_1594052644844_1594052732451_1614778493800.jpg "Covaxin showed interim clinical efficacy of 81% in Phase 3 trial: Bharat Biotech")
New Delhi: Bharat Biotech’s COVAXIN demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial, the Hyderabad-based pharmaceutical company announced on Wednesday releasing the first interim analysis of its coronavirus vaccine.
The phase 3 clinical trial of the whole virion inactivated SARS-CoV-2 vaccine involved 25,800 subjects, the largest ever conducted in India across 25 sites, in partnership with the Indian Council of Medical Research (ICMR). The Phase 3 study enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.
The primary endpoint of Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) covid-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The first interim analysis is based on 43 cases, of which 36 cases of covid-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6%, the company said in a statement.
The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
The clinical trial results now set aside the major criticism that Bharat Biotech faced recently after it got an emergency licensure from the Drugs Controller General of India (DCGI) V.G. Somani for COVAXIN despite not having efficacy data, following which administration of the vaccines started on 16 January in country’s nationwide covid-19 inoculation program.
“With today’s results from our Phase 3 clinical trials, we have now reported data on our covid-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. COVAXIN® demonstrates high clinical efficacy trend against covid-19 but also significant immunogenicity against the rapidly emerging variants," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
In another significant result of the trial for India, the analysis from the National Institute of Virology (NIV) ICMR indicated that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains. India has currently more than 213 cases of UK variant and recently also detected four South African variant and one Brazil coronavirus mutated strain.
The vaccine candidate scientifically known as BBV152 contains a whole virion inactivated SARS-CoV-2 vaccine, has been developed on the world health organization’s (WHO) prequalified vero cell platform, which is globally recognized with a well-established track record of safety. Vero cells are derived from the kidney of an African green monkey which are commonly used in developing vaccines.
The vaccine is stable at 2 to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels. BBV152 (COVAXIN) has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%, the company said in a statement.
COVAXIN is based on an established manufacturing platform with a better safety profile when compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to covid-19, leading to long-term protection. Algel-IMDG adjuvant is chemosorbed imidazoquinoline onto the aluminum hydroxide gel to boost immunity, the company said.
Bharat Biotech said that it would share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication, the company said.
“More than 40 countries globally have expressed their interest in COVAXIN®. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity," Bharat Biotech said in a statement.
The Phase 3 trial was jointly initiated by ICMR and Bharat Biotech in mid-November 2020. The ICMR said that pre-clinical studies in small animals and hamsters showed promising results in terms of safety and immunogenicity. Further studies conducted in rhesus macaques also established remarkable safety and protective efficacy of COVAXIN. Phase 1 and Phase 2 clinical trials conducted in 755 participants demonstrated high safety profile of the candidate vaccine with seroconversion rates of 98.3% and 81.1% on day 56 and 104 respectively.
As India started the first phase of nationwide covid-19 vaccine drive on January 16th 2021 and second phase on March 1st 2021 extending to elderly and 45 and over with comorbidities, covaxin is being administered along with Covishield—the AstraZeneca-Oxford University developed vaccine manufactured by the Serum Institute of India’s (SII).
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