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Bharat Biotech’s Covaxin gets WHO’s EUL status

 “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,” apex global public health agency said in a tweet.  “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 & suitability in low- & middle-income countries,” it said. 

The Technical Advisory Group for EUL is an independent advisory group that provides a recommendation to WHO whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions.  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 criteria of safety, efficacy and quality.  

 “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. 

WHO’s EUL procedure assesses the quality, safety and efficacy of covid-19 vaccines and is a prerequisite for COVAX vaccine supply, a multilateral initiative to foster global access to covid-19 vaccines. It also allows countries to expedite their own regulatory approval to import and administer covid-19 vaccines. 

With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer covaxin. Furthermore, UNICEF, Pan-American Health Organization (PAHO), 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 EUAs from 14 countries and another 50 are in the process. Covaxin is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune. 

The development assumes major significance for India as WHO’s approval will facilitate international travel for Indians who have received the home-made vaccine under India’s national covid vaccination programme. The decision will be a relief for students who wish to pursue studies overseas and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory.  As on Wednesday, over 12.14 crores doses of covaxin have been administered across India, according to the CoWIN platform.   

Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) which recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. However, the WHO also said, the available data on vaccination of pregnant women with the Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.  

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 extremely suitable for low- and middle-income countries due to easy storage requirements. 

Dr Poonam Khetarpal Singh, Regional Director, WHO South East Asia said “Congratulations India for Emergency Use Listing of its indigenously produced covid-19 vaccine covaxin.” Meanwhile Union health minister Mansukh Mandaviya thanked WHO for granting EUL to covaxin. 

With the approval, demand of covaxin is expected to rise. Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, earlier in August had said that pharmaceutical company is also exploring manufacturing partnerships with its partners in other countries, who have prior expertise with commercial scale manufacturing of inactivated viral vaccines under biosafety containment for further augmentation.     

 “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. 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,” Ella said on Wednesday. 

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 2-8ºC. 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 said. 

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