SII wants ''indemnity'' for all vaccine makers; seeks nod to manufacture Sputnik-V
04 June 2021
Serum Institute of India (SII), the maker of Covishield, the Indian name for Oxford-AstraZeneca's vaccine against the Wuhan virus, has sought indemnity for vaccine failures or side effects on lines demanded by foreign vaccine companies like Pfizer, saying that the government should apply “same rules for all”.
Covishield-maker Serum Institute of India (SII) has asked for indemnity from liability for vaccine makers, whether Indian or foreign, after Pfizer and Moderna have sought protection from litigation.
The Adar Poonawalla-led SII, which is involved in the trials of three new anti-Coronavirus vaccines, has also sought approval from the Drug Controller General of India (DCGI) for the manufacture of the Russian vaccine Sputnik-V.
"Not just Serum Institute of India (SII), all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted it," Serum sources said.
"Serum is hoping that rules should be same for everyone," the sources added.
SII, which has initiated advanced trials on Covovax being developed in collaboration with the pharma company Novovax, while Codagenix, a single-dose nasal vaccine, is in phase 1/2 trials in the UK and the third, SpyBiotech, is a novel virus-like particle vaccine, which is also in trials.
The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects. But this is a key condition put forth by foreign vaccine-makers Pfizer and Moderna for supplying their vaccines to India.
However, the union health ministry has hinted at granting indemnity to Pfizer and Moderna, saying that 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 Corona vaccine.
"If these companies have applied for Emergency Use Authorisation in India then we are ready to give them indemnity," reports cited health ministry sources as saying.
"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," they added.
Countries like the US have reportedly granted indemnity from liability to these companies for the possibility of something going wrong with their vaccines. They cannot be sued for compensation if there are any adverse effects from the shot.
Sources say Pfizer's demand for sovereign indemnity is a tough call as no other vaccine manufacturer has demanded or secured this so far.
"Pfizer continues to remain engaged with the government of India towards making its COVID-19 vaccine available for use in the government immunisation program in the country. As these discussions are ongoing, we are unable to share any additional details at this time," a Pfizer spokesperson said on Wednesday.
"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 and we are looking at what their expectations from the government are and they are looking at what our expectations from them are," VK Paul, the head of the National Expert Group on Vaccine Administration said last month.
"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 merits," Dr Paul had said.
SII has applied to the DCGI seeking permission to manufacture the Sputnik-V vaccine for examination, test and analysis at its licensed Hadapsar facility in Pune, official sources said on Thursday.
The Pune-based firm has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow for developing Sputnik-V at its Hadapsar facility.
On 18 May, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for the import of strains or seed lots and cell banks and for carrying out research and development, the sources said.
The committee has raised certain queries over the SII’s application and sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.