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How the world vaccine author stumbled upon his COVID dose record on Business and Economic News

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All over the world, from Bangladesh to Nepal and Rwanda, there have been weak sites with stagnant Covid-19 vaccine programs as doses are depleted. Many of these deficiencies are in a single company: The Serum Institute of India.

Serum was the world’s largest vaccine manufacturer and was named one of Covax’s leading suppliers of shots last year, an initiative sponsored by the World Health Organization that aims to ensure fair global equity. But the Indian company has suffered setbacks, from a ban on exports to factory fires, which has hampered its ability to comply with orders.

Covax has pledged to send shots to 92 countries, but has so far received only 30 million of the minimum 200 million doses prescribed by Serum, which was supposed to provide the bulk of the first supply. Efforts to inoculate Serum’s difficulties against Covid have become a key illustration of what has failed in the developing world, and a careful story of being overly dependent on a manufacturer in a global crisis.

The shortcomings have come as the WHO and public health experts have warned that low vaccine levels in the poorest countries could lead to the emergence of dangerous variants and a global pandemic. Other manufacturers have also struggled to meet targets or increase production of Covid shots. However, the shortcomings of Serum are particularly important, as Covax and emerging countries tell so much.

The company has not been able to send a shot overseas since April, when the Indian government banned Covid vaccine exports amid the country’s second devastating wave. But some of Serum’s problems started much earlier.

Last year, Serum CEO Adar Poonawalla pledged that the vaccine that created the colossus would extract the AstraZeneca Plc virus from 400 million doses to low- and middle-income countries by the end of 2020. A month from 2021, he said the company, which manufactured only 70 million shots, did not know when it would receive India’s license and when it did not have enough storage space.

Some nations also made direct contracts with Serum and are racing to find new suppliers. In Nepal – which is struggling with a serious outbreak that has reached the base camp on Mount Everest – the government says it has received only half of the 2 million shots fired directly at Serum in the Indian city of Pune. The rest were due by March.

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

In total, the country of 28 million people says it has received only 2.38 million doses: one million directly from Serum, another million in Indian aid and the rest from Covax. Nepal expected 13 million doses from Covax. But those flows have dried up because Covax relied on Serum for supply and the Indian company is no longer exporting due to government restrictions.

The decision to choose Serum Covax as a major supplier was based on “the company’s massive production capacity, low-cost delivery capacity and being one of the first to win its vaccine on the WHO emergency use list”. Berkley, Gavi, CEO of the Vaccine Alliance, who helped facilitate Covax and fund orders.

Berkley said Serum’s manufacturing capacity is now increasing, which will help India. However, Covax and many developing countries are making efforts to find new sources of vaccines, Serum said in recent weeks, as exports are unlikely to recover until the end of 2021 given the needs of his hometown.

It is a gap that Chinese vaccine makers can fill, with shots from Sinovac Biotech Ltd. and Sinopharm Group Co. both recently approved by the WHO for worldwide use. Bangladesh stopped providing first doses of vaccine after a shortage of serum supply and then stopped the whole campaign. After the limited supply of Chinese vaccines from Sinopharma, South Asian countries began with inoculations again for line and emergency workers, but a mass vaccination program has not yet begun.

Billionaire Family

The current state of serum is a change from a year ago. Then its owners – the multimillion-dollar Poonawalla family, who founded the company in 1966 to diversify the business from racehorse breeding – came into focus around the world after agreeing to mass-produce the AstraZeneca vaccine called Indian Covishield.

Adar Poonawall spoke about a third factory that would allow it to increase supply in November [File: Dhiraj Singh/Bloomberg]

Serum has long been a provider of measles and polio inoculations in the developing world and Adar Poonawalla, who became CEO in 2011, was at the center of the historic spread of the Covid vaccine. In late November, Prime Minister Narendra Modi spoke about showing a third factory at the company’s Pune headquarters, which will soon give the company more than a billion Covid shots a year.

However, as the situation changed, Poonawall’s projections also changed in public forums and the media.

In an interview in November, he said Serum was aiming to have 100 million doses ready in reserve by the end of December, just a quarter of the number promised by the end of the year. In January, that dropped even further to $ 70 million.

Poonawall told Bloomberg in early January that the deficiencies were due to a lack of storage space for the flasks, which was slower than expected in regulatory approvals in India. The company filed an emergency license application there in early December. In recent months, Poonawall has cited U.S. policies regarding some of his company’s problems, and has addressed complaints against a bill export ban imposed on some crucial vaccine raw materials.

Meanwhile, in January, a fire broke out in one of the Serum factories. The manufacturer initially underestimated its impact and Poonawall tweeted that the fire would not slow production. But it caused a loss of equipment and a delay in putting in additional manufacturing lines, and reduced deployment. A person who knew the subject did not want to discuss the internal business of the company.

“I think they’re really stuck right now – that’s a big blow to Covax,” said Cleo Kontoravdi, a member of Imperial College London’s Future Vaccine Manufacturing Research Center and Vaccine Research Network.

External factors

Serum did not respond to Bloomberg’s question list, and a spokesman said Poonawalla was not available for interview.

Within the company, there is frustration at the impact it has had on production, said a person who knew Serum’s operations. One of the main reasons the commitment was not fulfilled was because Covid’s global vaccination landscape was changing as changes in Indian regulations, approvals and other government controls were announced after each target was announced, the person said. The person said the company’s hands were tied to India’s export bans and other government regulations.

When the second devastating wave spread throughout India, the demand for vaccines increased [File: Dhiraj Singh/Bloomberg]

There has also been a shortage in India. Initially, the challenges of serum supply were not obvious, as the immunization campaign began slowly. The Modi government was also unclear about how much it would order from Serum, leaving the company with little foresight to know how much capacity it needed.

India’s initial January order form was unparalleled – only 11 million shots were fired after initially trying to publicly negotiate prices with the Poonawalla government. But as the second coronavirus wave spread across the country, demand rose and supplies dwindled.

With its two main suppliers currently stretched, India is relying on a second round of its own and imported secondary vaccines to alleviate that tension. Biological E., Cadila Healthcare Ltd. and plans by Novavax Inc. could expand to 271 million doses per month in three years, according to estimates by Investec Plc. This week Modik announced free vaccinations for all adults.

Serum is not the only vaccine author who has been left out of his commitments. AstraZeneca was unable to meet the targets set by the European Union due to production problems. Another company that supplies India’s expansion, Bharat Biotech International Ltd., has delivered only about 27 billion doses of the 1 billion doses prescribed for its annual launch. Russia, which began shipping Sputnik V packages to India last month, said it could start ordering 100 million doses by December last year.

“All of them have done more than promised and this trend continues,” said Malini Aisola, an assistant to the public health watchdog in New Delhi, the country’s India Drug Action Network said about the country’s vaccine managers. “Demand is much higher than what companies can manufacture.”



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