The United States Food and Drug Administration (USFDA) has rejected Covaxin’s application for emergency use authorisation (EUA). The regulatory body of the United States has asked Ocugen Inc, which is authorized to sell Bharat Biotech’s Covaxin in the country, to come up with more data for the last phase trial and apply for Biologics License Application (BLA).
“The company will no longer pursue an Emergency Use Authorisation (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data,” said Ocugen.
Despite the fact that Bharat Biotech’s vaccine is being used in countries around the world including in India with better results than its competitors, the United States regulator’s refusal shows the kind of insecurity and competition its big pharmaceutical companies have from India’s indigenous vaccine.
Previously, the Union government refused to buy vaccines from Pfizer, the American pharmaceutical giant, and other companies like Moderna and Johnson & Johnson whose vaccines are being used in the United States because they were asking for indemnity. Although the Union government gave states the freedom to import vaccines from other countries, most of the states prefer the indigenous ones manufactured by Serum Institute of India (SII) and Bharat Biotech, given the fact they are cheaper, more effective, and trusted as far as the side effects are concerned.
The Indian government is now close to providing indemnity to American vaccine manufacturers and probably the United States is waiting for the same to give approval to Indian vaccines. More than science, it is about market access, and unless India gives access to its markets to the American MNCs, the USFDA would not reciprocate.
However, the Modi government has played smart and taken over the vaccine purchase before giving indemnity to American manufacturers. Now, with the Union government in charge of purchase, it is very unlikely that any public purchase would be from foreign players, the private purchase might be liberalised later to accommodate the interest of American players.
On the other hand, Bharat Biotech’s vaccine would be going through the BLA path now and would take more weeks to get the FDA approval.
“Although we were close to finalising our Emergency Use Authorisation application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.
“This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect the US population in the long term,” he added.
Despite the fact that Bharat Biotech’s vaccine is cheaper and more effective, it is not getting access to the American markets because their MNCs do not have access to the Indian markets. This should serve as an important lesson for the Indian government as far as trade with China is concerned, because India has given access to Chinese goods in almost every sector while China is not opening up its IT and biotech sector for Indian players.