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Working with dangerous viruses sounds like trouble – but here’s what scientists learn from studying pathogens in secure labs

Scientists get up close and personal with deadly pathogens to give doctors the tools they need to treat people sickened by germs. The key is keeping the researchers – and everyone around them – safe.

Microbes are everywhere – and they aren't all friendly. spawns/E+ via Getty Images

There are about 1,400 known human pathogens – viruses, bacteria, fungi, protozoa and helminths that can cause a person’s injury or death. But in a world with a trillion individual species of microorganisms, where scientists have counted only one one-thousandth of one percent, how likely is it researchers have discovered and characterized everything that might threaten people?

Not very likely at all. And there’s a lot to be gained from knowing these microscopic enemies better.

So even though in day-to-day life it makes sense to avoid these dangerous microorganisms, scientists like me are motivated to study them up close and personal to learn how they work. Of course, we want to do it in as safe a way as possible.

I’ve worked in biocontainment laboratories and have published scientific articles on both bacteria and viruses, including influenza and the SARS-CoV-2 coronavirus. Here at Oklahoma State University, 10 research groups are currently studying pathogens in biosecure labs. They’re identifying genetic variations of viruses and bacteria, studying how they operate within cells of their hosts. Some are untangling how the host immune system responds to these invaders and is affected by so-called comorbidities of obesity, diabetes or advanced age. Others are investigating how to detect and eliminate pathogens.

This kind of research, to understand how pathogens cause harm, is crucial to human and veterinary medicine, as well as the health of mammals, birds, fish, plants, insects and other species around the globe.

Forewarned is forearmed

Think about all scientists have learned in the past century about how to prevent diseases based on understanding which microorganism is responsible, where it is in the environment and how it overcomes humans’ natural defenses.

Understanding what these organisms do, how they do it, and how they spread helps researchers develop measures to detect, mitigate and control their expansion. The goal is to be able to cure or prevent the disease they cause. The more dangerous the pathogen, the more urgently scientists need to understand it.

This is where lab research comes in.

Scientists have basic questions about how a pathogen conducts itself. What machinery does it use to enter a host cell and replicate? What genes does it activate, to make which proteins? This kind of information can be used to pinpoint strategies to eliminate the pathogen or lead to disease treatments or vaccines.

As the library of what is known about pathogens grows, there’s more chance researchers can apply some of that knowledge when faced with an emerging pathogen.

People might encounter new pathogens as they move into different parts of the world, or alter ecosystems. Sometimes a pathogen adapts to a new vector – meaning it can be carried by a different organism – allowing it to spread into new areas and infect new populations. Roughly 70% of emerging infectious diseases around the world are transmitted through animals to people; these are called zoonotic diseases. It is critical to understand how these pathways work in order to have even a modest ability to predict what could happen.

While there are patterns in nature that can provide clues, the tremendous diversity of the microbial world and the rate at which these organisms evolve new strategies for their own defense and survival makes it imperative to study and understand each one as it’s discovered.

seated researcher in PPE seen from behind in lab
A scientist wearing personal protective gear works with coronavirus within a biosafety cabinet. Pallava Bagla/Corbis News via Getty Images

Can this research be done safely?

There is no such thing as zero risk in any endeavor, but over many years, researchers have developed safe laboratory methods for working with dangerous pathogens.

Each study must document in advance what is to be done, how, where and by whom. These descriptions are reviewed by independent committees to make sure the plans outline the safest way to do the work. There’s independent follow-up by trained professionals within the institution and, in some cases, by the U.S. Centers for Disease Control and Prevention, the U.S. Department of Agriculture, or both, to ensure researchers are following the approved procedures and regulations.

Those who work with dangerous pathogens adhere to two sets of principles. There’s biosafety, which refers to containment. It includes all the engineering controls that keep the scientists and their surroundings safe: enclosed, ventilated workspaces called biosafety cabinets, directional airflows and anterooms to control air movement inside the lab. Special high-efficiency particulate air filters (HEPA) clean the air moving in and out of the laboratory.

We stick to good laboratory work practices, and everyone suits up in personal protective equipment including gowns, masks and gloves. Sometimes we use special respirators to filter the air we breathe while in the lab. Additionally we often inactivate the pathogen we’re studying – essentially taking it apart so it is not functional – and work on the pieces one or a few at a time.

Then there’s biosecurity, meaning the measures designed to prevent loss, theft, release or misuse of a pathogen. They include access controls, inventory controls and certified methods for decontaminating and disposing of waste. Part of these security measures is keeping the details close.

Biosafety levels are defined by how much risk is involved in working with particular pathogens. The Conversation, CC BY-ND

The research community recognizes four levels of biosafety practices. Biosafety level-1 (BSL-1) and BSL-2 are applied to general laboratory spaces where there is low to no risk. They would not work with microorganisms that pose a serious threat to people or animals.

BSL-3 refers to laboratories where there is high individual risk but low community risk, meaning there is a pathogen that can cause human disease but is not transmitted from person to person and the disease is readily treatable. This is the kind of work my colleagues and I, and many medical and veterinary schools, will do.

