As India braces for colossal vaccination campaign, one drugmaker has been waiting in the wings

Relaxed because there is a massive stockpile of some 55 million doses of a COVID-19 vaccine — developed by a team at AstraZeneca and Oxford University — in his cold storage freezers, laid out on pallets and stacked to the ceiling. Those doses will be used once they get approval from India’s regulatory body and won’t need to be adjusted.

The billionaire CEO of his family-run company, the Serum Institute of India, decided early on in the COVID-19 pandemic to bet big and go all out — striking a deal with Oxford-AstraZeneca to mass produce millions of doses of one of the more promising vaccine candidates before it was even close to being tested and approved by regulators.

On Monday, Poonawalla, 39, asked India’s regulatory body to authorize the vaccine, branded Covishield, for emergency use, 10 days after the British government asked its regulator on Nov. 27 to evaluate the same Oxford-AstraZeneca vaccine.

Official approval could come in record time, as it did when Britain gave the green light to the Pfizer vaccine candidate in a little over a week.

Poonawalla poured $300 million Cdn of his own money into the bid to prepare the vaccines fast — enduring criticism and skepticism, even from within his own family, he said, with some asking, “Am I doing the right thing, are we just throwing a fortune down the drain?”

He said his company, the world’s largest vaccine maker, is now in “autopilot mode,” waiting for the approval process to play out, but he vividly remembers the uncertainty and stress back in April.

“We didn’t know which vaccines would be safe. We didn’t know what would be effective.”

The Serum Institute also received $150 million US from the Bill & Melinda Gates Foundation through a collaboration with Gavi, the Vaccine Alliance, to boost manufacturing capacity for up to 200 million doses to improve global access to the vaccine.

Systems had to be quickly rejigged at the massive Serum facility in Pune, a city in the western India state of Maharashtra, with much more equipment shipped in, including millions more tiny glass vials to hold the final product.

Poonawalla also made a business sacrifice: He put the other vaccines his team was preparing on the backburner, deferring their launches for two or three years to make room for the COVID-19 doses to be manufactured.

The company is currently churning out between 50 million and 60 million coronavirus vaccine doses a month and aims to get that up to 100 million shots a month by early next year.

Company plans to supply poorer countries

The Serum Institute of India was in a unique position — already the world’s largest supplier of vaccines before the pandemic hit for such diseases as polio, diphtheria, tetanus and measles/mumps/rubella — and it will play a crucial role in providing much of the globe’s immunization doses against the novel coronavirus, particularly for poorer countries that have not been able to secure their own supply.

The company has decided it will sell half of all the doses it produces to lower- and middle-income countries for only $3 a dose, with the other half reserved for India, which Poonawalla has promised will get priority. The Indian government will also probably pay $3 a dose, while Serum will sell it privately for about $8 a dose.

WATCH | Inside the Serum Institute of India as it produces a COVID-19 vaccine:

A major vaccine manufacturer in India scrambling to mass produce the AstraZeneca COVID-19 vaccine so it can get into the arms of billions opened its doors to CBC News. 3:01

Wealthier countries such as Canada, Britain and the United States, lacking the natural manufacturing capacity that India has, have hedged their bets and scooped up enough vaccine options to immunize their populations several times over, leaving poorer countries at a disadvantage.

Canada tops that list, making deals with seven companies to purchase up to 414 million doses — the most doses per capita.

(It, along with more than 180 other countries, is also a member of the COVAX Facility, a pooled global effort to ensure that the vaccines are distributed equitably. Canada has pledged more than $500 million to the organization. The U.S. has not signed on.)

Contrast that with India, often referred to as the world’s pharmacy and a powerhouse in the vaccine domain, accustomed to contributing 60 per cent of the jabs used around the world.

India’s poverty rate sits at 13.4 per cent, according to the World Bank, but it is emerging as a global player because of years of rapid economic growth. The pandemic and the abrupt lockdown to control the spread of the coronavirus have stymied that growth — the country’s economy is one of the worst hit by the pandemic — but the situation has also allowed India’s pharmaceutical industry to shine.

It’s home to a half dozen vaccine manufacturers working on different candidates to tackle COVID-19, including a homegrown one now in Phase 3 trials and another about to start trials.

That’s a source of pride for Dr. Randeep Guleria, director of New Delhi’s All India Institute of Medical Sciences and a member of the country’s COVID-19 task force.

