It is scheduled for Friday that a meeting of the Subject Expert Committee (SEC) will take place to discuss the issue of allowing more coronavirus vaccination booster doses.
This week, the Serum Institute of India applied for authorisation from the Drugs Controller General of India (DCGI) for a COVID booster dosage, noting that it had sufficient supplies, and that new COVID variations had increased demand for booster doses.
Specifically, there is a distinction between a “booster” dosage and a “supplemental” dose. People who have basic immune system issues are given an extra dosage in addition to the first two doses, and the booster doses is given after a certain amount of time following the first two. The additional dosage of the COVID vaccination is administered if the immune function is not established correctly after the first two doses.
Meanwhile, Dr. Reddy’s Laboratories has applied for clearance from India’s pharma authority for a phase-3 study of its Sputnik Light vaccine as a booster dosage against COVID-19 in India, according to sources quoted by PTI.
P Madhavi, Director-Regulatory Affairs at Dr. Reddy’s Laboratories, proposed using batches of the vaccine manufactured at Hetero Biopharma Limited in Telangana and at its loan licence facility at Shilpa Biologicals Private Limited in Karnataka for the phase-3 trial, noting that the Sputnik Light is the Component 1 of the Gam-COVID-Vac Combined Vector Vaccine (Sputnik V).
The DCGI has not yet authorised Sputnik Light for emergency usage.
In the application, Madhavi requested permission to conduct a randomised, open-label, multi-center, clinical study in parallel with another assignment to evaluate the immunogenicity and safety of a booster doses of Sputnik Light vector vaccine against COVID-19 in healthy Indian subjects, according to a PTI source quoted by the news agency.”
Before, the Serum Institute of India (SII) requested DCGI clearance for the booster dosage of Covishield, stating a sufficient supply of vaccine and a growing need for a booster injection due to the introduction of new COVID strains.
To DCGI, Serum Institute’s Director, Government and Regulatory Affairs Prakash Kumar Singh noted in the application of AstraZeneca’s ChAdOx1 nCoV-19 vaccine booster dosage approval by the UK’s Medicines and Healthcare Products Regulatory Agency.
According to a November 29 advisory from the INSACOG, anyone over 40 should receive a booster dose of COVID-19 vaccination, with preference given to those who are at higher risk of infection and exposure.
Later, it was noted that the proposal was not for the national immunisation programme since further scientific studies are needed to evaluate its impact.
The National Technical Advisory Group on Immunization (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are currently deliberating and evaluating scientific evidence related to the administration of booster doses, according to Union Health Minister Mansukh Mandaviya.
