New Delhi: Bharat Biotech on Friday said that he had sent all the data to the World Health Organization (WHO) for an emergency use list (EUT) from the Covid-19 Covaxin vaccine and was awaiting feedback from the UN Public Health Agency.
In a series of tweets, Bharat Biotech said that Covaxin’s clinical trial was fully compiled and available in June 2021.
“#Covaxin clinical test data is completely compiled and available in June 2021.
All data is submitted for Emergency Use (EUL) applications for the World Health Organization in early July .
We have responded to the clarification sought # who and are waiting for further feedback, “Bharat Biotech tweeted.
As a manufacturer responsible for past approval for other vaccines, the company said it would not find it according to speculating or commenting on the approval and schedule process, then said.
“We continue to work diligently get the earliest EUL,” he added.
Previously on Monday, the source said that the approval of the World Health Organization (WHO) for Covaxin, it was expected this week.
Bharat Biotech has submitted its 3 phase 3 clinical trial data which showed a 77.8 percent efficacy in the subject (SEC) expert committee of the Central Medicine Standard Control Organization (CDSCO).
Previously in June, the pre-delivery meeting for emergency WHO used listing procedures (EUL), which gave advice before submitting the final dossier, also held.
Mansukh Health Minister Mandaviya had also met before who was the head of Dr.
Soumya Swinathan and held a discussion of the approval of Bharat Biotech Covid-19 Vaksin Covaxin.
Covaxin was developed by Hyderabad-based Bharat Biotech in relation to the Indian Medical Research Council and the National Virology Institute.
Covaxin, which has been developed in collaboration with the Indian Medical Research Council (ICMR), contains an inactive SARS-COV-2 vaccine, which is produced in Vero cells.
This vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (cooled) and sent in ready-made liquid formulations that allow the distribution using existing vaccine supply channels.
The WHO has approved the Covid-19 vaccine by Pfizer-Biontech, Astrazeneca, Johnson and Johnson, Moderna and Sinopharm