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.
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.
WHO has urged people at risk to keep up with their vaccinations with boosters.
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
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 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.
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.
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.
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.
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.
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 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.
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.
'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.'
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.
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
Adjuvants may be added to a vaccine to produce more antibodies and longer lasting immunity thus minimising the dose of antigen needed.
The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
The Centre's supplying price is pushing the pricing structure for the private sector upward.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
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.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
Ahead of Trump's inauguration here on January 20, the debate on foreign guest workers visas for highly skilled professionals, the H-1B, has intensified which has literally created divisions in both the Democratic and the Republican parties.
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.
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.
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.
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.
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.
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
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".
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
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.
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.
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.
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