New Delhi: News agency ANI reported that the Subject Expert Committee (SEC) will meet on Friday on the matter of allowing booster doses of coronavirus vaccines.
Recently, Serum Institute of India had sought approval from Drug Controller General of India (DCGI) for Covishield citing its adequate stock and demand for booster shots due to emergence of new COVID variants in the form of booster doses.
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Earlier this week, the National Technical Advisory Group on Immunization (NTAGI) held a lengthy meeting that did not make any final recommendations on additional COVID-19 vaccine doses and vaccines for children.
ANI quoted official sources as saying that both the issues were discussed in the meeting while booster dose was not on the agenda of the meeting.
“The meeting highlighted COVID-19 vaccination, additional dosage and immunization for children, but a final recommendation could not be made due to lack of consensus on the issues,” sources told ANI.
Specifically, there is a difference between a booster dose and an additional dose. A booster dose is given after a predetermined period of time after the primary two doses have been given, while an additional dose is given to people who have basic problems with their immune systems. Along with the primary two doses, an additional dose of the COVID vaccine is given if immunity does not build up.
Dr Reddy’s Labs seeks DCGI’s nod for Phase III trial of Sputnik Lite as a booster dose
In a related development, Dr Reddy’s Laboratories has received permission from India’s drug regulator to conduct a phase-3 clinical trial to evaluate the efficacy and safety of Sputnik Lite vaccine as a booster dose against COVID-19 in India. The news agency PTI is saying according to the reports of the sources.
Noting that Sputnik Lite is component 1 of the Gum-Covid-Vac Combined Vector Vaccine (Sputnik V), Dr P Madhavi, Director-Regulatory Affairs, Dr Reddy’s Laboratories, proposed using batches of the vaccine manufactured at Hetero Biopharma Ltd. Its loan license facility in Telangana, and Shilpa Biologicals Pvt Ltd in Karnataka for Phase-III trial.
Sputnik Light is yet to receive emergency use authorization from DCGI.
“To conduct a phase-3 randomized, open-label three-arm, multi-centre, clinical study in parallel assignment to evaluate the immunogenicity and safety of a booster dose of Sputnik light vector vaccine against COVID-19 in healthy Indian subjects. to ask for your permission. PTI source quoted Madhavi as saying in the application.
Earlier, Serum Institute of India had sought DCGI’s approval for Covishield as a booster dose, citing adequate stock of the vaccine and the demand for a booster shot due to the emergence of new COVID variants.
In an application to the DCGI, Prakash Kumar Singh, director of government and regulatory affairs at the Serum Institute, mentioned that the UK’s Medicines and Healthcare products regulatory agency has already approved a booster dose of the AstraZeneca ChAdOx1 nCoV-19 vaccine.
In its bulletin on November 29, INSACOG had recommended booster doses of COVID-19 vaccines for people above 40 years of age with priority to high-risk and high-risk populations.
It later clarified that the recommendation was not for a national immunization program as many more scientific experiments are needed to assess its impact.
On the administration of booster doses, Union Health Minister Mansukh Mandaviya recently informed the Lok Sabha that the National Technical Advisory Group on Immunization (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) concerned scientists. Were deliberating and considering the evidence. to this aspect.
(with inputs from agencies)
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