Drug regulator approves Corbevax, Covovax, anti-viral drug Molnupiravir for restricted emergency use

The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.

It also had recommended granting restricted emergency use approval to the drug Molnupiravir for treatment of adult patients with COVID-19 and who have high risk of progression of the disease.

In a tweet, the minister said, "Congratulations India. Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: - CORBEVAX vaccine - COVOVAX vaccine - Anti-viral drug 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.

"Corbevax vaccine is India's 1st indigenously developed RBD protein sub-unit vaccine against #COVID19, Made by Hyderabad-based firm Biological-E. It's a hat-trick! It's now 3rd vaccine developed in India," Mandaviya said in another tweet.

The Nanoparticle Vaccine, Covovax, will be manufactured by Pune-based firm Serum Institute of India, he said.

"Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for treatment of adult patients with COVID-19 and who have high risk of progression of the disease," Mandaviya said.

The SEC on COVID-19 of the CDSCO, which reviewed the EUA applications of the SII for the second time on Monday noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO, an official sources had said.

Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations.

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 COVID-19 vaccine candidate, in low and middle-income countries and India.

The World Health Organisation (WHO) had on December 17 issued emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.

As for Biological E's Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial.

The committee noted that the firm has submitted six months safety follow up post second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study.

The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said.

"After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in emergency situation subject to various regulatory provisions," the source said.

The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius,the source added.

The SEC on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for treatment of adult COVID-19 patients with SpO2 93 per cent and who have high risk of progression of the disease, subject to certain conditions.

Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in emergency situation along with various supporting documents. including clinical data in the country, official sources said.

As per conditions, the drug should be sold by retail only under prescription of medical specialists.

According to the conditions, 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, sources said.

It is not authorsied for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women. The US Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.

Before that in November, Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat COVID-19. The pill is intended to be taken twice a day for five days by people at home with mild to moderate COVID-19.

In a clinical trial of high risk people during the ealry course of illness, Merck's drug was shown to reduce hospitalisations and deaths by around 30 per cent.