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Any vaccine manufacturer, such as Pfizer Inc, which has sought emergency-use authorisation for its COVID-19 shot in India, must run a neighborhood”bridging” safety and immunogenicity study to be considered for the country’s immunisation programme, a senior government official told Reuters.
Serum Institute of India, the local maker of the vaccine developed by AstraZeneca Plc and Oxford University, has done a similar study on more than 1,500 people over months prior to seeking and receiving emergency approval in the nation.
Local media have reported that Pfizer had sought an exception when last month it became the first company to look for emergency-use approval in India because of its vaccine already in use abroad. The business has not attended subsequent meetings called by India’s drugs regulator.
“As of now, the pre-condition for any vaccine to be implemented in India is that you have to perform a bridging trial,” Vinod K. Paul, who heads a government panel on vaccine plan, said in an interview in his office near the parliament building.
A Pfizer spokeswomen did not immediately respond to a request seeking comment.
Paul also said Russia’s Sputnik V, a shot undergoing last-stage trials in India, will soon apply for emergency-use approval in the country.
No vaccine manufacturer will be given indemnity by the government should something go wrong, Paul said. Serum Institute had written to the government seeking indemnity. AstraZeneca has said it has obtained such indemnity in many other countries.
India has also qualified for emergency use a vaccine developed locally by Bharat Biotech.
