to contain the virus’ spread and prepare to deal with its inevitable fallout.