Serum Institute to Manufacture M72 TB Vaccine Under Gates MRI Partnership

The Serum Institute of India (SII) has reached a watershed agreement with the Gates Medical Research Institute (Gates MRI) on creating the capacity to manufacture the M72/AS01E tuberculosis (TB) vaccine candidate. This deal will give SII the opportunity to produce the vaccine in large quantities for countries with high tuberculosis prevalence, subject to the smooth completion of Phase III clinical trials and all regulatory approvals. The partnership constitutes another step in the global struggle against tuberculosis, one of the deadliest diseases in the world, and strengthens India’s status as a prime vaccine manufacturing center.

SII and Gates MRI Establish TB Vaccine Cooperative Pact

According to the cooperative pact, Serum Institute of India will create the M72/AS01E TB vaccine candidate and supply it if the Phase III clinical trials yield favorable results.

The aim of the partnership is,

• To establish large-scale manufacturing capability
• To make the vaccine more affordable
• To supply struggling countries
• To assist the international efforts of eradicating TB
• To improve access for lower and middle-income nations

This pact fortifies the SII’s status as a global manufacturer of vaccines combating major health emergencies.

What Is M72/AS01E Tuberculosis Vaccine?

The M72/AS01E vaccine is one of the most advanced candidates for vaccines against pulmonary tuberculosis (TB) in adults and adolescents.

The GlaxoSmithKline (GSK) company first developed the vaccine, which is now developed by the Gates Medical Research Institute based on medical research technology licensed from GSK.

If the vaccine succeeds, it will become,

• The first novel vaccine against pulmonary tuberculosis in adults in the last 100 years.
• A much-needed complement to the BCG vaccine, in active use for more than a century.

Unlike the BCG vaccine, which protects mainly babies from severe TB, the M72 vaccine targets older age groups.

Role of Serum Institute of India (SII)

The Serum Institute of India (SII) is the world’s largest vaccine producer by volume.

Among its current achievements are,

1. Supplying vaccines to over 170 countries across the globe
2. Supporting various global immunization initiatives
3. Commercial production of vaccines against many infections such as polio, measles, meningitis, influenza, and COVID-19.

This new agreement shows SII’s efforts to extend its traditional vaccination work into the development of next-generation vaccines against diseases that are very problematic for public health.

Latest Global Vaccine Ventures by SII

The Gates MRI partnership is part of multiple important international partnerships made by SII.

Bundibugyo Ebola Vaccine Trial

The company has initiated the world’s first Phase I clinical trial for an Ebola vaccine developed jointly with:

• University of Oxford’s Jenner Institute
• Oxford Vaccine Group
• Dengue Therapeutic Clinical Trial

Furthermore, SII made an announcement concerning a multinational clinical trial carried out in:

• Brazil
• Malaysia
• Thailand

This trial assesses a dengue treatment developed by SII.

These initiatives reflect the increasing global presence of the company in the fields of infectious diseases research and vaccine development.