New Delhi: Any vaccine maker, including Pfizer, which has sought emergency use authorisation for its COVID-19 shot in India, must conduct a local ‘bridging safety and immunogenicity study’. Then only will the vaccine be considered for India’s immunisation programme, a senior government official was quoted as saying by news agency ‘Reuters’.
Serum Institute of India (SII) is the local manufacturer of the vaccine developed by AstraZeneca and Oxford University. The SII has done a similar study on more than 1,500 people over months before seeking and receiving emergency approval in India.
A section of the media has reported that Pfizer had sought an exception when last month it became the first company to seek emergency use approval in India for its vaccine already in use overseas. The company since then has not attended subsequent meetings called by Drug Controller General of India (DCGI).
“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod K Paul, who heads a government panel on vaccine strategy has said.
Paul also said Russia’s Sputnik V, a shot undergoing last-stage trials in India, will soon apply for emergency use approval.
No vaccine maker will be given indemnity by the government should something go wrong, Paul said. SII had written to the government seeking indemnity. AstraZeneca has said it has received such indemnity in many other countries.
India has also approved for emergency use Covaxin developed locally by Bharat Biotech.