Covid vaccine: India may grant indemnity to Pfizer, Moderna, says report

The Indian government is expected to grant foreign vaccine makers Pfizer and Moderna indemnity against legal proceedings, as part of its bid to ramp up Covid-19 vaccine supply in the country. 
 

Countries like the US have granted these vaccine makers immunity where they cannot be sued for any adverse effects. "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," ANI on Wednesday quoted government sources as saying.
 

Pfizer is reportedly in talks with the Indian government for supplying 50 million vaccine doses to the country between July and October but has stressed indemnity as a crucial requirement. 
 

The Drug Controller General of India (DGCI) has also waived the requirement of bridging trials, where these companies were earlier required to test the quality and stability of their vaccines in India, even after approvals from other countries and their health bodies. 

In a letter, DCGI Chief VG Somani said this 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 continues to remain engaged with the Government of India towards making its COVID-19 vaccine available for use in the immunisation program in the country. As these discussions are ongoing, we are unable to share any additional details at this time," ANI quoted a Pfizer spokesperson as saying. 
 

In February, the expert body under India’s drug regulator had declined to recommend emergency use authorisation for Pfizer’s mRNA vaccine. Pfizer subsequently withdrew its application. However, as Covid cases swelled in India, on April 13, the government waived the condition of phase 2 and 3 clinical trials in the country for vaccines cleared by the US, EU, UK and Japanese regulators and listed by WHO.

Meanwhile, India multinational pharmaceutical company Cipla has said that clarity from the Indian government on four critical points -- price restriction, indemnification, bridging trial waiver and basic customs duty exemption -- will help it make a significant financial commitment of Rs 7310 crores advance to Moderna for its booster vaccine in India. 
 

As India faces a severe shortage of vaccines amid the second wave of the Covid-19 pandemic, the Centre has been trying to buy vaccines from foreign manufacturers. 
 

Last month, the joint secretary in the health ministry Lav Agarwal conceded that while the Indian government was trying to buy vaccines from Pfizer and Moderna, the order books of these companies were full with several nations ahead of India, waiting for the delivery of their ordered supplies. Medical experts have claimed that the Indian government was too late in initiating negotiations with global manufacturers, leading to a slowing pace of vaccinations in India since April.