New Delhi, December 28
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 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.
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 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 EUA 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.
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 for now. Any decision on whether the two new vaccines -Corbevax and Covovax which were cleared on Tuesday can be used for third dose would be taken in due course, sources said.
The Corbevax vaccine is administered through intramuscular route with 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, a health ministry statement said.
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 Covishield vaccine, it said.
The EUA proposal for Corbevax was reviewed by SEC on 10.12.2021 and 27.12.2021 wherein after detailed deliberation, it recommended for grant of permission for restricted use in emergency situation to manufacture and market Corbevax in 18 years and above, it said.
The Covovax vaccine of SII is a technology transfer of Novavax USA vaccine.
It is administered through intramuscular route with 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 (singledose) 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 emergency situation to manufacture and market the jab,” it said.
Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis. The UK MHRA on December 4 granted approval for Molnupiravir under special condition 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 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 prescription of medical specialists and the recommended dose should be 800mg twice daily for 5 days.
