FactCheck

Republicans Spin NIH Letter About Coronavirus Gain-of-Function Research

Republicans say a letter from a National Institutes of Health official is an admission that the agency funded so-called gain-of-function research on bat coronaviruses in China, with some falsely linking the work to the pandemic coronavirus. But the research, which the NIH maintains is not gain-of-function, could not have led to SARS-CoV-2, the virus that causes COVID-19.

On Oct. 20, the Republican staff of the House Oversight and Reform Committee released a letter from NIH Principal Deputy Director Lawrence A. Tabak responding to an inquiry about a grant awarded to EcoHealth Alliance, a U.S.-based scientific nonprofit focused on pandemic prevention and conservation.

The grant, which was awarded in 2014 and was canceled in April 2020, has been the subject of much controversy. It assessed the potential for bat coronaviruses in China to spillover and infect people and included some experiments mixing and matching elements of different viruses to better understand them. It also involved a collaboration with scientists at the Wuhan Institute of Virology.

In the letter, Tabak said EcoHealth Alliance had violated the terms of its grant by not immediately reporting an unexpected experimental result in which mice became sicker when infected with a modified coronavirus.

Republicans were quick to interpret the letter as an admission that the agency had funded gain-of-function research.

In commentary accompanying the shared letter, the committee said on Twitter that the NIH “confirmed today EcoHealth and the WIV conducted GOF research on bat coronaviruses” and that NIH was “lied to” by EcoHealth.

Other conservative media outlets echoed these statements, adding that Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, “lied” about the funding.

As we’ll explain, whether or not the experiments count as “gain-of-function” — research in which a virus or other pathogen is modified to become more virulent or infectious to humans — is up for debate. The NIH has said they do not qualify under its criteria and reiterated that position after the release of Tabak’s letter; other experts have expressed a range of views. There is no evidence that Fauci knowingly gave false information or misled anyone.

Some Republicans, however, went further, using the letter to falsely link the NIH-funded research to the COVID-19 pandemic. In an Oct. 21 interview on Fox’s Ingraham Angle, Rep. James Comer of Kentucky, the ranking member of the committee, erroneously said that the NIH letter “proves all along that this virus was started in the Wuhan lab.” 

The letter does not prove that. In fact, it goes to great lengths to explicitly state the opposite, noting that the viruses used in the experiments are “decades removed from SARS-CoV-2 evolutionarily” and that they “could not have been the source of SARS-CoV-2.”

Previously, other Republicans, including Florida Rep. Matt Gaetz and Sen. Rand Paul of Kentucky, have at times falsely insinuated that the work could have led to the creation of SARS-CoV-2. Paul got into a heated debate with Fauci in July when both men accused the other of lying.

The falsely suggestive hashtag #FauciLiedPeopleDied also started to appear on Twitter after the letter was posted on the platform.

No Connection to the Pandemic Virus

The EcoHealth Alliance experiments have nothing to do with the COVID-19 pandemic and did not produce SARS-CoV-2, the NIH says.

Analysis of published genomic data and other documents from the grantee demonstrate that the naturally occurring bat coronaviruses studied under the NIH grant are genetically far distant from SARS-CoV-2 and could not possibly have caused the COVID-19 pandemic,” NIH Director Dr. Francis Collins said in an Oct. 20 statement, referring to an analysis posted to the NIAID’s website. “Any claims to the contrary are demonstrably false.”

The analysis shows that the viruses used in the EcoHealth Alliance experiments share only around 80% of their genomes with SARS-CoV-2 — a huge difference when making these comparisons. 

Much more similar viruses that share 96% to 97% of their genomes with SARS-CoV-2 have been identified. These include BANAL-52, a bat coronavirus found in Laos and reported in September, and RaTG13, a virus sequence collected by the Wuhan Institute of Virology that has also been the subject of much misplaced speculation.

But even these, the analysis explains, are still much too dissimilar to have given rise to SARS-CoV-2.

