US pharma giant Pfizer has offered its COVID vaccine to India but the hitch is that it is seeking legal protection from any compensation claims that may arise in case there are serious side effects linked to use of the vaccine.
The U.S. pharma giant has been insisting on the indemnity citing the examples of countries like Britain and the USA where its vaccine has been extensively used and it has been granted such legal protection against claims.
However, the problem in the Indian context is that none of the three vaccines currently approved for use in the country- Covishield, Covaxin or Sputnik V – have been given such protection.
According to sources, the indemnity issue was discussed recently by Pfizer executives and Indian government officials but they have not yet reached a resolution.
A Pfizer spokeswoman said that the company is still in talks with India on a deal and they have not reached an impasse, adding that Pfizer remains hopeful about reaching an agreement.
Pfizer has been consistent in its position on indemnity and is not planning to change its approach for a deal with India, according to a Reuters report.
India pledged last month to fast-track approvals for overseas vaccine makers including Pfizer, Moderna and Johnson and Johnson. However, none have since sought permission from India's drug regulator to sell their vaccine in the country.
One source said that another issue being discussed between Pfizer and New Delhi was the Indian government's insistence on a local trial for any vaccine approval. The source added that Pfizer cannot finalize terms of a supply agreement, including indemnity, if the vaccine is not first authorized for use in India.
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Pfizer withdrew its application for emergency use authorisation for the vaccine developed with Germany's BioNTech in February after India insisted on such a trial.
Pfizer's chief executive Albert Bourla said earlier this month that he was hopeful that the government would change its policy of local trials and that a path to delivering the drugmaker's shots in India could be found.
The American pharma giant is in talks with the government over fast-track approval and is ready to roll out 50 million doses between July-October, according to PTI news agency.
Pfizer has told the government its Covid vaccine shows "high effectiveness" against the variant dominant in India and can be stored for a month in cold storage facilities with a temperature range of 2-8 degrees Celsius, the PTI report said.
Pfizer also told the government its vaccine had been proven suitable for everyone over 12.
