Corbevax, Covovax, Molnupiravir approved for emergency use
- Expanding India's vaccine basket, the Central Drug Authority has approved the Serum Institute of India's COVID-19 vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situation.
- With this approval, the number of Covid vaccines which have received emergency use authorisation 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.
- Covovax, a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), requires two doses.
- The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
- It is stable at 2 to 8 °C refrigerated temperatures.
- In addition to Covovax, India's Covishield, developed by the Serum Institute of India was issued EUL on 15 February 2021, while Covaxin by Bharat Biotech was given a nod on 3 November 2021.
- It has been manufactured by Hyderabad-based Biological E, is a protein subunit vaccine, which means that instead of the whole virus, it uses fragments of it to trigger an immune response.
- In this case, the subunit vaccine contains a harmless S protein.
- Once the immune system recognises the protein, it produced antibodies to fight a real infection when it happens.
- Biological E plans to begin production at 75 million doses per month, and anticipates reaching 100+ million doses per month from February.
- Biological E has completed Phase III trials on more than 3,000 subjects at 33 study sites across India.
- It says neutralising antibody titres against Delta strain “indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies”.
Molnupiravir: oral antiviral drug
- Molnupiravir, developed in collaboration by US firms Ridgeback Biotherapeutics and Merck, initially to treat influenza, is a repurposed oral antiviral candidate to treat Covid patients.
- It has been cleared for the treatment of adult patients with Covid-19 “who have a high risk of progression of the disease”.
- It works by introducing errors into the virus’s genetic code, which prevents replication.
- Molnupiravir comes in 200 mg pills; the recommendation in India is for 800 mg twice daily for 5 days.
- It will be manufactured by 13 Indian drug makers: Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Cipla, Sun Pharma, Torrent, BDR, Stride, and Pune-based Emcure.
- Sun Pharma has announced it is likely to be available in a week’s time.
- The drug regulator of the UK cleared molnupiravir on December 4 as it has been found “safe and effective”.