Setbacks for SII leave world short of Covid-19 shots

round the world, from Bangladesh to Nepal to Rwanda, vulnerable hotspots have been grappling with stalled Covid-19 vaccination programmes as they run out of doses. Many of those shortages can be traced back to a single company: The Serum Institute of India.

The world’s largest vaccine maker, Serum was last year named a top supplier of coronavirus shots to Covax, the World Health Organization-backed initiative aimed at securing an equitable global rollout. But the company has been dogged by setbacks, from a ban on exports to a factory fire, which have hampered its ability to fill orders.

Covax has pledged to send shots to some 92 countries, but has so far received only 30 million of the minimum 200 million doses it ordered from Serum. Serum’s travails have now become a cautionary tale for becoming over-reliant on one manufacturer.

Other manufacturers have also had trouble meeting targets, yet Serum’s shortfalls are particularly consequential because Covax and emerging countries were counting on it so heavily.

The company has been unable to send any shots overseas since April, when the India banned vaccine exports amid the country’s devastating second wave. But some of Serum’s problems began long before.

Last year, Serum’s chief executive officer, Adar Poonawalla, pledged that his vaccine producing colossus would churn out 400 million doses of AstraZeneca Plc’s coronavirus shot for low and middle-income countries by the end of 2020. A month into 2021, he said it had manufactured only 70 million shots because the company had been uncertain about when it would receive a license from India and didn’t have enough warehouse space.

A string of nations had also entered into direct contracts with Serum and are now racing to find new suppliers. In Nepal, the government says it has received only half of the 2 million shots it ordered directly from Serum. The rest were supposed to arrive by March.

“We are struggling with the shortage of vaccines,” said Tara Nath Pokhrel, the director of the family welfare division at Nepal’s health ministry.

The decision to choose Serum as a major Covax supplier “was based, largely, on the company’s massive production capacity, ability to deliver at low cost and the fact that its vaccine was one of the earliest to gain WHO emergency use listing,” said Seth Berkley, chief executive officer at Gavi, the Vaccine Alliance, which has been facilitating Covax.

Berkley says Serum’s manufacturing capacity is now expanding. Still, Covax and many developing countries are scrambling to find new sources after Serum said that exports are unlikely to resume until the end of 2021 given the needs of India. Bangladesh too briefly stopped giving out first vaccination doses after Serum’s supply shortages.

The situation Serum now finds itself in a turnaround. In November, Poonawalla said Serum was aiming to have 100 million doses ready in reserve by the end of December, just a quarter of the amount promised. In January, he lowered that to 70 million.

Poonawalla said in January that the shortfalls were due to a lack of warehouse space after slower than anticipated regulatory approvals in India. The company filed their application for an emergency license in early December. Over recent months Poonawalla has also cited US policies for some of his company’s problems, spearheading complaints against a de-facto American export ban on some vaccine raw materials.

Meanwhile, in January, a fire broke out at one of Serum’s plants. The manufacturer at first downplayed its impact, but it led to losses of equipment and delays in putting on additional manufacturing lines, according to a person familiar with the matter.

“Right now I think they are really, really stuck -- that’s a major blow to Covax,” said Cleo Kontoravdi, a member of Imperial College London’s Future Vaccine Manufacturing Research Hub and Vaccine Research Network.

Serum didn’t respond to a list of questions.

There have been shortages in India as well. India’s initial order sheet in January was parsimonious -- just 11 million shots at first. But as the second wave swept across the demand shot up, and supplies dwindled.