Setting aside the specific experiments performed with the grant funds, there is no evidence SARS-CoV-2 came from a lab, and many experts say that it’s virtually impossible for it to have been engineered.

The NIH Letter

In the letter, Tabak describes an alleged grant reporting infraction related to an experiment the agency said was conducted in 2018-2019 and related in a progress report EcoHealth submitted in August 2021.

The experiment, Tabak said, tested whether spike proteins from bat coronaviruses were capable of binding to human ACE2, the receptor that the viruses use to enter cells, in mice.

The experiment is similar to research published in PLOS Pathogens in 2017, which studied two of the same modified viruses. In that paper, researchers used the backbone of WIV1, a bat SARS-like virus reported in 2013, and swapped in the spike proteins of two newly identified bat coronaviruses to see if they, like WIV1, could use the ACE2 receptor to enter human cells grown in a petri dish. They could.

This time, the researchers did a similar experiment, but tested the chimeric viruses in mice. Since mice have their own ACE2 receptor, the animals were engineered to express the human form, but were otherwise unchanged.

“In this limited experiment, laboratory mice infected with the SHC014 WIV1 bat coronavirus became sicker than those infected with the WIV1 bat coronavirus,” Tabak wrote. “As sometimes occurs in science, this was an unexpected result of the research, as opposed to something that the researchers set out to do.”

As is shown in section 3.1 of the grant progress report, which was provided to and released by the Republicans on the House committee, infection with the viruses killed some of the mice, with the one chimeric virus being especially lethal. That virus killed six of the eight mice, replicated better than WIV1 in various mouse tissues and caused more pathology in the lung.

Tabak said in his letter that the research plan had been reviewed by the agency before funding, and the agency determined that it did not meet the NIH’s definition of gain-of-function — or what the agency terms research involving enhanced pathogens of pandemic potential — “because these bat coronaviruses had not been shown to infect humans.” It therefore was not subject to review under the Department of Health and Human Services’ framework for enhanced pathogens.

But, he added, “out of an abundance of caution and as an additional layer of oversight,” the agency had outlined criteria in the terms and conditions of the grant award for a secondary review, “such as a requirement that the grantee report immediately a one log increase in growth,” meaning a 10-fold increase in viral growth, to “determine whether the research aims should be re-evaluated or new biosafety measures should be enacted.”

“EcoHealth failed to report this finding right away, as was required by the terms of the grant,” the letter reads. “EcoHealth is being notified that they have five days from today to submit to NIH any and all unpublished data from the experiments and work conducted under this award.”

Tabak then spent the bulk of the letter’s second page explaining that bat coronaviruses used in the experiments “could not have been the source of SARS-CoV-2 and the COVID-19 pandemic,” as we’ve established.

For its part, EcoHealth disputes NIH’s characterization.

“EcoHealth Alliance is working with the NIH to promptly address what we believe to be a misconception about the grant’s reporting requirements and what the data from our research showed,” said Robert Kessler, the group’s spokesperson, in a statement provided to FactCheck.org. “These data were reported as soon as we were made aware, in our year 4 report in April 2018. NIH reviewed those data and did not indicate that secondary review of our research was required, in fact year 5 funding was allowed to progress without delay.”

The progress report notes that its experiments in mice were “continued” in year 5.

In his statement, Kessler confirmed that the organization’s grant was not ongoing. Collins similarly told CNN that the grant had been suspended “since last year.”

Gain-of-Function Debate

Although Tabak does not say in his letter that the EcoHealth experiment in question was gain-of-function, numerous Republicans interpreted it to be such an admission.

As we’ve written, gain-of-function can refer to a lot of scientific experiments that aim to add a function to a virus or organism that is entirely benign, such as making a viral stock easier to grow to better increase the yield for a vaccine. What is controversial is research that could make viruses or other infectious microbes more dangerous, either by increasing their transmissibility or virulence.

Some people have argued that very little or none of this research should be allowed because it is too risky, while others say the work needs to be done to better prepare for events such as pandemics.

