Serum Institute expects emergency Covid-19 vaccine authorisation by December

By Chris Kay

The world’s largest vaccine maker is ramping up production of AstraZeneca Plc’s Covid-19 shot, aiming to have 100 million doses ready by December for an inoculation drive that could begin across India that same month.

If final-stage trial data show AstraZeneca’s candidate gives effective protection from the virus, the Serum Institute of India Ltd. -- which is partnered to produce at least one billion doses -- may get emergency authorization from New Delhi by December, said Adar Poonawalla, chief executive officer of the family-owned firm based in the western city of Pune.

That initial amount will go to India, Poonawalla said in an interview on Thursday. Full approval early next year will allow distribution on a 50-50 basis with the South Asian nation and Covax, the World Health Organization-backed body that’s purchasing shots for poor nations. Serum, which has tied up with five developers, has so far made 40 million doses of AstraZeneca’s vaccine in the past two months and aims to start manufacturing Novavax Inc.’s contender soon.

Read | Serum Institute readies 4 crore doses of AstraZeneca Covid-19 vaccine

“We were a bit concerned it was a big risk,” said 39-year-old Poonawalla. But both AstraZeneca and Novavax’s shots “are looking pretty good.”

The haste underlines Poonawalla’s confidence in one of the main vaccine front-runners. AstraZeneca CEO Pascal Soriot has said he is preparing for the possibility of large-scale vaccinations as early as December and once the U.K. grants its own emergency license, Serum will submit that same data to Indian counterparts.

Drugmakers are just now getting data that will show how well their vaccine candidates work, but there are plenty of hurdles remaining as the global race to find an effective shot against the pathogen reaches its final stages. Astra and co-developer University of Oxford still need to see testing results. And even if their vaccine proves effective and gets a nod from regulators, there are questions over how easily and quickly the shot can be distributed.

Poonawalla reiterated that it will take until 2024 to vaccinate the entire world and two years to see a real reduction in infections, due to affordability and manufacturing hurdles.

After talks with the government, Poonawalla said he is confident in their plans to get initial vaccines to the vulnerable and frontline workers. The challenge, will be in getting it to India’s 1.3 billion population, especially in the vast countryside where past inoculation drives have struggled due to patchy health networks.

He said AstraZeneca has a significant edge over a rival candidate from Pfizer Inc. and BioNTech SE, which this week grabbed headlines after indicating it was more than 90% effective in stopping Covid-19 infections. Expensive cold-chain infrastructure is needed to transport and store that vaccine at -70 degrees Celsius. Poonawalla said it was “just impossible” for most of the world to use at scale, compared to those his company will produce that can be stored at fridge temperatures.

“I don’t think even 90% of the countries will be able to take it, because you just don’t have deep freezers everywhere,” he said of the Pfizer shot. “In a pandemic, always remember that simplicity is the key.”

For India, which has struggled to contain the world’s second-largest Covid outbreak, negotiations with the Serum Institute on vaccine pricing will be pivotal for the country’s efforts to emerge from the pandemic.

New Delhi has set aside about Rs 50,000 crores ($6.7 billion) for vaccines, people with knowledge of the matter said last month. However, in September, Poonawalla argued that India would need Rs 80,000 crores. Poonawalla declined to comment further.

Poonawalla is taking a big financial gamble. Operating in the low margin, mass volume world of vaccines, the Serum Institute -- founded in 1966 by Poonawalla’s billionaire father Cyrus -- supplies 170 nations with over a billion shots a year for diseases such as measles and mumps.

Quick question; will the government of India have 80,000 crores available, over the next one year? Because that's what @MoHFW_INDIA needs, to buy and distribute the vaccine to everyone in India. This is the next concerning challenge we need to tackle. @PMOIndia

— Adar Poonawalla (@adarpoonawalla) September 26, 2020

Close to $300 million of the company’s money has been invested in early production, said Poonawalla. The Bill & Melinda Gates Foundation and Gavi, the vaccine alliance, have also contributing $300 million this year, earmarking 200 million doses for the Covax effort. That leaves about $200 million left to bridge for Serum’s planned expenditure.

“I don’t need all of it right now, the capital we’ve deployed already is enough,” Poonawalla said, adding that advance orders recently signed with countries such as Bangladesh should fill the gap. Serum is also in discussions with India for an advanced commitment. “I think in the next one or two months I’ll be fully capitalized.”