NEW DELHI, Dec 28:
Expanding India’s vaccine basket, the Central Drug Authority has approved the Serum Institute of India’s COVID-19 vaccine Covovax, Biological E’s jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situation.
The announcement by Union Health Minister Mansukh Mandaviya on Tuesday 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 for treatment of adult patients with COVID-19 and who have high risk of progression of the disease.
In a tweet, the minister said, “Congratulations India. Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: – CORBEVAX vaccine – COVOVAX vaccine – Anti-viral drug Molnupiravir For restricted use in emergency situation”.
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 Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the 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! It’s now 3rd vaccine developed in India,” Mandaviya said in another tweet.
The Nanoparticle Vaccine, Covovax, will be manufactured by Pune-based firm Serum Institute of India, he said.
“Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for treatment of adult patients with COVID-19 and who have high risk of progression of the disease,” Mandaviya said.
The minister said the approvals will further strengthen the global fight against the pandemic.
“PM @NarendraModiJi has led the battle against #COVID19 from the front. All these approvals will further strengthen the global fight against the pandemic. Our Pharma Industries are asset for the entire world,” Mandaviya said.
The SEC on COVID-19 of the CDSCO, which reviewed the EUA applications of the SII for the second time on Monday, noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO, an official sources had 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 emergency situations.
In August 2020, the US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.
As for Biological E’s Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.
“After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions,” the source said. (PTI)
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