The Broncho Vaxom does not prevent COVID-19, but its sale skyrocketed and is now scarce in Mexico

It has recently been suggested in several Mexican media that the drug known as Broncho Vaxom, a bacterial lysate that has been on the market for years and is marketed in several countries, including Mexico, would be capable of preventing and treating COVID-19. 

This week the medicine has even been scarce in several pharmacies in the Mexican capital and other cities in the country, as a Telemundo News team was able to verify: after investigating and consulting with health professionals, Mexican authorities and researchers who have studied the possible effect of Broncho Vaxom against COVID-19, we conclude that

.

Here we explain it. 

What is the Broncho Vaxom? 

Broncho Vaxom is a bacterial lysate OM-85, an extract of semi-destroyed infectious respiratory bacteria, used as an immunostimulant for the prevention and treatment of recurrent respiratory diseases such as bronchitis, pharyngitis and rhinosinusitis in adults and children.

Previous studies have shown that its use decreases the frequency of respiratory infections and the time of antibiotic consumption.

It was developed by the Swiss pharmaceutical company OM Pharma and registered in Switzerland in 1978. In Mexico, it is sold by the German pharmaceutical company Grünenthal and costs between 700 and 800 Mexican pesos (between 34 and 40 dollars). 

Broncho Vaxom is an OM-85 bacterial lysate marketed by the German pharmaceutical company Grünenthal.

It is sold in several countries, including Mexico.Alejandro Erreguin

Where did the idea that the drug serves to prevent COVID-19 come from? 

Two studies were conducted last year to test whether OM-85 reduces infection caused by SARS-CoV-2, the virus that causes COVID-19.

A study, conducted at the University Hospital in Basel, Switzerland, the results of which were published in October, found that Broncho Vaxom reduced SARS-CoV-2 infection in human bronchial cells.

The researchers suggest that the OM-85 bacterial lysate "could be considered as an adjunct to therapy against COVID-19." 

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The other analysis was done by researchers at the University of Arizona and their results were published in December.

The conclusions are similar, although the authors clarify that "further studies are warranted to assess whether OM-85 can prevent and/or reduce the severity of coronavirus disease 2019." 

In December, one of the researchers from the University of Arizona, Italian doctor Donata Vercelli, spoke about the results of the study with the Italian media.

His statements caused a stir in that country, the information spread quickly and in a matter of days it was reproduced by the Mexican media.

As expected, people reacted and the drug was sold out in some pharmacies in the country. 

Is it true that Broncho Vaxom prevents COVID-19?

This is the key question, and the best answer is that,

For now,

.

This was explained to Noticias Telemundo by the researchers in charge of the studies, including Dr. Donata Vercelli.

The main limitation is that the analyzes were not done directly in humans, but with cells in laboratories, one of the studies was even carried out in mice. 

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"

(...) Properly designed clinical trials are needed," Vercelli, professor of Cellular and Molecular Medicine and associate director of the Research Center of Asthma and Airway Diseases at the University of Arizona. 

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“The effects of this treatment will have to be tested in vivo, in humans, before any conclusions can be drawn,” he said. 

A similar opinion was offered by Dr. Michael Roth, head of Lung Cell Research at the Department of Biomedicine at the University of Basel, who led the study on the possible effects of Broncho Vaxom against COVID-19.

“(In vitro data) showed that OM-85 reduced proteins that help the virus infect.

Therefore, OM-85 could have the potential to reduce SARS-CoV-2 infection,” he explained. 

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“However, it must be emphasized that proof of a preventive or curative effect of OM-85 on SARS-CoV-2 infection has yet to be demonstrated in humans, in clinical trials (...) any conclusions on the use of OM-85 85 in the prevention or therapy of COVID-19

,” Roth wrote to Noticias Telemundo in an email. 

“We have to wait for the results of the clinical studies,” he insisted. 

Clinical trials to determine whether a new treatment or vaccine works and is safe for people are done with volunteers and involve several phases that can take months or years.

Before starting, they must be approved by the health authorities of the country where they are carried out. 

