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Biological E Gets CDSCO Panel Nod to study safety of XBB 1.5-RBD Subunit Covid-19 Vaccine in 5-80 years old
New Delhi: The drug major Biological E has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase-III clinical trial of the SARS-CoV-2 (Covid-19) Vaccine (Variant XBB.1.5)
This came after Biological E presented the Phase –III Clinical trial protocol titled “ A prospective single-blind randomized Phase-III comparative study to evaluate immunogenicity and safety of Biological E’s XBB 1.5-RBD subunit Covid-19 vaccine in 5-80 years old Individuals.”
The COVID-19 Omicron subvariant XBB.1.5 has become more prevalent due to a potent combination of mutations that facilitate its transmission, even among individuals who have already been vaccinated or infected.
The COVID-19 Omicron strain has undergone several subvariants' mutations. It was BA.1 at first, and subsequently the Omicron subvariant of BA.5. After a while, it transformed into BQ.1.1 and BQ.1.
Next, there is XBB.1.5, sometimes known as the Kraken, which is a subvariant of BA.2 Omicron. It belongs to the XBB family of variants, which became identified a few months ago and attracted the attention of virologists due to the fact that it has more mutations that escape immunity than other variants that have been observed so far. It is thought that a mutation in the XBB.1.5 subvariant facilitates the virus's ability to bind to cells and increase its transmissibility.
Symptoms with XBB.1.5 appear to be similar to the earlier Omicron subvariants. Those can range from typical cold symptoms such as cough and congestion to shortness of breath and low oxygen levels that require emergency medical attention.
However, as XBB.1.5 continues to spread, the signs and symptoms of COVID-19 may seem different than what was seen earlier in the pandemic with Alpha or Delta variants. Symptoms such as the temporary loss of taste and smell can still happen in some instances, but it has become less common with the Omicron variant and subvariants.
Other symptoms may include fever, chills, fatigue, muscle or body aches, sore throat, nausea or vomiting, and diarrhea. Symptoms can last between five to seven days but vary from person to person.
At the recent SEC meeting for Covid 19 held on 7th December 2023, the expert panel reviewed the Phase –III Clinical trial protocol presented by Biological E titled “ A prospective single-blind randomized Phase-III comparative study to evaluate immunogenicity and safety of Biological E’s XBB 1.5-RBD subunit Covid-19 vaccine in 5-80 years old Individuals."
The expert panel noted that permission in CT-23 was already granted to the firm for the SARS-CoV-2 vaccine containing the Receptor Binding Domain (RBD) of SARS-CoV-2 gene (CORBEVAX) in the age group of ≥5 to <12 years, ≥ 12 years and ≥ 18 years old individuals.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase-III clinical trial as per the protocol presented by the firm.
Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751