'People
are already sending congratulatory messages. But I have said, "Please
don't until the trials are over".'
IMAGE: A quality control test conducted at the Serum Institute. All photographs: Kind
courtesy seruminstitute.com
India, a vaccine manufacturing hub, is in the thick of
the action as the global pharma industry races to find a cure or vaccine for
COVID-19.
The
Serum Institute of India is one Indian manufacturer that is developing a
vaccine and is hopeful of a successful partnership with researchers at Oxford
University.
But
its optimism is guarded, given the uncertainties involved in the various stages
of vaccine trials.
The
Pune-based company also plans to start trials on people to assess whether the
Bacille Calmette-Guérin (BCG) vaccine for tuberculosis can also protect against
the COVID-19 virus.
It
has also collaborated with American biotech firm Codagenix to develop a 'live
attenuated vaccine' (which reduces the virulence of a pathogen while keeping it
alive).
The
vaccine developed by an Oxford University group led by Andrew Hill, director of
the Jenner Institute, has held out the most promise in the global race.
The
Serum Institute has partnered with Hill's team to mass-produce the vaccine.
Human trials were carried
out in the UK last month, backed by government support.
At
the time, the Oxford attempt was reported as faring better than other research
projects.
The
New York Times reported that six rhesus macaques were
healthy after they were inoculated with the vaccine in March and exposed to the
COVID-19 virus.
The Oxford scientists now
intend to conduct trials on over 6,000 people by May-end, and hope that a
vaccine will be developed by September.
"People
are already sending congratulatory messages. But I have said, 'Please don't
until the trials are over'," says Adar C Poonawalla, CEO, Serum Institute
of India, the world's largest vaccine manufacturer by the number of doses
produced and sold globally.
The
Serum Institute will be ready with 40 million to 50 million doses of the
vaccine by September-October, Poonawalla says.
The
company is preparing for a best-case scenario, as Poonawalla recognises that
developing an effective vaccine could take up to a year or longer.
IMAGE:
From left Dr Cyrus S Poonawalla, founder, Serum Institute of India, Bill Gates
and Adar C Poonawalla, CEO, Serum Institute, aat the Serum Institute of India
offices in Pune
Cyrus S
Poonawalla established the Serum Institute of India in 1966.
His son Adar joined the company in 2001 and took
over a decade later.
The company produces 1.5 billion doses annually --
including for polio, diphtheria, tetanus, pertussis, BCG, measles, mumps and
rubella -- mainly from its two facilities in Pune.
It has acquired two smaller plants in The
Netherlands and the Czech Republic in 2012 and 2017, respectively, and supplies
vaccines to 170 countries.
In Pune, the pandemic hit the company's operations
as its plants are functioning with less than half its employee strength of
6,000.
Its exports, which make up more than half of its
turnover, have also ground to a halt.
"Parents of children in other countries are
not going to clinics for vaccination as they are afraid of COVID-19. So it's a
domino effect," says Adar Poonawalla.
The Serum Institute's readiness to manufacture a
vaccine before it is a proven success owes to its strength in terms of
additional capacity.
It is investing Rs 642 crore (Rs 6.42 billion) to
set up a dedicated plant that can eventually churn out half a billion doses,
but that will take at least two years.
Meanwhile, says Adar Poonawalla, the company had
already set up two facilities to add to its capacity for producing existing vaccines.
"So capacity (to produce a new vaccine)
is not an issue at all," he says.
As the lockdown foists a new order in our social
lives and prioritises the pandemic over all other diseases, there are concerns
over disruption of immunisation in general.
The Serum Institute has stocks of vaccines for
other diseases but demand is currently low.
"Only with fears going down will we be able to
vaccinate children against diseases such as pneumonia and measles, and ensure
there are no other serious outbreaks which could further strain our health
system," says Adar Poonawalla.
IMAGE:
A vaccine manufacturing lab at the Serum Institute of India.
The COVID-19
crisis has fuelled unprecedented research for a vaccine, with 100-odd vaccines
in preclinical stage and eight in human trials as of the middle of last week.
In India, half a dozen major companies, including
Zydus Cadila, Bharat Biotech and Indian Immunologicals, are developing
vaccines.
The Indian pharma industry supplies more than 50
per cent of the global demand for several vaccines, and accounts for 20 per
cent of the exports in generic drugs, according to data published in January
2019 by the India Brand Equity Foundation.
Adar Poonawalla realises it is a gamble, and a
vaccine other than Oxford's might win this massive global race.
But even as the enormity of the crisis offers an
opportunity and pits private profit against public health, he is confident that
the successful company and researcher would out-license to multiple
manufacturers just like Oxford has done.
Besides the Serum Institute, the UK-based
AstraZeneca has entered into a partnership with the university to manufacture
the drug.
The Serum Institute plans to sell the COVID-19
vaccine at Rs 1,000.
The central government will distribute it for free
under the Ayushman Bharat scheme, it has said.
IMAGE:
The Serum Institute's bio-parma Park in Pune
One eminent scientist, who
did not want to be named, feels the Oxford scenario is overly optimistic.
If the experimenters are extremely lucky, proof of concepts could be
available in three to four months.
But we will probably not get a vaccine for at least a year, says the
scientist.
The Oxford study yielding positive animal and antibody results has led
to the hope that it will work on humans too and quickly overcome regulatory and
manufacturing hurdles.
But the process is more complicated than that.
"Just having an immune response doesn't mean that a vaccine
protects you against the virus. We have to know what exactly constitutes a
protective immune response and then determine whether a vaccine produces that
effect," the scientist says, adding that many pharma companies also
overstate the ease of manufacturing.
Mass access to the vaccine will also remain a critical issue,
notwithstanding the promise of free distribution among the poor.
Much will depend on all stakeholders working together, and the fate of
initiatives such as the Access to Covid Tools Accelerator (ACT Accelerator), a
collaborative taskforce recently launched by the World Health Organisation.
Just before India's lockdown ends, the rapid spread of COVID-19 cases
with record single-day spikes puts a question mark on all efforts.
What lies ahead after restrictions are lifted?
Dr Jayaprakash Muliyil, an epidemiologist and former principal of the
Christian Medical College, Vellore, has pointed out that herd immunity (when
more than half of the population is infected) is a natural progression.
To attain this, he has suggested allowing transmission in the young,
which is a low-risk category compared to the elderly.
Of course, he points out, a vaccine is a superior option simply because
it can grant immunity to people without harming them, unlike natural infection.
"Unfortunately, for a vaccine to develop, we have to make sure it
is safe. And that takes a while. There are two issues: Does a vaccine work and
protect? And does it do any harm?
So it should be a vaccine without any side effects."
India has produced fairly good vaccines in large amounts in the past,
and the government has been able to negotiate with companies and fetch them at
competitive prices.
But, for now as a company like the Serum Institute of India would
attest, it's a race against time unlike any in recent memory.