The government of India is mulling over the modalities of emergency use authorisation of Covid-19 vaccines pending completion of phase-three trials. India has been reporting thousands of coronavirus cases and hundreds of related deaths every day, prompting the government to find a way to provide emergency authorisation to Covid-19 vaccine candidates.
According to people aware of the developments, Prime Minister Narendra Modi also wanted to know the details about the emergency authorisation process at a review meeting on Friday on procurement and delivery strategy of Covid-19 vaccines. “Held a meeting to review India’s vaccination strategy and the way forward. Important issues related to the progress of vaccine development, regulatory approvals, and procurement were discussed,” PM Modi tweeted after the meeting.
How does the emergency use authorisation work in India?
In the United States, the Food and Drug Administration (FDA) grants emergency use authorisation (EUA) and a process has been laid out for the same. US biotech firms Moderna and Pfizer have announced impressive early trial results from phase 3 trials and the latter has already submitted to the FDA for EUA.
According to a PTI report, Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation in India, and the National Expert Group On Vaccine Administration for Covid-19 (NEGVAC) will decide on vaccine pricing. India’s existing legal framework, which includes the Epidemic Diseases Act, 2020; National Disaster Management Act, 2005; and New Drugs and Clinical Trial Rules, 2019; provide for granting authorisation, officials aware of the developments said.
Pune-based Serum Institute of India (SII) is conducting the phase-three trial of the Oxford-AstraZeneca vaccine, while Bharat Biotech and ICMR have started the phase-three trial of the indigenously developed COVAXIN jab. SII CEO and owner Adar Poonawalla recently announced that India will have the vaccine for vulnerable population by January-February if it gets satisfactory trial results by November or early December.
On November 21, India recorded 45,209 cases of the coronavirus disease (Covid-19) and 501 related deaths, taking the country’s tally to over 9.09 million. The union health ministry’s data showed that the number of infections and deaths were less than Saturday’s 46,232 and 564 respectively.