The comments of the Congress leader came after ICMR DG Balram Bhargava's letter to Bharat Biotech and principal investigators of medical colleges to complete the trial procedure of indigenous COVID-19 vaccine in a fast track method so that results of a clinical trial can be launched by August 15.
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.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
COVAXIN, developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology, has got the nod for human clinical trials from the Drug Controller General of India
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.
Apart from the 1.1 crore doses of Covishield being procured from the Serum Institute of India, 55 lakh doses of indigenously developed Covaxin were being obtained from Bharat Biotech, Union Health Secretary Rajesh Bhushan said at a press conference.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- will be participating in the meeting.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
Dominic Xavier salutes every single person involved in making this miracle possible.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
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
"I appeal to all those who are eligible to take the vaccine. Together, let us make India COVID-19 free!" Modi said.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
'The US has invoked the Defence Act and banned export of raw materials.' 'This is as good as banning vaccines.'
The method of data collection has a high risk of bias, the ICMR DG said.
Replying to a question at a press conference in New Delhi, Union Health Secretary Rajesh Bhushan said, "At many places in the world, more than one vaccine are being administered, but presently, in no country, vaccine recipients have the option of choosing the shots."
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.
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.
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.
It is estimated the current Indian vaccine market is around $900 million, with a potential to touch $4.6 billion by 2017.
The needle-free vaccine will be available at private centres.
Covaxin, a whole-virion inactivated SARS-CoV-2 vaccine used for mass immunization in the country, showed a 65.2 per cent protection against the Delta variant in a double-blind, randomized, multicentre, phase 3 clinical trial.
The PM directed officials to evaluate various technology tools to ensure efficient and timely vaccination in due course of time. He also emphasised that detailed planning for such large scale vaccination should be undertaken immediately.
Tope also informed that the Centre has asked the state to reduce the number of inoculation centers from 511 to 350, saying the government should focus on other emergencies also.
Apollo Hospitals and Fortis Healthcare are open to importing vaccines.
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 Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
The third phase trial of Bharat Biotech's Covaxin began in the state on Friday and the 67-year old senior Bharatiya Janata Party leader was administered the trial dose at the Civil Hospital at Ambala Cantt.
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.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
Anil Vij was administered the trial dose of the indigenous COVID vaccine Covaxin last month
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.
'he Centre has not issued any mandate, the stand of centre is that it should be 100 per cent but it is not a mandate'
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.
A massive pan-India inoculation drive against COVID-19 was set in process on Tuesday with more than 56 lakh doses of the Covishield vaccine flown to 13 cities across India from Pune and taken to designated national and state-level stores amid tight security.
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