Prime Minister Narendra Modi on Sunday congratulated Indians after the country’s drug regulator approved two vaccines developed by the Serum Institute and Bharat Biotech for restricted emergency use against the coronavirus. In a series of tweets minutes after the approval, the prime minister said it would make every Indian proud that the two vaccine candidates were “made in India”.
The Serum Institute of India is the local maker of Covishield vaccine developed by Oxford University and pharmaceuticals company AstraZeneca. Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. The formal approval came a day after the Subject Expert Committee of Central Drugs Standard Control Organisation recommended that permission be granted “for restricted use in emergency situation in public interest”.
“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India,” Modi tweeted. “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.”
Modi called the emergency vaccine approval “a decisive turning point to strengthen a spirited fight” against the coronavirus pandemic, adding that the development accelerates the road to a healthier and coronavirus-free India.
The prime minister also congratulated Indian scientists and others for their contribution. “We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all corona warriors for the outstanding work done, that too in adverse circumstances,” he added. “We will remain eternally grateful to them for saving many lives.”
Adar Poonawalla, chief executive officer of the Serum Institute of India, said the decision clears the vaccine roll out in the coming weeks. “Happy new year, everyone,” he tweeted. “All the risks Serum Institute 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.”
On Monday, Poonawalla had said that the company has already made 40 million to 50 million doses of the vaccine. However, the government has not yet signed a deal with the firm.
Meanwhile, World Health Organization’s South-East Asia Regional Director Poonam Khetrapal Singh welcomed the drug regulator’s decision to grant emergency vaccine approval. “This decision taken today by India will help intensify and strengthen the fight against Covid-19 pandemic in the region,” Singh said. “The use of vaccine in prioritised populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of Covid-19.”
The government’s principal scientific adviser K Vijay Raghavan said vaccinations in India will begin soon. “Congratulations all,” he tweeted. “This is a result of focused work by scientists, national laboratories, government agencies, regulators, health care workers, and most importantly, all our people who have waited patiently following all Covid appropriate behaviour.”
He also said that there were full vaccination measures in place across the country.
Congress leader Shashi Tharoor opposed the Drugs Controller General of India’s approval to Bharat Biotech’s vaccine. Tagging Union Health Minister Harsh Vardhan, he said the authorisation was “premature” and could be dangerous as the vaccine has not yet conducted Phase 3 trials in India. He said the vaccine usage should be avoided till the last stage trials are over, asking the health minister to clarify about the matter. “India can start with the AstraZeneca vaccine in the meantime,” he wrote.
In the case of Bharat Biotech’s Covaxin, only data from studies on animals and phase 2 data on 800 volunteers were studied, according to DCGI chief VG Somani. “Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” Somani read out from a written statement at a press conference. He did not take questions from reporters or elaborate the conditions that the companies would have to adhere to after getting approval.
The Bharat Biotech data that has reportedly been submitted to the drug controller is, however, not in the public domain. A controversy had erupted early on after ICMR chief Balram Bhargava – in a letter to principal investigators working on Covaxin trial – had told them on 2 July, when the trials had not even begun, to launch the vaccine for public health use latest by August 15.