Corbevax, Covovax, Molnupiravir approved for restricted emergency use by CDSCO

The antiCovid19 drug Molnupiravir was shown to reduce hospitalisations and deaths by around 30 per cent during clinical trialUnion Health Minister Mansukh Mandaviya on Tuesday said that the Central Drug Authority CDSCO has approved the Serum Institute of Indias COVID19 vaccine Covovax Biological Es jab Corbevax and antiCovid pill Molnupiravir for restricted use in emergency situationThe announcement comes a day after the Subject Expert Committee SEC on COVID19 of the Central Drugs Standard Control Organisation CDSCO recommended granting emergency use authorisation EUA to the COVID19 vaccines Covovax and Corbevax with certain conditionsIt also had recommended granting restricted emergency use approval to the drug Molnupiravir for treatment of adult patients with COVID19 and who have high risk of progression of the diseaseIn a tweet the minister said Congratulations India Further strengthening the fight against COVID19 CDSCO MoHFW_INDIA has given 3 approvals in a single day for CORBEVAX vaccine COVOVAX vaccine Antiviral drug Molnupiravir For restricted use in emergency situationEight vaccinesWith this approval the number of Covid vaccines which have received emergency use authorisation in the country has increased to eightSix COVID19 vaccines mdash Serum Institutes Covishield Bharat Biotechs Covaxin Zydus Cadilas ZyCoVD Russias Sputnik V and the USmade Moderna and Johnson and Johnson mdash had already received EUA from the Indian drug regulator earlierCorbevax vaccine is Indias 1st indigenously developed RBD protein subunit vaccine against COVID19 Made by Hyderabadbased firm BiologicalE Its a hattrick Its now 3rd vaccine developed in India Mr Mandaviya said in another tweet The Nanoparticle Vaccine Covovax will be manufactured by Punebased firm Serum Institute of India he addedMolnupiravir 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 COVID19 and who have high risk of progression of the disease Mr Mandaviya saidThe SEC on COVID19 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 saidPrakash 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 situationsIn August 2020 the USbased vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVXCoV2373 its COVID19 vaccine candidate in low and middleincome countries and IndiaThe 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 diseaseAs for Biological Es 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 23 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trialThe committee noted that the firm has submitted six months safety follow up post second dose from phase1 clinical trial 90 days safety from the phase 2 part and 60 days safety data from phase 23 and phase 3 active comparator studyThe firm has submitted interim immunogenicity data from phase3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres the official source saidAfter detailed deliberation the committee recommended for grant of marketing authorisation permission of SARSCoV2 Covid19 Vaccine containing RBD antigen of SARSCoV2 for restricted use in emergency situation subject to various regulatory provisions the source saidThe vaccine should be administered intramuscularly in two doses of 05 ml each with interval of 28 days Day 0 and 28 and has to be stored between 2 degrees Celsius to 8 degrees celsiusthe source addedMolnupiravir permitted with ridersThe SEC on Monday also recommended granting permission to manufacture and market antiCovid pill Molnupiravir for restricted emergency use for treatment of adult COVID19 patients with SpO2 93 per cent and who have high risk of progression of the disease subject to certain conditionsDr Reddys 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 saidAs per conditions the drug should be sold by retail only under prescription of medical specialistsAccording 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 COVID19 at that stage However if it was initiated before hospitalisation due to COVID19 it may be continued sources saidIt is not authorised for use for longer than five consecutive days and for preexposure or post exposure prophylaxis for prevention of COVID19 for pregnant womenThe US Food and Drug Administration recently authorised Mercks Molnupiravir for treatment of mildtomoderate COVID19 cases in adults who are at risk for severe diseaseBefore that in November Britain granted conditional authorisation to Mercks coronavirus antiviral the first pill shown to successfully treat COVID19 The pill is intended to be taken twice a day for five days by people at home with mild to moderate COVID19In a clinical trial of high risk people during the ealry course of illness Mercks drug was shown to reduce hospitalisations and deaths by around 30 per centThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever