In a statement Bharat Biotech clarified that the vaccine's efficacy can only be determined 14 days after the second dose.
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.
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.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
Dominic Xavier salutes every single person involved in making this miracle possible.
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.
"I appeal to all those who are eligible to take the vaccine. Together, let us make India COVID-19 free!" Modi said.
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.
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 US has invoked the Defence Act and banned export of raw materials.' 'This is as good as banning vaccines.'
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.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
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
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.
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.
'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 Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
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.
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.
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."
The production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
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.
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.
Apollo Hospitals and Fortis Healthcare are open to importing vaccines.
A bench of Justices L Nageswara Rao and B R Gavai said bodily autonomy and integrity are protected under Article 21 of the Constitution.
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.
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.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
Experts, however, feel that given the intensity of the second wave and the high single dose coverage, India is in a good position to avoid any drastic wave in the near future.
Both manufacturers have sought funds in excess of Rs 150 crore under the department of biotechnology's Mission Covid Suraksha scheme. Announced last November, the scheme has an outlay of Rs 900 crore to help develop Covid vaccines, from the clinical development stage to setting up production sites.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
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.
While Bharat Biotech's Covaxin is in trials among children already, Serum Institute of India will begin Novavax vaccine trials on children from July, whereas the Pfizer vaccine has been approved for adolescents in the United States; and Cadila Healthcare's ZyCoV-D has done trials on 12 year-olds and above already, reports Sohini Das.
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.
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.
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.
The development comes after Prakash Kumar Singh, the Director, Government and Regulatory Affairs at SII, informed the Union health ministry that the firm would be able to supply 20.29 crore doses of Covishied in the month of September.
The NTAGI has not yet suggested any change in the schedule of Bharat Biotech's Covaxin.
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