The World Health Organisation (WHO) has granted Emergency Use Listing (EUL) to Hyderabad-based Bharat Biotech’s Covid-19 vaccine Covaxin after deliberations for several months.
The Organisation, after a meeting of the Technical Advisory Committee (TGA) today announced in its Twitter account, “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 TAG, 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 #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used,” it added.
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.
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, it added.
The Emergency Use Listing approval for indigenously developed Covid-19 vaccine Covaxin from Bharat Biotech, from the World Health Organisation (WHO), has been in deliberations for a few months now and the Government of India has been anticipating for the approval.
The approval could enable the company to export the vaccine to other countries.
Bharat Biotech earlier said that the clinical trial data was fully complied and available in June 2021 and all data submitted for Emergency Use Listing (EUL) Application to WHO in early July.
“As a responsible manufacturers with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” said the company in its Twitter page. Experts have been pegging the approval to be in place by the end of September itself.
An update from WHO in the second half of August, showed that the SARS-CoV-2 Vaccine, inactivated (Vero Cell)/ Covaxin, has completed the EOI acceptance and pre submission meeting stages and the rolling data started on July 6, 2021.
Earlier, Dr Mike Ryan, executive director of WHO Health Emergencies Programme, in a video released by WHO in its Twitter account, said, “It is really important that we gather all of the necessary information not only on the vaccine itself, but on the manufacturing processes, and all of that because we are recommending to the world that this vaccine is safe, effective and has been produced using the highest quality standards.”
WHO is very clear that it wants all countries to recognise EUL vaccines that have been given an Emergency Use Listing by the WHO advisory process. Those companies who put their vaccines forward, first of all, they have to request and respond and say, we want our vaccine to be put through EUL. Then they have to provide documentation on the whole process, the efficacy studies and the manufacturing process.
Covaxin, the two doses (Day 0 and 28) for people above 18 years of age, administered through intramuscular route, was approved by the CDSCO on January 3, 2021, along with Serum Institute of India Pvt Ltd’s Covishield, another two dose vaccine to be administered among population on or above 18 years of age.