What does WHO emergency use listing mean for Bharat Biotech’s Covaxin?

The World Health Organisation’s (WHO) emergency use approval for Covaxin will ensure wider global access to the India-developed COVID-19 vaccine, according to manufacturers Bharat Biotech. India’s External Affairs Minister S Jaishankar says the WHO recognition will facilitate travel for many Indian citizens besides contributing to vaccine equity. India and the United Kingdom were locked in a diplomatic row for months over the latter’s refusal to relax COVID-19 restrictions for fully vaccinated travellers from India. The United States included Covaxin in its updated list of approved vaccines, paving the way for those who have been inoculated with the vaccine to enter the country when it opens borders to vaccinated foreign travellers on November 8.

Covaxin received emergency use authorisation from India’s drug regulator, Central Drugs Standard Control Organisation, in January this year, but was considered invalid for use by many countries in the absence of Emergency Use Listing (EUL) by WHO.

The WHO also wants Bharat Biotech to join the global health agency’s technology access pool to share technology and know-how for “increased production of vaccines in different continents, said Dr Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products.

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“So this conversation is ongoing already that would allow for a good basis for technology transfer to other countries,” she said during a virtual Q&A session after Covaxin was granted EUL on Wednesday following months of assessment of the vaccine’s safety and efficacy. 

Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The WHO’s Technical Advisory Group (TAG) concluded Covaxin meets WHO standards for protection against COVID-19 and benefits far outweigh risks for the vaccine’s use globally.

Covaxin is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.

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Speaking on the efficacy of Covaxin, Dr Joachim Hombach from the Secretariat – WHO Strategic Advisory Group of Experts, said that WHO has the data from the clinical trial and the efficacy was estimated to be in the range of 79%.

Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.

Bharat Biotech said that with the validation from the WHO countries can now expedite their regulatory approval processes to import and administer Covaxin.

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United Nations Children’s Fund (UNICEF), Pan-American Health Organisation (PAHO) and GAVI COVAX facility will also be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.

Covaxin has been specifically formulated to meet the needs of global distribution chains and long-term storage at 2-8 degrees Celsius, the company said.

The WHO, however, said that 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 said in a series of tweets.

Covaxin was found to have 78 per cent 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, it said.

“Covaxin EUL expands the availability of Syringe, the most effective medical tools we have to end #COVID19. 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 stated.

(With inputs from Press Trust of India)