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India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: Health Minister Harsh Vardhan

Emphasising “atmanirbharta” or self-reliance, the minister said India’s focus is on developing an indigenous vaccine, adding that our vaccine manufacturing capacities “are not less than anyone.”

December 21, 2020 / 11:00 AM IST
Union Health Minister Harsh Vardhan

Union Health Minister Harsh Vardhan

Union Health Minister Harsh Vardhan has said that the Drug Controller General of India (DGCI) is “examining” Pfizer India’s application for emergency use authorisation (EUA) application of its COVID-19 vaccine.

In an interview with ANI, he said he is aware of the application and that regulators are examining the same. Adding: “If a politician speaks on the matter which is in the jurisdiction of experts, it will not be appropriate...perhaps they did not take part in the meeting.”

His comments come after the DGCI’s Subject Expert Committee (SEC) held a meeting to review applications submitted by pharmaceutical companies for EUA of their vaccine candidates. The regulator had in early December also safety and efficacy data from the Serum Institute of India (SII) and Bharat Biotech for their vaccines.

Follow our LIVE Updates on the coronavirus pandemic here

Emphasising “atmanirbharta” or self-reliance, the minister said India’s focus is on developing an indigenous vaccine, adding that our vaccine manufacturing capacities “are not less than anyone.”

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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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"Our country is moving towards self-reliance and we are not less than any other country in the world in vaccine development and research … and manufacturing capacities," he said.

The United Kingdom, United States, Canada, Mexico and Bahrain are among the countries that have approved Pfizer-BioNtech’s coronavirus vaccine. The US has also approved Moderna’s vaccine candidate. Meanwhile, India has six COVID-19 vaccines in various stages of clinical trial and three in pre-clinical trial stage.

Check here for the latest updates on all COVID-19 vaccines

Further speaking on India’s preparedness for the immunisation programme once a vaccine is approved, Harsh Vardhan told ANI the Centre has been working with state governments “at district and block level for the past four months.”

He also recalled India’s “vast experience in vaccination” due to the polio-free campaign and pointed out that our model was also followed by Southeast Asian countries. He added that India’s universal immunisation programme includes 12 vaccines and “there is no shortcoming in our ability.”

“We have made full preparation. We have involved the state governments, made task force at the state level, district, and block level. We have provided training to master trainers in the country and also at the state level we have provided training. We have given training in 260 districts to more than 20,000 people," he said.

He also spoke about the Centre’s mobile app called ‘Co-WIN’ which will conduct track in real-time the delivery of COVID-19 vaccines and its temperature and the potential beneficiary up to the point they get the second dose.

On the issue of cold chain points he said there are 28,000-29,000 such facilities and “procurement process for vaccine carriers for cold chains, deep freezers, mobile vans, and refrigerators” is on.

He said that detailed plans ready on the number of teams required at vaccination centre, volunteers required for assistance and the norms that will be put into place at these centres.

The minister added that India will begin its vaccination programme earliest in January 2021.

Follow our full COVID-19 coverage here
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first published: Dec 21, 2020 11:00 am

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