Wait for vaccine ends: Serum Institute of India, Bharat Biotech get DCGI nod for emergency use

The DCGI nod comes after experts panel recommended both the vaccines

India on Sunday approved two vaccines against Covid-19, including a home-made one, for commercial roll out in an emergency mode, setting the stage for vaccinating 30 crore Indians over the next few months starting with doctors, nurses and front-line workers.

“After adequate examination, the Central Drug Standards Control Organisation (CDSCO) has decided to accept the recommendations of the expert committee and accordingly, vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted,” V G Somani, the Drugs Controller General of India said here on Sunday.

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A subject expert committee constituted by the CDSCO met for long hours for the past two consecutive days to review the data presented by the two companies and recommended emergency commercial use of the two vaccines, which would initially be administered to one crore healthcare and two crore front-line workers free of cost.

The Serum Institute of India (SII) had submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies in which the overall vaccine efficacy was found to be 70.42%.

From the ongoing Indian trial on 1,600 patients, the firm also submitted the interim safety and immunogenicity data, which was found comparable with the overseas clinical trial data.

Also read — 'Covishield' ready to roll out in coming weeks: Adar Poonawalla

Serum Institute of India’s CEO Adar Poonawalla said in a tweet that all the risks that SII took "with stockpiling the vaccine, have finally paid off." He tweeted, “Happy new year, everyone! All the risks Serum Institute of India took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”

Bharat Biotech, on the other hand, generated safety and immunogenicity data in various animal species and conducted phase 1 and 2 clinical trials on about 800 subjects to demonstrate that the vaccine is safe and provides a robust immune response.

“The phase 3 efficacy trial was initiated in India in 25,800 volunteers and till date around 22,500 participants have been vaccinated across the country. The vaccine has been found to be safe as per the data available till date,” Somani said.

Both vaccines are to be administered in two doses at a gap of 28 days. Both can be stored in 2 to 8 degrees Celsius, making it easy for widespread use in India.

“The WHO welcomes the first emergency use authorization given to Covid-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against Covid-19 pandemic in the region," said Poonam Khetrapal Singh, Regional Director at the World Health Organisation, South-East Asia Region.

"The use of vaccines in prioritised populations, along with the continued implementation of other public health measures and community participation will be important in reducing the impact of Covid-19."

PM Modi lauded the move and dubbed it "a decisive turning point to strengthen a spirited fight!."

The prime minister further said, "It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion."

Also, the authority granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said.