Biological E gets permission for COVID-19 Vaccine SARSCoV-2-RBD203-N1_XBB.1.5 for restricted use in emergency

New Delhi: Recommending for strain change/update in the approved COVID-19 vaccine, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Biological E for the COVID-19 Vaccine SARSCoV-2-RBD203-N1_XBB.1.5, for restricted use in emergency situations, subject to various regulatory provisions.

The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of 5 years of age and above who have received primary vaccination series and are to be administered in a two-dose schedule (0.5 mL each) 28 days apart (Day 0 and Day 28).

This came after the vaccine major Biological E presented the proposal for the grant of permission to manufacture COVID-19 vaccine with variant SARS-CoV-2-RBD203-N1_XBB.1.5 for sale and distribution in India for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals of age ≥5 years.

Regarding the above proposal, the committee noted that the CORBEVAX vaccine with variant SARS-CoV-2-RBD219-N1C1 (ancestral strain) is approved for restricted use in emergency situations for age groups >5 years and above in a two-dose schedule, i.e., day 0 and day 28 and the vaccine is also approved as a heterologous booster dose to individuals previously vaccinated with COVAXIN/COVISHILED.

The committee also noted that the COVID-19 vaccine SARS-CoV-2-RBD203-N1_XBB.1.5 is for strain change/update in the approved COVID-19 vaccine.

The firm presented a report of the Phase III active comparator clinical trial conducted for the COVID-19 vaccine SARS-CoV-2-RBD203-N1_XBB.1.5 in the country in 360 subjects of age ≥5 to ≤80 years, including safety and immunogenicity data, including GMT of anti-XBB.1.5.RBD neutralizing antibodies (pseudovirus), GMT of Anti-XBB.1.5-RBD-IgG at day 28 and day 42. Additionally, the firm has presented data for protection against the JN.1 strain in terms of neutralizing antibody titers against the JN.1 strain (pseudovirus).

The committee reviewed the results of the phase III trial including safety and immunogenicity and noted the following:

1. Risk versus benefit: The safety profile of the vaccine from preclinical and clinical studies conducted justifies the grant of permission.

2. Innovation vis-a-vis existing therapeutic option: The vaccine elicits broadly cross-reactive neutralizing antibody responses against circulating SARS-CoV-2 variants, including XBB.1.5 & JN.1.

3. Unmet medical need in the country: Presently, there is only one vaccine with XBB.1.5 strain approved in the country & this may be used as an alternate option.

After detailed deliberation, based on the above observations, the committee recommended for strain change/update in the approved COVID-19 vaccine and granted permission for the COVID-19 vaccine, SARS-CoV-2-RBD203-N1_XBB.1.5, for restricted use in emergency situations, subject to various regulatory provisions including the following:

1. The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of 5 years of age and above who have received primary vaccination series and are to be administered in two-dose schedules (0.5mL each) 28 days apart (Day 0 & Day 28).

2. The firm should submit a revised PI, SmPC, and factsheet after incorporating the suggestions made during the meeting.

3. The vaccine should be supplied along with a factsheet and separate leaflet for the guidance of the healthcare provider.

4. The firm should ensure that a factsheet for the vaccine recipient/attendant is provided prior to the administration of the vaccine.

5. The firm should disseminate the instructions and educational material, including factsheet, PI, SmPC, storage instructions, etc. on their website.

6. The firm should submit safety data including the data on AEFI and AESI with due analysis as per the provisions and standard procedures.

7. The firm should submit a Pharmacovigilance and Risk management plan.

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