India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: 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.

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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.”

"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.

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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.

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