India approves Corbevax, Covovax, Molnupiravir for emergency use

SGT Times Reporter

New Delhi, December 29

Expanding India’s vaccine basket, the Central Drug Authority has approved the Serum Institute of India’s Covid vaccine Covovax, Biological E’s jab Corbevax and anti covid pill Molnupiravir for restricted use in an emergency.

The announcement by Union Health minister Mansukh Mandaviya came a day after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting Emergency Use Authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.

 It also had recommended granting restricted emergency use approval to the drug Molnupiravir to treat adult patients with COVID-19 and who have a high risk of progression of the disease. 

 The minister said: “Congratulations, India. Further strengthening the fight against COVID-19, CDSCO, MOHFW_INDIA has given three approvals in a single day for the use of CORBEVAX vaccine, COVOVAX vaccine, and Antiviral drug Molnupiravir for restricted use in an emergency.” 

With this approval, the number of covid vaccines which have received emergency use authorisation in the country has increased to eight.

 Six COVID-19 vaccines: Serum Institute’s Covid shield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V, US-made Moderna, and Johnson and Johnson had already received EUA from the Indian drug regulator earlier. 

 Corbevax vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against COVID19, Made by Hyderabad-based firm Biological-E. 

It’s a hat-trick! Now 3rd vaccine has developed in India, he said. 

The Nanoparticle Vaccine, Covovax, will be manufactured by Pune-based firm Serum Institute of India.

 “Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergencies for treatment of adult patients with COVID-19 and who have a high risk of progression of the disease.

 The minister said these approvals would further strengthen the global fight against the pandemic.

 PM has led the battle against COVID19 from the front. 

Our Pharma Industry is an asset for the entire world, he said.

 Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergencies. 

In August 2020, the US-based vaccine maker Novavax Inc announced a license agreement with SII to develop and commercialize NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries India. 

The World Health Organisation (WHO) on December 17 issued an emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.

As per conditions, the drug should be sold by retail only under the prescription of medical specialists. 

According to the Union Health ministry data updated on Tuesday, India logged 653 cases of the Omicron variant of Coronavirus across 21 states and UTs so far, out of which 186 people have recovered or migrated. 

Maharashtra recorded 167 cases followed by Delhi at 165, Kerala at 57, Telangana at 55, Gujarat at 49 and Rajasthan at 46. With 6,358 people testing positive for Coronavirus infections in a day, India’s total tally of Covid cases rose to 3,47,99,691. The active cases have declined to 75,456, according to the data updated at 8 am.

 The data stated that the death toll has climbed to 4,80,290 with 293 fresh fatalities. 

Meanwhile, people aged 60 years and above with co-morbidity will not be required to produce or submit any certificate from doctor at the time of administration of precaution dose of COVID-19 vaccine, the Centre told states and Union Territories on Tuesday.

In a letter to states and UTs, Union Health Secretary Rajesh Bhushan said personnel to be deployed in election duty in the poll-bound states will be included in the category of frontline workers.

 Eligibility of such beneficiaries for the precaution dose will be based on the date of administration of the 2nd dose as recorded in the Co-WIN system — completion of nine months—thirty-nine weeks from the date of administration of the second dose. 

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