DGCI allows Serum Institute to export malaria vaccine to UK
Sep 29, 2022, 18:17 IST
India's drug regulator has allowed the export of the first produced-in-India vaccine against malaria, developed by scientists at the University of Oxford and manufactured by Serum Institute to the UK, official sources said on Thursday.
The Drugs Controller General of India (DCGI) has granted permission to send two lakh doses of the vaccine.
The move comes after an application was submitted by Prakash Kumar Singh, director, Government and Regulatory Affairs, at Serum Institute of India (SII) to DCGI on September 27 seeking permission to export the vaccine against malaria, official sources told PTI.
"SII has developed the vaccine against malaria under leadership of our CEO Dr Adar C Poonawalla. We have been relentlessly working to make available made-in-India and world-class vaccines against malaria to our country and world at large," an official source quoted Singh as having said in the application.
Currently, only one vaccine against malaria is available globally and GSK is the manufacturer of that.
The malaria vaccine was designed at the Jenner Institute, University of Oxford, which collaborated with the SII in 2020 to manufacture and develop the jab for large- scale supply, the sources said.
The vaccine trial results which included 409 children in Nanoro, Burkina Faso showed that three initial doses followed by a booster after a year gives up to 80 per cent protection against the disease, they said.
The SII along with Oxford University is currently doing advanced-stage trials in African countries.
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The Drugs Controller General of India (DCGI) has granted permission to send two lakh doses of the vaccine.
The move comes after an application was submitted by Prakash Kumar Singh, director, Government and Regulatory Affairs, at Serum Institute of India (SII) to DCGI on September 27 seeking permission to export the vaccine against malaria, official sources told PTI.
"SII has developed the vaccine against malaria under leadership of our CEO Dr Adar C Poonawalla. We have been relentlessly working to make available made-in-India and world-class vaccines against malaria to our country and world at large," an official source quoted Singh as having said in the application.
Currently, only one vaccine against malaria is available globally and GSK is the manufacturer of that.
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The vaccine trial results which included 409 children in Nanoro, Burkina Faso showed that three initial doses followed by a booster after a year gives up to 80 per cent protection against the disease, they said.
The SII along with Oxford University is currently doing advanced-stage trials in African countries.
SEE ALSO:
World Heart Day 2022: Silent attacks account for 45% of heart attacks in men say doctors
Reliance Retail’s new lifestyle store AZORTE goes high-tech with smart trial rooms, self-checkout kiosks