In a massive win for India's fight against COVID-19, Union Health Minister Mansukh Mandaviya on Tuesday said that Central Drugs Standard Control Organisation (CDSCO) has approved the Serum Institute of India's (SII) COVID-19 vaccine Covovax and Biological E's Corbevax.
Additionally, anti-viral drug Molnupiravir has also been approved for restricted use. The announcement came a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
'Congratulations India,' tweeted Dr Mansukh Mandaviya:
Congratulations India 🇮🇳— Dr Mansukh Mandaviya (@mansukhmandviya) December 28, 2021
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. (1/5)
As per the Union Health Minister, "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."
RBD is a critical component of the viral spike glycoprotein that is found in coronaviruses including SARS-CoV-2, the virus that causes COVID-19.
As for Biological E's Corbevax, in light of the suggestions of the SEC meeting held on December 10, the firm submitted a 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.
The vaccine should be administered intramuscularly in two doses of 0.5 ml each with intervals of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius, mentioned the PTI, citing sources.
With the latest update, the number of vaccines that have received emergency use authorisation in India has now increased to eight. So far, 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 have received emergency use authorisation.
Mandaviya also tweeted asserting, "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."