“They’ve sensationalized the message, they misrepresent the study and its goals in its entirety.”

This 2020 electron microscope image provided by the National Institute of Allergy and Infectious Diseases – Rocky Mountain Laboratories shows SARS-CoV-2 virus particles which cause COVID-19, isolated from a patient in the U.S., emerging from the surface of cells cultured in a lab. National Institute of Allergy and Infectious Diseases via Associated Press

By Ross Cristantiello October 18, 2022

Researchers at Boston University are making a point to publicly refute a series of misleading claims published by certain media outlets.

The claims, and BU’s response, center around experiments that were conducted at the university’s National Emerging Infectious Diseases Laboratories (NEIDL). 

The research was detailed in a paper published online Friday, which has not yet been peer-reviewed. A team from BU laid out how they created a chimeric, or hybrid, version of SARS-CoV-2, the virus that causes COVID-19.

A group of lab mice was then exposed to samples of the hybrid virus. 

As a result, 80% of the mice died, showing that the chimeric virus was more lethal to this type of mice than the omicron strain.

It is important to note that the original virus strain from 2020 killed 100% of the mice it was exposed to in these experiments. 

On Monday, The Daily Mail published an article claiming that BU “created a new deadly Covid strain with an 80% kill rate.” Other outlets, like Fox News, picked up the reporting and similarly misrepresented the research, BU said in a statement. 

“They’ve sensationalized the message, they misrepresent the study and its goals in its entirety,” said Ronald B. Corley, NEIDL director and BU Chobanian & Avedisian School of Medicine chair of microbiology, in The Brink. The publication is run by BU’s Marketing & Communications office, specializing in news regarding research at the university. 

The research was reviewed and approved by BU’s Institutional Biosafety Committee, the university said. This body consists of scientists and local community members. The Boston Public Health Commission also approved the research, BU said.

The goal of the research was to study which parts of the SARS-CoV-2 omicron variant dictate the severity of disease experienced by people exposed to it. To do this, scientists set out to compare the original virus strain to the omicron strain. 

Researchers took the spike protein of an omicron version of SARS-2 and attached it to a virus of the original strain, creating the hybrid virus that was given to the mice. 

The university called out the Daily Mail article in a statement. The article insinuated that this work was gain-of-function research, BU said.

Gain-of-function research is simply the manipulation of pathogens to make them more dangerous. 

“We want to address the false and inaccurate reporting about Boston University COVID-19 research, which appeared today in the Daily Mail,” BU said in a statement Monday. “First, this research is not gain-of-function research, meaning it did not amplify the Washington state SARS-CoV-2 virus strain or make it more dangerous. In fact, this research made the virus replicate less dangerous.”

The research “mirrors and reinforces” work done by scientists at other organizations, such as the FDA, according to the university. 

Mohsan Saeed, a NEIDL investigator and one of the lead researchers involved, said that BU’s work gave valuable insights into why the omicron variant causes less-severe COVID-19. 

“Consistent with studies published by others, this work shows that it is not the spike protein that drives omicron pathogenicity, but instead other viral proteins,” Saeed told The Brink. “Determination of those proteins will lead to better diagnostics and disease management strategies.”

Friction with the Government 

Aside from the media commotion, this research also appeared to get BU into hot water with the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. 

Emily Erbelding, director of NIAID’s division of microbiology and infectious diseases, said in an interview with STAT that BU’s original grant applications did not clarify that this specific work would be done. 

The University also did not make it clear to NIAID that its experiments could involve enhancing a pathogen of pandemic potential in progress reports to government officials, STAT reported. In her interview, Erbelding added that she and her colleagues wished BU would have informed NIAID of their intention to do this research. 

BU said that its research was in line with “all required regulatory obligations and protocols.” In keeping with these guidelines, BU said, it did not have an obligation to disclose this research for two reasons. 

First, these experiments were conducted using funds from BU itself. The research team acknowledged NIAID funding because these dollars were used to help “develop the tools and platforms that were used in this research.” NIAID did not fund the research directly, according to BU. 

Second, BU was not obligated to report the specifics of this research because there was no gain-of-function involved. 

What is Gain of Function?Gain-of-function research (GoF research or GoFR) is medical research that genetically alters an organism in a way that may enhance the biological functions of gene products.

“If at any point there was evidence that the research was gaining function, under both NIAID and our own protocols we would immediately stop and report. All research at Boston University, whether funded by NIAID or not, follows this same protocol. We are in continued conversation with NIAID leadership and program officers,” the university said in a statement. 

What is Gain of Function?

Gain-of-function research (GoF research or GoFR) is medical research that genetically alters an organism in a way that may enhance the biological functions of gene products.

This may include an altered pathogenesis, transmissibility, or host range, i.e. the types of hosts that a microorganism can infect. This research is intended to reveal targets to better predict emerging infectious diseases and to develop vaccines and therapeutics. For example, influenza B can infect only humans and harbor seals.[1] Introducing a mutation that would allow influenza B to infect rabbits in a controlled laboratory situation would be considered a gain-of-function experiment, as the virus did not previously have that function.[2][3] That type of experiment could then help reveal which parts of the virus’s genome correspond to the species that it can infect, enabling the creation of antiviral medicines which block this function.[3]

In virology, gain-of-function research is usually employed with the intention of better understanding current and future pandemics.[4] In vaccine development, gain-of-function research is conducted in the hope of gaining a head start on a virus and being able to develop a vaccine or therapeutic before it emerges.[4] The term “gain of function” is sometimes applied more narrowly to refer to “research which could enable a pandemic-potential pathogen to replicate more quickly or cause more harm in humans or other closely-related mammals.”[5][6]

Some forms of gain-of-function research (specifically work which involves certain select agent pathogens) carry inherent biosafety and biosecurity risks, and are thus also referred to as dual use research of concern (DURC).[7] To mitigate these risks while allowing the benefits of such research, various governments have mandated that DURC experiments be regulated under additional oversight by institutions (so-called institutional “DURC” committees)[8] and government agencies (such as the NIH’s recombinant DNA advisory committee).[9][10][11] A mirrored approach can be seen in the European Union‘s Dual Use Coordination Group (DUCG).[12][13][14]