image credits: University of Waterloo
In a major concession to American vaccine makers Pfizer and Moderna, it is understood that the government of India may be willing to agree to the demands put forward by the two companies for supplying their vaccines to the country. A major demand of granting indemnity may get accepted as it has been done in many countries around the world, according to sources in the Ministry of Health and Family Welfare (MoHFW). The drug regulator of the country has already dropped the requirement of conducting India specific trials for vaccines approved in some specific countries and by the World Health Organization (WHO).
Among the concessions that can be offered to the vaccine makers, indemnity is the most important one. The vaccine makers- Pfizer and Moderna want protection from getting sued in court in case of an adverse reaction to their vaccines. Many countries including the United States have given this immunity to them. While India hasn’t given an indemnity to any vaccine maker till now, sources reveal that the government may be willing to grant it to foreign vaccine companies.
“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,” one source revealed. They will get the protection if they apply for Emergency Use Authorization in India, it added.
Another concession that has already been granted is to remove the need to conduct ‘post-launch bridging trials’ in India for foreign vaccines. The Drug Controller General of India(DCGI) had on April 13 decided to do away with the requirement for vaccines approved by the USA, UK, Japan and the WHO.
“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. This is under discussion and there is no decision as of now,” said Dr. VK Paul, head of India’s Covid-19 task force.
Even with these concessions though, the arrival of Pfizer and Moderna vaccines can be slow due to huge demand for them across the world. Pfizer has promised to deliver 5 crore vaccines to India from July to October if it is able to make a deal with the government. Moderna’s new single-dose vaccine may come to India in 2022.