New Delhi: As India battles an upsurge of dengue, a disease that has killed more than 20 people in Delhi, two vaccines of the disease, one foreign and one Indian, are awaiting regulatory clearances.
A bite from the blood sucking tiger mosquito causes dengue. There is no drug for the disease, which causes rashes, headaches, severe joint pains and in extreme cases, internal bleeding and death.
One of the two vaccines is one made by pharma giant Sanofi and recommended by the World Health Organisation that is effective only in the 9 to 45 year age group as a tool to tackle dengue.
Earlier this year, the Indian health ministry rejected the introduction of the Sanofi vaccine to India as the company wanted fast-track its introduction and sought a waiver of the Phase III clinical trials in India.
Before its launch in any country, the human clinical trial of a new drug or vaccine is essential and it is waived in rare cases.
But India is taking a precautionary approach on the introduction of the Sanofi dengue vaccine, which is already being used among others in Mexico and Philippines.
The Ministry of Health and Family Welfare noted that "evidence was not sufficient to waive conducting a clinical trial in India".
Jean-Pierre Baylet, the Country Head of Sanofi Pasteur India, Mumbai, said: "There are good reasons to believe in our dengue vaccines - 20 years of research including in India, a recommendation from the World Health Organization and 9 countries have already adopted the vaccine".
Dr Soumya Swaminathan, the Director General of the Indian Council of Medical Research, New Delhi, said: "The scientists who evaluated it felt it might be safe to wait for a little more data to get generated and to see its uptake and experience in other countries before we proceed in India."
The other vaccine is an Indian one made by the International Center for Genetic Engineering and Biotechnology in New Delhi, which is also awaiting its first human clinical trials.
A bite from the blood sucking tiger mosquito causes dengue. There is no drug for the disease, which causes rashes, headaches, severe joint pains and in extreme cases, internal bleeding and death.
One of the two vaccines is one made by pharma giant Sanofi and recommended by the World Health Organisation that is effective only in the 9 to 45 year age group as a tool to tackle dengue.
Before its launch in any country, the human clinical trial of a new drug or vaccine is essential and it is waived in rare cases.
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The Ministry of Health and Family Welfare noted that "evidence was not sufficient to waive conducting a clinical trial in India".
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Dr Soumya Swaminathan, the Director General of the Indian Council of Medical Research, New Delhi, said: "The scientists who evaluated it felt it might be safe to wait for a little more data to get generated and to see its uptake and experience in other countries before we proceed in India."
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