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Tag: Novavax

  • Govt panel recommends market authorisation for Covovax jab as heterologous booster dose

    By PTI

    NEW DELHI: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.

    Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India (SII) had recently written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating covid-19 pandemic situation in some countries, the sources said.

    “The subject expert committee (SEC) of the CDSCO on Wednesday deliberated on the issue and recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin,” an official source said.

    The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022 and also in children aged 7-11 years on June 28, 2022 subject to certain conditions.

    Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorization.

    It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with SII for development and commercialization of NVX-CoV2373, its ocvid-19 vaccine candidate in India and low-and-middle-income countries.

    NEW DELHI: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.

    Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India (SII) had recently written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating covid-19 pandemic situation in some countries, the sources said.

    “The subject expert committee (SEC) of the CDSCO on Wednesday deliberated on the issue and recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin,” an official source said.

    The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022 and also in children aged 7-11 years on June 28, 2022 subject to certain conditions.

    Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorization.

    It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with SII for development and commercialization of NVX-CoV2373, its ocvid-19 vaccine candidate in India and low-and-middle-income countries.

  • Serum Institute’s Covovax vaccine gets WHO emergency use nod, Poonawalla hails decision

    By PTI

    NEW DELHI: Serum Institute of India (SII) CEO Adar Poonawalla on Friday hailed WHO’s approval for emergency use of Covovax vaccine for children “as yet another milestone” in the fight against COVID-19.

    The World Health Organization (WHO) on Friday listed the Covovax as the ninth COVID-19 vaccine for emergency use with an aim to increase the access to vaccination in lower-income countries.

    It is produced by the Serum Institute of India under the licence from Novavax.

    Reacting to the development, Poonawalla tweeted, “This is yet another milestone in our fight against COVID-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration…..”

    He tagged Novavax, WHO, Gavi, the Vaccine Alliance, its CEO Seth Berkley and the Gates Foundation.

    Earlier this week, Poonawalla had said that SII planned to launch Covovax, a COVID-19 vaccine for children in the next six months.

    He had stated that Covovax which is under trial would offer protection to children all the way down to three years as it had shown excellent data during the trials.

    Currently, Covishield and other COVID -19 vaccines are approved for people above the age of 18.

    Poonawalla had asserted that there was enough data to show that the vaccine would work and protect children against the infectious disease.

    According to WHO, Covovax was assessed under its emergency use listing (EUL) procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

    “The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally,” it said.

  • Novavax and J&J’s COVID-19 vaccines seek regulator’s nod for launch in India

    Express News Service

    NEW DELHI: India’s pool of COVID-19 vaccines is set to receive a shot in the arm with two more vaccines reaching the doors of the country’s apex drug regulator for approval and looking to receive the permissions within days.

    The vaccines which have applied to the Central Drugs Standard Control Organisation for the restricted use authorisation include Novavax, being manufactured locally by the Serum Institute of India under the brand name of Covovax, and Johnson and Johnson’s single dose COVID vaccine

    Sources in the CDSCO said that the companies had moved the applications on Thursday and a meeting of the COVID-19 expert panel has been called to scrutinise their data before taking a final decision.  

    SII, in June, had already started the production of Covovax for stockpiling, which has shown an efficacy of over 90% in the phase 3 clinical trials in the US and is looking to launch the vaccine in India by September.

    ALSO READ: Booster dose not part of India’s vaccine plan yet

    In India, this recombinant nanoparticle protein-based vaccine—whose 20 crore doses have been projected to be available by the year end—is also undergoing a bridging trial.

    In June, Novavax had said that the vaccine has an efficacy of 90.4% in preventing infection and 100% efficacy against moderate to severe disease while announcing results from its late-stage trials.

    The company had also said in a statement that the vaccine was tested in nearly 30,000 volunteers between January-April in the US and Mexico and significantly, also included nearly 44% non-white participants.

    The two doses of the vaccine are administered 21 days apart and its efficacy results have since been compared to the coronavirus vaccines by Pfizer and Moderna, as the phase 3 trials of this vaccine conducted later meant that it was pitted against the more dreaded delta variant of the COVID virus.

    For the national COVID-19 vaccination programme, J&J’s single dose vaccine has also been slated as a crucial component in the coming days as it may be logistically easy to administer and offers quick coverage to a vast population.

    A bid by the Association of Healthcare Providers of India to procure the J&J vaccines in private hospitals had, however, failed last month due to regulatory hurdles.

    Nearly seven months since the launch of the nationwide COVID-19 vaccination programme, only about 8% of the adult population in India has been fully vaccinated and the government also missed the timeline of supplying 51 crore doses of vaccines by July.

    The inoculation programme against COVID-19 in the country so far has largely been driven by Covishield, being produced by SII which had supplied nearly 45 crore doses till August 5 while Covaxin, being produced by Bharat Biotech, has remained a minor player at less than 7 crore doses.