Pfizer eyes a market gatecrash as India’s Covid tally mounts
04 May 2021
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US pharma giant Pfizer is trying to convince Indian authorities that there is no need for regulatory scrutiny, at least for its corona virus vaccine that added $3.5 billion to its revenue in the first three months of this year,even as the Indian government insists on local trials of its vaccine whose efficacy and safety are still unknown.
The company insists that the safety and efficacy data of its vaccine, which it claims to be over 90 per cent, is backed by regulatory authorities in the United States, Britain, Japan and the World Health Organisation and that since India endorses these agencies there need not be any fresh trials in this country!
With India caught unawares by a devastating second wave of the corona virus pandemic and the country running short of medical supplies, including much-needed oxygen, the country’s vaccination drive looked too ineffective considering the size of its population. Pfizer is looking at this predicament of Indian authorities to push through its vaccine without testing its efficacy at least on a small scale.
As things stand, the country is delaying vaccination of its population in the most productive age group 18 to 44 years because there is a huge shortage of India-made vaccines, a situation Pfizer wants to exploit effectively.
In fact, the government had, earlier last month, allowed foreign vaccines approved in the West and Japan to market in India but after a local clinical trial to be initiated in a span of 30 days of receiving emergency use authorisation – a relaxation from the requirement of local trials before getting emergency use approval.
None of the foreign pharma majors, including Pfizer, Johnson & Johnson, and Moderna Inc, who have been allowed to sell their vaccines in India after short local clinical trials, were willing to abide by Indian regulations.
Pfizer is reported to have initiated fresh talks with the government after it has withdrawn the initial application in February over the earlier local trial rule. However, the company continues to harp on its earlier claims. "Pfizer’s application for emergency use authorisation was supported with data that shows an overall efficacy rate of 95 per cent with no safety concerns," reports cited a company spokesperson as saying.
At the same time, Pfizer, which produces the Covid-19 vaccine with German partner BioNTech SE, insists on sovereign government backing for supply of its vaccine.
Also, the vaccine has to be stored in ultra-low temperatures of minus 70 degrees Celsius (-90 F), whose cost will also be added to the cost for supplies to India.
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.
Pfizer, on its part, has committed medicines worth $70 million (over Rs510 crore), from its stocks for emergency supplies to India for treatment of Covid-19 patients, the company’s chairman and CEO Albert Bourla said.
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