Ground Report | New Delhi: Why the world is rejecting Indian covaxin; India is using two main vaccines Covishield and covaxine and also supplied to many countries on their demands. But some countries are not giving permission to the covaxine. Rejecting Covaxin’s application for emergency use authorisation in the US, the FDA sought more data on the clinical trials for the Covid-19 vaccine.
US FDA declines approval as well
Covaxin, Bharat Biotech’s India-made vaccine against the coronavirus disease (Covid-19), was not given approval for emergency use in the United States by the country’s public health regulator -the Food and Drug Administration (FDA).
Rejecting Covaxin’s application for emergency use authorisation in the US, the FDA sought more data on the clinical trials for the vaccine, the complete extent of which is still lacking.
Bharat Biotech, which is currently carrying out the Phase-3 clinical trials for Covaxin, informed news agency ANI on Wednesday that it will make the data public during July, following which the company will be applying for full licensure of the Covid-19 vaccine.
Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news agency. Bharat Biotech added that Phase-4 trials are also being done to check the “real-world effectiveness” of the vaccines” and to meet scientifically approved standards for safety and efficacy.
The Hyderabad-based vaccine maker will now be applying for a full license from the US FDA and a statement put out today says the US FDA has stopped all Emergency Use Approvals for COVID-19 vaccines.
The absence of efficacy data for Covaxin has seen a political tug-of-war in India as well with Congress-led states like Chhattisgarh opposing the Centre sending Covaxin to the state.
Why is Covaxin not approved by WHO?
The vaccine approval process by WHO consists of four stages: acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for review by WHO, decision evaluation on the status, and Final decision on approval.
In the case of Bharat Biotech’s Covaxin, its EOI has not yet been accepted, and in its status report, WHO comments that ‘more information is needed. (Why the world is rejecting Indian covaxin)
The Hyderabad-based biotech company had submitted its EOI on April 19. The second phase, the pre-submission meeting is scheduled for this month (June 2021).
Meanwhile, the Pune-based Serum Institute of India (SII), which manufactures AstraZeneca’s Covishield vaccine, was approved by the WHO on February 15 after clearing the same four phases.
Government’s stand on Covaxin?
The central government today said it respects the FDA decision not to allow a EUL for Covaxin, but stressed that it will have no impact on India’s immunization programme. Each country has its own regulatory system.
Some parameters may be general while some may be different which we respect. Our country’s regulatory system also takes decisions in a similar manner, said VK Paul, Member (Health) Policy The commission said.
The scientific framework is the same, but the specific area in context. These are scientific ideas, especially in countries where science is strong and manufacturing is strong for us, he said.