DGCI approves two vaccines for restricted emergency use

New Delhi: 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 the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (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 here.

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 C.

“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Somani told reporters after the press briefing.

His assertion came after a few raised concerns over the safety of the vaccines.

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).

Prime Minister Narendra Modi 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.

Health Minister Harsh Vardhan termed it a “watershed moment in India’s battle against Covid-19”.
The World Health Organization 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 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.

Department of Biotechnology secretary Renu Swarup 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 (Covidshield), 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.