India adds 2 new vaccines, 1 pill to Covid-19 arsenal

As many as 13 companies in the country will now manufacture Molnupiravir and it will be used for treatment of adult Covid-19 patients and those who have high risk of progression of the disease.

The European Medicines Agency has granted conditional approval to Novovax vaccine while Covovax has been granted emergency use listing (EUL) by WHO.
The European Medicines Agency has granted conditional approval to Novovax vaccine while Covovax has been granted emergency use listing (EUL) by WHO.

The Central drug authority has granted approval to 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. Union health minister Mansukh Mandaviya made the announcement in a series of tweets on Tuesday, a day after the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to Covovax and Corbevax with certain conditions.

As many as 13 companies in the country will now manufacture Molnupiravir and it will be used for treatment of adult Covid-19 patients and those who have high risk of progression of the disease.

With the latest approvals, the number of Covid vaccines that have received EUA in the country has increased to eight.

Biological E’s Corbevax has been approved for patients 18 years and older. The vaccine is stored at 2-8˚C temperatures and comes as 0.5 ml single dose and 5 ml (10 doses) vial pack. Bio E has conducted phase I/II, II/III clinical trials of its Covid-19 vaccine in the country. Further, it has also conducted phase III active clinical trial to evaluate superiority against the Covishield vaccine.

The Covovax vaccine from Serum has been approved for adults. It is a technology transfer of Novavax USA vaccine and a two-dose vaccine given on day 0 and 21. The vaccine is stored at 2-8˚C temperatures and presented as 0.5 ml single dose and 5 ml 10 doses vial pack. The European Medicines Agency has granted conditional approval to Novovax vaccine while Covovax has been granted emergency use listing (EUL) by WHO.

Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis. The UK MHRA had on December 12 granted approval for Molnupiravir under special condition for treatment of mild-to-moderate Covid-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. The USFDA granted EUA for Molnupiravir on December 23 for the treatment of mild-to-moderate coronavirus disease 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 hospitalisation or death, and for whom alternative Covid-19 treatment options authorised by the FDA were not accessible or clinically appropriate.

The CDSCO had received total 22 applications for manufacture and market of the drug Molnupiravir in the country. Of this, eight including five applicants of a consortium of 13 have submitted their clinical trial interim or complete reports.

Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent and BDR are the 13 companies which have been granted permission to manufacture and market Molnapiravir.

The SEC has recommended grant of permission to manufacture and market the Molnupiravir 200 mg capsule with recommended dose of 800 mg twice daily for 5 days for treatment of adult patients with Covid-19, with SpO2 >93% and who have high risk of progression of the disease, including hospitalisation. The Molnupiravir drug has to be sold by retail only under prescription of medical specialists.

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