'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 approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
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.
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.
Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.
The US Food and Drug Administration said on Sunday that over 70,000 patients in the country had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections.
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.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
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.
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed.
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.
Providing data, it said UK's Public Health England has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).
The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.
The CoWIN portal will be made available in Hindi and 14 regional languages by next week, while 17 more laboratories will be added to the INSACOG network to monitor the variants of COVID-19, the health ministry said on Monday.
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).
'Your body will be able to deal with Omicron at any time, but it depends (on when) if you are vaccinated.'
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
At least 85 people have died of coronavirus with the confirmed cases crossing 4,500 in the US.
Pfizer and BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy endpoints.
'The state government is putting Maharashtrians in danger by letting people escape institutional quarantine mandate for the sake of their personal vasuli'
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