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.
"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 said that it is disheartening to listen to some states complaining about company's intentions regarding supply of COVID vaccine Covaxin.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
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."
The Centre's supplying price is pushing the pricing structure for the private sector upward.
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.
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
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.
Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial will publish the data in July following that the company will be applying for the full licensure of Covaxin.
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.
Adjuvants may be added to a vaccine to produce more antibodies and longer lasting immunity thus minimising the dose of antigen needed.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
'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.'
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.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
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.
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 company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
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.
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.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
Raches Ella, project lead, Covid-19 vaccines at Bharat Biotech said in a series of tweets that he was 'surprised' that media and researchers were drawing conclusions based on non-peer reviewed work.
This apart, to further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the 'capabilities and expertise' to manufacture the inactivated viral vaccines at commercial scale.
In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.
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.
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.
The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
The technical advisory group will now meet on November 3 for a final assessment.
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
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.
"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 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.
Amid the reports of coronavirus vaccine shortage from various states, the central government and Hyderabad-based Bharat Biotech are willing to invite other companies which want to produce COVAXIN in a bid to scale up the vaccine production, said NITI Aayog member Dr VK Paul, on Thursday.
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
'iNCOVACC' is priced at Rs 800 for private markets and at Rs 325 for supplies to the government of India and state governments.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
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.
He responded to criticism in certain circles following emergency use authorisation to the vaccine and said,"Indian companies do not deserve this backlash".