America did not approve Bharat Biotech's vaccine, know how the government reacted to this
The government has said that India respects the regulatory system of every country, after the US did not approve the emergency use of Bharat Biotech's covaccine. Read this report to know the reaction of the Government of India.
The US Food and Drug Administration (FDA) has not approved Bharat Biotech's Covaccine for emergency use. The US food and drug regulator has advised Bharat Biotech's US partner, Okiagen Inc., to apply for approval to use the Indian vaccine through a biological license application with additional data. Amidst this development, the government has said that India respects the regulatory system of every country. America's refusal to give emergency approval to the vaccine will not affect our vaccine program.
Responding to a question on whether the vaccine was not approved, VK Paul, Member (Health) of NITI Aayog said that every country has its own regulatory system. Some criteria may be the same while some may be different. India respects the regulatory system of all countries. Our country's regulatory system also decides in the same way. The scientific framework is the same... These are scientific ideas in countries where science is particularly strong.
VK Paul said that we hope that our producer will be able to follow up by completing whatever it is required to do. Our current immunization program will not be affected by America's current move. We are satisfied that our regulator has approved this vaccine. We're doing pretty well.
At the same time, Bharat Biotech's US partner Ocugen Inc. says that it will file a BLA for Covaccine as per the advice of the FDA. The Biological License Application (BLA) is the FDA's full approval system. Medicines and vaccines are approved under this. In such a situation, it may take some more time for the vaccine to get US approval. OcuGen said it would no longer seek emergency use permission (EUA) for the vaccine. Some additional information and data has also been requested by the FDA.
OcuGen has also said that due to this stand of the FDA, there may be a delay in the introduction of Covaccine in the US. OcuGen is in discussions with the FDA to understand the additional information required for the BLA request. OcuGen Inc. anticipates that an additional test data will be needed for its application to be approved. It is noteworthy that recently Hyderabad-based Bharat Biotech had said that the final data of Phase III trial of Covaccine will be made public in July. Bharat Biotech says that only after this it will file an application for its full license.
On the other hand, amid reports of hesitation about vaccination among health workers working in rural areas, the Union Health Ministry said that it is working closely with the states and union territories to tackle the issue. The government says that it has been supporting the efforts of states and union territories to vaccinate since January 16 as part of the 'Sampoorna Sarkar' initiative. Hesitation about vaccination should be addressed through scientific studies and at the community level.