Hyderabad: COVAXIN, India's indigenous COVID-19 vaccine developed by Hyderabad-based Bharat Biotech (BB) in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), Pune, has finally got World Health Organisation (WHO)’s approval on Wednesday for Emergency Use Listing (EUL) for 18 years and above.
The Central Drugs Standard Control Organisation (CDSCO) has also approved the extension of shelf life of ‘Covaxin’ up to 12 months (from the present nine months), from the date of manufacture.
This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders, Bharat Biotech, who in the past has been approved by WHO for several other vaccines, said in a statement here.
Emergency Use Listing by WHO will expedite global access and availability of COVAXIN worldwide.
The WHO’s Emergency Use Listing (EUL) for COVAXIN facilitates countries to expedite their regulatory approval processes to introduce and administer India’s indigenously made COVID-19 vaccine developed and manufactured by Bharat Biotech.
It also allows procurement by UNICEF, PAHO, and the GAVI COVAX facility for distribution to countries in need.
Bharat Biotech, a global leader in vaccine development and innovation, had earlier announced safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with ICMR and NIV Pune.
Efficacy analysis demonstrates COVAXIN to be 77.8 per cent effective against symptomatic COVID19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group, it said.
Efficacy analysis demonstrates COVAXIN to be 93.4 percent effective against severe symptomatic COVID-19, the company said in a statement earlier.
Bharat Biotech Chairman and Managing Director Dr. Krishna Ella, said, “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN. The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency”.
Bharat Biotech Joint Managing Director Ms Suchitra Ella said COVAXIN has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peer reviewed journals and available for review in the public domain.
Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available, she said within a short period of 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.
Bharat Biotech has established COVAXIN manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021 and the technology transfer activities are also in progress to companies in India, the United States, and other countries, she added. (UNI)
