INDIA —The Serum Institute has applied to the Drugs Controller General of India seeking emergency use authorization (EUA) for its recombinant BCG (rBCG) vaccine for the prevention of tuberculosis, official sources have said.
The EUA application was submitted on March 22 by Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII).
India’s TB immunization program currently offers BCG vaccination at birth or as early as possible till one year of age.
SII already supplies life-saving vaccines to the government under the Universal Immunization Program, including Pneumococcal, IPV, and Rotavirus, Singh mentioned in his letter.
The Pune-based firm is one of the companies which supply BCG vaccine to the government.
“Our government is committed to eliminate TB. The vision of TB-free India has been energized by the clarion call of the prime minister to end TB from our country by 2025, five years ahead of the Sustainable Development Goal of ending TB,” Singh mentioned in his letter.
Recombinant BCG vaccines are manufactured through advanced technology that allows the insertion of foreign genes, or overexpression of native genes, into the BCG vaccine, an official explained.
The number of tuberculosis cases in India has seen a 19 percent rise in 2021 over the previous year, and there has been an increase in the mortality rate due to all forms of TB between 2019 and 2020 by 11 percent, according to the annual TB report released recently by Union Health Minister Mansukh Mandaviya.
The BCG vaccine currently in use is a live, weakened form of the bacteria to train the immune system. It is only for use in children.
Although it offers protection against the most severe forms of tuberculosis such as TB in the brain, it is not very effective against getting an infection, reactivation of latent infection, and against the most common form of TB in the lungs.
Yet, in the 100 years since the vaccine was developed, there have been no alternatives.
India’s strategy to eliminate TB hinges on funding 3-4 vaccine candidates for phase I or II trials and have at least one final product co-owned by the government by 2025.
One of the vaccines being tested to prevent tuberculosis of the lungs is Immuvac, which was developed to prevent leprosy.
Immuvac, also known as mycobacterium indicus pranii, displays antigens similar to both the leprosy bacterium and the TB bacterium.
The other vaccine candidate is VPM1002, a recombinant BCG that is the most widely used vaccine in the world.
The new vaccine developed in Germany has the genetic code of the BCG edited in a way that leads to better availability of the TB antigens, thus training the immune system to better fight tuberculosis.
Another trial of the same candidate is underway to prevent recurrence of TB in adults. VPM1002 is also being tested to see whether it can offer protection against Covid-19.
Although research into TB vaccines is a step in the right direction, experts say that for the time being, the mainstay of the elimination program is early detection of new cases, testing for drug resistance, and treating the disease completely.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.
