[Wealthy countries have already grabbed a major chunk of the available supply. The United States, the United Kingdom, Japan and Canada have struck deals large enough to vaccinate their entire populations. By contrast, a pooled global effort to distribute vaccines equitably to more than 150 countries — including dozens of low-income nations — has secured only 700 million doses.]
One
prominent vaccine candidate requiring ultra-cold storage is “a joke” that will
not work for the developing world. Anyone who declares how long a vaccine will confer
immunity is talking “nonsense.” The world’s entire population will not be
immunized until 2024, he says, contrary to rosier predictions.
Poonawalla
is equally frank about the gamble his company, Serum Institute of India, is
making in the pandemic. He is putting $250 million of his family’s fortune
into a bid to ramp up manufacturing capacity to 1 billion doses through
2021.
“I
decided to go all out,” said Poonawalla, 39. Among the initial skeptics: his
father, Cyrus, the company’s founder. “He said: ‘Look, it’s your money. If you
want to blow it up, fine.’ ”
It
is a bet with global repercussions. In the quest for effective coronavirus vaccines, India is poised to play a
critical role in supplying the developing world, which is starting the race
with a distinct disadvantage.
Wealthy
countries have already grabbed a major chunk of the available supply. The United States, the
United Kingdom, Japan and Canada have struck deals large enough to vaccinate
their entire populations. By contrast, a pooled global effort to distribute
vaccines equitably to more than 150 countries — including dozens of low-income
nations — has secured only 700 million doses.
Pfizer,
which announced stellar
early results for its vaccine candidate Monday, has struck very few
deals to supply its product to developing countries. Pfizer’s vaccine must also
be stored at ultra-low temperatures, a major challenge in much of the world.
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Rich
nations are “all cutting in line and hoarding vaccine supply to immunize as
many people as possible, even if this leaves other countries unable to immunize
those at highest risk,” said Nicholas Lusiani, a senior adviser at Oxfam
America, a nonprofit group devoted to fighting poverty.
Enter
Indian vaccine makers, led by Serum Institute, the largest manufacturer in the
world by volume. Well before the pandemic, India was a “vaccine powerhouse”
specializing in affordable exports to low- and middle-income countries, said
Andrea Taylor, an assistant director at the Duke Global Health Innovation
Center.
Taylor
said countries such as Brazil and China also have manufacturing capacity, but
she singled out Indian vaccine makers because they moved so quickly to form
tie-ups with global companies and increase their own production. India is
“going to be the absolute star in the story,” she said.
Anthony
S. Fauci, the top infectious-disease specialist in the United States, shared
that sentiment during
a panel earlier this year. India’s manufacturing capability is “going to be
very, very important” as effective vaccines emerge, he said
Four
major pharmaceutical companies — AstraZeneca, Novavax, Johnson & Johnson and Sanofi — have reached
agreements to eventually produce at least 3 billion vaccine
doses for low- and middle-income countries, according to an analysis of
publicly available data by Airfinity, a research firm in the United Kingdom.
Serum Institute is set to manufacture more than two-thirds of those doses.
Some
of the agreed-upon supply to low- and middle-income countries will come through
the pooled initiative backed by the World Health Organization, known as the
Covid-19 Vaccines Global Access Facility, or Covax. Covax includes higher- and
lower-income countries, more than 150 in total. The United States declined to
join.
Covax
is being co-led by Gavi, a nonprofit vaccine alliance. In September, Gavi
announced a partnership with the Bill and Melinda Gates Foundation to pay Serum
Institute in advance for 200 million vaccine doses, at a cost of $3 each,
to be distributed in developing countries, hopefully in early 2021. The
$600 million infusion will help Serum ramp up production.
Gavi
and the Gates Foundation “want to assure vaccine supply at an affordable
price,” said Poonawalla, Serum’s chief executive. His aim, meanwhile, is to
cover some of his costs. “At least my risk is taken away so I can sleep at
night,” he said.
The
partnership with Serum, given its size, is “crucial” to Gavi’s larger goal of
ensuring that no country is left behind in the quest for vaccines, said Dominic
Hein, who works on Gavi’s efforts to make vaccines more readily available in
low-income countries.
Under
the agreement, more than 60 countries — largely in Africa and Asia — would
receive the vaccine developed by Oxford University and AstraZeneca or the
vaccine under
development by Novavax.
Serum
Institute has struck deals to manufacture both vaccines, which are in Phase 3
trials. It has also inked deals to make two other vaccines, developed by the
American biotechnology company Codagenix and Britain’s SpyBiotech, and is
working on its own vaccine candidate that it hopes will enter trials late next
year. While the Indian company has reached manufacturing agreements with
American companies such as Novavax and Codagenix, it is not currently exporting
its vaccines to the United States.
India
has recorded the second-highest number of coronavirus cases in the world — more
than 8.5 million. Those numbers mean India is a crucial market for future
vaccines and an effective place to test them.
Advanced
clinical trials of three vaccine candidates are underway in India: the
AstraZeneca vaccine and vaccines developed by two Indian pharmaceutical
companies, Zydus Cadila and Bharat Biotech. An Indian company is also starting
clinical trials of Russia’s vaccine candidate, Sputnik V.
“Whether
India makes a vaccine by itself or not, from a manufacturing standpoint, it’s
going to be playing a very, very important role,” said Mahima Datla, managing
director of Biological E., a 67-year-old vaccine producer based in the city of
Hyderabad. Datla also sits on the board of Gavi.
India’s
health minister recently predicted that the country would be in a position to
start distributing a vaccine within
the next six months. The government is working on a plan to immunize
as many
as 250 million people by July, he said.
Reaching
that goal will require the manufacturing heft of Serum Institute. The company
has diverted capacity from existing vaccines and started work on a new
production facility to be completed next year at its headquarters in the
western Indian city of Pune.
Poonawalla
said the company has pledged to keep half of the vaccines it makes for use
within India. It has already begun manufacturing the AstraZeneca vaccine, he
said. About 20 million doses have been made, and he expects to have 10
times that amount ready in the next four months.
He
is optimistic that in 2021, a new coronavirus vaccine will be licensed for
public use every couple of months. “That’s the good news,” Poonawalla said. The
less-good news is that it remains unclear which vaccine, if any, will offer
long-term protection from the virus. “Nobody wants a vaccine that is only going
to protect you for a few months,” he said.
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