The Serum Institute of India has sought government permission to manufacture and store the locally developed quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer after the completion of phase 2/3 clinical trials to ensure its rapid availability in the country, official sources said on Sunday.
The company will soon seek marketing authorization as well as a manufacturing license from the Drug Controller General of India (DCGI) for the vaccine, they said.
In a letter to the Union Health Ministry, Prakash Kumar Singh, Director of Government and Regulatory Affairs at SII, reportedly said qHPV takes five to six months to manufacture. “We are prepared to manufacture and store qHPV at our own risk in view of the rapid availability of this life-saving vaccine to the citizens of our country,” an official source quoted Singh as saying in the letter.
The app mentions that every year thousands of women are diagnosed with cervical cancer and the mortality rate is also very high. In India, cervical cancer is the second most common cancer among women aged 15-44.
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“Currently, our country is entirely dependent on foreign cervical cancer vaccine manufacturers and the citizens of our country are required to purchase these vaccines at a very high price. We have been working for more than five years under the leadership of our CEO Adar C Poonawalla for making available a world-class indigenous vaccine against cervical cancer, i.e. the quadrivalent human papillomavirus vaccine,” Singh reportedly said in his letter.
“In line with our Prime Minister Narendra Modi’s clarion call (for) ‘Made in India for the World’ and ‘Vaccines Affordable for All’, we assure you that this year our qHPV vaccine will be available to the population of our country and the world at large,” he said.
An official source familiar with the development said that if the government approves the SII proposal, it would buy a lot of time to include locally developed qHPV in the universal vaccination program.