Hyderabad, June 16 (IANS) Bharat Biotech on Wednesday clarified that while new born calf serum is used in the manufacturing of viral vaccines, the final formulation of its Covid-19 vaccine Covaxin is free from all impurities."New born calf serum is used in the manufacturing of viral vaccines. It is used for the growth of cells, but neither used in growth of SARS CoV2 virus nor in the final formulation," the company said in a statement."Covaxin is is highly purified to contain only the inactivated virus components by removing all other impurities," it added.The Hyderbad-based vaccine manufacturer clarified that bovine serum is widely used in the manufacture of vaccines globally for several decades.It also stated that the usage of new born calf serum was transparently documented in various publications for the last 9 months.--IANSms/in
Hyderabad, June 16 (IANS) Bharat Biotech dispatched its Covid-19 vaccine Covaxin to nine states through the government of India and to 16 states through the respective state governments.Company's co-founder and joint managing director Suchitra Ella on Wednesday tweeted that Andhra Pradesh, Assam, Delhi, Gujarat, Karnataka, Madhya Pradesh, Maharashtra, Tamil Nadu and Telangana were supplied the vaccines through government of India from June 8 to 14.The Hyderabad-based vaccine maker also made supplies to 16 states during the same period. The states are Assam, Bihar, Chhattisgarh, Delhi, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Odisha, Punjab, Rajasthan, Tamil Nadu, Telangana, Tripura, Uttarakhand and West Bengal.She also tweeted that vaccine doses were also dispatched to private hospitals in 27 cities across the country from June 8 to 14.These include Delhi, Mumbai, Chennai, Kolkata, Bangalore and Hyderabad. A total of seven cities in Telangana and Andhra were dispatched the vaccine under this category.She, however, has not provided details like the number of doses dispatched under the three categories."Our mission is to deliver Covaxin to your towns-cities & states. Pls register & vaccinate @ govt or pvt hospitals near you," tweeted Suchitra Ella.The company had Monday defended differential pricing policy for the central and state governments and private sector.It said that the supply price of Covaxin to the government of India at Rs 150 per dose, is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs, it said in a statement.The company clarified that Covaxin is more expensive for private sector is due to fundamental business reasons, ranging from low procurement volumes, high distribution costs and retail margins.At Rs 1,200 per dose for private hospitals, Covaxin is reported to be third costly vaccine globally.Bharat Biotech had fixed the price of Covaxin for state governments at Rs 600 per dose but later slashed it to Rs 400.--IANSms/in
New Delhi, June 15 (IANS) The supply price of Covaxin to the government of India at Rs 150 a dose is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs, Bharat Biotech said on Tuesday.It said there are live examples of such pricing policies where Human Papilloma virus vaccine is priced for GAVI supplies at $4.5/dose (Rs 320), but is also available in the private market at Rs 3,500. Rotavirus vaccines are supplied to the Govt of India at Rs 60/dose, but is also available in the private market at Rs 1,700/dose. The prices for COVID-19 vaccines internationally have varied between $10 to $37/dose, (Rs 730 - Rs 2,700/dose). On why Coaxin is more expensive for the private sector, Bharat Biotech said another key point of discussion has been about pricing our vaccines for private sector players which is significantly higher than that given to governments and large procurement agencies. This is purely due to fundamental business reasons, ranging from low procurement volumes, high distribution costs and retail margins among few others. As directed by the Govt of India, less than 10% of our total production of Covaxin to date has been supplied to private hospitals, while most of the remaining quantity was supplied to State and Central Governments. In such a scenario the weighted average price of Covaxin for all supplies realized by Bharat Biotech is less than Rs 250/dose. Going forward, 75% of the capacity will be supplied to State and Central Governments with only 25% going to private hospitals. Unlike most medicines and therapeutics, vaccines are provided free of cost by the Govt of India to all eligible Indian citizens. "Thus, the procurement of vaccines by private hospitals is optional and not mandatory, albeit it gives a choice to citizens who are willing to pay for better convenience. In our view, the question of product pricing is only of extraneous interest to all concerned, especially when the same vaccine is made available free of cost", Bharat Biotech said that for the private sector it is optional. Bharat Biotech has so far invested over Rs 500 crores at risk from its own resources for product development, clinical trials and setting up of manufacturing facilities for Covaxin. The support from The Indian Council of Medical Research (ICMR) was with respect to provision of the SARS CoV2 virus, animal studies, virus characterization, test kits and partial funding for clinical trial sites. In return for this valuable support, Bharat Biotech will pay royalties to ICMR and the National Institute of Virology (NIV), based on product sales. Royalties are also payable to Virovax towards the licensure of IMDG agonist molecules, it said. Bharat Biotech is investing in new facilities and repurposing existing ones across several states in India for enhancing the production of Covaxin. It is pertinent to mention here that the urgent need to set up a significant number of manufacturing facilities and to divert existing ones for Covaxin has resulted in reduced production of other vaccines at our facilities, leading to loss in revenues. It added that low product price realization dispirits domestic R&D. Companies such as Bharat Biotech, which are innovators with specialized expertise in product development, and large scale manufacturing, should be allowed to maintain a differential pricing strategy for Governments and private hospitals. It is distressing to see that a large country like India has a very basic level of innovation in vaccines and pharmaceutical products, it added. It may well be argued that the low-price realization for home-grown innovators constraints innovation and product development in India. In the absence of a dual pricing system, Indian vaccine and pharmaceutical companies risk being reduced to mere contract manufacturers with intellectual property licensed from other nations, the company said. --IANS san/in
