According to an official statement, the FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an emergency use authorisation (EUA).
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
Trump administration will use "alternative legal authorities" to enforce tariffs on the countries, assuring that the tariff revenue will remain unchanged.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance
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.'
'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.
Sun TV Network has sued Chennai Super Kings in the Madras High Court for allegedly using songs and dialogues from Rajinikanth films Jailer, Jailer 2 and Coolie in IPL promotional content without permission, seeking 1 crore in damages.
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.
'We are considering this to ensure swift action on content for which the respective ministries have domain experts and can better determine the illegality of the content or the web site that needs to be taken down.'
Inspections conducted across 49 entities including pharmacies, wholesalers, and clinics to detect violations and misleading marketing practices.
According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.
Haryana State Vigilance and Anti-Corruption Bureau arrests 11 individuals, including bank employees and a government official, in connection with a fraud case involving IDFC First Bank and the illegal diversion of government funds.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
An elderly couple in Delhi was robbed of valuables in a staged ED raid orchestrated by their domestic help and her accomplices, including an ITBP constable and a former army personnel.
The official also advised all the trade partners to abide by the trade deals. The new 10 percent global tariff is part of Trump's protectionist trade agenda, aimed at addressing balance-of-payments issues and unfair trade practices.
The pause gives the US time to breathe, to regroup, to move its expeditionary force into position without risk of interception along the way. It gives Iran nothing -- on the ground, attacks against its infrastructure continue apace. Prem Panicker in his must read daily blog on the Gulf War.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
Iran is fighting a different war: Older, slower, and in some ways more dangerous. Iran doesn't need to shoot down an F/A-18. It only needs to make the Strait of Hormuz feel dangerous long enough for insurance markets, shipping companies, and oil futures traders to do the rest. Prem Panicker continues his must-read daily blog on the war in the Middle East.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
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.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
What we are watching is something different: A fog manufactured and maintained by the people who started the war, so that the question of why it was started never has to be answered, observes Prem Panicker in his must read blog on the war in the Middle East.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
'We need to give Pakistan something serious to think about on its eastern front -- that is the only way to actually help Afghanistan right now.'
Guterres emphasised that global structures and institutions must reflect the complexity and the opportunity of the "new times and realities"
The Congress chief appealed to the prime minister that with restrictions being imposed to stop the spread of the virus, he should put in place a minimum monthly guaranteed income scheme and transfer a sum of Rs 6,000 into every eligible citizen's account.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Britain has banned the entry of an Islamic preacher, Dr. Shadee Elmasry, over his defence of Hamas following the October 7, 2023, attack in Israel. The UK Home Office cited concerns about hate speech and extremist ideas.
Representatives Deborah Ross of North Carolina, Marc Veasey of Texas and Raja Krishnamoorthi of Illinois introduced the resolution on Friday in the House of Representatives to terminate Trump's national emergency authorising tariffs of up to 50 per cent on imports from India, helping to restore Congress' constitutional authority over trade.
Officials said the digital ban was intended to disrupt ideological channels that facilitate cross-border radicalisation, particularly in areas where socio-economic vulnerabilities are exploited by extremist networks.
Saurabh and Gaurav Luthra, the owners of the Goa nightclub wanted in connection with the fire tragedy that claimed 25 lives at the facility, have fled to Thailand, prompting police to seek the help of Interpol to trace them, officials said in Panaji on Monday.
One of the major concerns highlighted by the DGCA was about the fact that not all staff had completed mandatory fatigue management training.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
'If all of us (all the 57 Shiv Sena MLAs) stand together we can change the dynamic. We are not afraid of anyone.'
These vaccines are Sputnik V vaccine (in collaboration with Dr Reddy's), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila's vaccine, and Bharat Biotech's Intranasal Vaccine.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
As one of the federal appeal courts in the United States ruled that most of tariffs imposed by Trump administration are not accordance with the laws, US President Donald Trump on Friday (local time) affirmed that all tariffs imposed on the countries will remain in effect, calling a recent ruling by a 'highly Partisan Appeals Court' incorrect.
The Trump administration has told the US Supreme Court that it imposed tariffs against India for purchasing Russian energy products as part of its strategy to address the war in Ukraine.
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