54% effectiveness! Is there no new vaccine available in 102 years, or will the world's first vaccine be born?

Tech 2023-07-04 16:24:45 Source: Network

Source: Yaozhi.com official accountImage source: Photography NetworkRecently, the Bill and Melinda French Gates Foundation and the Wellcome Trust announced that they will invest 550 million dollars for the phase 3 clinical trial of the candidate vaccine M72/AS01E for tuberculosis, which is mainly used to prevent adolescents and adults from suffering from tuberculosis

Source: Yaozhi.com official account

Image source: Photography Network

Recently, the Bill and Melinda French Gates Foundation and the Wellcome Trust announced that they will invest 550 million dollars for the phase 3 clinical trial of the candidate vaccine M72/AS01E for tuberculosis, which is mainly used to prevent adolescents and adults from suffering from tuberculosis.

Before that, only BCG vaccine vaccine could be used to prevent infants and young children from suffering from tuberculosis in the world, while BCG vaccine vaccine was introduced in 1921, and no vaccine could be used to prevent tuberculosis for 102 years.

If the M72/AS01E clinical phase 3 trial is successful, it will become the first vaccine to prevent young people and adults from suffering from tuberculosis in the past century.

The vaccine has a efficacy of 54%,

Announcement of Clinical Phase 2b Results for M72/AS01E

It is reported that the candidate vaccine was developed by pharmaceutical company GSK and consists of M72 recombinant fusion protein and adjuvant AS01. At present, the vaccine has completed clinical phase 2 trials and is about to enter clinical phase 3.

Effectiveness aspectThe clinical 2b trial results showed that 10 participants who received M72/AS01E met the case definition, which means they were infected with tuberculosis. In contrast, 22 participants in the placebo group met the case definition, resulting in a vaccine efficacy of 54%.

Comparison of efficacy between M72/AS01 and placebo

Image source: Reference 1

Security aspectsWithin 30 days after injection, more adverse events were reported in the M72/AS01E group (67.4%) than in the placebo group (45.4%). The main differences were injection site reactions and flu like symptoms. In the two groups, Serious adverse event occurred, but the probability of potential immune mediated diseases and deaths was similar.

The above phase II clinical trial results show that M72/AS01E has a very high potential in preventing tuberculosis. It may become the first vaccine in the world that can effectively prevent young people and adults from suffering from tuberculosis in nearly a century.

According to data, BCG vaccine is the only approved vaccine for tuberculosis at present.Although it is moderately effective in preventing severe tuberculosis in infants and young children, it cannot fully protect adolescents and adults, who account for nearly 90% of the global transmission of tuberculosis.

According to a study commissioned by WHO, "tuberculosis New Vaccine Investment Demonstration", it is estimated that within 25 years, a vaccine with an effective rate of disease prevention of 50% among adolescents and adults can avoid up to 76 million new cases of tuberculosis, 8.5 million deaths, 42 million antibiotic courses and the $6.5 billion cost faced by families affected by tuberculosis. A vaccine with an efficiency of 75% can avoid up to 110 million new cases and 12.3 million deaths.

This study further indicates that for every $1 invested in a 50% effective vaccine, an economic benefit of $7 can be achieved in avoiding health costs and improving productivity.

So if the M72/AS01E vaccine can be finally launched, it will significantly reduce new cases and deaths of tuberculosis, and generate economic benefits of several billion yuan, with a return rate of about 7 times that of the investment.

There are over 10 million cases of tuberculosis worldwide,

Spending $13 billion annually

According to the estimation of the World Health Organization, about a quarter of the world's population has been infected with Mycobacterium tuberculosis, and about 5% -10% of tuberculosis infected people will eventually develop symptoms and develop into tuberculosis. According to the Global tuberculosis Report 2022 issued by the World Health Organization,About 10.6 million people worldwide will be infected with tuberculosis in 20216 million men, 3.4 million women and 1.2 million children. In 2021, 1.6 million people will die of pulmonary tuberculosis.

According to the statistics of the World Health Organization, about 87% of new cases of tuberculosis occur in 30 countries with high burden of tuberculosis, accounting for more than two-thirds of the global total, and new cases occur in Bangladesh, China, the Democratic Republic of the Congo, India, Indonesia, Nigeria, Pakistan and the Philippines,The current number of tuberculosis cases in China ranks among the top three in the world.

The following table shows the number of new cases and deaths of pulmonary tuberculosis in China in recent years.

Table 1: Number of Incidents and Deaths of Pulmonary Tuberculosis in China in Recent Years

Data source: Official website of China Health Commission

In recent years, the overall prevalence of tuberculosis in China has shown a downward trend. In 2008, the number of cases of tuberculosis in China was 1169540, while in 2021, the number of cases decreased to 639548. In 13 years, the number of cases of tuberculosis in China decreased by 45%, but the overall base is still large. And such a large population of tuberculosis patients has also brought a heavy burden to the country's medical system.

Such a huge population of patients is bound to generate a large drug market, and according to the World Health Organization, it is estimated that approximately13 billion US dollarsIt is used for the prevention, diagnosis, treatment and nursing of tuberculosis.

Tuberculosis drugs

And global research status of new drugs

Tuberculosis drugs.

In addition to the aforementioned drugs,Currently, over 7 drugs worldwide are in the clinical stagePlease refer to the table below for details.

2 Tuberculosis drugs

Data source:. clinicaltrials.gov and chinadrugtrials

Among them, the most noteworthy isWX-081 tablets developed by Shanghai Jiatan Pharmaceutical InstituteThis drug is a Class 1 new drug independently developed in China and is currently in clinical phase 3. It was initially developed by Chenxin Pharmaceutical, and later transferred patent applications, proprietary technology, intellectual property rights, and other rights to Shanghai Jiatan Pharmaceutical.

At present, the enterprise has not yet released the results of the phase II clinical trial of WX-081 tablet. If WX-081 tablet can be finally marketed, it will benefit tens of millions of patients with pulmonary tuberculosis and reduce the national medical burden.

Summary

Innovative medicine research and development is one of the strategic pillars to stop the disease. Just like the vaccine M72/AS01E, if it is finally launched, it will reduce about 76 million new cases of pulmonary tuberculosis among adolescents and adults. Cutting off the transmission of disease from the source is the most effective way.

Reference:

[1] Phase2bControlledTrialofM72/AS01EVaccinetoPreventTuberculosis

[2] WHO official websiteOfficial website of the National Health Commission

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