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Clinical Laboratories and Pathology Groups

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Monkeypox Outbreak Subsides in US, Europe, But Public Health Concerns Remain

Experts cite high vaccination rates and behavioral changes among at-risk groups, but warn about complacency; clinical laboratories should remain vigilant

In July, Scott Gottlieb, MD, Commissioner of the US Food and Drug Administration (FDA) from May 2017 to April 2019, wrote an op-ed in The New York Times titled, “Monkeypox Is About to Become the Next Public Health Failure.” In it, he wrote, “Our country’s response to monkeypox has been plagued by the same shortcomings we had with COVID-19.” But has it improved? Clinical laboratory leaders and pathology group managers will find it informative to find out what has taken place since Gottlieb made his stark prediction.

The global monkeypox outbreak that emerged last spring appears to have subsided in the US and Europe, though it remains to be seen if the disease can be completely eradicated, according to multiple media reports. As of Oct. 26, 2022, the Centers for Disease Control and Prevention (CDC) reported a 7-day rolling average of 30 cases per day in the US, down from a peak of nearly 440/day in early August.

Cases are also down in cities that earlier reported heavy outbreaks. For example, the New York City Health Department reported a 7-day average of just two cases per day on Oct. 25, compared with 73/day on July 30.

And the San Francisco Department of Public Health announced on Oct. 20 that it would end the city’s public health emergency on monkeypox (MPX) effective on Oct. 31. “MPX cases have slowed to less than one case per day and more than 27,000 San Franciscans are now vaccinated against the virus,” the agency stated in a press release.

Tedros Adhanom Ghebreyesus, PhD

“Once again, we caution that a declining outbreak can be the most dangerous outbreak, because it can tempt us to think that the crisis is over and to let down our guard,” said World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, PhD, in an Oct. 12 global press briefing. “That’s not what WHO is doing. We are continuing to work with countries around the world to increase their testing capacity, and to monitor trends in the outbreak.” Clinical laboratories should not assume the outbreak has passed but continue to be vigilant and prepared for increased demand in monkeypox testing. (Photo copyright: ITU Pictures.)

Changing Behavior Lowers Infection Rates

In addition to high vaccination rates, public health experts have attributed the decline to behavioral changes among at-risk groups. “There were really substantial changes among men who have sex [with] men,” infectious disease physician Shira Doron, MD, of Tufts Medical Center in Boston, told ABC News.

On September 2, the CDC published the results of a survey indicating that about half of men who have sex with men “reported reducing their number of sex partners, one-time sexual encounters, and use of dating apps because of the monkeypox outbreak.”

Another likely factor is the disease’s limited transmissibility. “Initially, there was a lot of concern that monkeypox could spread widely at daycares or in schools, but, overall, there has been very little spread among children,” NPR reported.  

But citing multiple studies, the NPR story noted “that often there isn’t very much virus in the upper respiratory tract,” where it might spread through talking or coughing. “Instead, the highest levels of virus occur on sores found on the skin and inside the anus.”

These studies, along with earlier research, “explain why monkeypox is spreading almost exclusively through contact during sex, especially anal and oral sex, during the current outbreak,” NPR reported.

Monkeypox Could Mutate, experts say

Despite the promising numbers, public health experts are warning that monkeypox could remain as a long-term threat to public health. According to an article in Nature, “At best, the outbreak might fizzle out over the next few months or years. At worst, the virus could become endemic outside Africa by reaching new animal reservoirs, making it nearly impossible to eradicate.”

In addition to the limited transmissibility of the virus, Nature noted that the outbreak stems from a relatively mild form of the pathogen and is rarely fatal. As of Oct. 28, the CDC reported a total of just six confirmed deaths in the US out of a total of 28,302 confirmed cases since the first infections were reported in May.

It is possible that the virus could mutate into a more contagious form, but Nature noted that monkeypox is a DNA virus, and that they tend to mutate more slowly than RNA viruses such as SARS-CoV-2 and HIV. Nevertheless, University of Alabama at Birmingham School of Medicine bioinformatician Elliot Lefkowitz, PhD, warned that a “worrisome mutation” could arise if the outbreak continues for much longer.

Another expert, Jessica Justman, MD, infectious disease specialist, epidemiologist, and associate professor at Columbia University Mailman School of Public Health, cautioned that declining case numbers might not reflect the true prevalence of the disease.

“I have no confidence that all the people who need to be tested are being tested,” she told Nature. She expressed concerns that people could resume risky behavior if they think the danger has passed.

Another question is whether currently available vaccines offer long-lasting protection. And though reported case numbers are down in the US and Europe, they are rising in parts of Africa and South America, Nature noted.

Gottlieb’s Dire Prediction

The decline in new infections followed dire warnings last summer about the possible consequences of the outbreak. In his New York Times op-ed, former Gottlieb criticized the CDC for being slow to test for the virus. He wrote, “[I]f monkeypox gains a permanent foothold in the United States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable.”

At the time of his writing, Gottlieb was right to be concerned. On July 29, the CDC reported a seven-day moving average of 390 reported cases per day. According to the federal agency, a reported case “Includes either the positive laboratory test report date, CDC call center reporting date, or case data entry date into CDC’s emergency response common operating platform, DCIPHER.”

Quashing the outbreak, Gottlieb estimated, would have required about 15,000 tests per week among people presenting symptoms resembling monkeypox. But between mid-May and the end of June, he noted, the CDC had tested only about 2,000 samples, according to the federal agency’s July 15 Morbidity and Mortality Weekly Report (MMWR).

As a remedy, Gottlieb called on the Biden administration to re-focus the CDC’s efforts more on disease control “by transferring some of its disease prevention work to other agencies,” including the FDA.

