Vaccine Makers Seek Indemnity For Rollout. What It Means

So far, India has not given any coronavirus vaccine manufacturer indemnity.

Vaccine Makers Seek Indemnity For Rollout. What It Means

India has dropped the requirement of bridge trials.

New Delhi:

American pharmaceutical giants Pfizer and Moderna are in talks with the Indian government to supply their Covid-19 shots to the country, but the vaccine makers have reportedly sought indemnity.

So far, India has not given any coronavirus vaccine manufacturer indemnity against the cost of compensation for any severe side effect. Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects.

Official sources have now indicated that the central government is considering granting the concession to the two foreign vaccines.

VK Paul, the head of the National Expert Group on Vaccine Administration and Niti Aayog member, said previously the companies indicated to them the availability of "a certain amount of vaccines" from July. "We are examining this request and will take a decision in the larger interest of people and on merits," he added.

What is Indemnity?
In terms of vaccination strategy, indemnity is a sort of protection pharma companies seek to shield themselves from potential compensation demands from those who may experience adverse effects after getting vaccinated.

If a vaccine maker is granted indemnity by the government of the land it is operating, it effectively means the public can't sue it for negligence related to the vaccine. And if someone suffers side effects and decides to sue, the company will not be liable but the government will have to be the respondent there.

What have other countries done?
Pfizer and Moderna have received protection against lawsuits through indemnity clauses for their COVID-19 vaccines in several other countries, including the US and Brazil. The vaccines developed by Pfizer and Moderna work on the same technology and they have proved to be more than 90 per cent effective against Covid-19. These vaccines have been approved in more than 40 countries.

The Timeline

Pfizer has insisted on getting indemnity from the beginning. In February this year, it was the first foreign drugmaker to apply for emergency use approval of its vaccine candidate in India, but the application was later withdrawn.

In early May, Pfizer said it is holding fresh talks with the Indian government, with a company spokesperson saying the safety and efficacy data of the vaccine had been backed by regulatory authorities in the US, Britain, Japan and the World Health Organization.

Recently, External Affairs Minister S Jaishankar visited the US for bilateral talks and vaccine diplomacy was high on his agenda.

Health Ministry sources have indicated that India may soon grant the concessions sought by Pfizer and Moderna to speed up approvals for their vaccines.