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.
This will be an upfront payment for the vaccine doses that these two companies will supply to the government.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals. The Pune-based Serum Institute of India, the world's largest vaccine maker in terms of volume, has announced a price of Rs 400 per dose for its COVID-19 vaccine, 'Covishield', for state governments and Rs 600 per dose for private hospitals.
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.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
Three temperature-controlled trucks rolled out of the Serum Institute gates shortly before 5 am and left for Pune airport, from where the vaccines will be flown across India.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
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).
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.
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.
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.
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.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
The technical advisory group will now meet on November 3 for a final assessment.
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.
Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.
'People are already sending congratulatory messages. But I have said, "Please don't until the trials are over".'
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
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.
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.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
'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.'
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.
He responded to criticism in certain circles following emergency use authorisation to the vaccine and said,"Indian companies do not deserve this backlash".
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'Even if Serum Institute and Bharat Biotech were successful in ramping up production overnight, what happens to the capacity after the demand from India is met?' asks Sanjeev Nayyar.
Dispatch of the vaccine is likely to start by early Tuesday morning, sources said. According to the order placed, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
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 fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
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.
'The US has invoked the Defence Act and banned export of raw materials.' 'This is as good as banning vaccines.'
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
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.
The PM's visit would signal a strong intent towards making sure India becomes a beneficiary as vaccines become a massively traded commodity in the coming years.
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.
Modi on Saturday will embark on a three-city tour to take stock of the COVID-19 vaccine development work.
Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
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