DCGI approves market authorisation for SII's Covid vaccine Covovax as heterologous booster dose

The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021

India’s apex drug regulator has approved yet another vaccine as a Covid-19 booster dose—Serum Institute’s Covovax—even though public health professionals have appealed to the government to restrict the booster dose coverage considering that a very high proportion of Indians have already been exposed to the natural infection.

While there is no official word, government sources said the Drug Controller General of India (DCGI) approved market authorisation to Covid-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin.

Covovax – manufactured by Serum Institute under technology transfer from Novavax – was approved by the DCGI for use in adults in emergency situations in December 2021 and subsequently for adolescents and kids. Just about 31,000 doses of the vaccine have been used so far.

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The National Expert Group on Vaccine Administration, however, is yet to approve Covovax as a heterologous booster. While four other vaccines – Covishield, Covaxin, BBV154 and Corbevax – have been cleared by the DCGI as boosters, the instra-nasal vaccine BBV154 is likely to be available in hospitals by January end.

Amidst efforts to increase people’s choices with Covid-19 boosters, two groups of public health professionals have advised the government to limit the booster campaign because individuals who have experienced natural infection due to SARS-CoV-2, may not gain any additional benefits with either two primary doses or precautionary/booster dose or any additional doses.

“Vaccination should be recommended for those having co-morbidities or never had Covid-19. Unnecessary and irrational use of vaccination against Covid-19 will divert resources and attention from other pressing public health tasks,” the Indian Public Health Association and Indian Association of Preventive and Social Medicine said earlier this month.

“With a very high proportion of the population having been exposed to SARS CoV-2 infection, vaccination against Covid-19 (after recovery from natural infection) will not provide any additional benefits,” they said. “On the other hand, vaccinations following natural infections may have the potential for some harm, however rare. It would be prudent to err on the side of safety and not insist on vaccination for those who have acquired immunity following natural infection.”