The Centre may grant indemnity from liability to Pfizer and Moderna to speed up approvals for the vaccines in India, health ministry sources have indicated.
A top official with the government has said that “there is no issue” in granting indemnity to the two giants in India and the approval will be in line with the approach taken by US and other countries administering both vaccines.
In what could prove to be another shot in the arm for India’s vaccination drive against Covid-19, foreign jabs approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) said on Wednesday.
The exemption will, however, be limited to COVID-19 vaccines approved in India for restricted use in emergency situation which are already approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing (EUL) and which are well established vaccine from the stand point that millions of individuals have already been vaccinated with the said vaccines.
The government earlier required local clinical trials or bridging studies that involves testing the vaccine in Indian participants to assess the safety and immunogencity in the local population for vaccines developed overseas.
Pfizer, which is ready to offer an undisclosed number doses to India between July and October, had in talks with the government stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO.
Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects. India has so far not given any manufacturer indemnity against the costs of compensation for any severe side effects.