Pfizer withdraws application for emergency vaccine authorisation in India
pharmafile | February 5, 2021 | News story | Medical Communications | COVID-19, Pfizer
Pfizer has withdrawn its application in India for emergency use authorisation of its vaccine, which it has produced with German biotechnology company BioNTech.
Pfizer were the first company to apply for emergency use of a COVID-19 vaccine in India but have reversed their application after a meeting with the Subject Expert Committee of the Drug Regulatory Authority of India on Wednesday.
India’s Central Drugs Standard Control Organization refused to approve the vaccine without an initial trial in the country to test the safety of the vaccine.
It is likely that Pfizer will submit a new application request in India once they have further information regarding the safety of the jab for the Indian population. A bridging trial has been suggested by India’s head of vaccine strategy, Vinod Paul. This analyses the immune response to the vaccine for those with a different genetic makeup.
Pfizer’s rollout in India is also complicated due to the sub-zero temperatures required to transport the vaccine, as well as its price, which is more than £14 a dose.
The Indian government have instead approved two cheaper shots – produced by Bharat Biotech International Ltd or Oxford University-AstraZeneca – which cost just £2 a dose.
In a statement to Reuters, 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.”
The company is hoping to resubmit its application with further information in the near future.
India began its vaccination programme on January 16 with the Bharat Biotech and Oxford University-AstraZeneca vaccines. More than 4,500,000 people have been vaccinated in the country to date.
Jack Goddard
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