Drug Regulator Green Lights Market Authorisation For Covovax As Covid Booster Dose

The Drug Controller General of India has given the nod for the market authorisation of Covovax as a heterologous Covid booster dose for adults.

The Drug Controller General of India has given the nod for the market authorisation of Covovax as a heterologous Covid booster dose for adults.

Source : PTI

The Drug Controller General of India (DCGI) has approved market authorisation for Covovax as a heterologous Covid booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday.

The DCGI's approval came following recommendations by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).

Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of the escalating COVID-19 pandemic situation in some countries, an official source had said.

"The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had 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 in children aged 7-11 years on June 28 last year subject to certain conditions.

Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. 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 the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries. 

The government has exempted customs duty on imports of Covid-19 vaccines till March 31, 2023 in a bid to ensure domestic availability amid fears of a surge in coronavirus infections.

In a notification, the Central Board of Indirect Taxes and Customs (CBIC) said Covid vaccines, when imported into India by central government or state governments, would be exempt from the whole of customs duty from January 14, 2023 till March 31, 2023.

The government had, in April 2021, first exempted Covid-19 vaccines from 10 per cent customs duty. The exemption was extended several times till June 2022.

With new variants causing significant rise in daily case load in certain countries, including neighbouring China, the government had re-introduced certain precautionary measures, like random passenger testing at airports and genome sequencing, to check Covid spread in India.

Currently, Covid vaccines administered in India include Covishield, Covaxin, Sputnik V, Corbevax and Covovax.

(This report has been published as part of the auto-generated syndicate wire feed. Apart from the headline, no editing has been done in the copy by ABP Live.)