Approve The Use Of Local COVID-19 Vaccines, Indian Government Protested

Illustration (Hakan Nural / Unsplash)

JAKARTA - Sunday January 3, 2021, India gave emergency approval to a local COVID-19 vaccine manufacturer, COVAXIN Bharat Biotech. But the decision has also been questioned by industry experts and opposition lawmakers. The reason is that Bharat Biotech has never published data on the effectiveness of the vaccine.

Quoting Reuters, Monday, January 4, 2021, the approval of COVAXIN, which was announced by the general of India's drug control (DCGI), was hailed by Indian Prime Minister (PM) Narendra Modi and his ministers. This is because the use of local vaccines is considered a success in encouraging state independence.

However, the Indian government also continues to import vaccines made in other countries. India approved the use of a vaccine developed by AstraZeneca and the University of Oxford which will be the main vaccine in India's immunization program.

COVAXIN is developed by a government agency. Use of COVAXIN means India joins a small list of countries that have approved their own viral vaccine.

Bharat Biotech has partnered with drug developer Ocugen Inc to jointly develop it for the US market. Brazil has signed a non-binding letter of intent to purchase the vaccine. The company says it is in discussions with more than 10 countries about COVAXIN.

"Our goal is to provide global access to the populations who need it most," said Biotechnology Chair Bharat Krishna Ella in a statement. "COVAXIN has produced very good safety data with strong immune responses against a variety of surviving viral proteins."

Its effectiveness is questionable

Neither the company nor the Indian Central Drug Standards Control Organization will disclose its efficacy results. A source with knowledge of the matter says that the effectiveness can be more than 60 percent with two doses. Opposition lawmakers and former ministers have questioned the lack of transparency in the vaccine deal.

"Agreement is premature and could be dangerous," said opposition lawmaker and former minister Shashi Tharoor. “Its use should be avoided until the full trial is complete. Meanwhile, India can start with the AstraZeneca vaccine. "

China also did not publish detailed data on the efficacy of the vaccine, which it passed on Thursday, December 31. But the developers have shared temporary data.

"On what basis is this approval given when Bharat Biotech has NOT shown sufficient data to prove safety and efficacy?" asked transparency activist Saket Gokhale on Twitter.

Gokhale has filed a request under India's right to information law asking the government for safety and other data for the two vaccines it approved. The Serum Institute of India (SII), the local maker of the AstraZeneca vaccine to be branded COVISHIELD in the country, also criticized the vaccine from Bharat Biotech.

"Until we have efficacy results, how do we know if something is working?" said Chief Executive of SII Adar Poonawalla.

A government scientist said in November the COVAXIN might be approved in February or March 2021. But it is now likely to be launched earlier after approval on Sunday 3 January.