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.
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 vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
Senior Congress leader Manish Tewari and Union Health Minister Harsh Vardhan sparred on Twitter on Saturday with the Opposition leader raising questions over the emergency use approval given to the indigenously developed vaccine Covaxin and the Bharatiya Janata Party leader hitting back alleging that Tewari was only passionate about spreading rumours.
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.
A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
Anil Vij was administered the trial dose of the indigenous COVID vaccine Covaxin last month
Bharat Biotech's Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
The method of data collection has a high risk of bias, the ICMR DG said.
There are 12 sites across India, including private and public hospitals, conducting Phase 1 and 2 human clinical trials for Bharat Biotech's Covaxin. Based on an earlier letter by the Indian Council of Medical Research (ICMR) to the 12 sites, volunteer recruitments for the clinical trials were to begin by July 7. At least three sites are yet to kick-start the process.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS in New Delhi on Thursday, with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.
The vaccine was well tolerated in all dose groups with no vaccine-related adverse events.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
The hospital authorities informed the Jaipur chief medical and health officer about the theft on Tuesday night following which an FIR was lodged on Wednesday.
The phase 3 trial findings indicate that Covaxin induces a robust antibody response with no severe vaccine-related adverse events or deaths reported among the trial participants, the authors of the study said.
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.
Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
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
According to respective company sources, Biological E is holding 200 million doses of its COVID-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses of Covaxin.
Karnataka Chief Minister Siddaramaiah alleged that the rushed approval and distribution of the COVID-19 vaccine may be a contributing factor to cardiac arrest deaths, citing several international studies that recently suggested a possible link between the vaccines and a rise in heart attacks.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
'Our problem is not a budget deficit but a trust deficit. We need to trust our institutions and industries to innovate and lead. That is the way forward for India.'
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
'Antibodies remain in the blood for at least seven to nine months.'
The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
Dominic Xavier ponders the Vaccine Dilemma: Should he take the shot or not?
Covishield comprises over 90 pc of 12.76 cr COVID vaccines administered so far
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
In a statement Bharat Biotech clarified that the vaccine's efficacy can only be determined 14 days after the second dose.
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
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