Vaccine assembly line is not waiting for trials

Researchers at the Serum Institute in Pune, India, work in mid-Ju- ly on a bioreactor to manufacture a possible coronavirus vaccine, still in clinical trials. The institute’s mammoth assembly lines are capable of producing 1.5 billion doses of vaccines a year. 
(The New York Times/Atul Loke)
Researchers at the Serum Institute in Pune, India, work in mid-Ju- ly on a bioreactor to manufacture a possible coronavirus vaccine, still in clinical trials. The institute’s mammoth assembly lines are capable of producing 1.5 billion doses of vaccines a year. (The New York Times/Atul Loke)

PUNE, India -- The Serum Institute, which is exclusively controlled by a small, rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a coronavirus 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 chief executive 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 great quantities of what everyone wants, possibly 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 a minute, and his phone rings endlessly.

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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, vaccine 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 of 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. Prime Minister Narendra Modi's government has already blocked exports of drugs that were believed to help treat covid-19, the disease caused by the coronavirus.

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, "Look, 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 proven 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.

Analysts said it was likely that Serum would eventually get some financial help from the Bill & Melinda Gates Foundation, which supports global immunization programs, or maybe the Indian government. Both declined to comment.

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