Pfizer Inc has declared it had withdrawn an application for emergency-use authorisation of its Covid-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
The decision means the vaccine will not be available for sale in the world’s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products.
Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens. There are, however, provisions under India’s rules to waive such trials in certain conditions. The drug regulator said on its website its experts did not recommend the vaccine because of 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 had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots — one from Oxford University/AstraZeneca and another developed in India by Bharat Biotech with the Indian Council of Medical Research.
Both companies had applied for approval of their vaccines after Pfizer, and their trials are on-going in India. Local company Dr Reddy’s Laboratories Ltd is running trials for Russia’s Sputnik V vaccine, which is expected to be approved this month or next.