After Pfizer, Serum Institute seeks indemnity over COVID-19 vaccine: Sources
NITI Aayog Member (Health) Dr VK Paul had said on May 27 that the government is still examining the American pharma company's request for indemnity.
New Delhi: Amid discussions over possible legal protection to foreign vaccine manufacturers Pfizer and Moderna over their COVID-19 jabs in India, the Serum Institute of India (SII) has also sought protection against liabilities, sources said on Thursday.
“Not just Serum Institute of India, all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted the same,” sources added. Earlier last year, SII CEO Adar Poonawala had advocated for indemnity for all vaccine manufacturers.
“We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits… Frivolous claims come up and you see in the media something being blown out of proportion. The government needs to step in with the right messaging,” he had said.
Amid the nationwide COVID-19 vaccine crunch, US pharma giant Pfizer is seeking an indemnity bond that will exempt it from legal claims in case there are any adverse effects from the vaccine.
NITI Aayog Member (Health) Dr VK Paul had said on May 27 that the government is still examining the American pharma company’s request for indemnity.
“We are examining this request and will make a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now,” he had said.
No company in India’s vaccination history has ever paid indemnity and the government, which is the biggest user of vaccines, has also not done it, Dr Nirmal K Ganguly, former ICMR chief had said on Wednesday.
The Drugs Controller General of India (DCGI) had earlier exempted specific trials of COVID-19 vaccines that have been approved by some other international regulatory bodies. This is likely to clear the way of foreign COVID-19 vaccines such as Pfizer and Moderna.
DCGI Chief VG Somani said in a letter that the decision will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
Pfizer said in a statement that it continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme.