Early or Late?

The Serum Institute in India aims to manufacture over 1 billion COVID-19 vaccine shots in 2021. This would be almost half the supply manufactured on the planet. Have you ever heard of the Serum Institute? What got them to this leading position?

The Serum Institute was started by Cyrus Poonawalla in the 1960s. He set it up in 1966 to turn his family’s aging race horses into living bioreactors. He realised that a stud farm had ‘no future in the socialist India of the time’. He tried to design a sports car, before deciding that there was much more promise in selling drugs to the masses, rather than products for the elite. The family’s horses were being donated to a government institution for manufacture of serums; Poonawalla figured he could do it himself. So the company started making tetanus vaccines, followed by vaccines for diptheria and whooping cough, and then snake anti-venin.

In 1994, Serum Institute was accredited by the World Health Organisation to export vaccines from India, and started supplying high quality vaccines to U.N. Agencies such as UNICEF (United Nations Children’s Fund), PAHO (Pan American Health Organisation). By 1998 Serum Institute was exporting vaccines to over a 100 countries and by 2000 one out of every two children in the world was vaccinated by one of their vaccines.

From the inception, Dr Poonawalla’s primary concept was not only to make life-saving drugs and vaccines, which were in shortage in the country, but also to see that every child was protected – his dictum was “Health for all by 2000 AD”. The resultant effort was the Indian National Program of Immunisation, largely dependent on the vaccines manufactured by Serum Institute. His philosophy has proliferated worldwide to U.N. agencies.

Bill Gates has put considerable money into the Serum Institute for them to develop and provide vaccines to less well off countries, including:

  • $1.9M in 2012 for HPV vaccines (prevention of cervical cancer)
  • $15M in 2014 for pneumonia vaccines
  • $150M for COVID vaccines in 2020

Serum Institute also has a longstanding relationship with Oxford University and Novovax, developed during the ongoing quest to find a vaccine for malaria, which kills the most people in the world of any disease annually.

The Serum Institute’s experience, facilities and relationships put them in an excellent position to move on COVID-19 vaccines. However, to me, the most critical matter was that they did move, while others were wondering which way to go. In April 2020, Adar Poonawalla (who took over the business from his father) and Cyrus, had a conversation in which they decided to take a punt on the Oxford/Astrazeneca vaccine and start ramping up their production capability to deliver the vaccine at scale, should it be successful. That was no small punt. The vaccine had yet to start any clinical trials, so there was no certainty of success. In less than a year the Serum Institute doubled their production capacity for this type of vaccine; building on their forward thinking mentality where, each year, they have built a new building and kept ahead of production demands. Their forward thinking ability has put them in a position to make an unmatched contribution to the capability of the world to get control of COVID-19 in the nearer term, and will also, no doubt, put them in a good financial position.

The Serum Institute didn’t only bet on the Oxford/Astrazeneca vaccine. They picked three others, for which they are ramping up production. The others are Novavax, Codagenix and SpyBiotech. In January, Novavax announced its vaccine had achieved 89.3% efficacy in Phase III trials, including trials in the UK and South Africa, against the new variants in each country. Therefore the Novavax investment for the Serum Institute is also likely to pay off.

Codagenix and SpyBiotech remain longer shots at this point in time. Codagenix is in there for the long haul. They are developing a single shot, nasal spray vaccine for COVID-19, with Phase I data due mid this year. COVID-19 isn’t going away any time in the foreseeable future, so they are betting on future purchasers looking for vaccines that only require one shot and are very easily administered – nasal drops will win out over injections. SpyBiotech was spun out from the University of Oxford and is developing a novel, virus-like particle that will target COVID-19 (based on a vaccine platform applicable to many diseases); it is just starting a Phase I/II trial. The advantage of their technology will be its low cost and simplicity of assembly of vaccines.

Serum Institute seems to have it all – huge scale, great business relationships, excellent facilities, forward thinking approach with a pipeline of new vaccines. And they have the ability and will to act promptly and rapidly. Prompt action is something that has been sadly lacking amongst many of the researchers whose proposals I have worked on over the last few months. The large grants that I assist people with take months to years to plan well, and a number of months to write well. Ideally, people are starting the process 6 months before the deadline with an relationships, and facilities, and an idea they have already fermented for some time. However, fewer than 10% of the researchers I have been involved with have acted early or with any apparent sense of urgency. In fact, it’s probably more like 5% early and 95% late.

I, and the support services in research organisations around the country, are bemused by the researchers’ apparently laissez faire attitude. This attitude has been considerably more noticeable in COVID-year. These grants are critical to the researcher’s careers. They run for 5 years, with funding generally in the order of $8 to $15 million dollars total. You might think this worth preparing well, and well in advance. But this is not the case.

A myriad discussions take place each year, pondering what could inspire more urgency amongst researchers. It isn’t forewarning – plenty of that takes place. It isn’t support – plenty of that is available. Perhaps it might be consequences – if people were going to lose their jobs if they didn’t get a grant they might be more incentivised. This is certainly the case at institutional level; if a Crown Research Institute has a large tranche of funding ending in a particular year they are much keener than usual to get people to write grants.

Chris and I are pretty much polar opposites on the prepare in advance front – I prepare well in advance and will start on something due months away if I have spare time now. Chris prefers to leave things until the last minute, and then some, if possible. A big advantage I can see in his approach is that he maintains flexibility. However, a major disadvantage is the degree of stress caused to himself, and those around him, as it becomes clear that he can’t achieve the desired outcome in time, or without assistance.

I think this assistance aspect is critical – many lead researchers seem to act as if they are the only people that matter in the process. The fact that there is a team of 20 people or more involved in a large research grant, who all have multiple calls on their time and cannot be available at the last minute, seems to pass many researchers by. Perhaps the lead researcher does their best work under pressure, but that can’t be said of everyone, and it becomes impossible to involve the multiple necessary parties if time runs short.

I could go on boringly about things like iterations of written documents improving their language and clarity, and blockages being difficult to resolve without time in which to discuss them. However, I may well be preaching to the un- and never-to-be converted, given my estimates of those who like to be prepared versus those who don’t. However, if anyone has insights into how to get those who like to delay, to act, I would love to hear them!

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Published by janecshearer

I'm a self-employed life enthusiast living in Gibbston, New Zealand

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