Covaxin gets WHO approval for EUL
India’s first indigenous COVID-19 vaccine Covaxin got its long-due approval from the World Health Organisation (WHO) on Wednesday.
The WHO’s Technical Advisory Group (TAG) granted the Emergency Use Listing (EUL) approval for Covaxin.
Bharat Biotech’s Covaxin vaccine has demonstrated 77.8 percent effectiveness against symptomatic COVID-19.
WHO tweeted, “WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19.”
🆕 WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19. pic.twitter.com/dp2A1knGtT
— World Health Organization (WHO) (@WHO) November 3, 2021
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.
WHO further tweeted, “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.”
Covaxin is a whole virion-inactivated vaccine is developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
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 materialized. 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 prioritize 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 organization, 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.
Bharat Biotech stated that the manufacturing capacity expansion was started during the first quarter of 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 annualized 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.
[With Inputs from IANS]
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