'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.'
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
'iNCOVACC' is priced at Rs 800 for private markets and at Rs 325 for supplies to the government of India and state governments.
After reports claimed that filings in patent offices in India, the US, and Europe did not mention ICMR or its scientists, but only BBIL and its scientists, the Hyderabad-based biotechnology (biotech) company clarified that in the "rush" to develop vaccines and file appropriate patents, BBIL had missed adding ICMR's name in the original filings.
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
"We have received feedback that certain immunisation centres are recommending taking three paracetamol 500 mg tablets along with Covaxin for children. No paracetamol or painkillers are recommended after being vaccinated with Covaxin," Bharat Biotech said in a Twitter post.
Bharat Biotech on Wednesday said a study has demonstrated that a booster dose of Covaxin has a neutralising effect on the Omicron and Delta variants of COVID-19.
The technical advisory group will now meet on November 3 for a final assessment.
Bharat Biotech said that it is disheartening to listen to some states complaining about company's intentions regarding supply of COVID vaccine Covaxin.
The Centre has accorded a security cover of armed Central Industrial Security Force (CISF) commandos for the Hyderabad premises of Bharat Biotech, one of the major COVID-19 vaccine manufacturers in the country, official sources said on Tuesday.
First a scientist and then a businessman, founder chairman Krishna Ella quit his faculty position at the Medical University of South Carolina in Charleston, United States, in 1996 to return to India.
The Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
iNCOVACC is the world's first intranasal vaccine for COVID-19 to receive approval for the primary two-dose schedule, and as a heterologous booster dose.
The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario, head of the Federal Comptroller General.
The company said it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.
Sources indicated that there were no fresh orders from the Government of India, and their supply commitments have ended as of March 31, reports Sohini Das.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
Adjuvants may be added to a vaccine to produce more antibodies and longer lasting immunity thus minimising the dose of antigen needed.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
Bharat Biotech on Thursday said it plans to produce additional 200 million doses of COVID-19 vaccine 'Covaxin' at its subsidiary's Ankleshwar (Gujarat) based facility, taking the overall production volume of the vaccine to 1 billion (100 crore) dosages per annum.
'He came back from the US only to work for his country.' 'He has invested his fortunes to build this company and is married to his work.' 'Rarely does one see such commitment.'
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
Vaccine major Bharat Biotech on Wednesday said its COVID-19 vaccine, Covaxin, has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
After having received the government purchase order for 55 lakh doses, Bharat Biotech shipped the first batch of vaccines (each vial containing 20 doses) to Gannavaram (Vijayawada), Guwahati, Patna, Delhi, Kurukshetra, Bangalore, Pune, Bhubaneswar, Jaipur, Chennai and Lucknow.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
In a joint statement posted on their respective twitter accounts, the companies said Serum Institute Chief Executive Officer Adar Poonawalla and Bharat Biotech Chairman Krishna Ella communicated their combined intent to develop, manufacture and supply the COVID-19 vaccines.
The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.
The Centre's supplying price is pushing the pricing structure for the private sector upward.
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.
Bharat Biotech's Joint Managing Director Suchitra Ella's tweet saying 50 of their employees tested positive for COVID-19 received bouquets and brickbats from netizens, with some saying Covaxin was saving lives while a few questioned as to why the staff were not vaccinated.
Speaking at a virtual conference organised by the Confederation of Indian Industry, Suchitra Ella, joint Managing Director of the city-based vaccine maker, said the company's facilities in four cities -- Hyderabad, Bengaluru, Pune and Ankaleshwar -- are currently producing Covaxin.
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).
He responded to criticism in certain circles following emergency use authorisation to the vaccine and said,"Indian companies do not deserve this backlash".
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