Amid rising concerns over the increasing cases of highly contagious Omicron covid variants in India, the drug regulator on Tuesday cleared two more covid vaccines and an anti-viral pill for emergency use authorisation (EUA). The EUA was granted to Molnupiravir Covid-19 pill, Corbevax and Covovax vaccines. The Central Drugs Standard Control Organisation (CDSCO) advised the regulatory board to grant the EUA considering the emergency situation in the country and unmet medical need in Covid-19, according to the Health Ministry. The regulatory board permitted the manufacturing and marketing of 200 mg capsules of molnupiravir with a recommended dose of 800 mg twice daily for 5 days, the ministry added. The government body has also recommended the drug to be sold only against a prescription from a medical specialist. Union Health Minister Mansukh Mandaviya also said that now India has developed a total of three vaccines and its a 'hat-trick!'. Bharat Biotech's Covaxin, Serum Institute of India's (SII) Covishield and Biological E's Corbevax are the three vaccines developed by India.
1. Two new vaccines approved - Corbevax and Covovax
a. Corbevax Vaccine
- Hyderabad-based Biological E has developed Corbevax and it is the first indigenously developed RBD protein sub-unit vaccine against Covid-19 in the country, the health minister wrote in a tweet.
- The vaccine uses fragments of the virus to trigger an immune response. The firm has also said that the vaccine had shown 'high persistence of immune response after the second dose'.
- The government has reserved 30 crore doses of Corbevax by making an advance payment of Rs 1,500 crore to the manufacturers.
- It also completed Phase III trials on over 3,000 subjects at 33 study sites across India. “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,” the company told The Indian Express.
b. Covovax Vaccine
- Covovax is also a protein subunit vaccine and it will be manufactured by the Serum Institute of India (SII). The vaccine was developed by the American biotechnology firm Novavax.
- Novavax has used an immune-boosting compound (adjuvant) in the vaccine, the same technology which is used in HPV and the Hepatitis B vaccine.
- The vaccine was evaluated in two Phase 3 trials, one in the UK and another in the US. The trials in the UK had demonstrated an efficacy of 96.4% against the original virus strain, 86.3% against Alpha, and 89.7% efficacy overall.
3. Molnupiravir (First Covid-19 pill)
- Molnupiravir is the first Covid-19 pill in the world and the antiviral drug was primarily developed to treat influenza.
-The drug will have restricted use under the emergency situation to treat adult patients under high risk due to COVID-19 infections.
- It will be manufactured by 13 companies in the country including Pune-based Emcure; Mumbai-based Cipla and Sun Pharma; Bengaluru-based Strides; Ahmedabad-based Torrent and BDR; and Hyderabad-based Dr. Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, and Mylan.
- The pill was developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with the American pharma giant Merck.
- According to reports, the drug works by introducing errors in the genetic code of SARS-CoV-2, which prevents the virus from replicating.
- Sun Pharma has also said that the anti-viral pill is expected to be available within a week and at an affordable price, the company told The Indian Express
- The UK drug regulator had cleared molnupiravir on December 4 and the oral antiviral pill was found 'safe and effective'. However, the US had only authorised its use for a maximum of five consecutive days and also restricted the use of the pill for patients younger than 18 as it may affect bone and cartilage growth, The Indian Express reported.