The Drugs Controller General of India (DCGI) on Monday approved Covovax, a local variant of Novovax, developed by Serum Institute India. The covid-19 vaccine was approved by the drug control body of India as a heterologous booster dose for adults who have already been administered two doses of either Covishield or Covaxin.
FAQ: What is a heterologous dose?
A heterologous booster is a vaccine dose that is different from the earlier doses, the previous two in the case of covid 19 vaccines.
The DGCI had initially restricted the vaccine usage only to those aged 18 and above in 2021 and later extended it to those between 12 and 17 last. On June 28, 2022, under subject to certain conditions, the DGCI gave nod to administer the vaccine to children belonging to the age group of seven and eleven years. The World Health Organisation (WHO) on December 17, 2021, approved Covovax as an emergency-use listing.
FAQ: What is Emergency Use Listing?
The EUL is a risk-based procedure by the WHO to assess and list unlicensed vaccines, therapeutics, and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The Economic Times reported that the Director of Government and Regulatory Affairs at the Serum Institute of India (SII), had previously written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 and above. The vaccine is manufactured through technology transfer from Novavax, created by an American company of the same name. Covovax was granted conditional marketing authorization by the European Medicines Agency.
Based on three phases of clinical trials, the overall efficacy rate of Covovax is estimated at around 89 per cent, confirmed by a UK-based study. The protein subunit vaccine is developed by using the genetic sequence of the original/first strain of the SARS CoV 2 virus which broke out the Covid-19 pandemic. Covovax is also said to have one of the shortest interval periods between two doses, which is 21 days.
The common side effects of the vaccine are enlisted to be tenderness and pain around the vaccinated area, fatigue, and headache; which tend to go away within 48 hours of the vaccination. The vaccine will be stored in containers with a temperature of around 2-8o Celsius.
While there has been no official revelation of its price, Covovax is estimated to launch at a tentative cost of around Rs. 1100 per dose.