Pfizer withdraws application for Emergency Use Authorisation in India

The company will resubmit application after getting more data

By DTE Staff
Published: Friday 05 February 2021

Pfizer Inc’s novel coronavirus disease (COVID-19) vaccine is not likely to come to the Indian market anytime soon. The company withdrew its application for emergency use authorisation February 5, 2021.  

The company’s representatives met with the Subject Expert Committee of the Drug Regulatory Authority of India February 3. The company had asked for a waiver of clinical trials on the Indian population. At the meeting, the additional information needed by the Indian authorities was discussed.

The company has said it will continue to work with the government to ensure that the data required is available. Pfizer will resubmit its application with additional information when it becomes available.

Pfizer was the first pharmaceutical firm to seek an emergency use authorisation in India. The vaccine requires ultra-cold storage and transportation at around -70 degrees centigrade, which will be difficult in India.

The vaccine is also expensive — around $19.5 a dose (approximately Rs 1,431), way above the Rs 200 per dose that the Indian government is paying to Bharat Biotech Inernational Ltd or Oxford-AstraZeneca and the Serum Institute of India.

The vaccine developed by Pfizer and BioNTech SE on the new messanger RNA technology. In the UK and the United States, there have been reports of adverse effects after inoculation though they have been mostly minor. Norway reported 23 deaths after vaccination, prompting calls from China to keep the Pfizer vaccine at bay. They, however, were confirmed to be not due to the vaccine.

Even if approved, it was likely that the vaccine would have come only in the private market and would not have been a part of the government’s vaccination programme.

This would have created inequities between those who have purchasing power and those who are eligible, according to World Health Organization recommendations and public health experts had advised against it on ethical grounds.

India began the first round of vaccination January 16, 2021 using the Oxford Astrazeneca vaccine Covishield and Bharat Biotech vaccine Covaxin. Covaxin was rolled out without completion of the phase 3 of the clinical trials and its use in the vaccination drive is limited as it can be given only after permission of the person receiving the vaccine. So far, more than 4,500,000 people have been vaccinated.

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