Omicron Scare: Subject Expert Committee To Hold Meeting Tomorrow Over Booster Doses

The NTAGI, earlier this week, held a long meeting where no final recommendation was made on additional COVID-19 vaccine dose and vaccine for children. 

Representative Photo

New Delhi: Subject Expert Committee (SEC) will on Friday hold a meeting over the matter of permitting booster doses of Coronavirus vaccines, news agency ANI reported. 

Recently, the Serum Institute of India had sought approval from the Drugs Controller General of India (DCGI) for Covishield as a booster dose citing its adequate stock and demand for booster shots due to the emergence of new COVID variants.

Earlier this week, the National Technical Advisory Group on Immunization (NTAGI) held a long meeting where no final recommendation was made on additional COVID-19 vaccine dose and vaccine for children. 

ANI reported official sources as saying that both issues were discussed in the meeting while the booster dose was not on the agenda of the meeting.

“The meeting put light on COVID-19 vaccination, additional doses, and vaccination for children but due to no consensus over the issues final recommendation couldn’t be made,” sources had told ANI.

Notably, there is a difference between booster dose and additional dose. The booster dose is given after a predefined period after the primary two-dose have been given while an additional dose is given to those people who have basic problems with their immune system. With the primary two doses, if the immune function is not built properly, the additional dose of the COVID vaccine is given.

Dr Reddy’s Labs Seeks DCGI Nod For Phase-3 Trial Of Sputnik Light As Booster Dose

In a related development, Dr Reddy’s Laboratories has sought permission from India’s drug regulator to conduct a phase-3 clinical trial to evaluate the efficacy and safety of Sputnik Light vaccine as a booster dose against COVID-19 in India, news agency PTI reported sources as saying.

Noting that the Sputnik Light is the Component 1 of the Gam-COVID-Vac Combined Vector Vaccine (Sputnik V), P Madhavi, the Director-Regulatory Affairs at Dr Reddy’s Laboratories, proposed to use batches of the vaccine manufactured at Hetero Biopharma Limited, Telangana, and at its loan license facility at Shilpa Biologicals Private Limited in Karnataka for the phase-3 trial.

Sputnik Light is yet to receive emergency use authorisation from the DCGI.

“Seeking your permission to conduct a phase-3 randomised, open-label three-arm, multi-centre, clinical study in parallel assignment to evaluate immunogenicity and safety of a booster dose of Sputnik Light vector vaccine against COVID-19 in healthy Indian subjects,” PTI source quoted Madhavi as having stated in the application.

Earlier, Serum Institute of India sought DCGI approval for Covishield as a booster dose citing adequate stock of the vaccine and a demand for a booster shot due to the emergence of new COVID variants.

In the application to DCGI, Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute mentioned that the UK’s Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine.

In its bulletin dated November 29, the INSACOG had recommended a booster dose of COVID-19 vaccines for those above 40 years with preference to high-risk and high-exposure populations.

Later it clarified that the recommendation was not for the national immunisation programme as many more scientific experiments are required to assess its impact.

On administration of booster doses, Union Health Minister Mansukh Mandaviya had 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) were deliberating and considering scientific evidence related to this aspect.

(With Inputs From Agencies)