All over the world, from Bangladesh to Nepal to Rwanda, fragile hotspots have been struggling to cope with the stagnation of the Covid-19 vaccination program because their doses have been used up. Many shortages can be traced to one company: the Serum Institute of India.

Serum, the world’s largest vaccine manufacturer, was named the top supplier of Covid vaccines last year. Covax is an initiative supported by the World Health Organization to ensure fair global promotion. But the Indian company has been plagued by setbacks, from export bans to factory fires, hindering its ability to fulfill orders.

Covax has promised to send vaccines to approximately 92 countries, but so far, it has only received 30 million doses of at least 200 million doses ordered from Serum, the latter being the bulk of its early supply. Serum’s tragic experience has now become a key example of how Covid inoculation efforts have failed in developing countries, and a warning story of over-reliance on one manufacturer in a global crisis.

When shortages emerge, WHO and public health experts have warned that low vaccination levels in poorer countries may encourage the emergence of dangerous variants and prolong the duration of a global pandemic. It is also difficult for other manufacturers to achieve their goals or increase the production of Covid lenses, but Serum’s shortage is particularly serious because Covax and emerging countries rely heavily on it.

The company has been unable to send any vaccines overseas since April, when the Indian government banned Covid vaccine exports during the country’s devastating second wave of outbreaks. But some of Serum’s problems started long ago.

Last year, Serum’s CEO Adar Poonawalla promised that by the end of 2020, his vaccine giant will produce 400 million doses of AstraZeneca Plc’s coronavirus vaccine for use in low- and middle-income countries. Entering the month of 2021, he said that only 70 million lenses were produced because the company is not sure when it will obtain a license from India and does not have enough warehouse space.

A series of countries have also signed direct contracts with Serum and are now racing to find new suppliers. In Nepal-where the epidemic is so severe that it has even reached the base of Mount Everest-the government says it has received only half of the 2 million vaccines ordered directly from Serum in the neighboring city of Pune, India. The rest should arrive in March.

Tara Nath Pokhrel, Director of the Department of Family Welfare, Ministry of Health of Nepal, said: “We are working hard to deal with the shortage of vaccines.”

In total, the country with a population of 28 million said it received only 2.38 million doses of vaccine: 1 million doses came directly from Serum, another 1 million doses came from grant assistance from India, and the rest came from Covax. Nepal has been looking forward to receiving 13 million doses of vaccine from Covax. But given that Covax relies heavily on serum supply, and the Indian company no longer exports due to government restrictions, these flows have dried up.

The decision to select Serum as the main supplier of Covax is “to a large extent based on the company’s large-scale production capabilities, low-cost delivery capabilities, and its vaccine being one of the first vaccines to receive the WHO emergency use list. Si said that Berkeley is the CEO of Gavi, a vaccine alliance that has been promoting Covax and funding its orders.

Berkeley said that Serum’s manufacturing capacity is expanding, which will help India. Nevertheless, after Serum has stated in recent weeks that, given the needs of its overwhelmed home country, it is unlikely that exports will resume before the end of 2021, Covax and many developing countries are scrambling to find new sources of vaccines.

Chinese vaccine manufacturers may fill this gap. The vaccines of Xinhua Biotechnology Co., Ltd. and Sinopharm Group Co., Ltd. have recently been approved by the World Health Organization for wider use worldwide. After the shortage of serum supply, Bangladesh stopped providing the first dose of vaccine, and then continued to stop the entire campaign. After the limited supply of Chinese vaccines from Sinopharm arrived, the South Asian country resumed vaccination for frontline and emergency personnel, but has not yet launched a large-scale vaccination plan.

Billionaire family

Serum now finds that his situation has improved compared to a year ago. Then, its owners-the billionaire Poonawalla family founded the company in 1966 to diversify their business from racehorse breeding-after agreeing to mass-produce AstraZeneca’s vaccines, they were pushed to the world Under the spotlight, this vaccine is called Covishield in India.

Adar Poonawalla talked about a third factory in November, which will allow it to increase supply [File: Dhiraj Singh/Bloomberg]

Serum has long been a supplier of measles and polio vaccines in developing countries, and Adar Poonawalla, who became CEO in 2011, revels in its position at the historic center of Covid vaccine launch. In late November, he talked about showing Prime Minister Narendra Modi (Narendra Modi) the company’s third plant at its headquarters in Pune, which will allow the company to produce more than 1 billion Covid vaccines each year.

However, as the environment changes, Poonawalla’s predictions in public forums and the media have also changed.

In an interview in November, he said that Serum’s goal is to prepare 100 million doses of vaccine by the end of December, which is only a quarter of the number promised by the end of the year. In January of this year, he further reduced this number to 70 million.

Poonawalla told Bloomberg in early January that the shortage was due to a lack of warehouse space to store vials after India’s regulatory approvals were slower than expected. The company applied for an emergency permit there in early December. In recent months, Poonawalla has also cited the U.S. policy on some of its company’s problems, and is the first to complain about the de facto export ban imposed by the U.S. on some key vaccine raw materials.

Meanwhile, in January, a fire broke out in a factory in Serum. The manufacturer played down its impact at first, and Poonawalla said on Twitter that the fire would not slow down production. However, a person familiar with the situation, who asked not to be named, said when discussing the company’s internal business that this caused equipment losses and increased production line delays, thereby inhibiting expansion.

“Now I think they are really, really stuck-this is a major blow to Covax,” said Cleo Kontoravdi, a member of the Future Vaccine Manufacturing Research Center and Vaccine Research Network at Imperial College London.

External factor

Serum did not respond to a series of questions from Bloomberg. A spokesperson said that Poonawalla could not be interviewed.

People familiar with Serum’s business said that within the company, people were frustrated with the impact on production. The person familiar with the matter said that one of the main reasons for the failure to fulfill the promise is that the global landscape of Covid vaccines is constantly changing. After each target is announced, India’s regulations, approvals and other government controls have changed. The person familiar with the matter said that the company’s hands are bound by India’s export ban and other government regulations.

With the devastating second wave of epidemic sweeping across India, demand for vaccines soars [File: Dhiraj Singh/Bloomberg]

India is also experiencing shortages. Initially, Serum’s supply challenges were not obvious there, as immune activities started to slow. The Modi government also doesn’t know how much it will eventually order from Serum, which makes the company hardly foreseeing how much capacity it will need.

India’s initial order volume in January was small—after Poonawalla tried to openly negotiate pricing with the government, there were initially only 11 million copies. But as the second wave of coronavirus swept across the country, demand soared and supply began to decrease.

As its two main suppliers are currently stretched, India is relying on the second round of domestic and imported vaccines to ease this pressure. According to estimates by Investec Plc, injections from Biological E., Cadila Healthcare Ltd., and Novavax Inc. may result in a nearly three-fold increase in launch scale by October, reaching 271 million doses per month. Modi announced this week that all adults will be vaccinated free of charge.

Serum is not the only vaccine manufacturer that has failed to deliver on its promise. Due to production problems, AstraZeneca was unable to achieve the goals promised to the EU. Bharat Biotech International Ltd., another company that supplies Indian products, also only provided about 27 million doses of the 1 billion injections it promised per year. Russia only started shipping batches of Sputnik V to India last month and said it could start delivering orders for 100 million doses before December last year.

Malini Aisola, the New Delhi co-convenor of the All India Drug Action Network, a public health watchdog, said of the country’s vaccine manufacturers: “All of them are over-committing. , And this trend continues.” “The demand is far greater than the quantity the company can manufacture.”