India recently added three new Covid-19 shots to its bank of vaccines against coronavirus, namely SII's Covovax and Biological E's Corbevax. A third "anti-viral" drug Molnupiravir has also been added to the arsenal. The three drugs have been given emergency use approval (EUA) by the Central Drug Authority, India's apex drug regulatory body on Tuesday.
With this approval, the number of Covid vaccines which have received emergency use authorisation in the country has increased to eight. The announcement was made by Union Health Minister Mansukh Mandaviya on Tuesday following the recommendations by the Subject Expert Committee (SEC) on Covid-199 of the Central Drugs Standard Control Organisation (CDSCO).
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The two new vaccines join the list of six already approved Covid-19 vaccines in India - 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.
SII's Covovax
Covovax has been developed by the Serum Institute of India and has for long been recommended by experts and noted epidemiologists like Shahid Jameel. The Nanoparticle Vaccine, Covovax, will be manufactured by Pune-based firm SII owned by Adaar Poonawalla. The approval for the vaccine adds yet another feather to SII's cap after it delivered Covishield, one of India's first Covis-19 vaccines produced developed in collaboration with Oxford Astrazeneca.
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An approval application for Covovax had been submitted by Prakash Kumar Singh, director, government and regulatory affairs at SII, to the DCGI in October.
In August 2020, the US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its own Covid-19 vaccine candidate, in low and middle-income countries and India.
The DCGI approval comes after the World Health Organisation (WHO) issued an emergency use listing for Covovax on December 17, expanding the bouquet of Covid-19 vaccines validated by the apex health body.
How to administer Covovax
The Covovax shot is to be administered through an intramuscular route. It has a two-dose schedule to be spread out between 21 days. The vaccine needs to be stored at a low temperature of 2 to 8 degrees celsius. It will be given in 0.6 ml single-dose and 5 ml for 10 doses vial pack.
Corbevax by Biological E
The Hyderabad-based Biological E's jab Corbevax, which has also received approval for emergency use, is the third Covid-19 vaccine to be developed in India. It has the distinction of being the first indigenously developed RBD protein sub-unit vaccine in India.
How to administer Corbevax
The vaccine should be administered intramuscularly in two doses of 0.5 ml each with an interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius.
A new Covid-19 pill
According to Union Health Minister Mansukh Mandaviya, the antiviral drug Molnupiravir will be produced by 13 companies in India. It will be used to treat Covid-19 patients with SpO2 93 per cent and those with a high risk of disease progression. Applications for the drug's approval were submitted by Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun along with various supporting documents including clinical data in the country. According to reports, the pill could be revolutionary for treating Covid-19 patients, especially those being treated at home.
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How to administer Molnupiravir
The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19. The drug should only be sold by retail under the prescription of medical specialists. The drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to Covid-19 at that stage However, if it was initiated before hospitalisation due to Covid-19, it may be continued. It is not authorised for use for longer than five consecutive days and for pre-exposure or post-exposure prophylaxis for prevention of Covid-19 for pregnant women.
