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Tag: dgci

  • Serum Institute seeks DCGI nod for Covid vaccine Covovax

    By PTI

    NEW DELHI: The Serum Institute of India on Friday sought permission from the Drugs Controller General of India (DCGI) to manufacture COVID-19 vaccine Covovax for restricted use in emergency situations at its Manjari manufacturing site, official sources said.

    The company has submitted interim phase 2/3 clinical study report on Indian adults, the interim report of Novavax UK and USA-Mexico phase-3 clinical study and response to the queries raised by the DCGI office, along with its application.

    There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.

    “In our government’s endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world class COVID-19 vaccine for our country and the world at large.

    “Approval of our COVOVAX and its availability will further strengthen India’s capability to fight COVID-19 pandemic and ensure vaccine security in line with our prime minister’s clarion call of Atmanirbhar Bharat,” an official source quoted Singh as having said in the application.

    In the phase 2/3 study in India, more than 1,400 participants have received at least first dose of the vaccine with no safety concerns reported so far, stated the application.

    In August 2020, 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.

    SII, which manufactures Covishield, plans to produce Covovax at its Manjari plant in Maharashtra.

    India has given emergency use permission to several COVID-19 vaccines, including Covishield, Covaxin of Bharat Biotech and Russian-made Sputnik V.

  • DCGI’s expert panel to review Phase III data of Covaxin today

    By ANI
    NEW DELHI: The Subject Expert Committee (SEC) under the drug regulator will discuss reviewing the Phase III data of Bharat Biotech’s Covaxin on Tuesday.

    The meeting is taking before Bharat Biotech’s ‘pre-submission’ meeting on Wednesday with the World Health Organization (WHO), for the approval for their COVID vaccine ‘Covaxin’.

    According to sources, “The Subject Expert Committee will meet today to review the Phase III data of Covaxin.”

    The Hyderabad-based COVID vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend, according to government sources.

    “We have received the data from the phase III trials,” a senior government official confirmed.

    Bharat Biotech’s Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine have been questioned various times and that is what makes the data crucial which will ascertain the efficacy of the vaccine.

    The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).

    In a press briefing a few days ago by the Union Health Ministry, Dr V K Paul, who is a member (Health) Niti Aayog and also the head of the COVID task force of the country, said that the company would be submitting the data within seven to eight days.

    In May, Bharat Biotech had said that an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals expected between July and September.

  • Vaccines approved! SII, Bharat Biotech get DCGI nod for restricted use in emergency situation

    Express News Service
    NEW DELHI: V G Somani, Drug Controller General of India (DCGI) on Sunday announced that the recommendations of a government-appointed panel to grant restricted emergency use authorization to Covid-19 vaccines by Serum Institute of India and Bharat Biotech in the country are being accepted.

    The Pune-based SII is manufacturing and clinical trial partner for the coronavirus vaccine by Oxford University-AstraZeneca under the brand name ‘Covishield’ while Bharat Biotech, in collaboration with the ICMR has developed the country’s first indigenous vaccine- ‘Covaxin’.

    After adequate examination, the Central Drugs Standard controller CDSCO has decided to accept the recommendations of the expert committee and accordingly vaccines of SII and Bharat Biotech for restricted use in emergency situations, said Somani in a press briefing.

    Prime Minister Narendra Modi took to Twitter to call the development a ‘decisive turning point to strengthen a spirited fight’, against coronavirus.

    In a briefing to the press, in which no questions were taken, Somani meanwhile said that the subject expert committee of the CDSCO consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine,  among others.

    In the case of Covishield, Somani said SII submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies.

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    “The overall vaccine efficacy was found to be 70.42 %..The firm also submitted the interim safety and immunogenicity data generated from local trial and the data was found comparable with the data from the overseas clinical studies,”

    #BREAKING | A very happy new year indeed! India’s drug controller has approved #Covaxin and #Covishield for emergency use in the country.#Covid19vaccine #CovidVaccine pic.twitter.com/QQWMzWufxs
    — The New Indian Express (@NewIndianXpress) January 3, 2021

    Somani said that despite the approval of the vaccine, the clinical trial ongoing within the country will continue.

    In case of Covaxin, the DCGI said that the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

    All these data has been shared by the firm with CDSCO, he said adding that phase 1 and 2 clinical trials were conducted in nearly 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.

    “The Phase 3 efficacy trial was initiated in India in 25,800 volunteers and till date about 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date,” said Somani.

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    Reading from a statement, the official also said that for the vaccine, an expert committee has recommended for grant of permission for restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.

    He, however, did not share specific details of what it meant to roll-out the vaccine in “clinical trial mode”. 

    As per the details shared, the clinical trial ongoing within the country by the firm will continue.

    Somani also said that both Covishield and Covaxin have to be administered in two doses and all the three vaccines—third being one by Zydus Cadila which has been issued permission to begin phase 3 trial- have to be stored at 2-8-degree Celsius.