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Tuesday, September 29, 2020

Govt starts talks with Pfizer, days after early Covid-19 vaccine data

Coronavirus (COVID-19) Vaccine: Pfizer and BioNTech had released the phase 1 data last Thursday and said they are “on track” to seek regulatory review as early as in October 2020.

Written by Kaunain Sheriff M | New Delhi | Updated: August 28, 2020 11:09:41 am
In India, sources said, Pfizer does not have any agreement with the government “as of now” or identified any manufacturing facility. (File)

The government has held an “initial meeting” with representatives of US-based Pfizer’s Indian subsidiary days after the global pharma giant released the early phase 1 data of its vaccine candidate for the novel coronavirus that, it said, demonstrated a strong immune response.

“We are in contact with Pfizer India. We have had an initial meeting,” top government sources told The Indian Express.

Pfizer and its German partner BioNTech, a biotechnology company, had released the phase 1 data last Thursday and said they are “on track” to seek regulatory review as early as in October 2020.

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So far, the pharma major has identified five facilities across the globe, including in the US and Germany, to manufacture the vaccine. In India, sources said, Pfizer does not have any agreement with the government “as of now” or identified any manufacturing facility.

Sources said, however, that there is the possibility of a “fill and finish” option. “We have to see how it evolves. They are also actively looking around,” they said. In the process of “fill and finish”, manufacturers use third parties to fill vials with the vaccine and complete the packaging process.

The Pfizer vaccine candidate —BNT162b2 — is currently in phase 3 of human trials in the US. It is made of a short segment of genetic material, which provides instructions to human cells to make harmless versions of a target protein — in this case, the spike protein of SARS-CoV-2 — to activate an immune response.

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Pfizer has said it will manufacture up to 100 million doses of the vaccine by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. It has so far announced agreements to supply the vaccine to a number of countries, including the UK, US, Japan and Canada.

On Wednesday, India began phase 2 trials of a separate Oxford University vaccine candidate with the first doses given to a set of six volunteers at Pune’s Bharati Vidyapeeth medical college and hospital. This candidate, which is being developed by Bharat Biotech and Zydus Cadila, is in phase 1-2 of clinical trials.

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