The Pfizer-BioNTech vaccine needs a minus 70 degrees Celsius cold chain requirement and is not being tested in India. So it isn’t very high on New Delhi’s watchlist but its approval and rollout in the UK are of much more than academic interest.
For the vaccine to be considered for use here, the Indian subsidiary of Pfizer will have to approach the regulator and share the data it has submitted to the UK regulator. “They can then ask for an approval and, accordingly, the regulator will take a decision,” an official told The Indian Express.
Top officials monitoring India’s vaccine plan said that Pfizer’s vaccine may not meet the country’s “immediate” domestic requirements given that the firm has prior delivery commitments with several countries. Still, talks are on.
V K Paul, who chairs the high-level National Expert Group on Vaccine Administration, had spelled out India’s strategy with respect to such candidates — like Pfizer and Moderna — which have shown positive results in Phase 3 abroad but are not being tested here. 📣 Follow Express Explained on Telegram
“We know that doses of this vaccine (Pfizer) will not be available in huge quantities… If this vaccine candidate has to come, and if we require it, we are preparing ourselves…we have parallel plans,” Paul had said.
“If we have to chalk a strategy for this vaccine candidate (Pfizer or Moderna), then we will move forward. However, it is a confirmed fact that even if we receive (any dose), we will get it only after a few months,” he said.
India’s current strategy, specifically keeping in mind its largescale requirement, is based on expected supplies of five vaccine candidates currently in clinical trials here: Astrazeneca-Oxford, Zydus Cadilla, Biological E, Dr Reddy’s and Bharat Biotech.
“We have high expectations…that these five vaccine candidates will come through. They are all easy platforms. And the availability of the doses (of the five vaccine candidates) is extremely high. They can bring the pandemic under control,” Paul had said.
Wednesday’s decision by the UK regulator is also significant for India on the tech front. Looking at the global discourse around Pfizer and Moderna’s mRNA vaccine, the Department of Biotechnology provided seed funding for Pune-based Gennova Biopharmaceuticals Ltd, the country’s first mRNA-based vaccine manufacturing facility.
“Never has an mRNA vaccine been used but these vaccines are synthetic and easier to produce. Ramping up capacity is that much easier,” a source said. “But more data and investigation will be crucial for approval.”
Incidentally, the Prime Minister Monday had a detailed discussion with Gennova which expects to launch its own mRNA-based vaccine candidate for Covid by March 2021.
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