New Delhi/Hyderabad, Nov 3: The World Health Organisation (WHO) on Wednesday approved Covaxin, India's first home-grown vaccine against Covid.
The WHO's Technical Advisory Group (TAG) granted the Emergency Use Listing (EUL) approval to Bharat Biotech's Covaxin vaccine, which has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19.
The TAG has determined that the Covaxin vaccine meets WHO standards for protection against the Covid pandemic and the benefit of the vaccine far outweighs risks and the vaccine can be used, the WHO said in a tweet.
"Covaxin vaccine was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above," the global health body said.
Developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, Covaxin is a whole virion-inactivated vaccine.
With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. Furthermore, UNICEF, Pan-American Health Organisation (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.
This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access, the vaccine maker said.
The EUL procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.
Commending the work of ICMR and Bharat Biotech scientists, Union Health Minister Mansukh Mandaviya said: "Today Prime Minister Narendra Modi's dream of self-reliant India has materialised. I also thank the WHO for granting the approval."
WHO Director General, Dr Tedros Adhanom Ghebreyesus said: "Glad to see one more vaccine, Covaxin, being granted emergency use listing. The more products we have to fight Covid-19, the better. But we must keep up the pressure to deliver Vaccine Equity and prioritise access to vulnerable groups who are still waiting for their 1st dose."
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. As an organisation, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification."
Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8 degrees Celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.
Bharat Biotech Joint Managing Director, Suchitra Ella, said: "Covaxin is a great example of a successful public-private partnership in developing a world-class Covid-19 vaccine. We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic."
The Phase 3 trial data for Covaxin was available during June 2021. The SAGE of WHO had reviewed Covaxin data on October 5 in a meeting and granted EUL on Wednesday.
Covaxin has been evaluated through neutralising 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.
Bharat Biotech stated that the manufacturing capacity expansion was started during first quarter 2021, as the first Phase 3 efficacy readouts were available. Within a short period of about 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.
It has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the US, and other countries.