NEW DELHI: India will vaccinate 20 lakh healthcare and emergency services
personnel against the deadly H1N1 virus by the end of January using an
imported swine flu vaccine.
The health ministry has set aside Rs 100 crore as an interim budget to purchase
these vaccines from any one of the four international manufacturers — Novartis,
GSK, Sanofi Pasteur and Baxter — whose candidates are presently undergoing human
trials.
However, India has one clear condition — the vaccine would have to undergo
safety and efficacy trials on the Indian population before being used in the
country.
According to experts, the vaccine may behave differently in Indians in
comparison to people of other nationalities and may cause serious side effects
like paralysis, urticaria and toxic reactions. Refusing to accept data from the
trials conducted in foreign countries, ICMR director general Dr V M Katoch wrote
to all four companies making it clear that even if it was not a largescale
trial, the companies would have to atleast undertake a two-month bridge study on
around 500 healthy volunteers.
Novartis and GSK have agreed to initiate a bridge study in India while the other
two are yet to get back.
The global vaccines are expected to be available by October-end. It will then
undergo a two-month bridge study in India. If found to be safe and efficacious
in the Indian population, the two-dose vaccine, expected to cost around Rs 500
per dose, will be imported for frontline health workers dealing with H1N1 cases.
India’s indigenous vaccine being developed by Serum Institute, Bharat Biotech
and Panacea Biotech is expected to be ready by April. The Indian vaccine will
then be picked up by the government at a much cheaper price to vaccinate other
high risk groups like children younger than five years old, people suffering
from chronic health disorders and pregnant women.
Speaking to TOI, Dr Katoch said, "India can’t use a new vaccine against a
completely novel virus without being sure that it is safe and effective for the
Indian population. Till now, two of the foreign companies have agreed to carry
out bridge studies in India. If all four companies carry out the study and their
vaccines prove safe, we will then buy from whoever gives us the cheapest price.
To start with, we will use it on healthcare workers for which we would require
around 40 lakh doses of the imported vaccine."
According to director general of health services Dr R K Srivastava, countries
like UK, France and US have booked vaccines from these international
manufacturers under an advance purchase agreement. This is because the candidate
vaccines have been tried on their population which isn’t the case with India.
An official said, "Even though these companies knew that most of their vaccines
will be purchased by developing countries like India and China, they didn’t
conduct trials here."
Source : The Times of India