BSL-4 refers to work with pathogens that pose a high risk of significant disease in people, animals or both that is transmitted among individuals and for which an effective treatment may not be available. BSL-4 laboratories are relatively rare, by one estimate only about 50 exist in the world.

At each level the increased risk requires increasingly stringent precautions to keep workers safe and prevent any accidental or malicious misuse.

[The Conversation’s most important coronavirus headlines, weekly in a science newsletter]

What’s at risk if science ignores these microbes?

In recent years, the world has seen outbreaks of severe disease caused by several types of pathogens. Even for the pathogens scientists do know about, much remains unknown. It is reasonable to expect there are more threats out there yet to be discovered.

It is critical for scientists to study new disease pathogens in the lab as they’re discovered and to understand how they move from host to host and are affected by conditions; what variations develop over time; and what effective control measures can be developed. In addition to more well-known viruses such as rabies, West Nile virus and Ebola, there are several critically important pathogens circulating in the world today that pose a serious threat. Hantaviruses, dengue, Zika virus and the Nipah virus are all under investigation in various labs, where researchers are working to understand more about how they’re transmitted, develop rapid diagnostics and produce vaccines and therapeutics.

Microorganisms are the most abundant form of life on the planet and extremely important to human health and the health of plants and animals. In general, people have adapted to their presence, and vice versa. For those microbes with the capacity to do real harm, it makes sense to study as many as scientists can now, before the next pandemic hits.

Jerry Malayer does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Spread & Containment

AstraZeneca antibody cocktail fails to prevent Covid-19 symptoms in large trial

AstraZeneca said a late-stage trial failed to provide evidence that the company’s Covid-19 antibody therapy protected people who had contact with an infected person from the disease, a small setback in its efforts to find alternatives to vaccines.

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Astra antibody cocktail fails to prevent COVID-19 symptoms in large trial

(Reuters; )

June 15 (Reuters) – AstraZeneca (AZN.L) said on Tuesday a late-stage trial failed to provide evidence that its COVID-19 antibody therapy protected people who had contact with an infected person from the disease, a small setback in its efforts to find alternatives to vaccines.

The study assessed whether the therapy, a cocktail of two types of antibodies, could prevent adults who had been exposed to the virus in the past eight days from developing COVID-19 symptoms.

The therapy, AZD7442, was 33% effective in reducing the risk of people developing symptoms compared with a placebo, but that result was not statistically significant — meaning it might have been due to chance and not the therapy.

The Phase III study, which has not been peer reviewed, included 1,121 participants in the United Kingdom and the United States. The vast majority, though not all, were free of the virus at the start of the trial.

Results for a subset of participants who were not infected to begin with was more encouraging but the primary analysis rested on results from all participants.

FILE PHOTO: A computer image created by Nexu Science Communication together with Trinity College in Dublin, shows a model structurally representative of a betacoronavirus which is the type of virus linked to COVID-19, better known as the coronavirus linked to the Wuhan outbreak, shared with Reuters on February 18, 2020. NEXU Science Communication/via REUTERS

“While this trial did not meet the primary endpoint against symptomatic illness, we are encouraged by the protection seen in the PCR negative participants following treatment with AZD7442,” AstraZeneca Executive Vice President Mene Pangalos said in a statement.

The company is banking on further studies to revive the product’s fortunes. Five more trials are ongoing, testing the antibody cocktail as treatment or in prevention.

The next one will likely be from a larger trial testing the product in people with a weakened immune system due to cancer or an organ transplant, who may not benefit from a vaccine.

TARGETED ALTERNATIVES

AZD7442 belongs to a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the body to fight off infections.

Similar therapies developed by rivals Regeneron (REGN.O) and Eli Lilly (LLY.N) have been approved by U.S. regulators for treating unhospitalised COVID patients.

European regulators have also authorised Regeneron’s therapy and are reviewing those developed by partners GlaxoSmithKline (GSK.L) and Vir Biotechnology (VIR.O) as well as by Lilly and Celltrion (068270.KS).

Regeneron is also seeking U.S. authorisation for its therapy as a preventative treatment.

But the AstraZeneca results are a small blow for the drug industry as it tries to find more targeted alternatives to COVID-19 inoculations, particularly for people who may not be able to get vaccinated or those who may have an inadequate response to inoculations.

The Anglo-Swedish drugmaker, which has faced a rollercoaster of challenges with the rollout of its COVID-19 vaccine, is also developing new treatments and repurposing existing drugs to fight the virus.

AstraZeneca also said on Tuesday it was in talks with the U.S. government on “next steps” regarding a $205 million deal to supply up to 500,000 doses of AZD7442. Swiss manufacturer Lonza (LONN.S) was contracted to produce AZD7442.

Shares in the company were largely unchanged on the London Stock Exchange.

The full results will be submitted for publication in a peer-reviewed medical journal, the company said.

