The Bill & Melinda Gates Medical Research Institute (Gates MRI) has announced that it’s ready to begin the third phase clinical trial evaluating the M72/AS01E tuberculosis (TB) vaccine candidate.
The Gates MRI said this in an official statement on Tuesday, March 19.
According to the statement, initial doses of the vaccine will be administered in South Africa, where TB is most prevalent, and should it prove to be “well-tolerated and effective,” could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults.
It explained that the efforts could mark the first new TB vaccine in over 100 years to reduce the incidence of pulmonary TB, which is the most common and contagious form.
The World Health Organisation (WHO) estimates that 10.6 million people globally fell ill with TB in 2022, with 1.3 million dying. In South Africa alone, about 280,000 people are diagnosed with TB every year.
The Gates MRI expects it to take up to five years to complete the trial, after which there will be data analysis before the preparation for submission of the data to regulatory authorities.
The only available TB vaccine, Bacilli Calmette-Guerin (BCG), dates back to 1921 and only protects babies and young children against severe forms of it, but is inadequate for adolescents and adults against the pulmonary form.
Nigeria ranks first in Africa and sixth amongst 30 countries globally with the highest burden of the disease. BCG is also the only available vaccine against the disease in the country.
(Premium Times)
