Bharat Biotech Unveils High Interim Efficacy Rate for COVID-19 Vaccine
Indian drugmaker Bharat Biotech has announced that its COVID-19 vaccine candidate, Covaxin (BBV152), proved to be 80.6 percent effective in the initial interim analysis of its late-stage clinical trials.
The company said that its first interim analysis, which was based on 43 cases, found that 36 COVID-19 infections were seen in the placebo group compared to only seven observed in the vaccine group, leading to an estimated 80.6 percent efficacy rate. Significantly, the vaccine also conveyed “significant immunogenicity” against viral variants, according to Krishna Ella, Bharat Biotech’s chairman and managing director.
Bharat Biotech is working with Ocugen to develop the vaccine for the U.S. market. Under their agreement, Ocugen will obtain U.S. rights to the vaccine and handle, in collaboration with Bharat, the clinical development, registration and commercialization of the vaccine in America (DID, Dec. 23, 2020).
The trials’ second analysis will be conducted at 87 confirmed cases, while its final analysis will be conducted at 130 cases, in order to generate more data and evaluate the vaccine’s efficacy in secondary study endpoints.
To date, Bharat Biotech has enrolled 25,800 participants between 18 and 98 years of age in its phase 3 trials, including 2,433 participants over age 60 and 4,500 with comorbidities, according to the company, who said that the inoculation was also found to be well-tolerated and safe. The interim analysis included a preliminary review of the safety database that showed a low number of severe, serious and medically attended adverse events split between the vaccine and placebo groups.
Covaxin, a double-dose inactivated vaccine given two weeks apart, can be kept at refrigerator temperatures and is shipped in a ready-to-use liquid formulation. Uniquely, the vials can be kept open for 28 days, which will help to reduce wasted vaccine, the company said.
The vaccine was cleared for emergency use by India prior to the phase 3 interim analysis, raising concerns that there was not enough efficacy data at that point to warrant the authorization. The drugmaker and the Indian government are in talks to work out a supply deal for doses of the vaccine, though details are not known at this time. This year, the company plans to make 700 million doses of its vaccine, according to Ella (DID, Jan. 5). — James Miessler