NEW DELHI (Reuters) – Any vaccine manufacturer, including Pfizer Inc, which has applied for emergency use license for its COVID-19 image in India, needs a “bridge” safety and immunogenicity study local government to discuss the country’s vaccination program, a senior government official told Reuters.
The Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, has conducted a similar study on more than 1,500 people over months before requesting and obtaining emergency clearance in the country.
Local media have reported that Pfizer had sought an exception when it arrived last month, the first company to apply for an emergency use permit in India for the vaccine used overseas. already over. The company has not attended meetings called for by the Indian drug regulator.
“So far, the precondition for any vaccine to be implemented in India is that you have to undergo a bridge test,” said Vinod K. Paul, who heads the government panel on vaccine strategy. , in an interview in his office near the parliament building.
A Pfizer spokesperson did not immediately respond to a request for comment.
Paul also said that Russia’s Sputnik V, a bullet that went through final stage tests in India, will soon apply for an emergency use permit in the country.
A vaccine manufacturer will not grant indemnity to the government if something goes wrong, Paul said. The Serum Institute had written to the government seeking disrespect. AstraZeneca has said it has found such secrecy in many other countries.
India has also approved the emergency use of vaccines developed locally by Bharat Biotech.
Reciting with Krishna N. Das; Additional narration by Anushree Fadnavis; Edited by Elaine Hardcastle