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Centre on Tuesday cleared two more covid vaccines and one pill. The two latest vaccines approved by drug regulator CDSCO are Corbevax and Covovax, while the anti-viral drug Molnupiravir can be used only in an emergency. The annoucement came after Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to both the vaccines with certain contiditions.
Taking to Twitter earlier today, Union Health Minister Mansukh Mandaviya 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 an emergency situation".
All that you need to know about the two new vaccines:
Corbevax:
Dosage:
Biological E's Covid-19 vaccine Corbevax is administered through intramuscular route with two dose schedule of day 0 and 28, a health ministry said adding that “it 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."
Trial:
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 December and then on 27 December 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.
Covovax:
Dosage:
Covovax vaccine of Serum Institute of India is administered through intramuscular route with two dose schedule of day 0 and 21, the ministry said adding, “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."
Trial:
The Covovax vaccine of SII is a technology transfer of Novavax USA vaccine. Serum has conducted phase 2/3 immuno bridging clinical in the country for comparing safety and immunogenicity of Covovax of Serum and Novavax vaccine.
Meanwhile, 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.
Corbevax and Covovax to be used as third dose?
Come January 10, healthcare, frontline workers and citizens above 60 years of age with comorbidities would be goven the third dose of the same vaccine they had been given before as for now, the government had already announced on Monday.
“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 told PTI.
With this, as many as 8 COVID vaccines have received EUA in the country. 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.
Molnupiravir anti-viral pill
The drug regulator 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.
Illaborating further in the statement said, the miniMolnupiravir 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.
"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.
Dosage:
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.
(With inputs from agencies)
