India’s drug regulator approved two Indian-made coronavirus vaccine candidates for emergency use Sunday, the Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin.
The firms behind the two candidates “submitted data on their trial runs and both have been granted permission for ‘restricted use’,” Drug Controller General of India (DGCI) Chief V.G. Somani said at a press conference Sunday, according to India’s WIO news.
“Safety immunogenicity data submitted by SII found efficacy was 70.42 percent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR [Indian Council of Medical Research] and NIV [India’s National Institute of Virology],” Somani said.
Indian Prime Minister Narendra Modi praised the vaccine candidates’ approval for limited use on Sunday.
“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 fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” he wrote on Twitter.
Modi referred to Aatmanirbhar Bharat, the Self-Reliant India initiative he launched last April in response to the Chinese coronavirus pandemic. The campaign aims to make India less reliant on China and other foreign countries for trade and manufacturing.
The vaccine candidates’ approval will launch one of the world’s largest vaccination drives in the coming days among India’s population of nearly 1.4 billion people.
“The government has already been holding nationwide drills ahead of the mass inoculation drive and 96,000 health workers have been trained to administer the shots,” WION reported Sunday.
Some Indian medical institutions claimed on Sunday that the approval process for the two experimental immunizations lacked transparency and called for the vaccine candidates’ efficacy data to be made public.
“In the case of each approved vaccine, there is no information regarding the specific provision of the law under which the DCGI is granting Restricted Emergency Use (REU) approval. Neither has information been provided regarding the conditionalities attached to either approval,” Malini Aisola, a member of the All India Drug Action Network (AIDAN), said Sunday.
“AIDAN has issued a statement requesting the [vaccine] regulator[s] to make all the data and analyses that were the basis of the decisions publicly available so that they can be independently verified,” according to the Times of India.
Responding to criticism of the vaccine’s approval process at Sunday’s press briefing, Somani said the DCGI would “never approve anything if there is the slightest safety concern.”
“The vaccines are 100 percent safe,” the DCGI chief assured.
The inoculations’ possible side effects, including “mild fever, pain, and allergy are common for every vaccine,” he added.
India has recorded more than 10.3 million cases and roughly 150,000 deaths from the Chinese coronavirus to date, “though its rate of infection has come down significantly from a mid-September peak,” WION noted.
The South Asian giant plans to inoculate 300 million of its 1.35 billion people in the first six to eight months of 2021.
“SII, the world’s biggest producer of vaccines, has already stockpiled about 50 million doses of the AstraZeneca/Oxford shot [Covishield], which will be sold to the government at about 250 rupees ($3.42) per dose and 1,000 rupees [$13.67] on the private market,” according to WION.
Covishield was developed by SII along with Oxford University and the multinational pharmaceutical company AstraZeneca.