NEW DELHI: The Drugs Controller General of India (DCGI) on Sunday granted conditional emergency use authorisation for Serum Institute of India (SII) and Bharat Biotech Covid-19 vaccines, setting the stage for the first jabs to be rolled out in the country within days and heralding a return to normal life, even as concerns were expressed by some experts at the speed at which Bharat Biotech was granted approval.
The government officials said India’s vaccination drive is likely to begin in the next one to two weeks. The government plans to vaccinate 300 million by July-August. Health Minister Harsh Vardhan has said 30 million healthcare and frontline workers will be inoculated for free in the first phase.
Bharat Biotech has been granted approval in clinical trial mode. Those take this jab will be monitored like trial participants.
Prime Minister Narendra Modi said the approval of thevaccines would accelerate the road to a healthier and Covid-free nation, while describing the development as ‘a decisive turning point to strengthen a spirited fight’.
All India Institute of Medical Sciences (AIIMS) director and national task force on Covid-19 management member Randeep Guleria said the SII vaccine would be rolled out first and that the Bharat Biotech vaccine had been approved as a backup plan. “The approval to Bharat Biotech is for an emergency situation… if there is a situation like number of cases going up or if the cases of mutant virus start to go up, we can introduce the Bharat Biotech vaccine without any delay. I don’t see Bharat Biotech’s Covaxin vaccine being used in early stages unless the situation changes,” he told ET. His statement came amid questions being asked about the approval given to the Bharat Biotech, which has not yet disclosed its efficacy data.
Some Questions Raised
“The decision to approve an incompletely studied vaccine, even under accelerated process raises more questions than answers and likely will not reinforce faith in our scientific decision-making bodies,” said All India Drugs Action Network, a non-government organisation.
Bharat Biotech chairman and managing director Krishna Ella said Covaxin has generated excellent data with robust immune responses to multiple viral proteins. The company conduct India’s first and only phase-3 efficacy study for a Covid-19 vaccine. Its phase-3 efficacy trials were the largest ever conducted for any vaccine in the country. “Covaxin has been evaluated in approximately 1,000 subjects… with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals,” said the company.
Earlier during the day, while accepting the Subject Expert Committee’s (SEC) recommendations and approving the two vaccines, the drugs controller general said they have to be administered in two doses and stored at 2-8 centigrade.
The drug regulator said SII had conducted phase-2/3 trials on 1,600 participants in India. The interim safety and immunogenicity data generated from this trial was found comparable with the one submitted from the overseas clinical studies by AstraZeneca-Oxford university. The SII vaccine is based on AstraZeneca-Oxford University technology.
Highest Number of Infections after US
With regard to Bharat Biotech, the regulator said phase-3 efficacy trials were initiated in India in 25,800 volunteers. Till date, around 22,500 participants have been vaccinated, and the vaccine has been found to be safe as per data available till now.
India has been eagerly awaiting the rollout of the vaccination programme. While daily cases have come down in the country, it still has the second-highest number of infections in the world after the US. More than 10 million people have been infected by the virus in the country and it has claimed lives of almost 150,000 people. The lockdown imposed in the initial months of 2020 and the disruption of normal business activity has led to a severe contraction in the economy.
The task of vaccinating 1.38 billion Indians will be a mammoth one. The state governments, district officials and municipal commissioners have been asked to get ground staff, logistics and IT systems in place to carry out the vaccination drive in a 148-page operational guidelines document drawn up by the health ministry and the National Expert Group on Vaccine Administration for Covid-19.
In the first phase, those on the priority list will be healthcare workers, estimated at about 10 million, and another 10 million frontline workers. Next will be the population of 50 years of age and above, followed by those below 50 with comorbidities — estimated at 270 million or so.
Within the priority age group, the health ministry document said those above 60 years may be prioritised in the first phase.
Those seeking the vaccine will have to register themselves on the Co-Win19 website, the IT backbone that will keep track of the drive.
Among those running the programme will be 19 cabinet ministers in charge of defence to food and public supplies. They will be responsible for managing transport of vaccines, including getting them to remote areas and
ensuring cold storage spaces for delivery, among other aspects.
On the storage front, India will use about 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers and 300 solar refrigerators.
Supply Issues Remain
Despite these preparations, issues regarding vaccine supply remain.
SII CEO Adar Poonawalla in an interview to ET last week had said that his company can supply 10 million jabs this month to the government. He said the government had not signed any purchase agreement with it yet and in the absence of any signed contract, the company cannot manufacture and store in factories. “Till we don’t have visibility on the purchase agreement we don’t want to take more risk.”
Poonawalla had added that the message from the government appeared to be that it was not looking at vaccinating the entire population and the company might have to supply for 20% of the population.
A government official said the authorities were awaiting final approval before purchase agreements were finalised.
