India to push for Covaxin recognition by WHO and EU

India to push for Covaxin recognition by WHO and EU

WHO has recognised several vaccines from the makers like Oxford AstraZeneca, Pfizer and Moderna which enables the vaccine makers to export the doses worldwide.

Faced with concerns that Indians receiving the Covaxin vaccine may face travel restrictions, the government has decided to help ensure that Hyderabad-based Bharat Biotech receives clearances from both the World Health Organisation (WHO) and subsequently, the EU’s European Medicines Agency (EMA).

According to sources, the Ministry of External Affairs (MEA) has been tasked with studying the matter, given both the need for recognition for the Indian-made vaccine, as well as the desire to push for more export orders in the future, and a team led by Foreign Secretary Harsh Shringla and officials from the Health Ministry are expected to meet with Bharat Biotech representatives on Monday. 

“There is certainly an interest in getting Covaxin on WHO’s Emergency Use List (EUL),” said an official familiar with the matter, adding that the European regulatory procedures are likely to take longer but are also being pursued.

The decision comes as 27 EU member countries on Thursday approved a proposal to allow “fully vaccinated” tourists from countries outside Europe under certain criteria. While the Astra Zeneca vaccine Covishield would be included on the WHO and EU’s listings, if travel from India is accepted, those who have taken Covaxin would not.

 Prime Minister Narendra Modi and members of the Cabinet are amongst those who have taken Covaxin doses. In addition, explained officials, getting Covaxin on the WHO’s EUL would be a big boost, and a first for an Indian-developed and produced vaccine. 

Officials stressed that the EUL processes are technical in nature, and the MEA and the government was only assessing what it can do “if anything, to expedite the process” for the Covaxin application already under review at the World Health Organisation.

Sources also pointed out that the WHO’s processes don’t allow for “diplomatic” or “political” inputs, and are based entirely on the vaccine manufacturer’s ability to provide the documentation required by the international agency and to validate its claims. Bharat Biotech did not respond to The Hindu’squery on the planned meeting.

According to the WHO’s latest status report, published on May 18, Covaxin is one of 19 vaccines for which applications have been submitted. Seven other applicants including vaccines made by Pfizer, Moderna, Johnson & Johnson’s ‘Janssen’ vaccine, Chinese Sinopharm, and three versions of the Astra Zeneca vaccine, including Indian-made Covishield from the Serum Institute of India, have all received the green-light for the Emergency Use Listing (EUL).

The notification alongside the Covaxin application confirms that the application, or Expression of Interest, was received on April 19 this year, but that “more information [is] required”, and that a pre-submission meeting prior to the EUL assessment would be planned in “May-June 2021”. According to sources, the WHO is awaiting Bharat Biotech’s Phase-3 final analysis data. 

Covaxin has not yet approached the European Medicines Agency (EMA), which has authorised four vaccines including Moderna, Astra Zeneca and Janssen, and has another four under review. 

The double recognition will help scientific research and collaboration between the Indian and foreign vaccine producers as well as help citizens to travel smoothly. Bharat Biotech has signed agreements with pharmaceutical companies from Brazil and the U.S. where the vaccine will be either co-produced or exported but the absence of endorsement from WHO and other multilateral bodies is creating difficulties for the vaccine. 

At present Covaxin has been approved for use in nine countries — Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, Zimbabwe and India. 

India has used both Covishield and Covaxin for its “Vaccine Maitri” export programme. According to clinical trials conducted by Bharat Biotech, Covaxin has claimed interim clinical efficacy of 81% in dealing with the original COVID-19 and the mutant variants and the Indian diplomats are expected to take up these arguments when helping the company make its case with international agencies. 

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