Covid-19 vaccine Covaxin maker Bharat Biotech on Thursday said it was proud to contribute to India reaching the one billion-mark of Covid vaccinations.

The Hyderabad-based vaccine maker said that reaching the one billion-mark in just nine-months is a remarkable achievement for India.

“Bharat Biotech is proud to have contributed to this historic landmark. This is a unified effort of the Government, vaccine manufacturers, healthcare workers and all the vaccinated citizens of India, making it a true success story of Atmanirbhar Bharat,” Asaid Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

“We thank the PMO, MOH, NRA, ICMR, academic collaborators, industry partners, stakeholders, suppliers & employees for enabling us to maximize our efforts & deliver COVAXIN successfully to India’s vaccination,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.

Bharat Biotech on Thursday announced that it is slashing the price of its Covid-19 vaccine Covaxin to Rs 400, from Rs 600 earlier, for state governments.

The announcement came a day after the Serum Institute of India (SII) cut the price of Covishield to Rs 300 from Rs 400 earlier.

The two vaccine makers slashed the prices after the Central government reportedly made a request to them amid the row over different pricing for the Central and state governments.

Bharat Biotech said in a statement on Thursday that it deeply concerned with the critical pandemic circumstances that India is facing at this time.

“Recognising the enormous challenges to the public healthcare system, we have made Covaxin available to state governments at a price of Rs 400 per dose,” the Hyderabad-based company said.

“We wish to be transparent in our approach to pricing which was determined by internally funded product development, several operationally-intensive BSL-3 manufacturing facilities (the first of its kind in our country) and clinical trials,” it added.

The company stated that for the last one year, Team Bharat Biotech has been fearlessly handling live SARS-CoV-2 virus strains, tirelessly working round-the-clock while overcoming many challenges given the uncertainty of the pandemic.

Bharat Biotech had on April 24 announced the prices of Covaxin. It fixed at Rs 1,200 as the price per dose for private hospitals. This is twice the cost fixed by the SII for Covishield.

For exports, it has priced India’s first indigenous Covid vaccine at $15-$20 (Rs 1,125-1,500).

Ever since the launch of Covid vaccination programme in India, Bharat Biotech and the SII have been supplying their vaccines to the Centre at Rs 150 per dose.

While Bharat Biotech is likely to continue the supplies to the Centre at the same price, the SII had hinted at revising this to Rs 400.

Leading vaccine maker Bharat Biotech on Tuesday announced scaling up of manufacturing capacity to produce about 700 million doses of its Covid-19 vaccine Covaxin annually.

The Hyderabad-based company stated that capacity expansion has been implemented across multiple facilities here and in Bengaluru, to reach 700 million doses a year, one of the largest production capacities for inactivated viral vaccines worldwide.

Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines.

Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years. Bharat Biotech is able to expand Covaxin manufacturing capacity in a short timeline, mainly due to the availability of new specially-designed BSL-3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines, the company said in a statement.

It said it was also exploring manufacturing partnerships with its partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.

To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals Ltd (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.

Covaxin has received Emergency Use Authorisations (EUAs) in several countries across the globe with another 60 in process. EUAs have now been obtained from Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUAs are in process in the USA and several European countries. Pricing for international markets and supplies to governments under EUAs have been established between $15-20/dose.

Bharat Biotech uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the IMDG component has been successfully indigenised and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialised in India.

“The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of our vaccines, these also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record,” it added.

After the alleged death of a volunteer enrolled in Bharat Biotech’s Covaxin clinical trial in Bhopal, the Hyderabad-based company clarified on Saturday that the death was unrelated to the vaccine and the probable cause of death was cardio respiratory failure as a result of suspected poisoning.

“As per the post-mortem report issued by the Gandhi Medical College, Bhopal, that the site received from the Bhopal Police, the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning and the case is under police investigation as well,” Bharat Biotech said in a statement.

The firm added, “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

The 42-year-old man died on December 21, 10 days after he participated in the clinical trial for Covaxin held at a private hospital in Bhopal. “Our sympathies are with the family of the deceased,” the company said.

According to Bharat Biotech, the volunteer, at the time of enrolment, had fulfilled all the inclusion and exclusion criteria to be accepted as a participant in the Phase III trial and was reported to be healthy in all the site follow up calls post seven days of his dosing and no adverse events were observed or reported.

“There are several factors that can cause an adverse event during a clinical trial, including the patient’s underlying disease, other pre-existing conditions or any other unrelated occurrence like an accident. We are also continuing to cooperate with the investigation requirements from the Madhya Pradesh Police in Bhopal,” Bharat Biotech added.

On January 3, The Drugs Controller General of India (DCGI) had approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

While the efficacy of Bharat Biotech’s Covaxin is yet to be determined, it was given a go-ahead by the DCGI citing ‘public interest’. Covaxin is an indigenously developed vaccine by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Bharat Biotech on Sunday said the approval for emergency use of its Covid-19 vaccine –Covaxin — is a giant leap for innovation and novel product development in India.

The Hyderabad-based vaccine maker expressed its delight after Drug Controller General of India (DCGI) granted permission for emergency use of its Covid-19 vaccine.

“The approval of Covaxin for emergency use is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most,” said Bharat Biotech Chairman and Managing Director Dr. Krishna Ella.

He said Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.

“The development of Covaxin was truly a public private partnership between ICMR, NIV and Bharat Biotech, we sincerely thank the Director General ICMR, Dr. Balram Bhargava for his visionary leadership in this project,” Dr. Ella added.

Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. This is India’s first and only Phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.

Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.

India’s indigenous Covid vaccine by Bharat Biotech has been developed in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.

The product development and clinical trial data thus far has generated 5 publications, which have been submitted to international peer reviewed journals, 4 of which have been accepted and will be published soon. The publication of phase II trial data is undergoing the peer review process. “As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO,” it said.

Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for phase-III clinical trial of its coronavirus vaccine ‘Covaxin’ across multiple sites in India.

The phase-III human clinical trials of Covaxin began mid-November, targeting 26,000 volunteers across India. This is India’s first and only phase III efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, the Hyderabad-based company said.

“We thank every volunteer who has taken the time to participate in this trial. Their volunteering spirit is a great morale boost for India and the world. We thank all the principle investigators, doctors, medical staff and the hospitals for their cooperation and support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.

Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.

The product development and clinical trial data thus far has generated five publications, of which four have been accepted by international peer reviewed journals and will be published soon.

“The publication of phase II trial data is undergoing the peer review process. As a part of our regulatory guidelines, all data has been submitted to the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organisation(CDSCO).”

Covaxin is a highly purified and inactivated 2-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

India’s first indigenous Covid-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, a one-of-its-kind facility in the world.

The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended Bharat Biotech’s ‘Covaxin’ for emergency use in India. The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI).

The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon today, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.

On Friday, the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) had held that the data provided by Bharat Biotech for its Coronavirus vaccine is not sufficient for grant of emergency use approval and asked for more information.

The expert committee, tasked with vetting Covid-19 vaccine proposals, had convened a meeting to take a call on emergency use authorisation sought by the Serum Institute of India and Bharat Biotech for their respective vaccine candidates.

Notably, the panel recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield’. It become the first vaccine to secure recommendation for emergency use in India. The nod of the DCGI is, however, awaited on the recommendation.

The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’ while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.

America’s Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.

The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly above the age of 50 years most of whom have co-morbidities .