Pfizer Applies for Emergency Use of Vaccine in India: Report

Pfizer has sought exemption from rules that require a vaccine to have trials in India.

Pfizer has sought exemption from rules that require a vaccine to hold trials in India.

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Days after the United Kingdom and Bahrain became the first two countries to approve the vaccine against COVID-19 developed by Pfizer, the Indian arm of the American pharmaceutical company has applied for emergency authorisation of its vaccine candidate before the Drugs Controller General of India (DCGI), reported news agency PTI.

What exactly has Pfizer sought permission for?

Pfizer, which is the first vaccine developer to apply for emergency authorisation on 4 December, has sought permission for importing and then selling its vaccine in the country.

“The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s COVID-19 mRNA vaccine BNT162b2 in the country.”

PTI quoted an official as saying.

How practical is the vaccine for India?

According to the report, the vaccine jointly developed by Pfizer and BioNTech has also sought an exemption from clinical trials in India, as trials for the vaccine were not held for the Indian population.

According to an NDTV report, for a vaccine to be approved in India, clinical trials must be held in the country. However, it must be noted that Drugs Controller General of India enjoys discretionary powers to skip this rule and allow a vaccine without trials in the country.

But even if Pfizer’s vaccine were to be approved, the fact that it can only be stored in minus 70 degree Celsius means that it would be a logistical nightmare to store and transport the vaccine across India.

Since the vaccine requires a complex network of super cold storage chains, vaccines developed by AstraZeneca and Moderna are somewhat better suited as they require storage in 2-3 degrees.

Can Pfizer’s vaccine prevent transmission?

However even as Pfizer’s vaccine, which has 95% efficacy in preventing COVID-19, has been authorised in the UK and Bahrain, the pharma major’s Chairman Albert Bourla told NBC that he is not certain if the vaccine can prevent transmission of coronavirus to others.

During a recent interview, Dateline NBC host Host Lester Holt had asked Bourla if a person vaccinated with Pfizer’s candidate would be “able to transmit it to other people.”

“I think this is something that needs to be examined. We are not certain about that right now with what we know.”

Albert Bourla to NBC.

Meanwhile both Pfizer and Moderna have applied for emergency authorisation of their respective vaccine candidates in the US, which are pending before the US Food and Drug Administration.