India fast-tracks approval for foreign vaccines
India yesterday said it will fast-track emergency approvals for Covid-19 vaccines that have been authorised by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.
Meanwhile, US health authorities yesterday recommended a pause in the use of the Johnson & Johnson vaccine over blood clot fears, as surging coronavirus cases in many parts of the world overshadowed the start of the Muslim holy month of Ramadan.
The Indian move, which will drop the need for companies to do small, local safety trials for their vaccines before seeking emergency approval, came following the world's biggest surge in cases in the country this month.
Vaccines authorised by the World Health Organization or authorities in the United States, Europe, the United Kingdom and Japan "may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial", the health ministry said in a statement.
"The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out," it said.
India, the world's biggest maker of vaccines, has so far administered more than 106 million doses of Covid-19 shots, but many states are now running short of supplies as inoculations expand due to surging cases.
India has sold more than 54.6 million vaccine doses abroad and gifted more than 10 million doses to partner countries.