The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) has granted Biological E permission to manufacture and distribute its updated COVID-19 vaccine, SARS-CoV-2-RBD203-N1_XBB.1.5. This decision comes in light of the need to update existing vaccines to address the evolving strains of the virus, particularly the XBB.1.5 variant. The vaccine will be available for restricted use in emergency situations in India, following various regulatory guidelines.
The newly approved vaccine is designed for active immunization against COVID-19 in individuals aged 5 years and older who have already completed their primary vaccination series. The vaccine is administered in a two-dose schedule of 0.5 mL each, with the doses being spaced 28 days apart, on Day 0 and Day 28.
Biological E, a major player in the vaccine manufacturing sector, had previously developed the CORBEVAX vaccine, which targets the ancestral strain of the virus. The SEC noted that the CORBEVAX vaccine is currently approved for emergency use in individuals aged 5 years and above and is also administered as a heterologous booster dose for those previously vaccinated with either Covaxin or Covishield.
The committee emphasized that the new SARS-CoV-2-RBD203-N1_XBB.1.5 vaccine is specifically designed as a strain update to the previously approved vaccine. Biological E presented data from a Phase III clinical trial conducted on 360 subjects aged 5 to 80 years within India. The trial results demonstrated the vaccine's safety and immunogenicity, including data on neutralizing antibody titers against the XBB.1.5 variant and another circulating strain, JN.1.
Key findings from the clinical trial data included the geometric mean titer (GMT) of anti-XBB.1.5-RBD neutralizing antibodies and IgG responses at both Day 28 and Day 42 after the initial dose. In addition, the company provided data on protection against the JN.1 strain through neutralizing antibody levels. Based on this evidence, the SEC determined that the vaccine's safety profile, cross-reactive antibody response, and potential for addressing an unmet medical need justified its approval.
The SEC's approval comes with several regulatory conditions. Biological E must update its product information (PI), summary of product characteristics (SmPC), and factsheet to incorporate recommendations made by the committee. Additionally, the company must provide guidance for healthcare providers and recipients in the form of a detailed factsheet. Information on the vaccine, including storage instructions and educational materials, will also need to be made publicly available on the company's website.
Further requirements include the submission of safety data, specifically on adverse events following immunization (AEFI) and adverse events of special interest (AESI), in accordance with standard procedures. Biological E must also present a comprehensive pharmacovigilance and risk management plan to ensure ongoing monitoring of the vaccine's safety post-approval.
The approval of the SARS-CoV-2-RBD203-N1_XBB.1.5 vaccine provides an additional option for immunization against COVID-19, particularly as the country continues to face the challenge of new virus variants. With only one other vaccine approved in India that targets the XBB.1.5 strain, this approval offers more flexibility for healthcare providers and patients in their fight against the virus.
(Input from various sources)
(Rehash/Ankur Deka/MSM)
