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.
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.
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
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.
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 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.
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 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.
Bharat Biotech started work on developing a vaccine against Zika way back in 2014.
Under the partnership, Bharat Biotech will use the patented virus like particle technology platform of Novavax to develop the single dosage pandemic influenza vaccine and undertake clinical trials before manufacturing and marketing the same.\n\n
This will be an upfront payment for the vaccine doses that these two companies will supply to the government.
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.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
WHO has urged people at risk to keep up with their vaccinations with boosters.
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.
Simplifying investment policies at the micro level and introducing a time-bound framework will be critical for India's growth targets, notes Krishna Ella.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
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.
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
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.
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.
The method of data collection has a high risk of bias, the ICMR DG said.
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.
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.
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.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
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.
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.
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.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
Bharat Biotech is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
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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