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HomeNews ReportsPfizer Inc withdraws application for emergency use authorisation of its Covid-19 vaccine in India

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

Pfizer said that the regulators in India needed more information regarding the vaccine, owing to which it was withdrawing the application for emergency use of the Pfizer vaccine.

Pfizer Inc, which has developed a COVID-19 vaccine in collaboration with Germany’s BioNTech, has reportedly withdrawn the application for emergency use of its vaccine in India. The US company, which was the first company to apply for emergency use authorization of its COVID-19 vaccine in the country, took the decision after it participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3.

Following the meeting, the company issued a statement in which it said that the regulators in India needed more information regarding the vaccine, owing to which it was withdrawing the application for emergency use of the Pfizer vaccine 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”.

It added that it will in the future look to resubmit its application with the additional information that the regulator requires. “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 US-based company had sought authorisation for the emergency use of its vaccine in India late last year. However, the Drug Regulatory Authority of India gave its approval to two much economical vaccines- the vaccine developed by Oxford University/AstraZeneca and another made in India vaccine developed by Bharat Biotech together with the Indian Council of Medical Research. 

India’s Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval unless it participated in a small local trial to determine the vaccine’s safety and immunogenicity for Indians. Indian health officials opined that since the genetic constitution of an Indian can be different from people in Western nations, this is a pre-requisite. The developer has to agree for the local trial to determine if a vaccine is safe and generates an immune response in its citizens.

Serious allergic reaction like Anaphylaxis reported after administration of Pfizer vaccine

The US-based pharma giant Pfizer and its German partner BioNTech had during initial trials of its vaccine had said that they had not found any serious safety concerns and claimed that the vaccine is more than 90% effective. Britain had become the first Western country to authorise the emergency use of a coronavirus vaccine developed by Pfizer and BioNTech. However, following the implementation of the first dose of the vaccination, reports of serious allergic reaction like Anaphylaxis emerged. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination.

Logistics is another major concern for the US-based vaccine

Besides this, another major issue pertaining to the Pfizer vaccines is its logistics, since the vaccine requires to be stored in minus 70 degrees (-94 F) or below. Amesh Adalja, the senior scholar at Johns Hopkins Center for Health Security, said, “The cold chain is going to be one of the most challenging aspects of the delivery of this vaccination.” Even in the big cities, the hospitals do not have such storage facilities where storing vaccines at ultra-low temperature is possible.

In general, the refrigeration system at most of the storage facilities across the globe store medicines at 2-5 degrees above the freezing point. In such a situation, the Pfizer vaccine will be viable only for five days after which it will spoil. Owing to this, the distribution of the vaccination in the developing countries and rural areas pose as a major challenge.

As compared to the US based vaccine, vaccine of Moderna Inc which works on similar technology as Pfizer, need not be stored at such low-temperature. Vaccines by Johnson & Johnson and Novavax Inc too can be stored at 2-8 degrees, which is in the normal range of storage facilities’ refrigeration units.

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