India's drugs regulator has 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.

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The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). "After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations," DCGI V G Somani told the media.

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," Somani said, adding these vaccines have to be stored at 2-8 degree celcius. 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 Prime Minister termed the approval a "decisive turning point" in India's fight against the novel coronavirus. "DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," he tweeted.

The Health Minister termed it a "watershed moment in India's battle against COVID-19". The World Health Organisation also welcomed the move, saying it will "help intensify and strengthen the fight against the pandemic in the region". The Serum Institute of India's CEO 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 suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, 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.

The Department of Biotechnology secretary said they partnered with Zydus Cadila to address the need for accelerated development of an indigenous vaccine for COVID-19. "The partnership exemplifies that such research endeavours demonstrate the government's focus on creating an ecosystem that nurtures and encourages new product innovation with societal relevance," she said.

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. On Covaxin, Somani said, "Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and globally."

Phases 1 and 2 clinical trials were conducted on approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response, he said. The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, Somani said. "The clinical trial ongoing within the country by the firm will continue," he said.

Dr Reddy's Laboratories is conducting phases 2 and 3 clinical trials of Russian vaccine Sputnik V, while Biological E is conducting phase 1 trial of its indigenously developed vaccine candidate. 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.

Meanwhile, the ruling party hit out at the opposition after some of its leaders questioned the approval process for Covaxin, with the party president alleging that whenever India achieves something commendable the opposition comes up with "wild theories" to "ridicule" the accomplishments.

Some opposition party leaders raised serious concerns over the grant of approval to Covaxin, saying it is "premature" and can prove dangerous. The Health Minister said Bharat Biotech's vaccine is more likely to work against newer variants of coronavirus, including the UK variant, and asked politicians not to "discredit" the approval protocol.