DCGI gives nod for restricted emergency use of Russian COVID-19 vaccine Sputnik V in India: Sources


Team Udayavani, Apr 13, 2021, 9:29 AM IST

New Delhi: India’s drug regulator has granted permission for the restricted emergency use of Russian COVID-19 vaccine ‘Sputnik V’ with certain conditions, paving the way for a third vaccine to be available in the country, sources said on Monday.

The approval by the Drugs Controller General of India (DCGI) came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.

The DCGI had in January given the emergency use authorisation for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.

According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months. The SEC on Monday deliberated upon the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V. The vaccine is indicated for active immunisation to prevent COVID-19 in individuals aged 18 years and above and is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days.

It has to be stored at -18 degrees Celsius.

According to recommendations by the SEC, the firm has been asked to submit revised factsheets to CDSCO after incorporating the latest safety and efficacy data and other suggestions made during the meeting, another source said.

Besides, the firm should submit the safety, efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for review as and when available.

The firm also has to submit safety data, including the data on AEFI and AESI with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, as per the recommendations.

The SEC had reviewed the application by Dr Reddy’s in two meetings held on April 1 and February 24.

The health ministry earlier had said three more COVID-19 vaccines by Zydus Cadila, Biological E and Gennova are also in the pipeline and are in advanced clinical trials in India.

Global healthcare major Johnson and Johnson is in discussions with the Indian government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.

In light of the SEC meeting held on April 1, Dr Reddy’s on Monday presented the interim safety and immunogenicity data from phase 2/3 clinical trial, including GMT titres for virus neutralising antibodies, comparative phase 3 immunogenicity data generated in Indian and Russian studies and unblinded data of serious adverse events and RT-PCR positive cases among others.

In September last year, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India.

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Kuwait blaze: 3 Indians, 4 Egyptians detained in connection with massive fire that killed 50 people, mostly Indians

Sharp rise in heatstroke cases, casualties in hospitals as heat wave batters Delhi

Flesh in ice cream: Mumbai cops trace factory worker who suffered finger injury during work

Union minister Savitri Thakur fails to write ‘Beti Padhao’ slogan correctly in Hindi; video goes viral

T20 World Cup: Hosts West Indies primed for Super 8 clash against defending champions England

Renukaswamy Murder Case: Darshan confessed to have given Rs 30 lakh to accused to dispose of body, say police

Dead frog ‘found’ in wafer packet, probe ordered

Related Articles More

Kharge writes to LS Speaker, RS Chairman; seeks relocation of Gandhi, Ambedkar statues back

Ex-CM Naveen Patnaik to be leader of opposition in Odisha assembly

Sharp rise in heatstroke cases, casualties in hospitals as heat wave batters Delhi

Flesh in ice cream: Mumbai cops trace factory worker who suffered finger injury during work

Decomposed bodies of woman, her lover recovered from car stuck in MP stop dam months after they eloped

MUST WATCH

udupi

Kamalashile

Mental Illness | Causes | Symptoms and Treatment

Minister Thimmapura statement

Vishweshwar Hegde Kageri


Latest Additions

Kuwait blaze: 3 Indians, 4 Egyptians detained in connection with massive fire that killed 50 people, mostly Indians

Nine Indian ports ranked among top 100 in Container Port Performance Index 2023

Chikkamagaluru: 3 tourists feared drowned as coracle capsizes in Bhadra River backwaters

Udupi: Wild elephants leave trail of destruction

Kharge writes to LS Speaker, RS Chairman; seeks relocation of Gandhi, Ambedkar statues back

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.