The US-based pharmaceutical major Pfizer Inc has told the Indian government that there are no concerns about the safety of its COVID-19 vaccine. India has been insisting on small local trials for foreign shots despite a record surge in infections and shortage of doses.
As per the rules, foreign companies would have to initiate a local clinical trial within 30 days of receiving emergency use authorisation. Previously, companies were required to do the trial prior to approval. The government has invited Pfizer, Johnson & Johnson, and Moderna Inc to sell their vaccines to India but none have applied to do so yet.
However, Pfizer said it is holding fresh talks with the government after having withdrawn its initial application in February over the earlier local trial rule. The government in mid-April made it easier for 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% with no safety concerns.
Asked about the vaccine's ultra-low temperature storage requirements, minus 70 degrees Celsius, Pfizer said the company could deliver the shot to vaccination centers using its specially designed, temperature-controlled thermal shippers.
It said doses could be stored in ultra-low-temperature freezers for up to six months, in the shippers for up to 30 days by refilling them with dry ice every five days, or in common refrigeration and freezer units for five days.
(With Reuters Input)
