As the world’s first vaccine producer has stumbled upon its COVID dose | Business and economic issues

Worldwide, from Bangladesh to Nepal and Rwanda, vulnerable hotspots have been struggling with Covid-19 vaccination programs installed while missing doses. Many of those shortcomings can be traced back to one company: The Serum Institute of India.

Serum, the world’s largest vaccine maker, was last year named a leading supplier of Covid vaccines to Covax, the initiative backed by the World Health Organization, aimed at ensuring a global equitable implementation. . But Indian society has been plagued by setbacks, from a ban on exports to a factory fire, which have hampered its ability to fulfill orders.

Covax has promised to send strikes to some 92 countries, but so far has received only 30 million of the minimum 200 million doses it ordered from Serum, which was supposed to supply most of its first supply. Serum work has now become a key illustration of how the effort to inoculate against Covid has failed the developing world, and a cautionary tale to become too dependent on a manufacturer in a global crisis.

The shortcoming comes when the WHO and public health experts warn that low levels of vaccination in the poorest nations could fuel the emergence of dangerous variants and prolong the global pandemic. Other manufacturers have also had problems meeting targets or increasing Covid stroke production, yet Serum deficiencies are particularly consequential because Covax and emerging countries counted so much.

The company has not been able to send shots overseas since April, when the Indian government banned the export of Covid vaccines amid the country’s devastating second wave. But some of the Serum problems start much earlier.

Last year, Serum CEO Adar Poonawalla promised that his vaccine-producing colossus would produce 400 million doses of AstraZeneca Plc coronavirus shot for middle- and middle-income countries at end of 2020. One month into 2021, he said he had manufactured only 70 million shots because the company was unsure about when it would receive a license from India and did not have enough warehouse space.

A chain of nations had also signed direct contracts with Serum and are now in the process of finding new suppliers. In Nepal – which is struggling with a severe fire that has also reached Mount Everest base camp – the government says it has received only half of the 2 million blows it has ordered directly from Serum, based on the city ​​of Pune in neighboring India. The rest was due in March.

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

In all, the nation of 28 million people says it has received only 2.38 million doses: 1 million directly from Serum, another million in grant aid from India, and the rest from Covax. Nepal had expected 13 million doses in total from Covax. But those flows have dried up since Covax relied heavily on Serum for supply and the Indian company no longer exports due to government restrictions.

The decision to choose Serum as a major supplier of Covax “was based, in large part, on the company’s massive production capacity, ability to deliver at low cost and the fact that its vaccine was one of the first to win the WHO emergency use list, ”said Seth Berkley, executive director of Gavi, the Vaccine Alliance, which facilitated Covax and helped fund its orders.

Berkley says Serum’s manufacturing capacity is now expanding, which will help India. However, Covax and several developing countries are struggling to find new sources of vaccines after Serum said in recent weeks that exports are unlikely to pick up until the end of 2021 given the needs of so overrated homeland.

It is a gap that could be filled by Chinese vaccine manufacturers, with hits from Sinovac Biotech Ltd. and Sinopharm Group Co. both recently approved for wider global use by the WHO. Bangladesh has stopped giving the first doses of vaccination after the shortage of Serum supply and has continued to halt its entire campaign. Following the arrival of a limited supply of Chinese vaccines from Sinopharm, the South Asian country has resumed inoculation for front-line and emergency workers, but is yet to start a mass vaccination program.

Billionaire family

The situation that Serum is in now is a change from a year ago. Later, its owners – the billionaire Poonawalla family, who founded the company in 1966 to diversify their business away from racing horse breeding – were put in the world spotlight after agreeing to mass-produce the vaccine. AstraZeneca, which is called Covishield in India.

Adar Poonawalla spoke in November about a third factory that will let it increase supplies [File: Dhiraj Singh/Bloomberg]

Serum had long been a supplier of measles and polio vaccines to the developing world and Adar Poonawalla, who became CEO in 2011, has stepped into his position at the center of the historic Covid vaccine rollout. In late November, he talked about showing Prime Minister Narendra Modi a third factory at the company’s Pune headquarters that will soon allow the company to launch more than a billion Covid coups a year.

However, as circumstances changed, so did Poonawalla’s projections in public forums and in the media.

In a November interview, he said Serum was aiming to have 100 million doses ready in stock by the end of December, only a quarter of the amount promised by the end of the year. In January, it dropped even more to 70 million.

Poonawalla told Bloomberg in early January that the shortages were due to lack of storage space to store the vials after slower regulatory approvals in India. The company filed its application for an emergency license here in early December. Over the past few months Poonawalla has also cited U.S. policies for some of his company’s concerns, leading complaints against a de facto ban on U.S. exports imposed on some crucial vaccination raw materials.

Meanwhile, in January, a fire broke out in one of the Serum plants. The manufacturer initially minimized its impact and Poonawalla tweeted that the fire would not slow production. But it led to equipment losses and delays in putting additional manufacturing into play, slowing the expansion, according to a person familiar with the matter who did not want to be named discussing the company’s internal activities.

“Right now I think they’re really, really blocked – it’s a big blow for Covax,” said Cleo Kontoravdi, a member of the Future College of Vaccine Manufacturing Research and the Vaccine Research Network of Imperial College. London.

External Factors

Serum did not respond to a list of questions from Bloomberg, and a spokesman said Poonawalla was not available for an interview.

In society, there is frustration over how production has been affected, said the person familiar with Serum operations. One of the main reasons that the promises have not been fulfilled is that the global landscape for Covid vaccines has changed continuously, with changes in India’s regulations, approvals and other government controls after each goal. it was announced, the person said. The company’s hands have been tied to India’s export ban and other government regulations, the person said.

As a second devastating wave spread to India, the demand for vaccines skyrocketed [File: Dhiraj Singh/Bloomberg]

There has also been a shortage in India. Initially, serum supply challenges were not apparent here because the vaccination campaign went to a slow start. The Modi government was also unclear on how much it would send to Serum, leaving society with little prediction of how much capacity was needed.

India’s initial order sheet in January was thrifty – only 11 million blows at the start after Poonawalla tried to publicly negotiate prices with the government. But when the second wave of coronavirus swept through the country, demand skyrocketed, and supplies began to fall.

With its two main suppliers currently expanding, India is relying on a second round of domestic and imported vaccines to alleviate this tension. Shots from E. Biologica, Cadila Healthcare Ltd. and Novavax Inc. they may lead to a triple scale close to the rollout to 271 million doses by October, according to estimates by Investec Plc. Modi this week announced free vaccinations for all adults.

Serum isn’t the only vaccine manufacturer that has fallen short of its promises. AstraZeneca has not been able to meet the objectives promised to the European Union due to production problems. The other company providing development to India, Bharat Biotech International Ltd., has also provided about 27 million pledges of 1 billion annual doses since its inception. Russia, which only began shipping lots of Sputnik V to India last month, had said it could begin shipping an order for 100 million doses by December last year.

“All has been too promising and this trend continues,” said Malini Aisola, co-convener of the New Delhi Public Health Guard, All India Drug Action Network, who spoke about the country’s vaccine producers. “The demand is so much bigger than what companies can manufacture.”

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