Any vaccine maker, together with Pfizer Inc, which has sought emergency-use authorisation for its COVID-19 shot in India, should conduct a neighborhood “bridging” security and immunogenicity examine to be thought of for the nation’s immunisation programme, a senior authorities official advised Reuters.
Serum Institute of India, producer of the vaccine developed by AstraZeneca Plc and Oxford College, has executed an identical examine on greater than 1,500 individuals over months earlier than searching for and receiving emergency approval within the nation.
There have been reviews that Pfizer had sought an exception when final month it grew to become the primary firm to hunt emergency-use approval in India for its vaccine already in use abroad. The corporate has not attended subsequent conferences known as by the nation’s medicine regulator.
“As of now, the pre-condition for any vaccine to be carried out in India is that it’s important to do a bridging trial,” Vinod Ok Paul, who heads a authorities panel on vaccine technique, mentioned in an interview.
A Pfizer spokeswomen didn’t instantly reply to a request searching for remark.
Mr Paul additionally mentioned Russia’s Sputnik V, a shot present process last-stage trials in India, will quickly apply for emergency-use approval within the nation.
No vaccine maker will likely be given indemnity by the federal government ought to one thing go mistaken, Mr Paul mentioned. Serum Institute had written to the federal government searching for indemnity. AstraZeneca has mentioned it has acquired such indemnity in lots of different international locations.