Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, said the global health body.
There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Swaminathan said.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency's chief scientist said.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
'WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,' the global health body tweeted.
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.
The technical advisory group will now meet on November 3 for a final assessment.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
Sources close to the development said the company had no further supply commitments to the WHO, and therefore, there was no suspension of any upcoming orders, reports Sohini Das.
Results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and present no serious safety concerns.
The decline in the effectiveness of Covaxin, India's indigenous COVID-19 vaccine, from 77.8 per cent to 50 per cent during a Delta-driven case surge in April and May this year is neither bad nor surprising, say scientists.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Briefing the media in Rome, Goyal said the Leaders adopted the 'Rome Declaration' at the G20 Summit and the communique gives a very strong message under the health section with the countries agreeing that the COVID-19 immunisation is a global public good.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," tweeted the minister.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
As the COVID-19 vaccination of children falling into the age bracket of 15 to 18 years is scheduled to begin from January 3, the Kerala health department has prepared an action plan for inoculation of all eligible beneficiaries.
In a letter to all states and Union territories, the ministry highlighted that under the emergency use authorisation, coronavirus vaccination is indicated only for 18 years and above. If required, COVID-19 vaccine and other vaccines should be separated by an interval of at least 14 days.
Stressing that the Covid virus may continue to transmit for a "very long time", senior WHO official Poonam Khetrapal Singh says the level of immunity in a community, through vaccination and previous infection, will determine whether it will become endemic in the long run.
It will be unfair to put a date for any COVID wave as the behaviour of coronavirus is unpredictable and a disciplined and effective pandemic response can help the country get away from any significant outbreak, COVID Task Force chief V K Paul said.
The prime minister in his intervention at the session on "global economy and global health" also flagged the issue of facilitating international travel and talked about the mechanism of mutual recognition of vaccine certification as a means of achieving this, according to the text of his intervention shared by his office.
The endemic stage is when a population learns to live with a virus.
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
As India holds its breath for the Covid vaccination to be begin, Sudhir Bisht provides a quick checklist of what you must know about the vaccines that will be administered to citizens.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
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