Category: COVID19

Bharat Biotech Announces COVAXIN® Capacity Expansion to Support vaccination campaigns in India and Worldwide

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  • Capacity expansion has been implemented across multiple facilities in Hyderabad and Bangalore, to reach ~ 700 million doses / year, one of the largest production capacities for Inactivated viral vaccines worldwide,
  • IMDG agonist molecule synthesis and manufacturing has been successfully implemented in India eliminating dependency on imports,
  • Raw materials, packing materials and single use consumables for manufacturing have been secured to meet our capacity requirements,

Hyderabad, India, April 20th, 2021: Bharat Biotech announces scale up of manufacturing capacity to produce ~ 700 million doses of COVAXIN® annually. 

Manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad, and Bangalore. 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.   

Manufacturing partnerships are being explored with our 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 (IIL) to manufacture the drug substance for COVAXIN®. The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.

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 indigenized and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialized 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.

COVAXIN® has received Emergency Use Authorizations in several countries across the globe with another 60 in process. EUA’s have now been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUA’s are in process in the USA and several European countries. Pricing for international markets and supplies to govt’s under EUA’s have been established between $15 – 20 / dose.     

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SALVE REGINACHARITABLE TRUST Organised COVID19- Awareness programme at Velankanni

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Awareness Program By
SALVE REGINA
CHARITABLE TRUST
We from Salve Regina Charitable Trust, had been to velankanni to spread awareness on corona virus and also on cleanliness.

As we had taken over a beggars colony we got an opportunity to donate Blankets and tarpaulins for shelter. Also we had also
opened a tuition centre for under privileged children gave hope to them on perusing studies also gave them awareness on corona
virus and cleanliness

On this occasion health inspector of velankanni had joined us on this occasion and also gave his part of cleanliness awareness to
the beggars and advised on health check ups and maintaining distance when they are around public and also among their
community.

This awareness programme was successfully concluded by us on offering lunch to children in tuition centre and beggars in their
colony.

We from “Salve Regina Charitable Trust” have stepped out to several place on conducting Awareness programmes to each and
every on for their beautiful and better life.

You can contact us to conduct any kind of Awareness programmes
near you we would love to give and spread awareness to the people of this world.

– Dr. Reginaseelan – +91 96327 29956.

-Alwin Nelson J
+91 9035148803.

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Bharat Biotech Announces Phase 3 Results of COVAXIN®

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Bharat Biotech Announces Phase 3 Results of COVAXIN®:
India’s First COVID-19 Vaccine Demonstrates Interim Clinical
Efficacy of 81%
 Data from 25,800 participants, received vaccine or placebo in a 1:1 ratio showed that
the vaccine candidate was well tolerated.
 COVAXIN® demonstrated 81% interim efficacy in preventing COVID-19 in those without
prior infection after the second dose.
 Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary
study endpoints.

Hyderabad, India, 03, March, 2021: Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, today announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.

“Today is an important milestone in vaccine discovery, for science and our fight against
coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on
our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants.
COVAXIN® demonstrates high clinical efficacy trend against COVID-19 but also significant
immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.

BBV152 contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

BBV152 has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by
approximately 10-30%.
BBV152 is based on an established manufacturing platform with a better safety profile when
compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell
immune responses to COVID-19, leading to long-term protection.

“I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Mrs. Suchitra Ella, Joint
Managing Director, Bharat Biotech. “We could not have achieved this public-private
partnership milestone without the relentless commitment of those involved.”

Interim Phase 3 Results: 81% Efficacy

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of Phase 3 clinical trial is
based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe)
COVID-19 with onset at least 14 days after the second study vaccination in serologically
negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6%.
The interim analysis included a preliminary review of the safety database, which showed that
severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial’s conduct and monitoring are as per
Good Clinical Practice guidelines and have been outsourced to IQVIA.

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in
bioRxiv.
https://doi.org/10.1101/2021.01.26.426986

Bharat Biotech expects to share further details of the trial results as additional data become
available. An additional interim analysis is planned for 87 cases, and the final analysis is planned
for 130 cases. All data from the second interim and final analyses will be shared via pre￾publication servers as well as submitted to a peer-reviewed journal for publication.

More than 40 countries globally have expressed their interest in COVAXIN®. These countries are
highly satisfied with the safe, inactivated vaccine technology and robust data package for safety
and immunogenicity

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Second wave will not be as severe as first one, and would be shorter and fizzle off sooner – say experts at Neuberg Diagnostics panel

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February 26, 2021: The experts at Neuberg’s Panel discussion on “Coronavirus – variants and vaccination” said there will be second wave of Coronavirus however it will not be as severe as first one and it will fizzle off sooner.

