Hyderabad: The Hyderabad-based vaccine maker has already approached the Drug Controller General of India (DCGI) for approval to conduct phase-III trials of its intranasal vaccine.
Intranasal vaccine (BBV154) has the potential to prevent transmission and its Phase-III trials are expected to commence in 2022.
“This non-invasive, needle-free, easy to administer vaccine is suitable for kids and adults. It is easy to scale the production to meet the global demand,” sources in Bharat Biotech told IANS.
Nasal vaccine can also be used as a booster dose against variants of concern. It can be given as a booster dose in combination with two doses of any intramuscular Covid vaccine.
Paediatric Covaxin: “Our vaccine for children was evaluated in the 2-18 years age group. It has now received approval for the 12-18 years age group from DCGI. To begin, India will administer the vaccine for children between 15 and 18 years. We have augmented our production, and are well prepared to support this programme,” sources said.
The vaccine maker says that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. With an established proven safety and efficacy record in adults for the original variant and subsequent variants, Covaxin is very well suited for children.
The company continues to invest, upgrade and expand its facilities. “Manufacturing scale up has been carried out in a stepwise manner across multiple, specially designed Bio-Safety Level-3 production facilities in Hyderabad in Telangana, Malur in Karnataka and Ankleshwar in Gujarat and Pune, Maharashtra, the productions are on track and on target, with an aim to touch an annualised ~1.0 billion doses of Covaxin,” sources told IANS.
Exports: Bharat Biotech has commenced exports of Covaxin. “To start with, long pending export orders will be executed in early 2022 to countries that have granted emergency use approvals for Covaxin and to those additional countries that are recently added to our export lists. More than 60 countries have already shown interest to use our Whole-Virion Inactivated Vero Cell derived platform technology vaccine against Covid.”
“When approved, Covaxin will create history and will become the first Made in India vaccine to gain access to the market in the US and in Canada. Covaxin will become an integral part of the global fight against this Pandemic,” they added.
The company believes that India has accomplished an incredible task tackling this pandemic, through the world’s largest vaccination drive. The development of Covaxin has contributed to India’s being self-reliant against Covid-19 and has successfully thwarted the onslaught of variants of concern largely, ensuring that severity, and hospitalisation is minimised to those administered during 2021.
2022 and beyond: The coming will see more publications from Bharat Biotech for Covid-19 vaccines and other vaccines under development. Human clinical trials for vaccines against Chikungunya, Cholera, Paratyaphi, non typhoidal Salmonella, Zika, Typhoid, Rotavirus, etc., will be ongoing worldwide.
“As Bharat Biotech is one of the youngest functioning vaccines companies in India, it is important that the startup ecosystem is alive well in our country. The success of the Public-Private partnership model resulting in world-class vaccines such as Rotavac, Typbar TCV, and now Covaxin will certainly stimulate more PPP in the years to come.”
The R&D and manufacture of Covaxin and other Covid-19 vaccines has developed partnerships with several Indian academic institutions and companies such as the ICMR, NIV Pune, IICT Hyderabad, Indian Immunologicals, Bibcol, Haffkine Institute, Hester Biosciences, Biovet, etc.
This is exactly the vision of Dr. Krishna Ella, whereby innovation and product development results in improving the science ecosystem and leads to nation building. India’s preparedness to deal with pandemics has become strong, and we will lead the world through major advancements in the development of vaccines and manufacturing prowess.
–IANS
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