Asia-Pacific Roundup: India rejects Comirnaty EUA

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Pfizer has withdrawn its application for emergency use authorization (EUA) in India for Comirnaty, its COVID-19 vaccine with partner BioNTech, after the country’s COVID-19 Subject Expert Committee (SEC) recommended against its authorization.

After reviewing data presented by Pfizer at an SEC meeting on 3 February, the committee did not recommend that an EUA be granted, citing serious adverse events including anaphylaxis and palsy as well as the companies’ lack of safety and immunogenicity studies in the Indian population.

“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 in a statement to Reuters.

The action ends the near-term prospect of bringing Comirnaty to the Indian market. Pfizer filed for EUA of the vaccine late last year, shortly before Serum Institute of India and Bharat Biotech did the same for their vaccine candidates. Serum Institute and Bharat received EUAs in the first week of 2021, somewhat controversially in the case of the latter company, but Pfizer had to wait another month to receive a decision (RELATED: Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines, Regulatory Focus 05 January 2021).

Pfizer continues to secure authorizations for Comirnaty in other markets. Last week, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) became the latest regulatory agency to clear Comirnaty for use. Medsafe is also conducting a rolling review of Johnson & Johnson’s COVID-19 vaccine.