Covaxin, India's first indigenous covid vaccine, has received EUAs from 14 countries, with another 50 in the process. In June, the drug maker had said its US partner, Ocugen, has received a recommendation from the US FDA to pursue Biologics License Applications path for Covaxin
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NEW DELHI :
Indian drug maker Bharat Biotech on Tuesday said it was diligently working with the World Health Organization (WHO) to obtain Emergency Use Listing (EUL) for its covid-19 vaccine Covaxin at the earliest.
"As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest," Hyderabad-based Bharat Biotech said in a statement.
The statement follows reports that said India's covid vaccine may face delays in getting EUL from the WHO as the apex global public health agency has asked for more data from the pharmaceutical company.
The meeting of Strategic Advisory Group of Expert on Immunisation (SAGE), which will discuss approval for Covaxin, is scheduled for 5 October.
Bharat Biotech said, “We request media organisations to exercise restraint while reporting on public health related issues and timelines, as it has an impact on millions of lives and livelihoods. At appropriate times, we will make announcements to indicate the availability of regulatory approvals."
Senior health officials earlier this month had said that Covaxin may get EUL from the WHO by the end of September. Union health minister Mansukh Mandaviya had met WHO's chief scientist Soumya Swaminathan on 12 August to discuss the UN agency's approval for Covaxin. Swaminathan in July had said that the WHO may take a decision on granting EUL to Covaxin in four-six weeks.
WHO’s Emergency Use Listing is a prerequisite for COVAX facility vaccine supply to other countries. The EUL assesses the quality, safety, and efficacy of covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions. So far, the WHO has given EUL to six vaccines.
Covaxin, India's first indigenous covid vaccine, has received EUAs from 14 countries, with another 50 in the process. In June, the drug maker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue Biologics License Applications (BLA) path for Covaxin, which is a full approval. Applications have to follow the BLA process, which is the standard for vaccines.
WHO approval would ease international travel for those Indians who have received Covaxin under the country’s vaccination programme. A delay in approval may impact students, business travellers, among other, who want to travel to other countries where vaccination certificates for WHO’s approved vaccines are deemed mandatory. Union health ministry officials have also been saying that covaxin would soon receive the EUL from WHO in coming days.
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