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CENTRE FAST-TRACKS EMERGENCY APPROVALS FOR FOREIGN-PRODUCED COVID VACCINES

India will fast-track emergency approvals for Covid-19 vaccines authorised by the WHO or authorities in the United States, Europe, the United Kingdom and Japan, said the health ministry, following the world’s biggest surge in cases in the country this month.

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others to be ready to come to India as early as possible,” said NITI Aayog member and senior government health official Vinod Kumar Paul during a press conference.

A meeting of National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) was held on 11 April, where the issue was discussed. “The NEGVAC, after comprehensive deliberation, recommended that vaccines for Covid-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India,” the government said in a release.

The Centre, after due consideration, accepted the recommendation of NEGVAC, it added. The government also said that beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.

The move will allow companies to seek emergency approval without small, local safety trials for their vaccines and possibly pave the way for imports of the vaccines manufactured by Pfizer, Johnson & Johnson, and Moderna.

This comes shortly after Russia’s Sputnik V was approved by India’s drug regulator Drugs Controller General of India (DCGI) for emergency use.  Pfizer has also said that it would work towards bringing its vaccine to India after withdrawing its application in February.

This comes after some states reported a vaccine shortage. Before the demand for vaccines skyrocketed within the country, India, which has the biggest vaccine manufacturing capacity in the world, had exported tens of millions of doses. India has administered more than 108 million doses, sold more than 54.6 million vaccine doses abroad and gifted more than 10 million to partner countries, reported Reuters.

Since 2 April, India has reported the world’s highest daily tallies of infections, exceeding 100,000 for the first time last week. It reported 161,736 cases on Tuesday, taking the total to 13.7 million. Deaths rose by 879 to 171,058. The numbers are around double the daily cases of the USA and Brazil, the two other worst-affected countries, although its daily death toll is lower.

The second wave of the infection, which began in major cities, is increasingly spreading into the hinterland, where healthcare facilities are often rudimentary. In Chhattisgarh capital Raipur, the main government hospital’s morgue has been struggling to keep up, joint director Dr Vineet Jain told Reuters. “All oxygenated and ICU beds are full in our set-up. Around 50 dead bodies are laying, we have a shortage of space. Some private hospitals do not have space to keep the dead bodies so they also send the bodies to us,” the news agency quoted him saying.

Concerns of a further spike have also been sparked due to the ongoing Maha Kumbh Mela and massive election rallies taking place in poll-bound states.

 

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