Health Ministry approves two Vaccines (CORBEVAX & COVOVAX) and anti-viral drug MOLNUPIRAVIR against COVID-19 in a single day

Today marks a momentous day in the COVID-19 trajectory of the country as Union Health Ministry has approved two Vaccines (CORBEVAX and COVOVAX) and anti-viral drug MOLNUPIRAVIR against COVID-19 in a single day.

In a tweet, Union Minister of Health & Family Welfare Dr. Mansukh Mandaviya congratulated India and commended the pharma industry of the country for this momentous feat.

“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.”

On Cobevax, he stated- “It's a hat-trick! It's now 3rd vaccine developed in India!”

CORBEVAX vaccine is India's 1st indigenously developed RBD protein sub-unit vaccine against COVID-19, made by Hyderabad-based firm Biological-E. The Nanoparticle Vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India. 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.

Approval to Corbevax of M/s Biological E Limited in the age group of adults aged 18 years and older-

 • CDSCO had received application from M/s Biological E Limited, Hyderabad for manufacturing of Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 (RBD antigen of SARS CoV-2 (Covid-19) for restricted use in emergency use situation on 03.12.2021.

• CORBEVAX is contains protein i.e. Receptor Binding Domain of SARS-CoV-2 virus (RBD antigen of SARS CoV-2) which is expressed in Pichia pastoris. Also the vaccine contains CpG1018 as Co-Adjuvant in the formulation.

• CORBEVAX vaccine is a suspension for injection with 25 μgof RBD antigen of SARS-CoV-2 and is administered through intramuscular route with two dose schedule of day 0 & 28. The vaccine is stored at 2˚C to 8˚C temperatures and presented as 0.5 ml (single dose) & 5 ml (10 doses) vial pack.

• M/s Biological E has conducted animal studies in Rats, Mice, Rabbits and also conducted challenge Studies in Non-human primates (monkeys).

• M/s Biological E has conducted Phase I/II, II/III clinical trials of itsCovid-19 vaccine in the country. Further, it has conducted Phase III active comparator clinical trial to evaluate superiority against COVISHIELD vaccine.

• As a rapid regulatory response, the proposal was reviewed by CDSCO in consultation with Subject Expert Committee (COVID-19) on 10.12.2021& 27.12.2021 wherein after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation to manufacture & market Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 (RBD antigen of SARS CoV-2 (Covid-19) in the age group of 18 years and above subject to various regulatory conditions.

• CDSCO has decided to accept the recommendations of the committee.

Approval of COVOVAX vaccine of M/s Serum Institute of India Pvt. Limited in the age group of adults aged 18 years and older-

• CDSCO had received application from Serum Institute of India Pvt. Limited, Pune for manufacturing of SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine   for restricted use in emergency use situation on 21.05.2021.

• SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine (COVOVAX) of M/s Serum Institute is a recombinant vaccine constructed from the full length wild-type SARS-CoV-2 S glycoprotein & is adjuvanted with the saponin-based adjuvant (Matrix-M). COVOVAX vaccine is a technology transfer of Novavax USA vaccine. 

• COVOVAXvaccine isa suspension for injection with 5 μgof SARS-CoV-2 rS and is administered through intramuscular route with two dose schedule of day 0 &21.The vaccine is stored at 2˚C to 8˚C temperatures and presented as 0.5 ml (singledose)& 5 ml (10 doses) vial pack.

• M/s Serum has conducted Phase II/III immuno bridging clinical in the country for comparing safety & immunogenicity of COVOVAX of Serum & NOVAVAX vaccine. M/s Novavax has conducted Phase III efficacy trials in USA & UK wherein the efficacy of vaccine is reported to be 90.4% &86.9% respectively. European Medicines Agency has granted conditional approval to NOVAVAX vaccine. Further Novavax & COVOVAX has been granted emergency use listing by WHO.

• As a rapid regulatory response, the proposal was reviewed by CDSCO in consultation with Subject Expert Committee (COVID-19) on 24.11.2021& 27.12.2021 wherein after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation to manufacture & market SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine (COVOVAX)in the age group of 18 years and above subject to various regulatory conditions.

• CDSCO has decided to accept the recommendations of the committee.

Approval to anti-viral drug Molnupiravir-

Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis

UK MHRA on 04.12.2021 granted approval for Molnupiravir under special condition for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.

USFDA on 23/12/2021 has granted Emergency Use Authorisation (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.

 CDSCO has received total 22 applications for manufacture and market of the drug Molnupiravir in the country. Out of which, 8 including 5 applicants of a consortium (total 13)have submitted their clinical trial report interim or complete report.

Considering the emergency & unmet medical need in Covid-19, the Subject Expert Committee has recommended in its meeting held on 27/12/2021 for grant of permission to manufacture and market the Molnupiravir 200mg capsule with recommended dose of 800 mg twice daily for 5 days for restricted use under emergency situation in the country for treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death subject to various conditions including following:

1. The drug should be sold by retail only under prescription of medical specialists.

2. The recommended dose should be 800mg twice daily for 5 days.

Based on recommendation of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), the drug is being approved for 13 companies who have submitted their clinical trial report interim or complete report.

Name of Companies:

1. M/s Dr.Reddy’s, Hyderabad.

2. M/s Natco, Hyderabad.

3. M/s MSN, Hyderabad.

4. M/s Hetero, Hyderabad.

5. M/s Optimus, Hyderabad.

6. M/s Aurobindo, Hyderabad.

7. M/s Mylan, Hyderabad.

8. M/s Strides, Bengaluru.

9. M/s Emcure, Pune.

10. M/s Cipla, Mumbai.

11. M/s Sun Pharma, Mumbai.

12. M/s Torrent, Ahmedabad.

13. M/s BDR, Ahmedabad.

By: Tapas Bhattacharya