The Subject Expert Committee (SEC) under Central Drugs Standard Control Organization (CDSCO) has set aside the application of the Pune-based Serum Institute of India (SII) request seeking approval for booster doses of Covishield to the people, stating that it cannot be recommended without clinical trials.
The SEC was reviewing the application of the Serum Institute of India (SII) for the booster dose in a meeting that took place on Friday. The panel has sought additional data from the SII before another meeting.
Amid the emergence of the new Covid-19 variant Omicron, the SII had sought approval to administer the booster dose of its Covishield vaccine on the basis of adequate stock of the jab and rising demand for the booster shots.
Prakash Kumar Singh, director, government and regulatory affairs at SII, had at the time cited that the UK's Medicines and Healthcare Products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine.
"People of our country, as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield, are also continuously requesting our firm for booster doses," Singh had stated in an application submitted before the DCGI.
Many experts have also recommended a booster dose in India especially after the emergence of the new Covid-19 variant Omicron. But the government has not taken any decision so far. In fact, according to a new UK study, two shots of a COVID-19 vaccine may not be enough against the Omicron variant, and a third dose or a booster shot could prove necessary to prevent the super mutant variant.
The study, released by the UK Health Security Agency (UKHSA), showed that a full two-dose vaccination course was less effective against symptomatic disease with Omicron than with the original strain of COVID-19 or the Delta variant.
On the other hand, a moderate to high vaccine effectiveness of 75 per cent is seen in the early period after a booster dose.
“Early estimates of vaccine effectiveness (VE) against symptomatic infection find a significantly lower VE for Omicron infection compared to Delta infection. Nevertheless, a moderate to high vaccine effectiveness of 70 to 75 per cent is seen in the early period after a booster dose," the agency said in a statement.
However, India has decided to deliberate the issue with the scientific community before taking any community in this regard as was also indicated by Union Health Minister Mansukh Mandivya in the Lok sabha on Friday.
The National Technical Advisory Group on Immunization (NTAGI) also conducted a virtual meeting regarding the additional doses of Covid-19 vaccines in India, but the meeting resulted in no consensus over the issue.
A clarification statement released by the Indian SARS-CoV-2 Genomics Consortium (INSACOG) has also said that they have never recommended a booster dose.