Pfizer has told the government its Covid vaccine shows “high effectiveness” against the India-dominant variant of the virus experts believe is behind the devastating second wave of infections and deaths in the country, sources told news agency PTI Wednesday.
Sources said Pfizer also told the government its vaccine had been proven suitable for everyone over the age of 12 and, crucially, can be safely stored for a month in cold storage facilities with a temperature range between two and eight degrees Celsius.
The American pharma giant is in talks with the government fast-track approval and roll out five crore doses between July and October – if it receives significant regulatory relaxations, including indemnification, or protection from compensation claims in case of adverse events.
The two sides have held a series of meetings over the past few weeks, some of which also involved Pfizer Chairman and CEO Albert Bourla, to resolve issues, including grant of legal indemnity.
None of the three vaccines currently approved for use in India – Covishield, Covaxin or Sputnik V – have been given such protection. Pfizer has insisted on this, which it has been given by other countries that use the drug, including the United States and several European nations.
According to PTI, sources told the Indian government it should “rely on the 44 authorisations, including WHO approval (to) facilitate emergency use authorisation…” The company, however, is open to considering surveillance of the first 100 subjects to get its vaccine.
“The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too,” Pfizer told the government, according to PTI.
Pfizer, sources told PTI, has shared the most recent data points regarding trials, efficacy rates and approvals from various countries and by the World Health Organization (WHO).
Other issues key to accelerating approval for the Pfizer vaccine are procurement through a central government pathway and regulatory requirement for post-approval bridging studies.
Pfizer (and Moderna, another US pharma giant with a Covid vaccine) was last week approached by the Delhi government, which was looking to buy vaccines directly from them. The offer was rejected; Pfizer cited company policy to say it would only deal with the centre.
Moderna cited similar policies to refuse the Punjab government.
India has administered over 20 crore vaccine doses so far, but is still a long way short of vaccinating a significant-enough proportion of its 130-crore population.
A shortage of vaccine doses is one of the primary reasons for the recent slowdown, with several states flagging low stocks and being forced to suspend vaccination for the 18-44 age group that government data says accounts for nearly 26 per cent of all new Covid cases this month.
India is currently using mainly two ‘made-in India’ jabs – Covishield, manufactured by the Serum Institute, and Covaxin of Bharat Biotech – and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.
Covaxin is expected to shortly start trials for the 2-18 age group.
With input from PTI