Covaxin’s approval, which has been pending for long, was delayed further by the World Health Organization (WHO) as it has sought additional information and clarifications from Bharat Biotech, the developer of the vaccine. WHO also stated that it will meet again for a final assessment on November 3, if data is received soon.
This information was posted on Twitter by Soumya Swaminathan, the Chief Scientist at WHO.
Covaxin was jointly developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, and the Indian Council of Medical Research (ICMR). An emergency approval for Covaxin was issued on January 3 by the Central Drugs and Standards Committee (CSDCO), India’s top drug regulator.
The WHO approval is an essential step for Covaxin to be recognised by foreign countries and ensure hassle-free international travel for the people who have received its jabs.
An emergency use listing (EUL) by WHO will also ensure that the vaccine is eligible for global distribution to low and middle-income countries under the COVAX facility.
In a series of tweets, the WHO had stated that while it’s aware people are waiting for WHO’s recommendation for Covaxin however it “cannot cut corners” before recommending it for emergency use, and it must evaluate it thoroughly to ensure the vaccine is “safe and effective.”
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It also added that WHO is expecting one additional piece of information from Bharat Biotech which has been submitting data to WHO on a rolling basis. The timeframe for EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, and efficacy.
This is the second time that Bharat Biotech has applied for vaccine approval. An Expression of Interest (EOI) for an EUL was submitted back in April 19 but was asked to provide more data by who before it could give a nod for the vaccine. WHO had stated that it must evaluate the vaccine thoroughly in order to ensure that it is “safe and effective.”
