Central drug authority CDSCO on Tuesday approved the Serum Institute of India's Covovax, Biological E's Corbevax vaccines and anti-viral pill Molnupiravir for restricted use in emergency situation.
With the two additions, the number of Covid vaccines which have received emergency use authorisation in the country 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.
Here's everything you need to know about the vaccines and the drug:
Covovax
Novavax, the maker of Covovax has partnered with Serum Institute of India to produce Covovax. The World Health Organisation (WHO) on December 17 issued an emergency use listing for Covovax. It is a protein-based Covid-19 vaccine known as NVX-CoV2373 and is a "recombinant nanoparticle" vaccine, with the company saying it is the "first protein-based option." In August, Novavax had given SII the licence to manufacture and supply the vaccine. Covovax has reported efficacy of over 89 per cent during its clinical trial. It is different from SII's Covishield, which uses a separate virus to carry the weakened spike protein to trigger an immunity response.
"We are proud to deliver a highly-effective protein-based COVID-19 vaccine of more than 90 per cent efficacy rate, based on clinical data demonstrating a favorable safety profile," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India (SII).
"We expect the authorisation of our vaccine to serve a vital need in India, helping to increase the vaccination rate in a country where a significant number of doses is needed to control the pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax.
Corbevax
The other vaccine approved is protein-based Corbevax, produced by Hyderabad based firm Biological E Ltd. The company first submitted preliminary data from the clinical trial to the drug regulator in October 2021. The Centre has made an advance payment of Rs 1,500 crore to reserve 300 million doses of Corbevax.
Corbevax was developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC). It partnered with Biological E to conduct studies through its Translational Health Science Technology Institute (THSTI), Faridabad.
The vaccine was tested on 1,268 subjects in the age group from 18-80 years having moderate to high-risk co-morbidities.
The pharma company has started manufacturing the vaccine in advance and stock pile the vaccine to be rolled out in one go as soon as it gets the DCGI nod.
Molnupiravir
Cipla will launch Molnupiravir under the brand name Cipmolnu®. Molnupiravir is the first oral anti-viral approved by the UK Medicines and Healthcare products Regulatory Agency for the treatment of mild-to-moderate COVID-19 at high risk of developing severe disease.
Cipla entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir in India and to over 100 low and middle-income countries (LMICs).
Cipla will make Cipmolnu® 200mg capsules available at all pharmacies and Covid treatment centers across the country, the company said in a statement.
"We continue to be guided by the power of science to address the unmet needs of patients across the globe and bring care closer to the patients," said Umang Vohra, Global CEO, Cipla Limited.
The company name for Molnupiravir is 'EIDD 2801' the 'E' indicating it was developed at Emory University. Molnupiravir works by altering critical enzymes necessary for the virus to begin replicating in the body's host cells. A key challenge has been that many such antivirals, following a similar mechanism, are not effective as oral pills.
However, it is yet to be seen if these will work against the Omicron variant.