Amid COVID surge, India fast-tracks approval for foreign vaccines

India 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-BioNTech, Johnson & Johnson, Novavax and Moderna shots.

The 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 ministry said the decision was aimed at speeding up the use of shots made in other countries and expanding the “basket of vaccines” available for domestic use.

“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out,” it said.

The country of almost 1.4 billion people is seeing a crippling surge of infections that is threatening to overwhelm hospitals in hard-hit cities. The only way out of the crisis, experts say, is to vaccinate more people.

But this has global implications since India is a major vaccine producer and India’s domestic needs have delayed the delivery of shots to the United Nations-backed COVAX initiative that aims to distribute vaccines equitably.

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 is currently using the AstraZeneca shot and a homegrown vaccine developed by Bharat Biotech.

Russian vaccine approved

On Tuesday, the health ministry said a third vaccine – Russia’s Sputnik V – had also been green-lit for emergency use.

Russia’s sovereign wealth fund RDIF said the drug controller-general of India had approved the use of Sputnik V, developed by Moscow’s Gamaleya Institute.

“India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40 per cent of the global population,” a statement from RDIF said.

Sputnik V will be manufactured by five pharmaceutical companies in India, which will produce 850 million doses annually, RDIF said.

Limited doses are going to be made available by the end of April, RDIF chief executive Kirill Dmitriev told India’s broadcaster, NDTV.

Record surge in cases

Since April 2, India has reported the world’s highest daily tallies of infections, reaching more than 100,000 a day in the last week, compared with fewer than 10,000 a day earlier in the year.

India reported an all-time high of 161,736 cases on Tuesday – the seventh consecutive day that more than 100,000 infections have been recorded – taking its total to 13.7 million. Deaths rose by 879 to 171,058.

Meanwhile, hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of a religious festival, even as peaks in daily coronavirus infections have prompted government critics to demand the cancellation of huge events.

The widely-read Hindustan Times newspaper called for an immediate halt to mass gatherings.

“Governments have happily allowed mega religious festivals, (and) political leaders are still, even in the middle of this nightmarish pandemic, addressing hundreds of thousands,” it said in an editorial.