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.
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