Recognizing the debate, the U.S. government instituted a pause in 2014 on new funding for research that “may be reasonably anticipated” to enhance the transmissibility or virulence of influenza, MERS, or SARS viruses. Three years later, the government lifted the moratorium and unveiled a new framework for making funding decisions for these types of projects on a case-by-case basis.

The framework pertains to funding decisions on “proposed research that is reasonably anticipated to create, transfer, or use” what it calls “enhanced potential pandemic pathogens,” or ePPPs. A potential pandemic pathogen, or PPP, is one that is both “likely highly transmissible and likely capable of wide and uncontrollable spread in human populations” and “likely highly virulent and likely to cause significant morbidity and/or mortality in humans.” An ePPP is a PPP “resulting from the enhancement of the transmissibility and/or virulence of a pathogen.” Even if a virus has the potential to spark a pandemic, it would not be considered “enhanced” if it is found in nature.

This formal definition differs in a few possible respects from what is described in the grant progress report — namely, that the research would need to be expected to produce an ePPP and that the virus in question would have to be “likely highly” virulent and transmissible, specifically in humans.

The NIH argues that the EcoHealth Alliance experiments, although they produced a more virulent virus in mice, did not meet that definition.

“The bat coronaviruses used in this research have not been shown to infect humans, and the experiments were not reasonably expected to increase transmissibility or virulence in humans,” an NIH spokesperson told the New York Times following the release of the letter, adding that the experiments would not have triggered a review.

The NIH says it has only ever greenlighted three projects under its ePPP framework.

It’s worth noting that, as before with their 2017 experiments, the researchers were working with WIV1, a virus that already had the ability to bind to human ACE2, so swapping in spike proteins from other viruses was aimed at replacing a function, not giving the virus a new ability, as King’s College London virologist Stuart Neil has pointed out before.

The NIH also explains on its website that WIV1 “is not known to cause infection in humans but has been shown in the laboratory to infect both human cells and ACE2 transgenic mice, making it an ideal tool to use for these studies.”

We reached out to the NIH for more information but did not receive a reply.

Other experts disagree. Richard Ebright, a professor of chemistry and chemical biology at Rutgers University who is a vocal critic of gain-of-function research, sided with Republicans about the interpretation of the letter. “NIH corrects untruthful assertions by NIH Director Collins and NIAID Director Fauci that NIH had not funded gain-of-function research in Wuhan,” he wrote on Twitter.

Multiple other experts told the Intercept, which published other similar documents last month after suing the NIH, that the work EcoHealth Alliance was doing would be considered gain-of-function, although one said it wasn’t problematic.

Angela Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, told the Intercept that the research clearly was not gain-of-function because it’s not possible to conclude the viruses would be harmful to humans. “You can’t predict that these viruses would be more pathogenic, or even pathogenic at all in people,” she said. “They also did not study transmissibility.”

Still other experts say regardless of the technical definition of gain-of-function, the research described in the progress report strikes them as too risky and raises concerns about the NIH review process.

Fauci has defended himself, responding in an Oct. 24 ABC News interview to claims from Sen. Paul that he “lied” by saying that neither he nor Collins “lied or misled” anyone because he was operating under the framework. “There are people who interpret it that way,” he said, referring to those who view the work as gain-of-function, “but when you look at the framework under which the guidance is, that is not the case.”

Rasmussen said that the committee’s tweet was “wrong” since the letter “clearly states that this wasn’t GOF by the P3CO definition, which for NIH-funded work is the relevant standard,” referring to gain-of-function and the policy framework for handling such research. 

But she also criticized EcoHealth, saying the “lack of transparency & failure to comply with NIH requirements is indefensible.”

Collins pinned blame on EcoHealth as well.

“They messed up here. There’s going to be some consequences for EcoHealth,” he told the Washington Post in an interview.

