At a time when Pfizer Inc has tightened the global supplies of vaccines because of limited supplies, the American drug major has said that it will continue its request to seek approvals for coronavirus vaccine in India only if the government committed to purchasing the shots first.
It should be noted that Pfizer was the first pharma company in the world to seek emergency-use authorisation (EUA) for a Covid-19 vaccine not only in India but in other countries as well.
But government in India instead gave a go-ahead to two vaccines – one indigenously produced by Bharat Biotech while the other developed by Oxford University-AstraZeneca – owing to their cheaper rates in comparison to those developed by Pfizer and the lesser maintenance requirement as Pfizer ones need a cold storage processor of a minimum -70 degree Celsius for effective sustenance.
No response to application initially
India's Central Drugs Standard Control Organisation (CDSCO) has reportedly said that Pfizer officials did not turn up for meetings after the pharma company had filed an application for approval in December last year, to which Pfizer officials have said that the meeting was scheduled at a very short notice.
In a statement, Pfizer further said that the India drug regulatory body had also declined the company's request seeking approval for use without conducting a small local trial on the vaccine's safety as well as testing its immunogenicity among the people.
However, proving its stance, the company referred to the global study wherein the vaccine tests, conducted outside India, had proven it to have an overall efficacy rate of 95 per cent despite serious safety concerns.
Britain, the United States, the European Union and Canada have all approved the use of Pfizer vaccine based on this global research only, the statement read.
Lure to India's largest pharmaceutical market
At present, Pfizer is only expecting confirmation on supply from the Indian government and based on it, it will continue the regulatory process in India. The company said in the statement that it is "committed in its engagement" with the Indian government to make the vaccine available in the country.
The largest pharmaceutical market in India attracts most of the foreign investors and that is an important reason why majorly all vaccine developers are in talks with the Indian government in a bid to make their vaccines available in the country.
Other than Pfizer, Indian officials are engaged in continuous discussions with Moderna Inc to make their vaccine shots in India.
But since the beginning of the world's largest immunisation drive on January 16, the government has only relied upon shots which have already been approved in the country following trials as well as the ones that are currently undergoing clinical trials.
Bad reputation of Pfizer due to undercut deliveries
It was in news last week that Pfizer has unexpectedly slashed its vaccine deliveries by almost half the volume to some European Union countries due to limited supplies. Relatively, the supply cut has further hampered vaccination drive in several European countries.
Local authorities informed that the supply cuts have undermined their efforts to inoculate their citizens and control the pandemic which has killed over two million people in the European continent.
According to a Reuters report, Romania received only 50 per cent of its planned volume last week, while the other half is expected to be allocated gradually by the end of March, according to the pharma giant, who further assured that deliveries will probably return to normal level next week onward.
Stuck in a similar situation, Poland received 176,000 doses, a drop of around 50 per cent from what was expected, whereas the Czech government is said to be bracing up for the imminent disruption.
Europe's disease surveillance agency reportedly warned last week that three other variants of Covid-19 that emerged in Britain, South Africa and Brazil may lead to more infections, hospitalisations and deaths throughout the globe.