Dr V Ramasubramanian, Infectious Diseases Specialist, Apollo Hospital, said, “US, UK, Brazil and few other countries in Europe had second wave of Coronavirus. It was inevitable. There is no reason why India would be exception to this rule. Probably the severity of second would be much milder, because about 60% of our population is younger. The second wave would be far milder than what UK and US are witnessing. We are seeing a surge in several states, but it will not be as severe as first one and would be shorter and fizzle off sooner.”

Dr V. Ravi, Former professor of Neurovirology at NIMHAN and Nodal Officer for genomic confirmation of SARS-CoV-2 Government of Karnataka, said, “If you are not infected or not vaccinated, then be sure that the virus will catch you. Sooner or later, the virus will catch most of us.

When there is a huge surge, people behave responsibly. That’s one reason why infection comes down. Whenever, there is a surge, there is continuous, testing, tracking and tracing for containing the infection. Once the first wave subsided, the complacency has set in. Historically, it is true that any respiratory wave will have second wave. So, we will have second wave. But it will not be to the extent of first wave.”

Dr Saranya Narayan, Chief Microbiologist, Neuberg Diagnostics, said, “To certain extent, vaccination will help us in combating the second wave.”

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BGS Gleneagles Global Hospital hosts a mega Hand Hygiene – Relay

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-A total of 1500 plus people participated in the activities organized by hospital staff-

Bangalore, February 25th, 2021: It’s been more than a year since the pandemic and every single healthcare expert and concerned individuals have started advocating for the need of handwashing, to reduce the transmission of infection. A rapid surge in COVID cases has encouraged BGS GGH team to voice the need of spreading awareness about “Hand Hygiene to Save lives”. BGS Gleneagles Global Hospital hosts “Hand Hygiene Relay” to spread awareness on Handwashing, a universal solution for the safety of the community and patients. The event was inaugurated today in the esteemed presence of Dr Ananth Rao, Assistant Vice President, Operations at Parkway Healthcare India, Sandeep Kumar, CEO, BGS Gleneagles Global Hospitals, Dr Kuttapa, HOD Medical Services and Dr ME Mohan, the principal of GIMS at the hospital premises. A mixed crowd of hospital staff, hospital attenders, doctors, and a large community from GIMS, participated in the drive, learning about the 7 steps of handwashing techniques which must be followed to prevent transmission of infection.

The main objective of the event was to educate the hospital staff on how to maintain hygiene in the healthcare facility. The hospital staff and the attenders were explained the importance of using alcohol-based hand sanitizers before handling any patients to avoid any transmission of infection. The nursing staff took the lead in briefing all the other staff of the hospital and the attenders, explaining about when and how to attend critical patients who are vulnerable to various diseases.

To keep the hospital clean and safe, not only includes the active participation of the hospital staff but the patients and visitors at the hospital. It is essential for every individual to follow the 7 steps of Handwashing techniques introduced by WHO, to prevent the spread of the novel coronavirus. According to the past research, adequate handwashing can lower the rate of gastrointestinal and respiratory diseases in people.

Sandeep Kumar, CEO, BGS Gleneagles Global Hospitals said, “Many health workers in the hospital are constantly exposed to pathogenic bacteria and virus transmitted by patients, while treating them. Our hospital has always given an utmost priority to the health of our staff and clean environment, which eventually leads to providing quality patient care and safety from any external virus invading their body.

“This event has enlightened a larger community on the techniques they must follow while using the hand sanitizer and handwashing to keep diseases at bay. It is essential for them to adopt these hand hygiene techniques in their day to day life, as we live through this pandemic.”

The event was followed by dance performance where the nursing staff demonstrated the 7 steps of handwashing. Later, certificates were awarded to those who participated in the 7 steps programme on Handwashing technique organized by the hospital.

Dr Kuttapa, HOD Medical Services said, “Handwashing in today’s scenario has to be the integral part of our daily routine, especially after getting in contact with the infected person. It is essential to spread this initiative in the public and private sector to create a culture of hand hygiene, which will prevent the spread of COVID infection.”

It is believed that a standard technique of handwashing with soap or using hand sanitizers can avoid diseases such as diarrhea, skin and eye infection, respiratory infection and prevent transmission of viruses.

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