Pune: A couple of days after the Drug Controller General of India (DGCI) approved the market authorisation of Covovax—a vaccine against Covid, the Serum Institute of India has urged the Union Health Ministry to allow its inclusion of in the CoWIN portal as a heterologous booster dose for adults.
Officials said that Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India (SII) has written a letter to this effect on Wednesday. The National Technical Advisory Group on Immunisation (NTAGI) is likely to hold a meeting soon to decide on the matter.
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The DGCI had approved the market authorisation for Covovax as a heterologous booster dose for adults who have been administered two doses of either Covishield or Covaxin. The DGCI gave its go ahead for Covovax as the precaution dose following the recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation.
Officials said that 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 seven to 11 years on June 28 last year subject to certain conditions.
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Covovax is manufactured through technology transfer from Novavax. The European Medicines Agency has also given conditional marketing authorization for Novavax for emergency-use listing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc. had earlier announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.
