Family betting big on vaccine production
PUNE, India — In early May, an extremely wellsealed steel box arrived at the cold room of the Serum Institute of India, the world’s largest vaccine maker.
Inside, packed in dry ice, sat a tiny 1-milliliter vial from Oxford, England, containing the cellular material for one of the world’s most promising coronavirus vaccines.
Scientists in white lab coats brought the vial to Building 14, carefully poured the contents into a flask, added a medium of vitamins and sugar and began growing billions of cells. Thus began one of the biggest gambles yet in the quest to find the vaccine that will bring the world’s COVID-19 nightmare to an end.
The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work.
But if it does, Adar Poonawalla, Serum’s CEO and the only child of the company’s founder, will become one of the most tugged-at men in the world. He will have on hand what everyone wants, possibly in greater quantities before anyone else.
His company, which has teamed up with the Oxford scientists developing the vaccine, was one of the first to announce, in April, that it was going to mass-produce a vaccine before clinical trials even ended. Now, Poonawalla’s fastest vaccine assembly lines are being readied to crank out 500 doses each minute, and his phone rings endlessly.
National health ministers, prime ministers and other heads of state (he wouldn’t say who) and friends he hasn’t heard from in years have been calling him, he said, begging for the first batches.
“I’ve had to explain to them that, ‘Look, I can’t just give it to you like this,’” he said.
With the coronavirus pandemic turning the world upside down and all hopes pinned on a vaccine, the Serum Institute finds itself in the middle of an extremely competitive and murky endeavor. To get the vaccine out as soon as possible, developers say they need Serum’s mammoth assembly lines — each year, it churns out 1.5 billion doses of other vaccines, mostly for poor countries, more than any other company.
Half the world’s children have been vaccinated with Serum’s products. Scale is its specialty. Just the other day, Poonawalla received a shipment of 600 million glass vials.
But right now, it’s not entirely clear how much of the coronavirus vaccine that Serum will mass-produce will be kept by India or who will fund its production, leaving the Poonawallas to navigate a torrent of cross-pressures, political, financial, external and domestic.
India has been walloped by the coronavirus, and with 1.3 billion people, it needs vaccine doses as much as anywhere. It’s also led by a highly nationalistic prime minister, Narendra Modi, whose government has already blocked exports of drugs that were believed to help treat COVID-19.
Poonawalla, 39, says he will split the hundreds of millions of vaccine doses he produces 50-50 between India and the rest of the world, with a focus on poorer countries, and that Modi’s government has not objected to this.
But he added, “they may still invoke some kind of emergency if they deem fit or if they want to.”
The Oxford-designed vaccine is just one of several promising contenders that will soon be mass-produced, in different factories around the world, before they are proved to work. Vaccines take time not just to perfect but to manufacture. Live cultures need weeks to grow inside bioreactors, for instance, and each vial needs to be carefully cleaned, filled, stoppered, sealed and packaged.
The idea is to conduct these two processes simultaneously and start production now, while the vaccines are still in trials, so that as soon as the trials are finished — at best within the next six months, though no one really knows — vaccine doses will be on hand, ready for a world desperate to protect itself.
U.S. and European governments have committed billions of dollars to this effort, cutting deals with pharmaceutical giants such as Johnson & Johnson, Pfizer, Sanofi and AstraZeneca to speed up the development and production of select vaccine candidates in exchange for hundreds of millions of doses.
AstraZeneca is the lead partner with the Oxford scientists, and it has signed government contracts worth more than $1 billion to manufacture the vaccine for Europe, the U.S. and other markets. But it has allowed the Serum Institute to produce it as well. The difference, Poonawalla said, is that his company is shouldering the cost of production on its own.
But Serum is distinct from all other major vaccine producers in an important way. Like many highly successful Indian businesses, it is family run. It can make decisions quickly and take big risks, such as the one it’s about to, which could cost the family hundreds of millions of dollars.
Poonawalla said he was “70 to 80 percent” sure that the Oxford vaccine would work.
But, he added, “I hope we don’t go in too deep.”
Initial trial results of the Oxford-designed vaccine showed that it activated antibody levels similar to those seen in recovering COVID-19 patients, which was considered very good news.
Serum has already produced millions of doses of this vaccine for research and development, including large batches for ongoing trials. By the time the trials finish, expected around November, Serum plans to have stockpiled 300 million doses for commercial use.
But even if this vaccine fails to win the race, the Serum Institute will still be instrumental. It has teamed up with other vaccine designers, at earlier stages of development, to manufacture four other vaccines, though those are not being mass-produced yet.
And if all those fail, Poonawalla says he can quickly adapt his assembly lines to manufacture whatever vaccine candidate does work, wherever it comes from.
“Very few people can produce it at this cost, this scale and this speed,” he said.
Under the AstraZeneca deal, Serum can make 1 billion doses of the Oxford vaccine for India and lowerand middle-income countries during the pandemic and charge an amount that is no more than its production costs.
After the pandemic passes, Poonawalla expects that he will be able to sell the vaccine at a profit — if it works.
Either way, Poonawalla said he felt an obligation to take this risk.
“We just felt that this was our sort of moment,” he said.