Other specialists who read the in vitro studies at the request of Noticias Telemundo offered the same warning.

A woman receives the result of a COVID-19 test outside a pharmacy in Mexico City, on Monday, January 10.

In December, cases of the virus tripled in Mexico.

Marco Ugarte / AP

Dr. Daniel Pahua Díaz, evaluation coordinator at the Department of Public Health of the Faculty of Medicine of the National Autonomous University of Mexico (UNAM), explained that the OM-85 bacterial lysate was not designed to prevent COVID-19, and consuming it does not offer immunity to the virus. 

“It would not make any sense for us to consume this type of product, which, although it does stimulate the immune system,

(...) There would be no reason to think that a lysate of bacteria is protecting us against a virus, because they are also different strains,” said Pahua.

“The treatment does look promising, but it was a study that was carried out in a laboratory.

This was not a human study.

These studies cannot tell us whether the treatment is safe or effective for the prevention or treatment of COVID-19," said epidemiologist Sandra Albrecht, a professor at Columbia University in New York. 

unjustified rage

Noticias Telemundo visited several pharmacies in Mexico City this week and found that the drug was out of stock.

The same thing happened in cities like Guadalajara and Monterrey.

Dependents of several pharmacies said that since the news of the alleged benefits of the drug to treat COVID-19 came out, its sale increased.

Some people go so far as to buy it and show the news articles on their cell phone, they said.

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Mexican health authorities are aware that misinformation has spread among the public and warn that the furor over OM-85 is misguided.

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"This has become a confusion (...) there is no official recommendation by health authorities in Mexico to use this drug, Broncho Vaxom or OM-85, to treat COVID-19," Dr. José Antonio Ortega Martell, member of the multidisciplinary panel for the recommendations of treatment against COVID-19 of the Mexican Government.

"The confusion probably arose because these studies popularized the subject, but these are in vitro studies, they are not clinical studies," Ortega said. 

Is it dangerous to consume a bacterial lysate if we are healthy?

The health professionals consulted agree that OM-85 is not dangerous to health.

In some cases, headaches and stomachaches have been reported among people who consume it, but

, explained Dr. Ortega.

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“Based on clinical studies conducted for other pulmonary infectious diseases, OM-85 is unlikely to have a negative effect on a healthy person,” Dr. Michael Roth wrote.

The real danger is that people believe that the drug will protect them from COVID-19

and abandon prevention measures such as getting vaccinated, wearing masks, good ventilation and avoiding crowds, specialists explain. 

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“The important thing is that it doesn't give a false sense of security.

Believing that by taking this type of bacterial lysate product I am not going to get sick or contract the infection,” said Dr. Pahua. 

“That is the risk, in addition to the economic one, because they are not cheap products, they are somewhat expensive, so it will affect the economy of people with a false idea that they are going to do something against COVID-19,” added Dr. Ortega . 

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The specialists consulted affirm that

and reduce the possibility of becoming seriously ill.

"At this time, vaccines remain our strongest strategy against COVID-19," said Dr. Donata Vercelli. 

Do not abuse these drugs

As Dr. Albrecht explains, the lack of current evidence does not imply that the treatment does not have the potential to be used as part of the treatment against COVID-19 in the future.

However, for that to happen, adequate clinical studies must be carried out. 

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Dr. Roth said that the company that produces the drug has already begun its own studies, but that information could not be independently verified by Noticias Telemundo.

We sent several questions on this topic to the pharmaceutical company Grünenthal, but at the time of writing this article they had not responded. 

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Meanwhile, Dr. José Antonio Ortega Martell believes that the Mexican health authorities should issue an official statement warning the public so that they

and have already been proven against this infection (caused by SARS-CoV-2)," he said. 

And if, despite the lack of evidence of its supposed benefits against COVID-19, people insist on taking the OM-85 bacterial lysate, Dr. Pahua recommends that they go to a health professional so that they "indicate the relevance or not to consume it”. 

Ronny Rojas reported from New York.

Albinson Linares reported from Mexico City.