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.

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 yesterday, 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”.

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

The total number of virus deaths is approaching three million globally, as the World Health Organization warned infections are rising exponentially despite efforts aimed at stopping them.

Europe, the worst-hit continent, passed the threshold of one million coronavirus deaths, while South Asian countries battle a spiralling outbreak of the disease that has crippled the global economy.

More than 800 million vaccine doses of vaccines have now been administered globally, according to an AFP tally, as governments ramp up inoculation efforts in a bid to emerge from the bruising pandemic.

But the US campaign to vaccinate most of its population hit a hurdle yesterday as regulators recommended the use of the single-shot Johnson & Johnson vaccine be paused “out of an abundance of caution”.

The US Food and Drug Administration (FDA) and the Centers for Disease Control are looking into six reported cases of a rare blood clot in patients who have received the shot — among more than 6.8 million J&J doses administered in the US.

“Until that process is complete, we are recommending this pause,” the FDA tweeted.

Meanwhile, a highly contagious variant of Covid-19 first identified in Britain does not cause more severe disease in hospitalised patients, according to a new study published in the medical journal The Lancet Infectious Diseases on Monday.

The strain, known as B.1.1.7, was identified in Britain late last year and has become the most common strain in the United States, according to the United States Centers for Disease Control and Prevention.

The study analysed a group of 496 Covid-19 patients who were admitted to British hospitals in November and December last year, comparing outcomes in patients infected with B.1.1.7 or other variants. The researchers found no difference in risks of severe disease, death, or other clinical outcomes in patients with B.1.1.7 and other variants.

A separate study published in The Lancet Public Health medical journal found that vaccines were likely to be effective against the British variant since there was no apparent increase in reinfection rate when compared to non-UK variants.

According to British scientists, the British variant was about 40%-70% more transmissible than previously dominant variants.

The studies also confirmed the previous findings that B.1.1.7 was more transmissible. (The Daily Star)

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