Pfizer drops India vaccine application after regulator seeks local trial

NEW DELHI, Feb 5 (Reuters) – Pfizer Inc (PFE.N) said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and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. read more

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 U.S. company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany’s BioNTech (22UAy.DE), made the withdrawal decision after a meeting with India’s Central Drugs Standard Control Organisation (CDSCO) on Wednesday.

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.

“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 said in a statement.

“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.”

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 (AZN.L) 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 ongoing in India. Local company Dr. Reddy’s Laboratories Ltd (REDY.NS) is running trials for Russia’s Sputnik V vaccine, which is expected to be approved this month or next.

India says it is the nation fastest to reach the milestone of 4 million vaccinations, with the United States taking 18 days and Israel and Britain 39 days each. Reuters could not find comparable data for China.

Except for the United States, India has the most virus infections, reporting 11,039 new cases on Wednesday, taking its tally to 10.78 million. Deaths rose 110 to stand at 154,596.

(Interactive graphic tracking global spread of coronavirus:

India says it is the nation fastest to reach the milestone of 4 million vaccinations, with the United States taking 18 days and Israel and Britain 39 days each. Reuters could not find comparable data for China.

Except for the United States, India has the most virus infections, reporting 11,039 new cases on Wednesday, taking its tally to 10.78 million. Deaths rose 110 to stand at 154,596.

(Interactive graphic tracking global spread of coronavirus: https://graphics.reuters.com/world-coronavirus-tracker-and-maps/)

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