No Concerns Over Safety, Assures Pfizer As Govt Insists On Local Trials For Foreign Shots

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With the country facing an acute shortage of medical supplies including vaccines delaying the vaccination drive between 18-44 years in several states, global pharma major Pfizer Inc gave assurance over the safety of its Covid-19 vaccine even as the government insists on small local trials for foreign shots.

In April, the government allowed foreign vaccines approved in the West and Japan to market in India insisting on a local clinical trial to be initiated in a span of 30 days of receiving emergency use authorization. Earlier these companies were required to conduct the trial even before getting the approval.

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Even as the global pharma companies including Pfizer, Johnson & Johnson, and Moderna Inc have been allowed to sell their vaccines in India, but none have applied so far, as per the Reuters report.

Pfizer is in fresh talks with the government after it has withdrawn the initial application in February over the earlier local trial rule. On asked whether the company is looking for an exception to the current trial rule, the company spokesperson said, “Pfizer’s application for emergency use authorization was supported with data that shows an overall efficacy rate of 95 percent with no safety concerns.”

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The company reiterated that the safety and efficacy data had been backed by regulatory authorities in the United States, Britain, Japan and the World Health Organization – agencies that India endorses.

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The company which produces the Covid-19 vaccine with German partner BioNTech SE have stated that it would supply doses only through government contracts. On concerns over the requirement of ultra-low temperature storage requirements for its vaccine at minus 70 degrees Celsius (-90 F, the company said the shot to vaccination centers can be sent using its specially designed, temperature-controlled thermal shippers.

The doses can 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.

Meanwhile, Pfizer has committed medicines worth $70 million (over Rs 510 crore), from its distribution centers in the U.S., Europe, and Asia, that have been identified as part of India’s COVID-19 treatment protocol, the company’s Chairman and CEO Albert Bourla said.

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