leads India’s Swine Flu Vaccine Race
largest biotech company and also one of the world’s top
pediatric vaccine makers, Serum Institute of India, based in Pune, is
lead player from the country in the global race to develop an
effective vaccine against the
“unstoppable” spread of the swine flu virus. Two
other companies—Panacea Biotec and Bharat Biotech—
too have joined the race. A Special Report.
It is a quiet corner of the sprawling campus of Serum
Institute of India in the western Indian city of Pune, a crack team of
16 scientists has been running a battle against time. This team, chosen
specifically by the senior management of India’s largest
biotechnology company, has no time to relax, as they are part of the
global race to develop a vaccine against the swine flu.
The crack team now works out of BioSafety Level 2 (BSL 2) facility,
enhanced with various facilities as per current global standards. The
facility suitable for work involving agents of moderate potential
hazard to personnel and the environment. It includes various bacteria
and viruses that cause only mild disease to humans, or are difficult to
contract via aerosol in a lab setting, such as Hepatitis A,
B, and C, influenza A, Salmonella, mumps, etc.
The team was put together just a few weeks after the first Influenza A
infection, caused by a new, virulent strain H1N1 was first detected on
April 12, in a small village near Veracruz in Mexico. It was
transmitted from pigs to a five-year-old son of a worker in a pig farm.
And it was quickly named, the “swine flu” virus.
The summer in the Northern Hemisphere is the time when influenza
viruses normally lie low, waiting for their turn to strike as the
winter set in around October-November.
However, this H1N1 strain has had other ideas and aided by air travel,
it has traveled to the farthest corners of the world within weeks. And
the global health agency, the World Health Organization (WHO) of the
United Nation has now termed it “unstoppable.”
Normally, it takes about 25 weeks for a new influenza virus to cover
the planet. But H1N1 reached all continents within nine weeks and WHO
was forced to term it a pandemic, the term used to describe a viral
infection present widely in all the continents on Earth. And it
triggered a global response to find a solution to secure
people in the years to come in the shortest possible time.
“The flu transmission didn’t stop even after the
increase in summer temperatures. And studies have indicated that people
born after 1975 were more vulnerable due to the inability of their
immune system to recognize this H1N1 virus strain,” said Dr
Suresh S Jadhav, executive director, Serum Institute, and coordinator
of the company’s swine flu vaccine initiative.
WHO has decided to take the H1N1 challenge head on and hence roped in
as many companies as possible with expertise in manufacturing vaccines
to develop a vaccine against the H1N1 influenza strain. Though Serum
Institute is not a manufacturer of seasonal influenza vaccine, Serum
was chosen from India by WHO to lead the challenge. Technical and other
inputs to Serum followed.
WHO has roped in 21 current manufacturers of influenza, located mainly
in the US, Europe, Japan and Australia for the global efforts. Serum
Institute and five other companies—Birmax, Mexico, Bio Farm (
Indonesia), Government Pharmaceutical Organization (GPO),
Thailand, Vabiotech ( Vietnam) and Butantan,
Brazil—were chosen by WHO to join the global swine flu
vaccine production efforts.
Developing a vaccine against the H1N1 virus strain is complex and
time-consuming process. Serum Institute’s team is very much
aware of the complex process, informed Dr Rajeev M Dhere, senior
director, handling the effort at the Pune company.
Influenza viruses change frequently and usually a vaccine made against
a specific strain is useful only for vaccination during single season.
So each year the seasonal influenza vaccine is changed. The seasonal
vaccine production for the influenza viruses which were expected to
activate in the winter of 2009 is almost fully ready and stocked up in
major consumption areas of the world. Experts indicated that the
current year’s seasonal influenza vaccine has used three
virus strains: A/Brisbane/59/2007 ( H1N1), A/ Uruguay/716/2007 ( H3N2)
Dr Dhere said experts at the Centers of Disease Control (CDC) in the US
have determined the genetic sequence of the new H1N1 influenza virus.
The genetic sequence is significantly different to the H1N1 contained
in the current seasonal influenza vaccine. So the current seasonal
vaccines will not provide any protection against the new H1N1 strain
and hence a different vaccine is required.
Several strains of the H1N1 viruses have been extracted from the
infected people in Mexico and California. The A/Mexico and A/California
strains are the basis for the vaccine production.
