SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine
A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.
The vaccine variant is a different strain from the Covid-19 vaccine the company manufactures under technology transfer from Novovax. SII has been manufacturing Covid-19 recombinant spike protein Nanoparticle Vaccine Covovax in India, following the technology transfer and approval from the national drug regulator.
The SECs recommendation follows SII’s proposal for grant of permission to manufacture Covid-19 Vaccine, Adjuvanted 2023-2024 Formula [SARS-CoV-2 rS Protein (Covid-19) Nanoparticle Vaccine, Omicron XBB.1.5 variant] for sale and distribution in India for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
The firm presented the preclinical studies reports along with interim report of ongoing clinical trial in USA to evaluate the safety and immunogenicity of a XBB.1.5 booster dose (NVX-CoV2601) in previously mRNA Covid-19 vaccinated and baseline SARS-CoV-2 seropositive Covid-19 vaccine naïve participants before the committee. Novovax has approval from various countries including the US, European Union, among others, for NVX-CoV2601, which is branded in some countries as Nuvaxoivid XBB 1.5 vaccine.
The Committee also noted the results of non-clinical studies on the variant and the interim report of the ongoing clinical trial in the USA. It also observed that approximately 42 million doses have been exported to USA and Europe till date and 200,000 vaccine doses have already been administered to the vaccines in the USA with no safety concern till date. The World Health Organisation has also recommended for the emergency use listing of Covid-19 XBB 1.5 variant vaccine, it said.
The safety profile of the vaccine from preclinical and clinical studies conducted globally justify the grant of permission, it says, adding that the Covid-19 continues to be a global health challenge with important genetic and antigenic evolution of the spike protein. The vaccine elicits broadly cross-reactive neutralising antibody responses against circulating SARS-CoV-2 variants, it said, adding that presently, there is no vaccine with XBB 1.5 strain approved in the country.
“After detailed deliberation, based on the above observations, the committee recommended for strain change in the approved Covid-19 vaccine and grant of permission of the Covid-19 Vaccine, Adjuvanted 2023-2024 Formula [SARS CoV-2 rS Protein (Covid-19) Nanoparticle Vaccine, Omicron XBB.1.5 variant] with local clinical trial waiver, for restricted use in emergency situation, subject to various regulatory provisions…,” said the Committee in its meeting held on April 29, 2024.
The Committee put forward various conditions including the company should conduct a phase IV study in the country, with protocol submitted within three months; And the vaccine is indicated for active immunisation to prevent Covid-19 disease in individuals of 12 to 18 years of age as primary series of two doses (0.5 mL each) three weeks apart, and as single precautionary dose in individuals of over 18 years of age, who have received primary series of vaccinations.
The company should submit revised Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet to the Central Drugs Standard Control Organisation (CDSCO) after incorporating the latest safety and immunogenicity data and the suggestions made during the meeting, and the vaccine should supplied along with factsheet and separate leaflet for the guidance of the healthcare provider.
The SEC also mandated that the firm should ensure that factsheet for the vaccine recipient/attendant is provided prior to administration of the vaccine; the firm should disseminate the instructions & educational material including factsheet, PI, SmPC, storage instructions etc. in their website; It should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in India and overseas for review as and when available.
Besides, the company should submit safety data including the data on AEFI and AESI with due analysis as per the provisions and standard procedures and submit India-specific Pharmacovigilance and Risk management plan.
According to the Union ministry of health and family welfare, the total vaccination against Covid-19 in the country is 220.69 crore as on May 9, 2024, and around 4.45 crore patients were discharged after recovery from the pandemic. There have been 5.33 lakh deaths due to Covid-19 till May 9, it says
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