New Delhi: Expanding India's basket of COVID-19 vaccines, the country’s drug regulator Drugs Controller General of India (DCGI) recently gave it nod to Serum Institute of India's vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situations.


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The announcement in this regard was made by Union Health Minister Mansukh Mandaviya on Tuesday, 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 had also 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.


With this approval, the number of Covid vaccines which have received EUA in the country has increased to eight. The Health Minister said the approvals will further strengthen the global fight against the pandemic. 


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.


Healthcare, frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before as of now. Any decision on whether the two new vaccines -Corbevax and Covovax which were cleared on Tuesday can be used for the third dose would be taken in due course, sources said.


Corbevax 


 


“Corbevax vaccine is India's 1st indigenously developed RBD protein sub-unit vaccine against COVID-19. It has been developed by Hyderabad-based firm Biological-E. It's now the 3rd vaccine developed in India. The Nanoparticle Vaccine, Covovax, will be manufactured by Pune-based firm Serum Institute of India.


The Corbevax vaccine is administered through an intramuscular route with a two-dose schedule of day 0 and 28 and is stored at 2 degrees Celsiua to 8 degrees C temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack, according to a health ministry statement.


The company has conducted phase 1/2, 2/3 clinical trials of its Covid-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.


The EUA proposal for Corbevax was reviewed by SEC on 10.12.2021 and 27.12.2021 wherein after a detailed deliberation, it recommended for grant of permission for restricted use in an emergency situation to manufacture and market Corbevax in 18 years and above, it said.


Covovax 


 


The Covovax vaccine of SII is a technology transfer of the Novavax USA vaccine. It is administered through an intramuscular route with the two-dose schedule of day 0 and 21. The vaccine is stored at 2 degreees C to 8 degrees Celsius temperatures and presented as 0.5 ml (single-dose) and 5 ml (10 doses) vial pack.


Serum 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 vaccine is reported to be 90.4 per cent and 86.9 per cent respectively, the statement said.


"The EUA proposal for Covovax was reviewed by SEC on November 24 and Dec 27 after which it recommended grant of permission for restricted use in an emergency situation to manufacture and market the jab," it said.


Molnupiravir


 


Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis. The antiviral drug will now be manufactured in the country by 13 companies for restricted use under emergency situation for the treatment of adult patients with COVID-19 and who have a high risk of progression of the disease," Health Minister Mandaviya said.


The UK MHRA on December 4 granted approval for Molnupiravir under special conditions for treatment of mild to moderate coronavirus disease in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness, the statement said.


The US FDA on December 23 has granted EUA for Molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.



"Considering the emergency and unmet medical need in Covid-19, the SEC on December 27 recommended for grant of permission to manufacture and market the Molnupiravir 200mg capsule for restricted use under an emergency situation in the country for treatment of adult patients with COVID-19," the statement said.


As per conditions, the drug should be sold by retail only under the prescription of medical specialists and the recommended dose should be 800mg twice daily for 5 days. 


(With Agency Inputs)


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