US pharma major Pfizer Inc said on Friday it had withdrawn its application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to comply with the drug regulator’s rules for carrying out a local safety and immunogenicity trial for the shots.
The decision means the vaccine will not be available for sale in India in the near future.
Unlike other companies such as Russia's Spuntik V who are carrying out trials in India for vaccines developed abroad, Pfizer had sought an exemption based on trials done in the United States and Germany.
However, Indian rules stipulate domestic trials as well to determine if a vaccine is safe and generates an immune response in local citizens. There are, however, provisions under India’s rules to waive such trials in certain conditions.
Central Drugs Standard Control Organisation said its experts did not recommend the vaccine because side effects reported abroad were still being investigated. It also said Pfizer had not proposed any plan to generate safety and immunogenicity data in India.
Pfizer said, “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time.”
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future,” the company said.
Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper vaccines which are being produced in India. While one is being manufactured by Pune-based Serum Institute in collaboration with UK pharma giant AstraZeneca and Oxford University, the second has been developed in India by Bharat Biotech with the Indian Council of Medical Research. Both vaccines have been cleared for emergency use.
Local company Dr. Reddy’s Laboratories Ltd is running trials for Russia’s Sputnik V vaccine, which is expected to be approved in the coming weeks. The vaccine has already been cleared for mass use in Russia.
