Animal trials start for
India’s swine flu vaccine
Slowly and steadily India’s swine flu vaccine developing
companies are making good progress even as the influenza virus infects
hundreds of people every day across the country.
“Serum Institute will be ready to seek permission from the
regulator ( DCGI) in November to seek permission for clinical trials of
its swine flu vaccine on human volunteers,” said Dr Satish D
Ravetkar, senior director of Serum Institute who is handling the
vaccine project. If that happens, the human trials could start in early
Hyderabad-based Bharat Biotech International has developed the swine
flu vaccine using the cell lines method. “We are now doing
the characterization and quality control studies on the
vaccine,” said Dr Krishna Ella, chairman of Bharat Biotech.
While most companies in the world have used the traditional chicken egg
method, Bharat has used cell lines methodology like Novartis and Baxter.
Bharat Biotech is likely to approach the regulator for approvals to
start animal trials in September to generate data for human trials
after three to four months.
What is worrying the vaccine makers, however, is the absence of any
firm commitment from the government to buy the swine flu vaccines. So
far, the government has announced its intention to order 10 millions
doses of the swine flu vaccine when it is ready. “But we have
not got any firm order from the government on purchase quantities or
price,” said sources handling the government negotiations in
both Serum Institute and Bharat Biotech.
Panacea Biotec’s joint MD Rajesh Jain had talked
about the absence of support from the government to these vaccine
making initiatives with no indication of quantity requirements. This is
in contrast to national governments in most developed countries making
advance orders to influenza H1N1 vaccine companies in the US, Europe,
China and Australia to stock up as much vaccine as possible when it is
ready, pointed out an industry expert.
Dr Ella indicated that if everything goes well, the swine flu vaccine
will be ready for the flu season starting in the winter of
2010. Bharat Biotech is even planning to use its animal
vaccine manufacturing facility, run by its associate company, Biovet,
to make the swine flu vaccine, if the nation requires it.
However, even with all these preparation, the company will be aiming to
manufacture just 50 to 70 million doses of the vaccine, said
Dr Ella. At Serum too, an elaborate exercise is on to determine the
manufacturing capacities which could be readied for large scale
production. “As the influenza strain is new, the vaccine
yield will be very low during the initial stages. Further, we still
don’t know what will be the standard dosage to combat the
H1N1 virus,” Dr Ravetkar said.
The process itself is complex and time-consuming. Dr Ravetkar indicated
that the immunogenicity trials will take four-to-five weeks. The
toxicity studies could be taken only after reviewing these results. The
toxicity studies will take another six to seven weeks. Bangalore-based
Advinus Therapeutics is understood to be conducting some of the
immunogenicity trials for Serum Institute. A Pune-based laboratory,
Toxicology Research Foundation is reportedly doing the toxicity studies.
CSL starts pediatric
trials in US
CSL Biotherapies has meanwhile started clinical trials of its influenza
vaccine in the US too. The US government-funded trials will happen in
24 sites in the country. It is anticipated that findings from these
trials will be used to determine the most appropriate dosing schedule
of the Influenza A/H1N1 2009 vaccine for use in the general population.
CSL said this clinical trial program was part of a larger,
global effort by CSL Biotherapies, in partnership with government and
regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market
in the US, Australia and in select regions of the southern hemisphere.
“The H1N1 pandemic has had a significant toll on the health
and well-being of people worldwide, which makes the development of an
effective vaccine against the virus an urgent public health
need,” said Dr Kawsar Talaat, principal investigator of the
CSL vaccine adult trials and assistant scientist in the Johns Hopkins
Bloomberg School’s Department of International Health.
“Through these trials, we hope to identify the most effective
dose and dosing regimen to protect the public against this highly
infectious new strain of influenza virus.”
“Children are often at greater risk from influenza infection
and its complications than adults, so it is extremely important to
understand the efficacy of an H1N1 vaccine in this very vulnerable
population,” said Dr Pedro Piedra, principal investigator for
the vaccine pediatric trials and professor in the department of
molecular virology and microbiology, and pediatrics at Baylor College