Pune-based Serum Institute is the world’s largest manufacturer of vaccines by volume. It has joined hands with U.S. biotech firm Codagenix, its U.S. rival Novavax and Austria’s Themis to potentially manufacture three COVID-19 vaccine candidates.
Apart from developing its own vaccine, one of its biggest projects is plan to mass produce the vaccine to be created by AstraZeneca/Oxford university. This project has garnered garnered global headlines.
The efforts are partly being shepherded by Umesh Shaligram, the head of research and development. His employer is a private company but every day, shortly before midnight, he receives a WhatsApp message from the government asking for updates, and about any new hurdles he faces.
The message is usually from K. Vijay Raghavan, Prime Minister Narendra Modi’s top scientific adviser – an indication of the critical, and even strategically important, nature of the race to develop the vaccines the whole world is waiting for.
Shaligram promptly responds with a progress report and details any bottlenecks.
“Any delays, you just tell them,” said Shaligram, adding the government has been doing everything it can to fast-track clearances, and resolve import delays and other issues.
While most of the attention regarding vaccines typically goes to the pharmaceutical developer, India quietly plays a key role in manufacturing 60%-70% of all vaccines sold globally with the Serum Institute playing a lead role, said the company’s Chief Executive Adar Poonawalla.
Mr. Poonawalla, whose family owns the vaccine maker, said scientists, drugmakers and manufacturers were collaborating at an unparalleled scale to spur development and availability. “We are all in a race to battle the disease, there is no one-upmanship here,” he said.
The United States has secured almost a third of the first 1 billion doses planned for the potential vaccine, initially known as ChAdOx1 and now as AZD1222, by pledging up to $1.2 billion.
Mr. Poonawalla aims to initially produce 4-5 million doses a month, beginning from June, and then gradually ramp up to 350-400 million doses a year.
However, in conversation with ThePrint’s Editor-in-Chief Shekhar Gupta at the digital version of Off The Cuff, Poonawalla said, “For another two or three months, I would urge everyone to completely ignore any vaccine news that comes out.”
The Pune-based company’s CEO explained that all interim reports and media articles coming in are from animal testing or Phase 1 of clinical trials for vaccines. It’s only after Phase 3 trials that efficacy and yields of production can be established.
A vaccine is tested on animals in the pre-clinical stage. During Phase 1, the safety of the vaccine is assessed by administering it to a handful of human subjects. The two subsequent phases increase the number of participants to up to 3,000 to establish if a safe vaccine is also effective.
Poonawalla said the US-based firm Codagenix’s vaccine, which SII has tied up with to manufacture, is exciting because it is genetically modified to offer broad spectrum protection in such a manner that it could likely provide protection even if the new virus mutates significantly.
“So far, there has not been any significant mutation that we think could pose a problem to the existing vaccines under development, but going forward that could change,” he added, referring to the ability of some viruses, like the influenza virus, to mutate so fast that vaccines rapidly become ineffective.
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