Johnson and Johnson (J&J) and Pune-based Serum Institute of India (SII) have applied to the Central Drugs Standard Control Organisation for the restricted use authorisation of newer vaccines. While J&J has sought the approval for its single-dose vaccine, SII has approached Novavax, being manufactured locally under the brand name of Covovax.
J&J submitted its emergency use approval application on August 5.
Earlier, J&J had approached the drug regulator for conducting a bridging trial in India, but withdrew its application as the Centre did away with the need for local trials for those vaccines that were already approved for restricted use by select regulators. These include the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as those on the emergency use list of the World Health Organisation (WHO) besides well-established vaccines that have been administered to millions of people.
On Friday, SII CEO Adar Poonawalla had expressed hope that the two-dose Covovax will be launched in October for adults and for children by the first quarter of 2022. He added that Covovax for kids would be launched in October, depending on DCGI approvals.
The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol last week.
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.
Courtesy – www.theweek.in