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INSIGHT-How one Indian company could be world's door to a COVID-19 vaccine

Fri, 22nd May 2020 16:56

By Abhirup Roy and Euan Rocha

PUNE, May 22 (Reuters) - If the world is to gain access to a
vaccine for COVID-19, there's a good chance it will pass through
the doors of Serum Institute of India.

Serum Institute, the world's largest manufacturer of
vaccines by volume, is working on several candidates for the
novel coronavirus - including potentially mass-producing the
AstraZeneca/Oxford university one that has garnered global
headlines - as well as developing its own.

The efforts are partly being shepherded by Umesh Shaligram,
the head of research and development. His employer is a private
company but every day, shortly before midnight, he receives a
WhatsApp message from the government asking for updates, and
about any new hurdles he faces.

The message is usually from K. VijayRaghavan, Prime Minister
Narendra Modi's top scientific adviser - an indication of the
critical, and even strategically important, nature of the race
to develop the vaccines the whole world is waiting for.

Shaligram promptly responds with a progress report and
details any bottlenecks.

"Any delays, you just tell them," said Shaligram, adding the
government has been doing everything it can to fast-track
clearances, and resolve import delays and other issues.

"We have begun to see approvals come through in days, even
on a Sunday night, for trials and things like that," he said,
noting some of these processes typically took 4 to 6 months.

While most of the attention regarding vaccines typically
goes to the pharmaceutical developer, India quietly plays a key
role in manufacturing 60%-70% of all vaccines sold globally with
the Serum Institute playing a lead role, said the company's
Chief Executive Adar Poonawalla.

At the company's sprawling, 150-acre campus in the western
Indian city of Pune, Shaligram and his team are working
flat-out. Dozens of buses ferry in hundreds of workers each day
to the grounds, which are buzzing with activity even as the city
around it remains largely under lockdown.

The push comes as the number of cases of COVID-19, both
globally and domestically, continue to surge and world leaders
look to vaccines as the only real way to restart their stalled
economies, even though none have yet been proven to be effective
against the coronavirus.

Poonawalla, whose family owns he vaccine maker, said
scientists, drugmakers and manufacturers were collaborating at
an unparalleled scale to spur development and availability.

"We are all in a race to battle the disease, there is no
one-upmanship here," he told Reuters, sitting in his office
beside his family's 74-year-old stud farm.

VACCINE CANDIDATES

Serum, founded in 1966 by Adar's father Cyrus Poonawalla,
has partnered with U.S. biotech firm Codagenix, its U.S. rival
Novavax and Austria's Themis to potentially manufacture
three COVID-19 vaccine candidates that are still in development.

Another candidate in the works is the experimental vaccine
developed by a team at the University of Oxford and now licensed
to drugmaker AstraZeneca, with whom Serum are in talks
to mass produce the vaccine, which is now in the clinical trial
stage.

The United States has secured almost a third of the first 1
billion doses planned for the potential vaccine, initially known
as ChAdOx1 and now as AZD1222, by pledging up to $1.2 billion.

Poonawalla aims to initially produce 4-5 million doses a
month, beginning from June, and then gradually ramp up to
350-400 million doses a year.

"Hopefully we will build a stock of a few million doses to
give to our country and other high-risk areas across the globe
come October-November when the trials ought to be concluded,"
the 39-year-old said, while giving Reuters rare access to tour
his facilities.

He added he had been given to understand by the development
team that the trials had an 80% chance of success, given that
the vaccine is based on a tried-and-tested platform.

Based on the information currently available, Poonawalla
also said he anticipated AZD1222 would be a single-dose vaccine
and not require a booster dose.

He sees AZD1222 potentially priced at about 1,000 rupees
($13) per dose in India, but expects it will be procured and
distributed by governments without charge.

Serum is also working on developing its own in-house vaccine
options to tackle the disease, Poonawalla said.

VIALS, TUBES, CHEMICALS

Even if a vaccine does succeed, a treatment to fight
COVID-19 would still be required, said Poonawalla, noting some
people do not get the desired immune response, even if
vaccinated.

"You may get mild symptoms, you may get severe symptoms. It
depends on your system, but there is a chance," he added. "Not
all vaccines are fully effective."

The Serum Institute produces more than 1.5 billion doses of
vaccines every year, for everything from polio to measles.

Poonawalla says that gave the company an edge in securing
supplies of vials and high-quality chemicals required to make a
vaccine in bulk once all approvals are in place.

"We have partnered with many of our suppliers to have one to
two-year inventories of glass vials and tubing glass stocked in
advance, so luckily for us that won't be an issue."

Any successful vaccine is however bound to be in short
supply at first, he stressed.

India recorded more than 6,000 new cases of the coronavirus
on Friday, bringing its total to over 118,000 cases with more
than 3,500 deaths, even as it gradually begins to ease its
nearly two-month long nationwide lockdown.

There have been more than 5 million infections and over
330,000 deaths reported worldwide.

The Indian government stands ready to cover the costs of
trials of any vaccine in the country, said Poonawalla, adding
that the government had also expressed interest in placing
advance orders for a potential vaccine.

"We've reached out and they have been very positive," he
added. "But we've said hold on ... as we don't want to take
government money until we are very confident we can deliver."

UNLOCKING VALUE IN THE 'HYPE'

Serum, one of the few companies ramping up hiring during the
health crisis, is also designing a separate facility to make
vaccines for pandemic-level diseases that could handle 90% of
the current vaccine candidates being developed, beyond just the
COVID-19 ones.

That facility, which will be ready in the next two to three
years, would be able to potentially churn out 700-800 million
doses a year, according to Poonawalla.

The CEO said he considered taking the company public some
years ago to fund some large acquisitions, but changed course
when the deals fell through.

Now he's considering a different approach. He is exploring
creating a holding entity that will host the company's
pandemic-level technologies, including manufacturing rights,
intellectual property and the sale of all of Serum's
COVID-19-related candidates, and selling a minority stake in the
venture.

"That will unlock value in the main hype," he said.

Poonawalla said he had engaged bankers to test the waters on
this, but stressed he would only consider selling a stake to
ethical, long-term funds or sovereign funds that do not expect
huge returns and want to "make a difference to the world".

"After getting them onboard, I don't want to be in a
situation where I have to charge high prices to give them
returns."

(Reporting by Abhirup Roy and Euan Rocha; Editing by Pravin
Char)

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