Drugs regulator chief’s press conference today, approval of Covid-19 vaccines likely

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The chief of India’s drugs regulator will address a press conference on Sunday, a day after its experts recommended that the Oxford-AstraZeneca and Bharat Biotech vaccines against the coronavirus disease (Covid-19) be allowed for emergency use in the country, reports have said. The Drugs Controller General of India (DCGI) will speak with at 11am and according to reports the watchdog may formally announce the approval for these two vaccines.

The development comes after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use. Covaxin is the indigenous vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The recommendations by the SEC have been sent to DCGI VG Somani, who heads Central Drugs Standards and Control Organisation (CDSCO). “The approval is confirmed. It’s now a mere formality for the national drugs controller to put out an order,” said a senior health ministry official, who asked not to be named.

The country’s top drug regulator had indicated earlier this week that India is likely to get a vaccine against Covid-19 in the New Year. “We will have a Happy New Year with something in hand, that’s all I can hint at,” VG Somani, DCGI, had said on Thursday.

If DCGI grants his nod, India will be among a handful of countries, including the US and UK, that have begun vaccinations. Both the US and the UK too have approved two vaccines, but in their case, all of the candidates have completed the requisite scientific process.

Union information and broadcasting minister Prakash Javadekar had said on Saturday said India is perhaps the only country where four vaccines against Covid-19 are getting ready. “One was approved yesterday for emergency use, Serum’s Covishield,” he said.

Javadekar had told reporters earlier that two other vaccines were waiting to be approved – Zydus Cadila’s ZyCoV-D and Russia’s Sputnik V that are both on trial in India. Six Covid-19 vaccines are undergoing clinical trials in India, including the frontrunners Covishield and Covaxin. There are also ZyCOV-D, which is developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Centre’s department of biotechnology, and NVX-CoV2373, which is being developed by Serum Institute in collaboration with Novavax. There are two other vaccines, one manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, US and the other one developed by Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, US.

Another vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, US, which is at the pre-clinical stages. The trial of Russia’s Sputnik V is also going on by Dr Reddy’s Lab.

SII’s Covishield, which is based on an adenovirus vector, has shown an efficacy rate of 62% in trials held in the United Kingdom and Brazil. The Bharat Biotech vaccine is based on an inactivated virus platform, one of the oldest known methods to develop an inoculation. This technique has been used historically for several other diseases including Hepatitis A, Influenza, Polio and Rabies.

All states and Union territories conducted mock inoculation drills in a test run on Saturday ahead of the launch as India is also gearing up to carry out the world’s largest vaccination programme. Union health minister Harsh Vardhan said on Saturday that shots administered in the first phase of India’s inoculation drive will be free of cost. The government aims to vaccinate 300 million people in the high-risk category of the population by July-August in the first phase.

India reported 19,078 new cases of Covid-19 and 224 related deaths in the last 24 hours, according to the Union ministry of health and family welfare on Saturday, which have taken the second worst-affected country’s tally to over 10.3 million.

By Hindustan Times