- Pfizer, a pharmaceutical company based in the United States, has also sought legal protection from Indian government.
- Foreign manufacturers are hesitant to introduce their vaccines to the India because of lack of indemnity.
- Indemnity is protection to vaccine-makers from legal action, which means that they can’t be sued in India.
The government is considering giving indemnity to covid-19 vaccine makers such as Serum Institute of India (SII) and Pfizer, which would relieve them of liability in case of adverse effects, said two people familiar with the situation.
While discussions on indemnity have so far focused on international vaccine manufacturers, current thinking in government is that if foreign vaccine manufacturers are given legal liability protection, domestic manufacturers should be given the same protection.
Most developed and some developing countries have agreed to this indemnity so that they can quickly immunise millions of people without having to worry about the side effects of a vaccine created in the middle of a pandemic. But not in India, where the Serum Institute’s request has so far gone unanswered. In addition to Serum, Pfizer, a US vaccine manufacturer, has demanded similar legal protection. One of the reasons why foreign vaccine manufacturers are hesitant to bring their vaccines to India is a lack of indemnity.
The second wave of covid-19, which began in April, has shifted government thinking, according to the people cited above, who spoke on the condition of anonymity. However, it is unclear if the government will provide blanket indemnity to all vaccine manufacturers or will consider each one separately.
Bharat Biotech, which makes the Covaxin vaccine, has not asked for indemnity, according to the company on Tuesday.
According to the first person mentioned above, “It is only logical that Indian vaccine manufacturers be given indemnity if international vaccine manufacturers get it. Otherwise, it wouldn’t make sense.”
Since last year, the Serum Institute has demanded indemnity for the duration of the pandemic and only for these vaccines. “Serum’s reasoning is that if foreign firms get indemnity, then they should get it as well,” said the second person.
An indemnity is a type of insurance that protects vaccine beneficiaries from legal action if they have so-called serious adverse events (SAEs) after getting a dosage. If indemnity is awarded, rather than the vaccine manufacturer, the government will compensate the persons who have been affected.
Indemnity has been a difficult issue because India lacks a compensation mechanism for adverse outcomes following immunisation (AEFI) in mass vaccination programmes. “For Covid vaccines, the indemnity is likely to come with a compensation mechanism, which is also to be addressed,” the second person stated.
Indemnity critics have urged for more transparency.
“Other than sharing that talks with Pfizer are ongoing, the government has provided no explanation for considering indemnity for the company, which is expected to generate tens of billions of dollars in vaccine sales this year alone,” All India Drug Action Network co-convenor Malini Aisola said. “The general public has a right to know what terms are being debated. However, there are no details. What, for example, is the nature and scope of the proposed indemnity? Would it cover deliberate acts, fraud, or negligence? How would the company’s liabilities be transferred to the government?” she added.
“Because of the potential of striking an uneven bargain for 50 million doses,” Aisola added, “the government should most definitely be on its guard and should take the people into confidence.”