Corbevax, Covovax, Molnupiravir approved for emergency use
New Delhi: Expanding India's vaccine basket, the Central Drug Authority has approved the Serum Institute of India's Covid vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for restricted use in an emergency situation.
The announcement by Union Health minister Mansukh Mandaviya on Tuesday came 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 a 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 minister said the approvals will further strengthen the global fight against the pandemic.
"PM @NarendraModiJi has led the battle against #COVID19 from the front. All these approvals will further strengthen the global fight against the pandemic. Our Pharma Industries are asset for the entire world," 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, 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 license 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 a 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.
"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 an 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 the treatment of adult COVID-19 patients with SpO2 93 per cent and who have a 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 the 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 the prescription of medical specialists.
India logged 653 cases of the Omicron variant of Coronavirus across 21 states and UTs so far out of which 186 people have recovered or migrated, according to the Union Health ministry data updated on Tuesday.
Maharashtra recorded the maximum number of 167 cases followed by Delhi at 165, Kerala 57, Telangana 55, Gujarat 49 and Rajasthan 46. With 6,358 people testing positive for Coronavirus infections in a day, India's total tally of Covid cases rose to 3,47,99,691.
The active cases have declined to 75,456, according to the data updated at 8 am. The death toll has climbed to 4,80,290 with 293 fresh fatalities, the data stated.
Meanwhile, people aged 60 years and above with co-morbidity will not be required to produce or submit any certificate from doctor at the time of administration of precaution dose of COVID-19 vaccine, the Centre told states and Union Territories on Tuesday. Such persons are expected to obtain the advice of their doctor before deciding to avail of the precaution dose or third dose.
In a letter to states and UTs, Union Health Secretary Rajesh Bhushan said personnel to be deployed in election duty in the poll-bound states will be included in the category of frontline workers.
Eligibility of such beneficiaries for the precaution dose will be based on the date of administration of 2nd dose as recorded in the Co-WIN system — completion of nine months i.e. 39 weeks from the date of administration of the second dose — Bhushan said.
He informed that CoWIN will send reminder messages to all those eligible for precaution dose, which will be reflected in digital vaccination certificates.
