Bengaluru: “Very few people can produce it at this cost, this scale and this speed.”
This, as Adar Poonawalla told the New York Times for a profile the American newspaper ran of the CEO of Serum Institute, the world’s largest vaccine manufacturer, is the company’s principal advantage.
While a gradual trickle of vaccines are entering the final stages of clinical trials, and a plethora of drugs are being tested and often being awarded ’emergency use authorisations’, manufacturers are staring at a gamble.
Either they make plans early to enter the market as soon as they can – even before they know if a given vaccine will prove to be safe and efficacious – and have a chance to set their price, or enter the market late, saddled with fewer risks, and also potentially lower profits.
To make this decision easier as well as to ensure their respective citizens won’t face a supply shortage, American and European governments have promised vaccine-makers billions of dollars to offset potential losses. Most recently, as Reuters reported on July 31, “The US government will pay $2.1 billion to Sanofi SA and GlaxoSmithKline Plc for COVID-19 vaccines to cover 50 million people and to underwrite the drugmakers’ testing and manufacturing.”
The Indian government itself hasn’t announced any such schemes, although the Indian Council of Medical Research (ICMR), the National Institute of Virology and other notable government bodies at the forefront of the country’s COVID-19 response are already working with Biocon Limit and Bharat Biotech – two major drug-makers – to catalyse tests and, potentially, production.
However, the New York Times also reported that India’s Serum Institute is uniquely positioned because it is rich and isn’t beholden to shareholders. As a result, the reporter Jeffrey Gettleman wrote, “It can make decisions quickly and take big risks, like the one it’s about to, which could cost the family hundreds of millions of dollars.”
Poonawalla’s most prominent bet right now is a coronavirus vaccine being tested by researchers at the University of Oxford. This vaccine, currently designated AXD1222, is currently undergoing clinical trials in the UK, South Africa and Brazil. According to results of the phase I and II trials, published in The Lancet on July 20, the vaccine candidate appears to be safe and provoked a significant immune response in trial participants.
While this is encouraging, only the results of the phase III trials will determine the eventual fate of the vaccine – as well as of the investments of companies that have signed deals to manufacture and distribute it in different regions.
The biggest of them is AstraZeneca, which, the newspaper reported, has signed deals worth upwards of $1 billion to sell the vaccine in the US and Europe, and some other geographies. Another of these companies is the Serum Institute, and its CEO Poonawalla has said his company’s ability to quickly scale production while keeping costs low is a key advantage.
Even so, given the risks involved and the lack of state protection, Poonawalla said he’s “70 to 80 percent” sure AXD1222 would pan out but also hoped “we don’t go in too deep”. This depth, he has estimated, is currently about $450 million, or Rs 3,372 crore.
India has had an uneven history vis-à-vis vaccines. As Y. Madhavi, a senior principal scientist at the National Institute of Science, Technology and Development Studies, New Delhi, and a vaccine policy expert, wrote for The Wire Science on April 29 this year:
“As it happens, vaccine development and production has been one of India’s strengths for over a century, and the public sector has ensured we have been self-reliant and cost-effective. However, these enterprises were undermined by globalisation, and we began to depend more on imports. At the same time, privatisation increased our immunisation cost and facilitated the backdoor entry of frivolous vaccines.”
Indeed, the lack of government support for vaccine self-reliance has been a thorn in the country’s side, as exemplified by the case of the Central Research Institute, Kasauli; the Pasteur Institute of India, Coonoor; and the BCG Vaccines Lab, Chennai – which were suspended for not following good manufacturing practices by the same ministry that, as Madhavi wrote, was responsible for facilitating their compliance. These labs were reopened in 2012 but not before their closure triggered a vaccine shortage that the government decided to meet in the intervening years by increasing imports. Madhavi continued:
“Adar Poonawalla, CEO of the [Serum Institute in Pune] stated on NDTV on April 27 that his company has stopped producing some other vaccines to free up capacity for a COVID-19 vaccine being tested with the University of Oxford. What if any of those vaccines were important to protect against some of the more deadly diseases affecting Indians?”
But even as the Serum Institute, Biocon Limited and Bharat Biotech have stepped in to both solve an important problem – i.e. COVID-19 mortality – and cash in, this public-private skew within India is reflected at the global scale by vaccine nationalism, a simple phenomenon that precipitates a variety of consequences. For example, as Usha Raman wrote for The Wire Science, for its August 1 report on bioethics during the pandemic,
“B.R. Shamanna [– a public health expert and epidemiologist at the University of Hyderabad –] also warned of what has come to be called ‘vaccine nationalism’, falling into a competitive mindset that frames vaccine development as a “race” that will be “won” by the country that puts most resources into the game at the earliest stages.”
This said, a more raw form of nationalism has also been in evidence. For example, on July 2, ICMR director-general Balram Bhargava issued a controversial letter asking institutes participating in the clinical trials of a vaccine candidate developed by Bharat Biotech to conclude their tests, deliver the trial data and manufacture the vaccine by August 15, India’s Independence Day. As Vasudevan Mukunth, editor of The Wire Science, wrote then:
“Since a vaccine’s entry into the healthcare system depends on the results of [phase III] trials, researchers usually perform them with large cohorts of participants – typically in the thousands – and over many months, allowing themselves room to check for rare and/or delayed side-effects as well. This is why Dr Bhargava’s, and by proxy ICMR’s, decision to conduct human clinical trials as well as manufacture the vaccine in a span of five weeks on the assumption that the vaccine will work without any modifications raised questions about whether science is in command or politics.”
Shamanna himself told The Wire Science in Raman’s report, “Of course, in such a situation, decision-making has to be relatively quick, yet scientific integrity has to be maintained.”
Ultimately, as Gettleman wrote, “Mr Poonawalla said he felt an obligation to take this risk. ‘We just felt that this was our sort of moment,’ he said.”