Dr Dhere explained the process. The first step in the vaccine
production is the making of the “seed” virus.
Experts at CDC have prepared the “seed” virus from
A/Mexico and A/California H1N1 strains. The
“seed” virus is a safe form of the influenza virus,
stripped of its parts that spread the infection. The live virus is
genetically altered to make it safe. This is a time consuming
process and takes about three to four weeks.
This “seed” virus is supplied to vaccine
manufacturers chosen by the WHO around the world. The
“seed” viruses from various strains are then
prepared to be ready for vaccine production by a process called
“assortment.” These reassorted viruses
are then injected into specially prepared pathogen-free, fertile
chicken eggs. The safe virus then grows inside the eggs for four to six
weeks. The viruses are then extracted from the eggs, purified and
inactivated and then formulated into a vaccine.
Serum Institute has got the “seed” viruses. During
this period, H1N1 strains have been extracted from infected patients in
India and Turkey too. And the viruses are identical indicating that the
new vaccine should work against the swine flu which has spread to all
these regions effectively.
The normal dosage of influenza vaccine is 15 mg. From each chicken egg,
one dose of influenza vaccine is produced. Sometimes, two eggs may be
required to produce each dose of standard influenza vaccine.
Serum’s team is now confronted with another tricky
part of the project. That is to source enough chicken eggs to grow the
vaccine. Luckily, Venkateshswara Hatcheries, India’s largest
poultry maker is situated in the same city.
“Currently, the company will supply us about
100,000 pathogen-free eggs. But if there is urgent requirement to step
up the vaccine production, they will be able to give us up to 2.5
million eggs a month,” says Suresh
Jadhav. There are two other major poultry suppliers near
Bangalore. They too will be roped in if the swine flu virus spins out
of control in the country. But so far things have been under control
with less than 500 H1N1 infections reported in India till July-end.
Under the scheme supported by WHO, Serum Institute is committed to
provide at least 10 percent of its swine flu production for use in
other countries. “Such an assurance has been guaranteed by
the Indian government. This is just to ensure that in the case of a
national emergency, the government does not stake claim to the entire
production leaving nothing for global use,” explains Serum
Institute’s senior director, Dr Satish Ravetkar.
Though the Indian government has given the go ahead for mass scale
production of the H1N1 influenza vaccine, it has yet to give firm
orders to either Serum Institute or the two other India
companies—Panacea Biotec, New Delhi, and Bharat Biotech,
Hyderabad—about the quantity requirements.
“We have given approvals to these three companies
(Serum Institute, Panacea Biotec and Bharat Biotech) to get
seed strains from CDC, Atlanta and the UK-based National Institute for
Biological Standards and Control (NIBSC) to start preliminary
research,” said Drug Controller General
of India (DCGI), Dr Surinder Singh. The companies will now have to go
through the other stages of development like pre-clinical trials and
Scientists at Serum expect to have the vaccine ready by September. They
are also preparing a limited human trial involving at least 25
volunteers. It will be another six months before the vaccine will be
ready for mass use. In the event of an emergency, WHO has clarified
that countries could relax some of the stringent provision related to
approvals to speed up the vaccine’s availability to fight a
raging swine flu pandemic.
Authorities in China have been more proactive and the Beijing city
government has already placed the order to supply at least 4
million doses by the end of September to local vaccine maker, Sinovac.
This order will be administered to 2 million people in the high risk
group. Additional orders are expected beginning in October and, in
total, Sinovac expects to supply approximately 10 million doses to the
Beijing government. The 10 million doses will be administered to five
million people in Beijing.
Serum plans to invest over $30 million (Rs 150 crore) to set up a
separate facility to make the swine flu vaccine. “This is
part of our commitment to make available affordable vaccine to the
people who will need it the most,” asserted Serum’s
chairman, Dr Cyrus S Poonawalla. He will be happy if the Indian
government makes a firm announcement about its plans to tackle the
swine flu which is likely to be around for some more years to come.
India’s citizens are waiting for a similar announcement from
their government. Of course, the government is not concerned too much
because of the mild form of infection that has surfaced in the country
so far. Yet again, the beneficiaries of the technological prowess
demonstrated by a company like Serum in developing an influenza vaccine
in the shortest possible time could be many global citizens.
Narayanan Suresh in Pune