New Delhi: Serum Institute of India which is one of the two Covid vaccine manufactures in India has sought for indemnity protection against liabilities. The move comes after reports said that the of Government of India is to likely grant American vaccine-makers Moderna & Pfizer indemnity protection.
The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects.
“Not just Serum Institute of India, all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted the same,” sources said according to ANI.
According to an ANI report, former ICMR official Dr Nirmal K Ganguly said that in no company in India’s vaccination history have ever paid indemnity & the government, which is the biggest user of vaccines, has also not done it.
“No Indian company has ever paid indemnity in India’s vaccination history, and neither the government, the biggest vaccine user, has done that. Even deaths after COVID-19 vaccination have not come under this umbrella,” former ICMR Chief was quoted as saying on Wednesday by ANI.
Indemnity is security or protection against a financial liability. Under which vaccine-makers will be protected from legal proceedings, which means that they can’t be sued in India.
Indemnity to Pfizer
Pfizer, which said that it is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one last week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).
Pfizer has indemnity in all the countries it has exported its vaccines. So the government of India can extend indemnity on the lines of what other countries did, media reports said.
Sources privy to the discussions said that following recent meetings between the Indian government and Pfizer’s Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company’s COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies.
According to PTI, NITI Aayog Member (Health) V K Paul last week said at a press conference, “Yes we are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July.”
“We are looking at what their expectations are from the government and they are looking at what our expectations are from them. That’s the process in which this will move. Because they will have to come to India and apply for licensure in India, that’s one path and there are imperatives of cold chain and supply.
Indemnity to Moderna-Cipla
Seeking fast-track approvals to bring Moderna’s single-dose COVID-19 booster vaccine in India expeditiously, Cipla has requested the government for indemnification and exemptions from price capping, bridging trials and basic customs duty, while stating that it is close to committing over USD 1-billion as advance to the US major, sources said on Monday. Requesting the government to provide confirmation on four critical points – exemption from price restriction, indemnification, bridging trial waiver and basic customs duty exemption, Cipla has said such an assurance will help make this significant financial commitment of more than USD 1 billion (over Rs 7,250 crore) advance to Moderna for its booster vaccine in India, sources privy to the development said according to PTI.
Cipla has sought indemnity in case of any adverse effects or complications caused by the Moderna vaccine and cited instances of the US Countermeasures Injury Compensation Program (CICP) and similar programmes in the UK, Canada, EU, Singapore and even the WHO-led Covax, that protect vaccine manufacturers/distributors from claims and underwrite the compensation burden.
Indian companies demanding Indemnity
Reportedly, Serum Institute of India told the government that all vaccine makers, whether Indian or foreign, should be granted the same protection. SII produces Covishield which is currently the only other Covid vaccine avilable in India side from Bharat Biotech’s Covaxin. SII is involved in trials for three new anti-Covid vaccines.
Advanced trials are on for Covovax being developed in collaboration with the pharma company Novovax. Codagenix, a single-dose nasal vaccine, is in phase 1/2 trials in the UK. The third, SpyBiotech, is a novel virus-like particle vaccine, which is also in trials.
Health Ministry sources said other countries have granted this concession and “there is no problem” in granting indemnity or legal protection from any claims linked to the use of a company’s COVID-19 vaccine. “If these companies have applied for Emergency Use Authorisation in India then we are ready to give them indemnity,” ANI report said.
“It is expected that they will be granted indemnity against legal proceedings along the lines of what has been allowed in other countries for Pfizer and Moderna,” it added.
NITI Aayog Member (Health) Dr VK Paul had said earlier that the government is still examining the American pharma company’s request for indemnity. “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,” he was quoted as saying according to ANI.