But he also acknowledged that this new information did not mean anything that happened was risky. Had the group reported its result earlier, he said, “it would not have been a reason to sort of hit the panic button and say my god this is dangerous stuff.”

“In this one instance, they failed to report the results of an experiment that they should have told us about immediately,” Collins also said of EcoHealth Alliance in an interview with CNN. “This is not a circumstance where I think you could say there was a major failure that put human lives at risk.”

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

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FEMA Staff and Contracted Medical Workers Are Required to Follow Vaccine Mandate

SciCheck Digest

The Federal Emergency Management Agency is deploying contracted medical workers to understaffed hospitals, where they are required to comply with COVID-19 vaccine mandates. But social media posts falsely claim that “doctors and nurses are being forced to quit over the mandates,” while the workers sent by FEMA are “exempt.”

How do we know vaccines are safe? How do we know vaccines are safe?

No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.

One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”

Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.

Another monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time.

In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks.

The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. 

For more, see “How safe are the vaccines?

Link to this

Full Story

The Federal Emergency Management Agency, or FEMA, coordinates with other federal agencies, such as the Department of Defense and the Department of Health and Human Services, to prepare for and respond to major disasters. Throughout the COVID-19 pandemic, FEMA has worked to identify and deploy additional medical staff at the request of state, tribal and territorial governments.

But social media posts falsely claim that FEMA workers are replacing unvaccinated health care workers at understaffed facilities and are not required to be vaccinated themselves.

One viral Facebook post, which has been shared more than 350 times, claims that “Drs & Nurses refusing the poke are being fired cuz their being around patients would be just an absolute public health catastrophe! YET, their replacements from Fema do NOT have to have the poke… makes a ton of sense.”

Screenshots of tweets reposted on Instagram similarly assert that “DOCTORS & NURSES ARE BEING FORCED TO QUIT OVER THE MANDATES UNDER A SLEEPY CREEPY ADMINISTRATION, BUT YET FEMA DOCTORS & NURSES ARE EXEMPT UNDER THE SAME ADMINISTRATION!”

These posts are wrong for multiple reasons.

First, as we’ve previously reported, President Joe Biden’s Sept. 9 executive order requiring federal employees to receive a COVID-19 vaccine applies to all executive branch employees. FEMA is within the Department of Homeland Security, which is listed under Title 5 as an executive department.

“FEMA employees like all federal employees are required to be vaccinated,” Nicholas Morici, a FEMA spokesperson, told FactCheck.org in an Oct. 19 email.

The social media posts also misrepresent FEMA’s role in assisting states’ response to the COVID-19 pandemic. FEMA works with other federal agencies to identify medical workers that can be deployed to understaffed health care facilities across the country — but these personnel are not FEMA employees.

“These deployed medical staff abide by the vaccination and other preventive measures … established by the receiving facility,” Caitlin Justesen, acting press secretary at FEMA, told us in an email on Oct. 20.

The agency does not have a permanent medical staff, a FEMA representative who asked not to be named told us in a phone interview. Instead, FEMA and its partner agencies have contracts with medical providers who are temporarily relocated to areas with acute health care needs. These medical providers include physicians, nurses, paramedics, emergency medical technicians and public health experts.

The FEMA representative said that as of Oct. 14, 917 contracted medical staff were working in 21 states and one territory, the majority of which were clinical personnel supporting patient care as the delta variant spreads in vulnerable areas.

FEMA also has shipped more than 3,000 critical medical supplies — including ventilators, nasal cannulas, dialysis machines and oxygen regulators — to states experiencing surges in COVID-19 cases since July.

During the week of Oct. 19, at the request of FEMA, U.S. Army North deployed about 40 military medical personnel — including respiratory therapists, doctors and nurses from the U.S. Navy — to medical centers in Spokane and Wenatchee, Washington, to assist in treatment of COVID-19 patients.

Nine additional teams from ARNORTH are actively supporting the COVID-19 response in hospitals and medical centers across the country — three teams in Louisiana, two in Mississippi, two in Alabama, one in Idaho and one in Tennessee.

