US-based pharmaceutical major Pfizer Inc. has told the Indian government that there is no concern about the safety of its COVID-19 vaccine. India is insisting on small local tests for foreign shots, despite a record increase in infection and dose reduction.
According to the regulations, foreign companies must initiate a local clinical trial within 30 days of obtaining an emergency use authorization. Previously, companies were required to test before approval. The government has invited Pfizer, Johnson & Johnson and Modern Inc. to sell their vaccines to India but no one has yet applied to do so.
However, Pfizer said that it is in talks with the government afresh after withdrawing its initial application in February. In mid-April, the government made it easier to make foreign vaccines approved in the West and Japan to sell in India.
Pfizer is producing the COVID-19 vaccine with German partner BioNTech SE. Pfizer claims to have an overall efficacy rate of 95% without safety concerns.
When asked about the vaccine’s ultra-low temperature storage requirements, minus 70 ° C, Pfizer said the company could give shots to vaccination centers using its specially designed temperature-controlled thermal shippers.
It stated that up to six months in ultra-low temperature freezers, refilling with dry ice every five days or for up to 30 days in normal refrigeration and freezer units for five days could be given.
(With Reuters input)
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