Paula Fujiwara, MD, MPH, scientific director for the International Union Against Tuberculosis and Lung Disease (The Union), the group hosting this week's meeting in India, said in a press release today, "A vaccine is the ultimate prevention tool and the announcement today is welcome news, but as researchers discuss how to move the trial into its final phase, we simultaneously need to be doing all we can to prevent tuberculosis with medications that we already have at our disposal".
In September 2018, a proof-of-principle study found that the GSK vaccine was protective against tuberculosis disease, with 54.0% vaccine efficacy.
"According to vaccine experts, it won't be until 2028 that a workable vaccine for Tuberculosis will be available".
GSK's M72/AS01E candidate vaccine contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the Adjuvant System AS01, which is also a component of GSK's RTS, S malaria vaccine and vaccine against shingles, Shingrix. These results demonstrate an overall vaccine efficacy of 50 per cent during the three years after vaccination.
The results were described as "groundbreaking" and experts hope they may mark a turning point in the battle against the disease which kills roughly 1.5 million people a year.
A chronic lung disease that is curable, TB was one of the top 10 killers worldwide previous year, particularly in developing countries.
According to GSK, a more effective vaccine is needed to achieve the World Health Organization's target of decreasing the number of new cases by 90% and the number of TB deaths by 95% between 2015 and 2035.
Between five to 15% develop active TB. However, the GSK vaccine's phase IIb clinical trial was quite promising.
In a significant step towards developing vaccine against tuberculosis, final analysis of Phase IIb study of pharma major GlaxoSmithKline (GSK)'s candidate vaccine M72/AS01E "demonstrated a sustained level of protection against active tuberculosis".
An exciting first step " These results demonstrate that for the first time in nearly a century, the global community potentially has a new tool to help provide protection against TB", GSK Vaccines' chief medical officer Thomas Breuer said in a statement released at a conference on lung health in Hyderabad, India. "I want to thank our scientists for their dedicated effort and scientific innovation in developing this impactful vaccine candidate".
The new vaccine, known as M72/AS01E, was tested at 11 sites in Kenya, South Africa and Zambia in about 3300 adults who were HIV negative and whose blood tests showed they had latent TB, an infection that might or might now progress into active tuberculosis.
India has the highest TB burden in the world with just over one in four of all estimated global cases reported in this country. Of the total MDRTB patients worldwide, 6.2 per cent are likely to become XDR-TB patients.