Move allows recipients to travel abroad, sets stage for vax exports
The EUL’s approval is a prerequisite for COVAX, an initiative to foster global access to vaccines, to start supplying the jabs
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NEW DELHI :
The World Health Organization (WHO) granted emergency approval to Bharat Biotech’s Covaxin, allowing millions of recipients of the indigenously developed vaccine to travel overseas without restrictions and setting the stage for its export.
“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," the UN health agency said in a tweet on Wednesday.
“Covaxin EUL expands the availability of the most effective medical tools we have to end covid-19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and suitability in low- and middle-income countries," it said.
The Indian drug was signed off by the Technical Advisory Group, an independent advisory group that advises the WHO on whether a vaccine can be recommended for emergency use.
The EUL procedure assesses the suitability of novel health products during public health emergencies. The aim is to make medicines, vaccines, and diagnostics available as rapidly as possible while adhering to stringent safety, efficacy, and quality criteria.
“The Technical Advisory Group convened by WHO and made up of regulatory experts from around the world has determined that the Covaxin vaccine meets WHO standards for protection against covid-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used," the WHO said.
The EUL’s approval is also a prerequisite for COVAX, a multilateral initiative to foster global access to covid-19 vaccines, to start supplying the jabs.
With validation from the WHO, countries can now expedite regulatory approval processes to import and administer Covaxin. Further, UNICEF, Pan-American Health Organization (PAHO), in addition to the GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide. This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access, Bharat Biotech said.
Covaxin, India’s first indigenously developed covid vaccine, has received approvals from 14 countries, and 50 more are in the process, according to Bharat Biotech. Covaxin was developed in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune.
The development is significant for India as WHO’s approval will facilitate international travel for Indians who have received the vaccine. As of Wednesday, over 120 million doses of Covaxin had been administered across India, according to the Cowin platform.
Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which recommended its use in two doses with an interval of four weeks for those who are 18 and above. However, the WHO also said the available data on vaccination of pregnant women with Covaxin is insufficient to assess vaccine safety or efficacy.
The WHO noted that Covaxin was found to have 78% efficacy against covid-19 of any severity, 14 or more days after the second dose, and is suitable for low- and middle-income countries due to easy storage requirements.
Union health minister Mansukh Mandaviya thanked WHO for granting emergency authorization to Covaxin.
With the approval, the demand for Covaxin is expected to rise. In August, Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said that the pharmaceutical company is also exploring manufacturing partnerships in other countries. “Validation by the 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. The EUL authorization for Covaxin will enable us to contribute to accelerating the equitable access of the covid vaccine and the access to our vaccine globally, thereby addressing the current public health emergency," Ella said on Wednesday.
Covaxin can be shipped and stored for long periods at 2-8ºC. Bharat Biotech said the vaccine is formulated to adhere to a multi-dose vial policy, reducing open vial wastage and saving money for procurement agencies.
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