The government has announced that it will be giving COVID-19 vaccines free of cost across the country. However, Serum Institue of India's CEO Adar Poonawalla stated that if the government allows sale in the retail, the vaccine will be commercially available at ₹ 1,000 per dose, reported NDTV.
India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The Drugs Controller General of India (DCGI) granted approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
This clears the way for the roll-out of at least two vaccines in India in the coming days.
Serum and Bharat Biotech vaccines have to be administered in two doses and these vaccines have to be stored at 2-8° C.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The World Health Organisation also welcomed the move, saying it will "help intensify and strengthen the fight against the pandemic in the region".
Serum Institute of India's CEO Adar Poonawalla, after the approval, tweeted, "COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks." In his media statement, Somani also said Zydus Cadila has been granted the permission to conduct Phase III clinical trial of its plasmid DNA vaccine candidate in India.
"The firm initiated Phase-I/II clinical trials in India in more than 1,000 participants which is ongoing. The interim data suggest that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct Phase-III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee," he added.
Pune-based SII's shot is a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield), encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.
"The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent," Somani said.
Further, SII was granted permission to conduct Phase-2/3 clinical trials on 1,600 participants within the country, he said.
SII had applied to the DCGI seeking nod for its vaccine on December 6, while Bharat Biotech submitted its application on December 7. Pfizer had also applied for regulatory approval for its vaccine on December 4, but not much progress has been made on it after that.
(With inputs from PTI)