India approves two new Covid-19 vaccines, an oral pill: All you need to know

With the new approvals, the number of Covid vaccines in India's armour against the virus has increased to 8

Expanding India's basket of Covid-19 vaccines, the Drug Controller General of India (DCGI) has approved Serum Institute of India's (SII) vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for emergency use.

The announcement by Union Health Minister Mansukh Mandaviya 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 emergency approval to the drug Molnupiravir for treatment of adult patients with Covid-19 and who have a high risk of progression of the disease.

Read more: Biological E gets DCGI nod to conduct booster dose trials for Corbevax

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.

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 can be used for the third dose would be taken in due course, sources told PTI.

Corbevax

How does it work?

The Corbevax vaccine is administered through the intramuscular route with a two-dose schedule of Day 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 company has conducted phase 1/2, 2/3 clinical trials of its vaccine in the country. Further, it has conducted phase 3 active comparator clinical trial to evaluate superiority against the Covishield vaccine.

The EUA proposal for Corbevax was reviewed by SEC on December 10 and December 27 wherein after a detailed deliberation, it recommended for grant of permission for restricted emergency use to manufacture and market Corbevax in 18 years and above.

How effective is it?

Neutralising antibody titres against the Delta strain “indicate a vaccine effectiveness of >80 per cent for the prevention of symptomatic infections based on published studies”, The Indian Express reported.

After phase III active clinical trials, the company said, "In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, Corbevax demonstrated superior immune response in comparison with Covishield vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant".

Read more: Omicron risk remains 'very high': WHO

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 Day 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.

Serum has conducted phase 2/3 immuno-bridging clinical in the country for comparing safety and immunogenicity of Covovax of Serum and Novavax vaccine.

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 health ministry statement said.

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

How effective is it?

Two phase 3 trials of the jab in UK and US/Mexico indicated 96.4 per cent efficacy against the original strain, 86.3 per cent against Alpha and 89.7 per cent overall (UK), and '100 per cent protection against moderate and severe disease' with 90.4 per cent overall efficacy, according to SII.

Molnupiravir

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 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 US FDA on December 23 had granted EUA for Molnupiravir for the treatment of mild-to-moderate coronavirus disease 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 hospitalisation or death, and for whom alternative Covid-19 treatment options authorised 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 200 mg capsule for restricted use for the treatment of adult patients with Covid-19," the government 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 800 mg twice daily for 5 days.

In India, it has been cleared for the treatment of adults with Covid-19 “who have a high risk of progression of the disease”. It introduces errors into the genetic code of the virus halting replication, IE reported.

Manufacturers for the drug include Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Cipla, Sun Pharma, Torrent, BDR, Stride, and Pune-based Emcure.

How effective is it?

UK's drug regulator gave their nod to the pill on December 4 after it was found “safe and effective”. The US FDA (clearance on December 23) did not authorise it for use beyond five consecutive days, or in patients aged below 18 years since it may affect bone or cartilage growth.

(With agency inputs)

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