Hyderabad, June 14 (IANS) The Central Industrial Security Force (CISF) on Monday took over the security of Bharat Biotech International Ltd's facility here to protect it against any terror threat or sabotage that may lead to a biological disaster.The CISF deployed 64 personnel headed by an Inspector-rank officer as part of the security for Bharat Biotech, the developer and manufacturer of Covaxin, India's first indigenously-developed vaccine for Covid-19.The contingent of the paramilitary force was inducted at a ceremony held at the facility located in Genome Valley, the cluster of biotechnology companies.Bharat Biotech Chairman and Managing Director Dr Krishna Ella, Joint Managing Director Dr Suchitra Ella, CISF Inspector General in-charge of the southern sector Anjana Sinha, and Deputy IG, South Zone-II, Shyamala Dinavahi attended the induction ceremony.The CISF flag was unfurled on Bharat Biotech campus on the occasion. The CISF will control access to the facility and its armed troopers, including a vehicle-borne quick response team (QRT), will be stationed at vantage positions in case of a terrorist attack or sabotage.The cost of the security will be borne by company. The decision to provide CISF security was taken recently in view of the increased threat perception to Bharat Biotech as the biotechnology company is considered vulnerable to threats from anti-nationals and saboteurs.On the direction of the Union Home Ministry to provide armed security cover to the premises of Bharat Biotech, CISF officials recently carried out survey of the facility.Bharat Biotech is the 11th private facility to get CISF security since the government took a decision to use its services to provide security cover to important installations in private sector following 2008 Mumbai terror attacks.The Infosys campuses in Bengaluru, Pune and Mysuru, the Reliance Corporate IT Park in Navi Mumbai and yoga guru Ramdev's Patanjali factory premises in Uttarakhand's Haridwar are among the private facilities guarded by the CISF.--IANSms/vd
Hyderabad(IANS) Aimed at demonstrating data generation and data transparency, Covaxin maker Bharat Biotech on Saturday said that the company has published nine research studies on the safety and efficacy of its vaccine in a year.
"The company has published as many as nine research studies on the safety and efficacy of Covaxin in five globally reputed peer-reviewed journals in a span of just twelve months," Bharat Biotech said in a statement.
As part of its preclinical studies involving testing of vaccine candidates on laboratory animals, the company has already completed three studies which were published in 'Cellpress'.
Likewise, Covaxin's phase I studies carried out to assess vaccine's safety, immune response and right dosage as well as phase II clinical trials which also evaluate a vaccine's ability to generate immune response were published in the 'The Lancet - Infectious Diseases' journal.
"The full data from studies on Covaxin's neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine," the pharmaceutical major said.
Similarly, the study on neutralisation of beta and delta variants (B.1.351 and B.1.617.2 respectively) and the study of B1.1.28 variant were published in the 'Journal of Travel Medicine'.
Studies on B.1.617 variant and Alpha variant B.1.1.7 were published by the journal of 'Clinical Infectious Disease' and the 'Journal of Travel Medicine' respectively.
"The published studies are widely cited for the rigor and breadth that Bharat Biotech brings to its clinical trials. Currently, data from both efficacy and safety follow-up of Covaxin's phase III trial is being analysed and compiled," the statement added.
According to the company, complete data for phase I, II and partial data from phase III trials of Covaxin have been thoroughly scrutinised by the Indian regulators.
The Hyderabad-based company promised that it will make phase III trials data from the final analysis public soon.
"Demonstrating its scientific commitment to data generation and data transparency, Bharat Biotech shares full data of all research studies of its Covaxin, India's first indigenous Covid-19 vaccine," the statement added.
New Delhi, June 11 (IANS) A day after the US Food and Drug administration (FDA) denied approval for emergency use of Covaxin, the Hyderabad-based Bharat Biotech on Friday said that it is following the recommendation for additional data and will work for full approval.The process will extend Covaxin timelines for seeking US approvals, the company said in a statement.The FDA had on Thursday recommended Ocugen, the US partner of the Indian vaccine maker, to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data"."Our US partner, Ocugen, has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN which is full approval instead of EUA. All applications have to follow the BLA process, which is the standard process for vaccines," Bharat Biotech said in a statement."Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN This process will extend our timelines," it added.The company said that no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA."Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved.""With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines," the statement noted.Covaxin has received approval for emergency use from 14 countries with more than 50 countries in the process. More than 30 million doses of the vaccine have been supplied in India and other countries."Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, in a statement on Thursday."This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term," Musunuri added.Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval."The Company will pursue expedited authorisation for Covaxin under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 in Canada," the statement said.Covaxin has so far emerged safe in clinical trials to date, said Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.The "Ministry of Health and Family Welfare of Republic of India reported no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin," Forrest added.Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).It is an inactivated vaccine that is manufactured using a vero cell manufacturing platform. Covaxin has showed strong results in all the studies conducted to date including a vaccine efficacy rate of 78 per cent overall efficacy and 100 per cent in severe Covid-19 disease, including hospitalisations, in second interim results of Bharat Biotech's Phase 3 clinical trial.Covaxin studies show that it effectively neutralised the Brazil variant of SARS-CoV-2, B11282, the alpha variant, B117, which was first identified in the UK, as well as the delta variant, B1617, which was first identified in India.--IANSrvt/in