"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.
"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.
Prime Minister Narendra Modi | Twitter
Health Minister Harsh Vardhan termed it a "watershed moment in India's battle against Covid-19".
A watershed moment in India’s famed battle against #COVID19 under the charismatic leadership of Hon’ble PM Sh @narendramodi Ji !
Our wait for
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Union Minister for Health Harsh Vardhan | Photo: PTI
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 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 (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." "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 BJP hit out at the Congress after some of its leaders questioned the approval process for Covaxin, with party president J P Nadda alleging that whenever India achieves something commendable the opposition comes up with "wild theories" to "ridicule" the accomplishments.
Some Congress leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, raised serious concerns over the grant of approval to Covaxin, saying it is "premature" and can prove dangerous.
Health Minister Vardhan 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.