“I think we have to move away from vaccine nationalism,” Guleria said, stressing the importance of a global vaccination strategy that India is keen to help with.

“We have to look at [helping] everyone, even our neighbours and other countries, so that we are able to control the pandemic,” he said.

It also doesn’t hurt India’s reputation globally. India, which will eventually have more than enough vaccine capacity, has the luxury to share even though supply will be tight in the first year.

Still, many Indians are anxiously awaiting word on how quickly they can get vaccinated.

The country is struggling to contain COVID-19, with the world’s second-highest coronavirus caseload at just under 9.7 million and 140,573 deaths as of Monday, according to Johns Hopkins University.

Guleria said he expects the Indian government will have a clearer picture of how the rollout will go come March, when a host of different types of vaccines with different storage requirements are expected to be approved for use, giving every country more options.

The government has set a goal of immunizing 250 million Indians by next July.

“I’m very hopeful by the end of next year, [the vaccine] should be something that will be easy for everyone [in India] to get,” Guleria said.

India has vast immunization programs

But what comes next will be the most daunting challenge of all: administering two doses to a population of roughly 1.4 billion people as fast as possible to halt the pandemic’s spread. It hasn’t yet been decided if everyone in the country will be vaccinated or if people will have the right to refuse.

All too aware of the unprecedented challenge is Shahid Jameel, a leading virologist and director of Ashoka University’s Trivedi School of Biosciences.

While Jameel doesn’t doubt that the Indian government will “pull out all the stops” to urgently get its vaccination program up to scale by recruiting and training more staff or medical students and getting billions more needles and syringes, he said there’s a massive amount of work to do.

India has gained expertise from running one of the world’s most vast public health immunization programs, even in rural areas, but it concentrates on babies and pregnant women. Scaling it up to cover so many people — including hundreds of millions of adults — and tracking their second doses of the vaccine will be difficult, Jameel said.

The country’s current capacity to deliver vaccines to adults, in terms of trained staff, is about 18 million doses a year, he said, far short of the goal for rapidly distributing the shot against this virus.

“We want to deliver 500 million doses in a year. It would take about 27 years to do that at present staff capacity,” Jameel said.

“How do we train and ramp up staff that is able to deliver 500 million doses in a year’s time? That’s to me the biggest challenge.”

The other challenge — one that every country in the world is struggling to address but that has a particular impact on warmer places such as India — is enhancing the cold chain to ensure the vaccines can be stored properly and delivered to all regions.

In that respect, the Oxford-AstraZeneca vaccine has an edge over candidates from Pfizer and Moderna. That’s because it’s far cheaper and would be much easier to distribute in warm countries. It’s stored at 2 C to 8 C, so it doesn’t require dry ice or special freezers, which are needed by Pfizer and Moderna so the shots can be stored in a freezer at –80 C to –60 C, or –30 C, respectively.

All of the intricate vaccine distribution details can be overwhelming for a nation struggling to contain the virus’s spread and enforce physical-distancing rules.

“We’ve been going at this for about eight months now, so there is also COVID fatigue,” Jameel said.

‘If the disease doesn’t kill me, hunger surely will’

Getting vaccinated is hardly a worry for Adar Poonawalla, surrounded by millions of doses at the Serum Institute facility in Pune.

“Well, I can take it any time I want,” he told CBC News, adding he’ll likely film himself getting the jab for a promotional video, as soon as the vaccine gets approved and licensed.

Elsewhere, there’s an urgency mixed with anxiety.

Walk through the crowded streets in the Lajpat Nagar market, one of Delhi’s busiest, and you can feel the anxiety over the vaccine.

Many of the vendors, who work here day in and day out trying to sell their products, are afraid of catching the virus.

Anil Kumar is preoccupied with staving off infection, as he tries to hawk a stack of cloth masks.

The 24-year old turned to selling the face coverings after he heard Indian Prime Minister Narendra Modi urge the whole country to wear them.

He’s happy to hear about the progress on a vaccine but would like assurances that the countries that make the vaccines, such as India, will get their people vaccinated first.

A few stalls away, Sarojini, who like many Indians has only one name, is working despite her fear of the virus. She has no other options to support her family.

She’s pleased to know a viable vaccine is around the corner, but she wants it to be available to all Indians quickly because, she said, people she knows are dying and struggling.

“If the disease doesn’t kill me, hunger surely will,” Sarojini, 45, said, surrounded by the colourful plush toys she’s trying to sell.