Hospitals across the country are struggling with staffing shortages, exacerbated in part by health care workers who have refused to comply with Biden’s mandate requiring COVID-19 vaccinations for those in most health care settings that receive Medicare or Medicaid reimbursement.

The mandate affected 17 million health care workers. Thousands have reportedly been terminated or quit rather than receive the vaccine.

According to Justesen, FEMA has not received any formal requests from state governments for additional medical support due to staffing shortages caused by personnel refusing the vaccine.

In Hawaii, about a dozen FEMA-contracted medical personnel worked in local hospitals performing monoclonal antibody treatments and vaccinations during the week of Oct. 18. Hawaii has experienced health care staffing shortages since before the start of the pandemic, but these contracted workers are not intended to replace full-time employees.

“FEMA contracts are not intended to address staff vacancies; the FEMA-funded staff may only perform COVID-19 related work to relieve the burden on existing medical staff,” Adam Weintraub, communication director at Hawaii Emergency Management, said in an Oct. 25 email to FactCheck.org.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

White House. Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. 9 Sep 2021.

Hale Spencer, Saranac. “White House and HHS Employees Aren’t ‘Exempt’ from Vaccine Mandate.” FactCheck.org. 7 Oct 2021.

Justesen, Caitlin. Acting press secretary, Federal Emergency Management Agency. Email to FactCheck.org. 20 Oct 2021.

Lenthang, Marlene. “Hundreds of hospital staffers fired or suspended for refusing COVID-19 vaccine mandate.” ABC News. 30 Sept 2021.

Morici, Nicholas. Spokesperson, Federal Emergency Management Agency. Email to FactCheck.org. 19 Oct 2021.

Muoio, Dave. “How many employees have hospitals lost to vaccine mandates? Here are the numbers so far.” Fierce Healthcare. 15 Oct 2021.

White House. Path out of the Pandemic. Accessed 22 Oct 2021.

Reavis, Charlotte. “ARNORTH military hospital support to FEMA begins in Washington, continues in five states.” U.S. Army. 19 Oct 2021.

Szekely, Peter and Barbara Goldberg. “A few skeptical U.S. hospital workers choose dismissal over vaccine.” Reuters. 3 Oct 2021.

Weintraub, Adam. Communication director, Hawaii Emergency Management Agency. Email to FactCheck.org. 25 Oct 2021.

5 U.S. Code § 101 – Executive departments. Law.cornell.edu. Accessed 22 Oct 2021.

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Video: Tucker Carlson Misrepresents Vaccine Safety Reporting Data

Social media posts repeatedly misuse unverified reports to a federal database designed to detect safety issues in vaccines to falsely claim that COVID-19 vaccines are dangerous. In this video, FactCheck.org and Univision Noticias teamed up to debunk misleading statements spread by Fox News host Tucker Carlson. 

More than 400 million COVID-19 vaccines have been administered in the U.S., and the vast majority of the reported side effects have been minor, such as pain at the injection site or fatigue.

But on May 6, Fox News host Tucker Carlson incorrectly suggested that more than 3,000 people have died from the COVID-19 vaccines as of April 23. Social media posts then spread this claim further.

Carlson’s claim is based on a misrepresentation of data collected by federal agencies to identify potential safety issues with vaccines. As we have reported, the Vaccine Adverse Event Reporting System, or VAERS, accepts any reports of adverse events following vaccination to help regulators detect potential problems. Anyone can submit a report, whether or not the incident is vaccine-related.

For more details, see our story “Tucker Carlson Misrepresents Vaccine Safety Reporting Data,” which, like the video, is available in English and Spanish.

This video with Univision Noticias is part of a joint project funded by the Google News Initiative to produce bilingual videos and articles about COVID-19 immunization misinformation.

The post Video: Tucker Carlson Misrepresents Vaccine Safety Reporting Data appeared first on FactCheck.org.