New Delhi: The decision of the World Health Organization (WHO) to suspend the United Nations (UN) supply of Bharat Biotech’s Covaxin will not affect Indians travelling to the UK, US and Canada, among over 90 other countries, top government officials have told ThePrint.
According to the sources, the suspension won’t affect Indian travellers going to countries that have an agreement with the Government of India for mutual recognition of vaccine certificates.
India has such an agreement with 99 countries. That status will not change with the “temporary” decision, the sources said.
In a statement on 2 April, the WHO said the UN suspension for Covaxin was “in response to the outcome of a WHO inspection on 14-22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP)”.
Bharat Biotech, it said, “has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO”.
“In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future,” it added.
The government sources said Bharat Biotech has assured the Government of India that it will reply to the WHO about the “deficiencies found in its manufacturing”.
“The WHO has sent a small query, which is normal whenever inspections are undertaken. We are constantly monitoring the situation and Bharat Biotech has assured us that they will rectify the issue quickly and respond to WHO within 15 days,” a top health ministry functionary told ThePrint.
“They have only slowed down Covaxin supply, not stopped it. The 99 countries that have an understanding with us for recognition of vaccines will continue to do so and Indian travellers will not be affected,” the functionary added.
On Sunday, a day after the WHO statement, Bharat Biotech issued a clarification that there is “no impact on efficacy and safety” of Covaxin.
“For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” read a statement issued by Bharat Biotech.
The vaccine-maker said the company is slowing down production of Covaxin for facility optimisation, adding that they are working to further improvements and upgrades to ensure the production of the vaccine continues to meet the increasing global regulatory requirements.
However, it stressed that “the quality of Covaxin was never compromised at any point in time”.
Covaxin received EUL in November
Covaxin received Emergency-Use Listing (EUL) from the WHO in November last year, only the eighth vaccine in the world to do so.
While the EUL is an essential enabling criterion for a vaccine to be procured by international organisations, countries are entitled to take their own individual decisions on whether they accept a certain vaccine. The EUL may at best influence that decision.
“The WHO Emergency Use Listing (EUL) is a procedure for assessing unlicensed vaccines, therapeutics and in vitro diagnostics during public health emergencies with the ultimate goal of expediting the availability of these products to people who need them,” reads the EUL information on the WHO website.
Government of India officials have also told ThePrint that neither the slowing of Covaxin nor the reduction of manufacturing of Covishield by Serum Institute of India (SII) is a matter of concern for India’s Covid vaccination programme.
This report has been updated with the statement issued by Bharat Biotech Sunday
(Edited by Sunanda Ranjan)
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