He said this marks the beginning of the review process for the vaccine. The desi Covid-19 vaccine has shown an efficacy of 77.8% as per the final Phase-3 data analysis made public by the company earlier this month.
“All documents required for EUL of Covaxin have been submitted to WHO as of July 9th. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” said a statement by Dr Ella tweeted from Bharat Biotech’s official Twitter handle.
COVAXIN® EUL https://t.co/dCilH7KbSk
— BharatBiotech (@BharatBiotech) 1626103788000
WHO had accepted the company’s expression of interest (EOI) for Covaxin in mid-June. Over the weekend, WHO chief scientist Sowmya Swaminathan had indicated that Bharat Biotech has submitted the complete data and the global health body is expected to take a decision on the EUL over the next four to six weeks.
Bharat Biotech’s joint managing director Suchitra Ella too had recently tweeted about this. “Covaxin will cross new frontiers, adhering to highest international regulatory guidelines. A new vaccine from India is all set to make history once again, with proven data, safety & quality,” she had said.
A WHO nod will be a major booster shot for Covaxin as it would grant it global acceptance and ease concerns of international travellers about not being allowed entry.