Reporting by Vishwadha Chander in Bengaluru; Editing by Shounak Dasgupta

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-says-its-antibody-treatment-failed-in-preventing-covid-19-exposed-2021-06-15

 

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Government

Former FDA Head Takes on Exec Role at Flagship’s Preemptive Health Initiative

Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration under former President Donald Trump, took on a new role as chief medical officer of a new health security initiative launched by Flagship Pioneering, a life sciences venture firm…

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Former FDA Head Takes on Exec Role at Flagship’s Preemptive Health Initiative

 

Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration (FDA) under former President Donald Trump, has taken on a new role as chief medical officer of a new health security initiative launched by Flagship Pioneering, a life sciences venture firm that incubates and curates biopharma companies.

First announced Monday, Flagship’s Preemptive Medicine and Health Security initiative aimed at developing products that can help people before they get sick. This division will focus on infectious disease threats and pursue bold treatments for existing diseases, including cancer, obesity, and neurodegeneration. 

In a brief statement, Hahn, who served as commissioner from December 2019 until January 2021, said the importance of investing in innovation and preemptive medications has never been more apparent. 

“In my career I have been a doctor and a researcher foremost and it is an honor to join Flagship Pioneering in its efforts to prioritize innovation, particularly in its Preemptive Medicine and Health Security Initiative. The more we can embrace a “what if …” approach the better we can support and protect the health and well-being of people here in the U.S. and around the world,” Hahn said in a statement. 

During his time at the FDA, Hahn was at the forefront of the government’s effort to battle the COVID-19 pandemic. His office oversaw the regulatory authorization of antivirals, antibody therapeutics and vaccines, as well as diagnostics and other tools to battle the novel coronavirus. 

Kevin Dietsch-Pool/Getty Images

Hahn bore the brunt of verbal barbs aimed at the FDA by the former president for not rushing to authorize a vaccine for COVID-19 ahead of the November 2020 election. The second vaccine authorized by the FDA for COVID-19 was developed by Moderna, a Flagship company. 

Prior to his confirmation as FDA Commissioner, Hahn, a well-respected oncologist, served as chief medical executive of the vaunted The University of Texas MD Anderson Cancer Center. Hahn was named deputy president and chief operating officer in 2017. In that role, he was responsible for the day-to-day operations of the cancer center, which includes managing more than 21,000 employees and a $5.2 billion operating budget. He was promoted to that position two years after joining MD Anderson as division head, department chair and professor of Radiation Oncology. Prior to MD Anderson, Hahn served as head of the radiation oncology department at the University of Pennsylvania’s Perelman School of Medicine.

Flagship Founder and Chief Executive Officer Noubar Afeyan said the COVID-19 pandemic that shut down economies and caused the deaths of more than 3.8 million people across the world was an important reminder that health security is a top global priority. In addition, the ongoing pandemic brings into “stark focus” the importance of preemptive medications. 

Hahn, who helmed the FDA for three years and before that served as chief medical executive at The University of Texas MD Anderson Cancer Center, has extensive experience overseeing clinical and administrative programs. Afeyan said the new division would benefit from Hahn’s experience as FDA Commissioner and help steer the Preemptive Medicine and Health Security initiative as it explores Flagship’s “growing number of explorations and companies in this emerging field.”

It is not unusual for former FDA heads to take prominent roles with companies. For example, former FDA Commissioner Scott Gottlieb, Trump’s first FDA Commissioner, took a position on the Pfizer Board of Directors weeks after departing his government role. He has also taken positions on other boards since then, including Aetion, FasterCures and Illumina.

 

BioSpace source:

https://www.biospace.com/article/former-fda-head-stephen-hahn-takes-cmo-role-at-flagship-pioneering-preemptive-health-initiative-

 

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Government

Five U.S. states had coronavirus infections even before first reported cases – study

At least seven people in five U.S. states were infected with the novel coronavirus weeks before those states reported their first cases, a new government study showed.

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Five U.S. states had coronavirus infections even before first reported cases – study

(Reuters) – At least seven people in five U.S. states were infected with the novel coronavirus weeks before those states reported their first cases, a new government study showed.

Participants who reported antibodies against SARS-CoV-2 were likely exposed to the virus at least several weeks before their sample was taken, as the antibodies do not appear until about two weeks after a person has been infected, the researchers said.

The latest results build on findings from a Centers for Disease Control and Prevention study that suggested the novel coronavirus may have been circulating in the United States last December, well before the first COVID-19 case was diagnosed on Jan. 19, 2020.

A protective face mask lays, as the global outbreak of the coronavirus disease (COVID-19) continues, beside leaves at the lakefront in Chicago, Illinois, U.S., December 6, 2020. REUTERS/Shannon/File Photo

The positive samples came from Illinois, Massachusetts, Mississippi, Pennsylvania and Wisconsin, and were part of a study of more than 24,000 blood samples taken for a National Institutes of Health research program between Jan. 2 and March 18, 2020.

Samples from participants in Illinois were collected on Jan. 7 and Massachusetts on Jan. 8, suggesting that the virus was present in those states as early as late December.

“This study allows us to uncover more information about the beginning of the U.S. epidemic,” said Josh Denny, one of the study authors.

The findings were published in the journal Clinical Infectious Diseases.

Reporting by Mrinalika Roy in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/five-us-states-had-coronavirus-infections-even-before-first-reported-cases-study-2021-06-15

 

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