Corbevax & COVOVAX vaccines & Molnupiravir drug approved: Mandaviya congratulates India

In a major boost to the ongoing COVID-19 vaccination nationwide, on December 28, the Central Drugs Standard Control Organisation (CDSCO) approved the CORBEVAX vaccine for emergency use. In addition, the Union Health Minister Mansukh Mandaviya stated that CDSCO and Health Ministry has issued emergency use authorisation (EUA) to COVOVAX vaccine and anti-viral drug Molnupiravir, 'in a single day'.

Taking to Twitter, Mandaviya shared, "Further strengthening the fight against COVID-19, CDSCO, Health Ministry have given 3 approvals in a single day for: - CORBEVAX vaccine - COVOVAX vaccine - Anti-viral drug Molnupiravir For restricted use in an emergency situation."

Third indigenous COVID-19 vaccine gets CDSCO's nod

While CORBEVAX vaccine is set to become the country's first indigenously developed RBD protein sub-unit vaccine against SARS-CoV-2. The same will be manufactured by Hyderabad-based firm Biological-E.

"It's a hat-trick! It's now 3rd vaccine developed in India!" shared the Health Minister on Twitter. 

Notably, the Nanoparticle Vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India. Anti-viral drug Molnupiravir will be manufactured by 13 companies and it will be prescribed for restricted use for emergency purposes, such as treating adult patients who have contracted COVID-19 or the ones with 'high risk of progression of the disease', as per the Health Minister.

Conclusively, Mandaviya shared, "PM Narendra Modi 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 assets for the entire world."

COVOVAX

Earlier it was reported that the DCGI had asked SII to provide details on the 'Matrix component' used in Covovax, given that it is a technology transfer of the Novovax vaccine. "The apex drug regulator has also asked the SII to provide details on Matrix component used in the vaccine," PTI had stated. Along with its application, the SII had also submitted interim safety and immunogenicity data of phase two and phase three clinical trials in India as well as interim phase three trials data conducted in the US and the UK. 

Notably, the vaccine was granted emergency use approval by the World Health Organisation (WHO) on December 17. WHO has said that NVC-CoV2373 was accessed under the Emergency Use Listing (EUL) based on data on efficacy, quality, safety, a risk management plan and other things. Since Covovax is part of the COVAX facility portfolio, it will help vaccinate more people in low-income nations, it had said. 

Molnupiravir

Subject Expert Committee of CDSCO had proposed giving the approval to manufacture and commercialise Molnupiravir, an anti-COVID tablet, for limited emergency use in adult patients infected with COVID-19 with a SpO2 of 93% and a high risk of disease progression, subject to specified criteria. Dr Reddy's Laboratories, in collaboration with Cipla, Mylan, Torrent, Emcure, and Sun Pharma, submitted a proposal for approval of Molnupiravir 200mg capsules for emergency use, along with different supporting documentation.

Image: PTI - Representative Image