An advisory panel on immunisation recommended increasing the gap between two doses of Covishield COVID-19 vaccine to 12-16 weeks. However, it did not recommend any change in interval for Covaxin, the second of two COVID 19 vaccines in India.
In another development, the Drugs Controller General of India (DCGI) accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years.
The National Immunization Technical Advisory Group will now sent the recommendation to the National Expert Group on Vaccine Administration. The national expert group has to give the final nod. This is the second time that the Centre is asking to widen the gap between the two doses. The Centre in March had asked the States and Union territories to increase the gap of the two doses to four to eight weeks.
The recommendation comes at a time the country is facing an acute vaccine shortage. Moreover, some states such as Kerala placed global tenders for procuring vaccines.
Meanwhile, India is struggling to contain a second wave of COVID-19 infections and deaths. In the last few weeks, the country witnessed an increase of the COVID 19 cases.
The Drugs Controller General of India accepted the recommendation of Subject Expert Committee and accorded permission to Bharat Biotech for carrying out the trail of Covaxin in the 2 to 18 year age group. The manufacturers will hold the trial in 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on May 11, 2021. The Committee held a detailed deliberation. It then recommended for grant of permission to conduct proposed Phase II/III clinical trial on certain conditions.