Talks with regulators next, India cold chain a challenge


Written by Kaunain Sheriff M
| New Delhi |

November 10, 2020 2:46:45 am





Talks with regulators next, India cold chain a challengeA subgroup formed by India’s high-level expert group on vaccine administration has started to map cold storage facilities across the country, including those available with the food processing industry. (File photo)

One of the key takeaways for India from Monday’s announcement by Pfizer is the US pharma giant’s decision to hold discussions with regulatory authorities worldwide.

In August, The Indian Express had first reported that the Indian government had had an “initial meeting” with representatives of Pfizer’s Indian subsidiary days after Pfizer released the early phase 1 trial data of its vaccine candidate for the novel coronavirus, which, it said, demonstrated a strong immune response.

Pfizer has so far identified five facilities across the globe, including in the United States and Germany, to manufacture its Covid-19 vaccine. Top government sources had confirmed earlier to The Indian Express that while Pfizer did not “as of now” have an agreement with the government, and had not identified any manufacturing facility, it was possible that a “fill and finish” option might emerge.

Pfizer has said it would 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 countries including the US, United Kingdom, Japan, and Canada.

Should the company (and its partner, the German biotech firm BioNTech) decide to approach Indian regulatory authorities, a key issue that will have to be addressed is that of the cold chain. Pfizer’s mRNA vaccine candidate requires storage and shipping in sub-zero temperature conditions.

A subgroup formed by India’s high-level expert group on vaccine administration has started to map cold storage facilities across the country, including those available with the food processing industry. The 28,000-unit cold storage network that the country’s universal immunisation programme uses, currently handles temperates in the range of 2-8 degrees Celsius.

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