The Indian government and the pharma major Pfizer are unable to come to an agreement over a demand by the US company for indemnity (legal protection) from any claims linked to the use of its COVID-19 vaccine in India. This at a time when India is facing a massive shortage of vaccines and the government has pledged to fast-track approvals for foreign vaccine makers.
India has not given any vaccine manufacturer indemnity against the costs of compensation for any severe side effects. Many countries where Pfizer has rolled out its shots, including the US and the UK, have agreed to indemnify the company.
“The whole problem with Pfizer is the indemnity bond. Why should we sign it?” Reuters quoted an Indian government source as saying in an exclusive report.
“If something happens, a patient dies, we will not be able to question them [Pfizer]. If somebody challenges in a court of law, the central government will be responsible for everything, not the company,” the source added.
Another source told the news agency that the company was not going to change its position on the issue.
Pfizer has developed a two-dose COVID-19 vaccine in partnership with BioNtech and has made its doses available in Europe and the US, besides other countries. The pharma major had applied for emergency-use authorisation (EUA) of its vaccine in India in February, but withdrew later after failing to meet the Drugs Controller General of India’s (DCGI) requirement for a local safety and immunogenicity study.
Last month the Centre said it plans to fast-track approvals for overseas vaccine makers including Pfizer, Moderna and Johnson & Johnson.
However, none has since sought permission from the DCGI to sell its vaccine in the country.
Currently there are three COVID-19 vaccines available for sale in India: Oxford-AstraZeneca’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V.