'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
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.
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.
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
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.
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.
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 technical advisory group will now meet on November 3 for a final assessment.
'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.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
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.
"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.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
A critical drug developed on a DRDO technology for radiological and nuclear emergencies has received approval from the Drugs Controller General of India (DCGI), the defence ministry said on Tuesday.
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.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
With the threat of COVID-19 pandemic continuing to loom over the world, the Ministry of Ayush has come out with a comprehensive document putting forth the concept of 'holistic health'.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Niclosamide, a drug on the World Health Organisation's list of essential medicines, has been used to treat tapeworm infestation for more than 50 years. The oral antiviral drug was also used to treat patients during the SARS outbreak of 2003-04.
Apart from making efforts to meet the requirements of India, the company is also trying its best to balance the needs of the rest of the world, he added.
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."
The DCGI's approval came following recommendation by the Subject Expert Committee 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.
The US will lift all restrictions for fully vaccinated international travellers, including from India, from November 8 but they will have to show proof of a negative coronavirus test before boarding a flight to the country, the White House has announced.
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'.
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.
Other Indian-origin personalities on the list are Instacart founder and CEO Apoorva Mehta, doctor and Executive Director of nonprofit Get Us PPE Shikha Gupta and founder of nonprofit Upsolve Rohan Pavuluri.
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.
World leaders thanked India for its help and support in combating the coronavirus pandemic through "early and meaningful" shipments of COVID-19 vaccine doses, as they addressed the high-level UN General Assembly session this year.
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.
Cricket South Africa (CSA) suspended all forms of cricket for the next 60 days to minimise the impact of the coronavirus. South Africa men's cricket team coach Mark Boucher suggested to turn off cell phones for two weeks amid the ongoing global lockdown due to coronavirus pandemic.
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.
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.
An overarching law governing public healthcare is a glaring gap in India's fight against the COVID-19 pandemic. In India it is left to individuals to quarantine themselves voluntarily. Moreover, the 123-year old The Epidemic Diseases Act, 1897, governs healthcare emergencies in India.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
Lack of sleep, unhealthy eating habits, physical inactivity and a stressful daily schedule stemming from demanding career paths to juggling multiple hats on the personal front are some factors that increase health challenges, especially in young Indians, notes dietician Sheryl Salis.
However, in two different dose regimens, the vaccine's efficacy was 90 per cent in one and 62 per cent in the other.
