New Delhi: Term it another hope for the COVID-19 vaccine in India, Indian Council of Medical Research (ICMR) and Serum Institute of India (SII) has partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from the USA.
Minister of State for Health and Family Welfare Ashwini Kumar Chaubey informed in the Lok Sabha that the trial will be initiated in the second half of October after the vaccine is manufactured by SII.
"The trial is led by ICMR-National AIDS Research Institute, Pune," said Chaubey.
Giving details of the COVID-19 vaccine in India, Chaubey said that vaccine candidates of Bharat Biotech International Limited (BBIL) and Cadila Healthcare Limited have completed Phase I clinical trial.
"The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trial for both the vaccine is undergoing," said Chaubey.
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He said that Phase II and III clinical trial for an Oxford vaccine candidate ChAdOx1 initiated by ICMR and SII are undergoing in 14 clinical trial sites.
The minister has informed that the Central Drug Standard Control Organisation (CDSCO) has granted test license permission for the manufacture of the COVID-19 vaccine for preclinical tests, examination, and analysis to seven pharmaceutical companies including the Serum Institute of India, Cadila Healthcare Limited, BBIL, among others.
He said that all vaccine candidates in India at following the New Drugs and Clinical Trial Rules, 2019.
And accordingly, the vaccine candidate undergoes preclinical studies before it starts Phase I, II, III, and IV clinical trials.
The Phase I clinical trial establish the safety of the product with 100 volunteers, the Phase II trial determine the immunogenicity or immune protection with 1000 volunteers, Phase III trial determine efficacy with several thousand volunteers before the vaccine candidate goes for the Phase IV or post-marketing surveillance studies.
He said that India has one of the lowest COVID cases per million population. "It's 3445 for India ad compared to 19295 for the USA, 20146 for Brazil, 7283 for Russian Federation, and 10929 for South Africa. However, cases per million population for India is high as compared to other countries in South East Asia," said Chaubey.
The minister has informed that the e-Sanjeevani telemedicine service is being rolled out in 1.5 lakh health and wellness centers (HWCs) under the Ayushman Bharat scheme.
The telemedicine implementation at HWCs linked with doctors has helped to address the shortage of doctors and their healthcare professionals, said Chaubey.
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