By Sachin Ravikumar and Anuron Kumar Mitra
BENGALURU (Reuters) – The Bharat Biotech vaccine showed 81% effectiveness in preventing symptomatic COVID-19 in an interim analysis of a final-stage trial in India, said on Wednesday, a major boost to the injection avoided by some due to the lack of this data.
The positive result also illuminates the prospects for sales abroad, with the vaccine, the first successful home vaccine COVID-19 in India, which has already attracted the interest of more than 40 countries, according to the company.
“COVAXIN demonstrates a trend towards high clinical efficacy against COVID-19, but also significant immunogenicity against emerging variants,” Krishna Ella, president of Bharat Biotech, said in a statement, referring to the vaccine.
He said the analysis is based on 43 cases of patients with COVID-19 who had symptoms ranging from mild to moderate and severe, and of the total cases, 36 were from a placebo group, while seven were from those who received the vaccine .
The results come as India struggles to convince its health and frontline workers to take the Bharat Biotech injection, which passed in January with no final stage efficacy data.
Only about 11% of the more than 10 million vaccinated Indians had received the Bharat Biotech injection last week, Reuters reported.
Many politicians in India, including Prime Minister Narendra Modi, were vaccinated with COVAXIN this week, instead of a rival developed by AstraZeneca Plc and the University of Oxford, in an attempt to boost confidence in the locally developed vaccine.
With more than 11 million infections to date, India is battling the largest outbreak of COVID-19 in the world outside the United States.
COVAXIN, which can be stored at normal refrigerator temperatures, is likely to be effective against the British coronavirus strain, a study reported in late January. The injection is an inactivated vaccine that introduces the dead virus into the body to trigger an immune response.
Bharat Biotech is headquartered in the southern Indian city of Hyderabad, a center for manufacturers of medicines and vaccines. It began operating in 1996 and has distributed more than 3 billion doses globally of various types of vaccines, including vaccines against hepatitis B and typhoid.
The goal is to produce around 700 million doses of COVAXIN this year.
The company, which signed an agreement with Brazil to provide 20 million doses of the injection, said the next interim analysis will target 87 cases and the final analysis will be based on 130 cases.
Its first provisional analysis was based on a Phase III clinical trial involving 25,800 participants that was conducted with the Indian Medical Research Council (ICMR), a federal government agency. The study included 2,433 participants over the age of 60 and 4,500 participants with comorbidities.
The test results were evaluated by an independent data security and monitoring board, the ICMR said in a separate statement.
(Reporting by Sachin Ravikumar and Anuron Kumar Mitra in Bengaluru; Editing by Shailesh Kuber, Miyoung Kim and Bernadette Baum)