The process for getting Covaxin’s Emergency Use Listing (EUL) authorisation by the World Health Organisation (WHO) is proceeding very well, Dr VK Paul, member of NITI Aayog said on Monday. Dr Paul also said the government is hoping that the decision will come soon, according to news agency PTI.
Covaxin is one of the three vaccines which are currently being used in India for inoculation of people against the coronavirus disease (Covid-19). The vaccine is developed by Hyderabad-based pharmaceutical company Bharat Biotech in association with the Indian Council of Medical Research (ICMR). Serum Institute of India's Covishield and Russia's Sputnik V are the other two vaccines which have been administered to Indian citizens so far.
The lack of endorsement from WHO has been hampering travel plans for individuals as many countries are only accepting vaccines approved by the public health body.
On June 22, the vaccine manufacturer said that Covaxin has shown the efficacy of 77.8% in phase-3 of the medical trial on 25,800 subjects. The positive findings of the trial are likely to help the firm secure an EUL from the WHO.
Earlier, Bharat Biotech also expressed confidence in getting the UN body's approval based on "its experience of getting its other vaccines prequalified by WHO." It also said that emergency approval is expected during July-September. The manufacturer has also claimed that around 90 per cent of the required documents have already been submitted to WHO and the remaining will be sent in July.
{{/usCountry}}Earlier, Bharat Biotech also expressed confidence in getting the UN body's approval based on "its experience of getting its other vaccines prequalified by WHO." It also said that emergency approval is expected during July-September. The manufacturer has also claimed that around 90 per cent of the required documents have already been submitted to WHO and the remaining will be sent in July.
{{/usCountry}}In June, the company also held meeting pre-submission meeting with the WHO.
In India, the vaccine received emergency approval in January this year. It was given "restricted use in an emergency situation in the public interest", which raised questions and was also seen as contributing to vaccine hesitancy that marked the early stages of India's vaccination drive.