New Delhi | Jagran News Desk: Expanding India's basket of COVID-19 vaccines, the Central Drug Authority has approved Serum Institute of India's vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situations. 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.
The committee also had recommended granting restricted emergency use approval to the drug Molnupiravir for treatment of adult patients with COVID-19 and who have a high risk of progression of the disease. 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.
Know about Corbevax:
The Corbevax vaccine is administered through an intramuscular route with a two-dose schedule of days 0 and 28 and is stored at 2 degrees Celsius to 8 degrees C temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack, a health ministry statement said. The SEC recommended for grant of permission for restricted use in an emergency situation to manufacture and market Corbevax in 18 years and above.
The company has conducted phase 1/2, 2/3 clinical trials of its Covid-19 vaccine in the country. Further, it has conducted phase 3 active comparator clinical trial to evaluate superiority against the Covishield vaccine, it said.
Know about Covovax:
The Covovax vaccine of SII is a technology transfer of the Novavax USA vaccine. It is administered through an intramuscular route with a two-dose schedule of days 0 and 21. The vaccine is stored at 2 degrees C to 8 degrees Celsius temperatures and presented as 0.5 ml (single-dose) and 5 ml (10 doses) vial pack.
SII has conducted phase 2/3 Immuno bridging clinical in the country for comparing safety and immunogenicity of Covovax of Serum and Novavax vaccine. The Novavax has conducted phase-3 efficacy trials in the USA and UK wherein the efficacy of the vaccine is reported to be 90.4 per cent and 86.9 per cent respectively, the statement said.
How do Corbevax and Covovax work?
Corbevax and Covovax are protein subunit vaccines. The jab injects the spike protein that teaches the body to develop antibodies against the novel coronavirus. While the spike protein injected is without the virus, the body uses the antibodies generated to fight the real virus when it looks to infect the person.
How many doses are needed and what will be the dose gap?
Both Covovax and Corbevax are two-dose vaccines. While an update from Union Health Ministry on the dose gap is awaited, the WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) has recommended a gap of three to four weeks between two doses of both Covovax and Corbevax COVID-19 vaccines.
How efficiant are Corbevax and Covovax?
The Ministry of Health in June had permitted Biological E to conduct phase 3 clinical trials of Corbevax based on promising results in phases 1 and 2. However, the data from phase 3 and phase 2 trials have been made public yet. For Covovax, the company had in June claimed that it can provide 90 per cent efficiency in preventing symptomatic infection from Covid-19.
Posted By: Talibuddin Khan