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Exclusive: Pfizer says will continue to engage with govt to make its COVID-19 vaccine available in India

In February, had the firm withdrawn an application for emergency-use authorisation of its vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study. Now, as per a new rule, the company is eligible to directly seek EUA from the Drugs Controller General of India.

April 21, 2021 / 01:34 PM IST
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Drug maker Pfizer on Wednesday said it would continue engagement with the Central government towards making the Pfizer-BioNTech vaccine part of the government’s immunisation programme in the country.

“As we have stated earlier, during this pandemic phase, Pfizer will prioritise supporting governments in their immunisation programmes and supply the COVID-19 vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the company told Moneycontrol.

Pfizer, in February, had withdrawn an application for emergency-use authorisation (EUA) of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.

But circumstances have changed now, with Pfizer becoming eligible to directly seek EUA from the Drugs Controller General of India (DCGI) to import its COVID-19 vaccine, as the government last week waived off the requirement of submitting local bridge trial data upfront for vaccines approved by the USFDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or those listed with the WHO under Emergency Use Listing. All these regulatory agencies have approved Pfizer vaccine.

Recently, Pfizer signed a deal with South Africa to supply Pfizer-BioNTech COVID-19 vaccine at $10 per dose.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Pfizer’s vaccine is based on genetic material or mRNA. The vaccine is safe with an efficacy of 95 percent after the second dose. The vaccine needs to be taken in two full doses, with a gap of 21 days and storage temperature of -70 degrees Centigrade.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Apr 21, 2021 01:34 pm

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