India, overwhelmed by COVID surge, fast-tracks approval for foreign vaccines

[April 13, 2021]  By Alasdair Pal and Krishna N. Das

NEW DELHI (Reuters) -India is to 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.

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 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.

It is currently using the AstraZeneca shot and a homegrown vaccine developed by Bharat Biotech for its own immunisation drive. The country this week approved Russia's Sputnik V shot for emergency use.

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 daily cases earlier in the year.

India reported 161,736 cases on Tuesday, taking its total to 13.7 million. Deaths rose by 879 to 171,058.

The world's second-most populous country has also stopped exports of anti-viral drug Remdesivir, developed by Gilead Sciences, due to a local shortage. Indian drug maker Cipla Ltd said it had doubled production of the drug to meet "unprecedented demand".

RALLIES, RELIGIOUS EVENTS

Hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of a weeks-long festival, even as peaks in coronavirus infections have prompted government critics to demand the cancellation of such huge events.

Beds with oxygen support are seen at a recently constructed quarantine facility for patients diagnosed with the coronavirus disease (COVID-19), in Mumbai, India, April 13, 2021 REUTERS/Francis Mascarenhas

Nearly a million Hindus bathed in the Ganges on Monday in the belief that its waters would wash away their sins. More than 100 of those people have tested positive for COVID-19 in random testing carried out by authorities, local media said.

Few of the throngs at the mass religious gathering called the Kumbh Mela, or pitcher festival, observed precautions such as social distancing or mask wearing, Reuters witnesses said.

Hundreds of thousands more are expected to plunge into the waters in the northern city of Haridwar on Wednesday, the next key day of the festival.

Elsewhere, massive election rallies by the ruling Bharatiya Janata Party and opposition parties during polls in four states and one federally-run region have fuelled concern.

Prime Minister Narendra Modi and Home Minister Amit Shah addressed huge rallies on Monday in the eastern state of West Bengal, a key political prize, with Shah posting Twitter pictures of meetings with crowds of supporters while unmasked.

The second wave of infections that began in India's major cities, such as its financial capital of Mumbai, is increasingly spreading into the hinterland, where healthcare facilities can often be rudimentary.

Health Minister Harsh Vardhan has blamed several factors for the surge.

"There have been elections, religious gatherings, reopening of offices, lots of people travelling, attending social functions, not following rules, little mask-wearing in functions like weddings, even on crowded buses and trains," he told a video conference last week.

India is currently reporting around double the daily cases of the United States and Brazil, the two other worst affected countries, though its daily death toll lags those of both nations.

India's total infections rank after only the United States, having overtaken Brazil on Monday.

(Reporting by Krishna N. Das; Editing by Nick Macfie and Ana Nicolaci da Costa)

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