Breakthrough of the Pfizer Covid-19 vaccine: discussions with regulators then, the cold chain in India is a challenge

Pfizer says an early snapshot of its vaccine data suggests vaccines could be 90% effective in preventing Covid-19, but that doesn’t mean a vaccine is imminent. (Ryan Remiorz: The Canadian Press via AP)

One of the main takeaways for India from Monday announcement by Pfizer is the decision of the American pharmaceutical giant to hold discussions with regulatory authorities around the world.

In August, the Indian Express first reported that the Indian government had had an ‘initial meeting’ with representatives from Pfizer’s Indian subsidiary days after Pfizer released the first data from the Phase 1 trial. of his vaccine candidate against the new coronavirus, which he says has demonstrated a strong immune response.

Pfizer has so far identified five facilities around the world, including the United States and Germany, to manufacture its Covid-19 vaccine. Leading government sources had earlier confirmed to The Indian Express that while Pfizer did not agree with the government “for the time being” and did not identify any manufacturing facilities, it was possible that an option to “Fill and finish” emerges. ? Express Explained is now on Telegram

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 countries including the United States, United Kingdom, Japan and Canada.

If the company (and its partner, German biotechnology company BioNTech) decides to approach Indian regulatory authorities, a key issue that will need to be addressed is that of the cold chain. Pfizer’s mRNA vaccine candidate should be stored and shipped under subzero temperature conditions.

A subgroup formed by India’s High Level Expert Group on Vaccine Administration has started mapping cold storage facilities across the country, including those available in the processing industry. food. The 28,000-unit cold storage network used by the country’s universal immunization program currently manages temperatures between 2 and 8 degrees Celsius.

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