Pfizer’s Monday announcement on holding talks with regulatory authorities across the world comes as an important takeaway for India. The Indian government had an “initial meeting” with the representatives of Pfizer Indian subsidiary in August. The meeting took place after Pfizer had published the data from its phase one trial of its vaccine candidate.
Pfizer’s early trial data was said to have shown a strong immune response.
By far Pfizer has identified five locations across the globe for the manufacturing of its coronavirus vaccine which includes the United States and Germany.
Pfizer till now didn’t have an agreement with the Indian government and had not identified any manufacturing facility in India yet. But a “fill and finish” option might appear.
Pfizer has announced that by the end of 2020, it would produce up to 100 million doses of its vaccine and possibly 1.2 billion and additional doses by the end of 2021.
The pharma has declared that it has agreed with countries like the US, United Kingdom, Japan, and Canada to supply with the vaccine.
India will have to address a key problem of the cold chain facility if Pfizer Inc and its German partner company biotech firm BioNTech chooses to approach Indian regulatory authorities. Pfizer’s mRNA vaccine candidate requires storage and shipping in sub-zero temperature conditions.
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The central government has composed a high-level expert group on vaccine administration and management. The expert group has started to plan a blueprint to found out cold storage facilities across the country, including those that are available with the food processing industry.
The 28,000-unit cold storage network that the country’s universal immunisation programme uses currently handles temperature in the range of 2-8 degrees Celsius.