Bharat Biotech started work on developing a vaccine against Zika way back in 2014.
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 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 phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
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 first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
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.
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.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
This will be an upfront payment for the vaccine doses that these two companies will supply to the government.
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.
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.
Restoring weighted tax deductions and adopting a petty patents regime can foster firm-level innovative activity critical for competitiveness, points out Nagesh Kumar.
'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.'
WHO has urged people at risk to keep up with their vaccinations with boosters.
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
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 vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
'If you align your ambition with India's rise, the peak of your careers will unfold alongside the peak of India's power.'
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The Brazilian health regulator's decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.
India's pharmaceuticals and medical devices industries are still hopeful that trade negotiations with the US could cut a fairer deal for both sides, after President Donald Trump announced a 25 per cent tariff rate on India on a social networking platform without divulging the finer details.
Sources close to the development said the company had no further supply commitments to the WHO, and therefore, there was no suspension of any upcoming orders, reports Sohini Das.
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.
Homegrown vaccine maker Bharat Biotech will launch its intranasal COVID-19 vaccine iNCOVACC, the first of its kind in India, on January 26, the company's chairman and managing director Krishna Ella said in Bhopal on Saturday.
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
The BJP received the highest amount in large donations among national parties in the financial year 2023-24, with over Rs 2,243 crore declared from 8,358 donations, according to a report by poll rights body the Association for Democratic Reforms (ADR). The report, based on data submitted to the Election Commission, highlighted trends in political donations above Rs 20,000. The total declared donations to national parties stood at Rs 2,544.28 crore from 12,547 contributions - a sharp 199 per cent increase compared to the previous year.
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency's chief scientist said.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
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.
Microsoft Chairman and CEO Satya Nadella along with Alphabet Inc and its subsidiary Google CEO Sundararajan Pichai are also among those from trade and industry who have been awarded the Padma Bhushan for their distinguished services.
Simplifying investment policies at the micro level and introducing a time-bound framework will be critical for India's growth targets, notes Krishna Ella.
According to respective company sources, Biological E is holding 200 million doses of its COVID-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses of Covaxin.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
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