Pfizer withdraws application for emergency use of its Covid-19 vaccine in India

Three other vaccines receive permission for phase-I clinical trial

Pharmaceutical major Pfizer on Friday withdrew its application seeking emergency use approval for its Covid-19 vaccine in India after the company failed to secure a regulatory approval for its mRNA vaccine because of safety concerns.

The company officials presented their proposal before a subject expert panel of the Central Drug Standards Control Organisation, which didn’t recommend its use in India after taking note of multiple serious adverse effects whose causality links are being investigated.

Generally the CDSCO asks for a “bridging study” on a limited number of Indian patients for foreign vaccines, but Pfizer sought an exemption from such a requirement under a special provision of the Indian law.

The expert panel noted that incidents of palsy, anaphylaxis and other serious adverse events have been reported during the post-marketing of the Pfizer-BioNTech Covid-19 vaccine and the causality of the events with the vaccine was being investigated.

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Further, since the firm has not proposed any plan to generate safety and immunogenicity data in Indian population the committee decided not to grant the permission for emergency use in India at this stage.

“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 resubmit its approval request with additional information as it becomes available in the near future,” said a Pfizer spokesperson.

Pfizer-BioNTech vaccine BNT162b is the world’s first Covid-19 vaccine that is being used by many countries around the world. India, on the other hand, is using Serum Institute of India’s Covishield vaccine – based on the AstraZeneca-Oxford University technology – and Bharat Biotech’s Covaxin so far for its ambitious plan to inoculate 300 million Indians.

The SEC approved a phase-II/III trial (bridging study) for Serum Institute-Novavax vaccine, which is based on the recombinant nano-particle technology. In a phase-III clinical trial in the UK, the vaccine that remains stable at 2-8 degrees Celsius temperature has been found 89.3% efficacious.

A similar bridging study has been permitted for a synthetic peptide based vaccine, developed by the US company Covavaxx, which has partnered with Hyderabad-based Aurobindo Pharmaceutical to manufacture and commercialise the vaccine in India. The vaccine UB-612 doesn’t need any freezing and can be stored in normal refrigerators.

An intra-nasal investigational vaccine being developed by Bharat Biotech, Hyderabad and Washington University School of Medicine also received approval for phase-I clinical trial to evaluate the vaccine’s safety.