Serum Institute, the Risk Taker

Even if you’re the world’s largest vaccine maker, you’re not ready for production on the scale needed for COVID-19. Serum Institute of India (SII)’s CEO, Adar Poonawalla, described some of the steps taken to get there.

 

First, they bet on several vaccines long before regulators had approved any:

“We took a huge calculated risk. It wasn't a blind risk, because we knew the Oxford scientists from our earlier collaboration with the malaria vaccine.”

Back in April last year, Bill Gates had recommended exactly this policy, promising to fund factories for seven of the most promising vaccines, even though most of them would fail. In fact, SII too raised some money from Gates.

 

Second, decision making was fast at SII, probably helped by the fact that it is a private company. Third, he procured items like glass vials early:

“I got 600 million doses worth of glass vials ahead of time and locked it in my warehouse by September.”

 

Fourth, SII was willing to take a big risk by starting manufacturing long before regulatory clearances for any vaccine had happened. That’s why SII had 70-80 million doses ready in January: they had started making them in August last year. That’s a risk almost no other vaccine manufacturing companies anywhere in the world took. And it shows now in the scarcity of supply worldover.

 

Poonawalla is critical of the fact that the major Western regulatory agencies didn’t unite. If only the US, UK, and EU bodies had united their approval process, there wouldn’t have been time lags amongst those countries. Instead, as we know, the US and UK approved early, got started early, and have vaccinated big chunks of their population. The EU is lagging far behind on all fronts, and it’s not only because of the supply problem.

 

It is the non-West’s approach that continues to be pragmatic. Hungary, a former Soviet bloc nation, recently announced that “any vaccine administered to at least 1 million people worldwide to be used without undergoing review by the country’s medicines regulator”.  As Alex Tabarrok wrote:

“Authorize any vaccine already used by at least 1 million people is a type of reciprocity or peer-review rule in which you speed up approval in your country based on data from another country. As with all such rules, it’s imperfect–new and extensive use will reveal common, serious side effects and many uncommon ones as well but extensive use is not a guarantee of safety or efficacy. Nevertheless, when time is of the essence the 1 million+ rule is a smart rule.”

 

It's almost as if every aspect of Western systems is the worst fit for the pandemic.