With five vaccines, Serum set for global race

As pharma giants get ready for a global Covid-19 vaccine race, Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, is prepared for a stunning start. Apart from Covishield, it is also developing/manufacturing four other vaccines, and more than doubling its production capacity in Pune at breakneck speed.

Of the five vaccines, three are in alliance with international pharma companies, while the remaining two are being developed indigenously.

Pune-based SII, which claims to have raked in $900 million in revenues last year, is scaling up its annual production capacity to 2.4 billion doses with a second facility going on stream by March, from 1.5 billion available today. It is now looking to scale up capacity further with a third facility as the demand for vaccines is going through the roof. While Covishield production is going on in full swing, SII is also gearing up for production of four other vaccines.

At present, more than half of the capacity is utilised for producing Covishield, which was recently approved for use by the Drugs Controller General of India (DCGI). A dry run is currently underway across the country.

“We have already manufactured 10 crore [100 million] doses of Covishield,” a senior SII official, who requested not be identified, told Fortune India. This includes stockpiling of 50 million doses and an equal number of doses that are ready, awaiting to be packed. The company is busy stockpiling the vaccine as India gets into a massive vaccination drive.

The government is yet to start lifting Covishield vaccines from Serum. "The lifting is likely to start any day now. Considering the urgency of rolling out the vaccine, we are sending them via air," the official said.

SII has already got its logistics in place. "We usually move vaccines by road in temperature-controlled atmosphere,” the official added.

Efforts to reach out to Adar Poonawalla, chief executive of Serum Institute, were unsuccessful. The company is yet to respond to a questionnaire sent by Fortune India.

Covishield is the local version of the Covid-19 vaccine SII has licensed from the Oxford University-AstraZeneca combine.

What is more, enquiries for huge quantities of doses are pouring in from abroad. The fact that certain mutations of the virus are being discovered in some countries is creating another battlefront for vaccine manufacturers.

Serum has signed deals to develop and manufacture four other vaccines simultaneously at its Pune facility. Of the four, two prominent ones are COVOVAX and COVI-VAC, being developed in alliance with two U.S.-based companies.

SII and the Indian Council of Medical Research (ICMR) had collaborated for the clinical development of COVOVAX, developed by Novavax and upscaled by SII. Novavax is a Nasdaq-listed vaccine research company. COVOVAX will seek DCGI's nod for a roll-out in India after the successful completion of its clinical trials.

The other vaccine SII is involved in is COVI-VAC. The U.S.-based Codagenix and SII have already begun a first-in-human clinical trial of the Covid-19 vaccine. It is a single-dose intranasal vaccine and has the potential to make an immediate presence in the crowded marketplace. What makes it extremely handy is the fact it is stable outside the ultra-low temperature freezers, rendering easy transportation.

Of the two indigenous vaccine candidates, the one being developed in alliance with SpyBiotech, is undergoing the first phase of clinical trials. SpyBiotech has an exclusive global licensing agreement with Serum for the development of the vaccine. The second vaccine, being developed indigenously, is still under wraps.

So far, SII has invested around $270 million in building infrastructure, seeking technology transfer, and purchasing raw materials, among others. “All raw materials for the vaccine are sourced locally. We do not need any imported inputs,” the official said.

There had been some ambiguity over the export of vaccines by Serum.

A day after Poonawalla reportedly said that India would not allow the export of Covishield for several months, the health ministry on January 5 clarified that the government had not taken any such decision. The health secretary, Rajesh Bhushan, had said the government had not banned the export of any of the Covid-19 vaccines. “When I say government, I mean ministry of health and family welfare, ministry of commerce, the department for promotion of industry and internal trade, directorate general of foreign trade. These are the departments which can ban the export of vaccines in any hypothetical situation. They have not taken any action regarding this,” he had said.

Following the health secretary’s statement, Poonawalla, too, clarified that there was no such ban.

However, confusion prevails over the sale of vaccines in the open market by vaccine manufacturers. Poonawalla had earlier said his company had been barred from selling the vaccine in the private market.

“Serum on its own has decided against any export till April. The idea is to stockpile all the vaccines required for India as a priority,” said the official.

An industry official clarified that the exports of vaccines are not banned, but they are permitted only if the exports are meant for immunisation programmes of various governments. The fact is that the vaccine makers can't sell it in private markets in India or abroad.

“SII has already signed deals with Bangladesh, Saudi Arabia, and Morocco, while a few others are in the pipeline. These are for immunisation programmes of the respective governments through bilateral deals,” said the official.

On January 7, South Africa, which is in the throes of a second wave of the pandemic, announced that it would airlift one million doses of Covishield from Serum this month, followed by an additional 500,000 doses in February. This deal is under a bilateral agreement, said the SII official.

SII has also joined hands with the World Health Organization (WHO)-supported global vaccine partnership called COVAX. Under this agreement, Covishield doses will be airlifted to 67 countries. SII has signed a deal for 200 million doses, with an option of 900 million additional doses.

Under the COVAX alliance, Serum has received at-risk pre-funding of $300 million. SII is hopeful that it can provide vaccines worth ₹5,000 crore free for India under this alliance.

“The export of Covishield is yet to start as it awaits pre-qualification by the WHO. SII’s partner, AstraZeneca, is taking care of the process. The WHO's nod is expected within a month,” said the official.

The Indian government has decided to vaccinate 300 million people on an immediate basis. This means 600 million doses since it is a two-dose vaccine. SII, however, hopes that the government will lift the vaccines in a phased manner, with the most vulnerable such as senior citizens and frontline healthcare workers getting the first shots.

Serum is selling Covishield to the Indian government at a special price of ₹200 per dose. This is for the first 100 million doses, after which the prices would be higher. The vaccine will be sold on the private market at ₹1,000 per dose. Covishield is priced much lower than the two other global competitors—Moderna’s vaccine is at $32-$37 per dose and Pfizer’s is around $20.

“We are a socially-committed organisation and not here for profiteering. We are the largest vaccine manufacturer, providing vaccines to 170 countries across the globe,” the official added.

Poonawalla, who is celebrating his 40th birthday on January 14, is gung-ho about the unlimited business opportunities the company has. He believes that the pandemic has, in fact, presented a chance to foster structural reforms in building robust public healthcare infrastructure in the country. Serum will stand at the forefront of the battle against the pandemic, he once said.

His father Cyrus S. Poonawalla, who founded Serum Institute in 1966, is known as the ‘Vaccine king of India’. His family fortune stands at around $13 billion, according to Bloomberg.