The Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee is set to meet on Wednesday to discuss granting market authorization for the SII’s COVID-19 vaccine, Covovax, as a booster dose for adults who have already received two doses of either Covishield or Covaxin.
Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Serum Institute of India, had recently submitted a letter to the Drugs Controller General of India requesting approval for the use of Covovax as a booster dose in light of the escalating pandemic situation in some countries.
The DCGI had previously approved the use of Covovax for emergency situations in adults and children aged 12-17 and 7-11 respectively, but under certain conditions. Covovax has also been granted conditional marketing authorization by the European Medicines Agency and emergency-use listing by the World Health Organization. The vaccine is developed and manufactured by SII via technology transfer from Novavax.