Pfizer headquarters in New York Photograph:( AFP )
The company is demanding indemnity and according to reports the Indian government just might grant it
Drugs Controller General of India recently did away with specific trials of COVID-19 vaccines to improve the pace of vaccinations in the country and to invite more players to the country.
This waiver will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for "Emergency Use" by the World Health Organization.
For the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval bridging clinical trials and testing of every batch of the vaccine by the Central Drugs Laboratory (CDL) in Kasauli can be exempted if the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin.
While this move is likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement, pharma company Pfizer wants more. The company is demanding indemnity and according to reports, the Indian government just might grant it.
But what exactly is ‘Indemnity’?
Indemnity is a legal exemption from future lawsuits over their vaccines. It basically means that if the vaccine maker is sued in India, it will be the government's problem, and not the company's.
India has not given such indemnity to any vaccine producer, why should Pfizer be the first?
Pfizer and Moderna are among the best shots on the international market. Both vaccines work on the same technology. They are more than 90 per cent effective. Together, they have been approved by more than 40 countries. India wants them too. Countries like the US and Britain have already signed such indemnity clauses.
Can the Government of India grant indemnity to Pfizer?
To date, no vaccine maker in India has this immunity. Granting such immunity to one company may solicit similar demands from other pharma companies. But according to reports, Pfizer has indemnity in all the countries it has exported its vaccines. So the government can extend indemnity on the lines of what other importer countries did.
As per Niti Ayog member VK Paul, "They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now,".
Will the company have indemnity in severe cases?
As of now, a "complete waiver" won't be given on the Pfizer vaccine by India. As per sources, "reactions to the vaccine are indemnified" but the "reaction amounting to death or serious ailment like paralysis can't be given waiver and will carry liability".
The final decision on the matter is yet to be taken.
A Pfizer spokesperson on Wednesday said that the company continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme, adding that "as these discussions are ongoing, we are unable to share any additional details at this time,".
(With inputs from agencies)