Perhaps his suggestions helped. Confirmed monkeypox case are way down. Nevertheless, clinical laboratory leaders should continue to be vigilant. Growing demand for monkeypox testing could indicate an increase in reported cases as we enter the 2022 influenza season, which is predicted to be worse than previous years. Dark Daily covered this impending threat in “Australia’s Severe Flu Season Could be a Harbinger of Increased Influenza Cases in US and Canada Straining Already Burdened Clinical Laboratories.”

Stephen Beale

Related Information:

Monkeypox Cases in the US Are Way Down—Can the Virus Be Eliminated?

What Does the Future Look Like for Monkeypox?

NYC Has Almost Eliminated Monkeypox. An NYU Biology Prof on What the City Needs to Reach Zero

New York and Nevada Announce First Monkeypox Deaths as Official CDC Tally Rises to Four

Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

Gottlieb Predicts Monkeypox Will Become Public Health Failure

Monkeypox Is About to Become the Next Public Health Failure

Australia’s Severe Flu Season Could be a Harbinger of Increased Influenza Cases in US and Canada Straining Already Burdened Clinical Laboratories

CDC National Wastewater Surveillance System Locates and Tracks SARS-CoV-2 Coronavirus in the Public’s Wastewater

Smaller cities and rural towns are finding the NWSS a useful early warning tool for tracking COVID-19 in their communities

In a move that mirrors similar programs around the world, the federal Centers for Disease Control and Prevention (CDC) now monitors sewage nationwide and records levels of SARS-CoV-2 in an effort to prevent new outbreaks of COVID-19 and spot any new variants of the coronavirus.

Advances in gene sequencing technologies are enabling the CDC’s National Wastewater Surveillance System (NWSS), and in many communities, clinical laboratories and health system laboratories have worked with local health authorities to test wastewater since onset of the pandemic.

Dark Daily first covered the CDC’s intention to develop the NWSS in a 2020 ebriefing, titled, “CDC, HHS Create National Wastewater Surveillance System to Help Monitor and Track Spread of COVID-19.” The CDC detailed its latest progress implementing the NWSS in a recent media telebriefing.

“What started as a grassroots effort by academic researchers and wastewater utilities has quickly become a nationwide surveillance system with more than 34,000 samples collected representing approximately 53 million Americans,” noted epidemiologist Amy Kirby, PhD (above) during the telebriefing.

Kirby is a Senior Service Fellow in the Waterborne Disease Prevention Branch at the CDC.

“Currently, CDC is supporting 37 states, four cities, and two territories to help develop wastewater surveillance systems in their communities. More than 400 testing sites around the country have already begun their wastewater surveillance efforts,” she added.

Amy Kirby, PhD
“Estimates suggests between 40% and 80% of people with COVID-19 shed viral RNA in their feces, making wastewater and sewage an important opportunity for monitoring the spread of infection,” said epidemiologist Amy Kirby, PhD (above), a Senior Service Fellow in the Waterborne Disease Prevention Branch at the CDC. The NWSS’ findings could enable public health officials to better allocate mobile clinical laboratory testing and COVID-19 vaccination sites around the country. This would be especially beneficial in rural and underserved healthcare populations. (Photo copyright: Center for Global Safe Water, Sanitation, and Hygiene.)

Genetic Sequencing Enables Tracking of Virus and Bacteria

At the time of the telebriefing, the federal agency anticipated having an additional 250 sites online within a few weeks and even more sites added within the coming months. Many of the participating sites are sequencing the genes of their biological samples and reporting that data to the CDC.

“So, we’ve seen from very early days in the pandemic that rates of detection in wastewater correlate very well with other clinical indicators, like pace rates and hospitalization and test positivity,” Kirby stated. “That data continues to come in and it continues to be a very solid indicator of what’s going on in the community.”

Wastewater, also referred to as sewage, includes water from toilets, showers, and sinks that may contain human fecal matter and water from rain and industrial sources. To use the CDC’s wastewater surveillance system:

  • Wastewater is collected from a community area served by the surveillance system as it flows into a local water treatment plant.
  • Collected samples are sent to an environmental or public health laboratory where they are tested for SARS-CoV-2.
  • Health departments submit the testing data to the CDC through the online NWSS Data Collection and Integration for Public Health Event Response (DCIPHER) portal.
  • The DCIPHER system then analyzes the data and reports the results back to the health department for use in their COVID-19 response.

Beginning in February 2022, members of the public can view the results of collected data online through the CDC’s COVID Data Tracker.

Wastewater Sampling Is a ‘Critical Early Warning System’

According to the CDC NWSS website, there are many advantages to using wastewater surveillance in the fight against COVID-19, including:

  • Wastewater can capture the presence of the virus shed by people both with and without symptoms.
  • Health officials can determine if infections are increasing or decreasing within a certain monitoring site.
  • Wastewater surveillance does not depend on people having access to healthcare or the availability of COVID-19 testing.
  • It is possible to implement wastewater surveillance in many communities as nearly 80% of the US population are served by municipal wastewater collection systems.

“These built-in advantages can inform important public health decisions, such as where to allocate mobile testing and vaccination sites,” Kirby said. “Public health agencies have also used wastewater data to forecast changes in hospital utilization, providing additional time to mobilize resources and preparation for increasing cases.”

The wastewater sampling represents a critical early warning system for COVID-19 surges and variants, and the CDC hopes this type of sampling and research can be utilized in the future for other infectious diseases. 

“Wastewater surveillance can be applicable to a wide variety of health concerns. And so, we are working to expand the National Wastewater Surveillance platform to use it for gathering data on other pathogens, and we expect that work to commence by the end of this year,” Kirby said. “Our targets include antibiotic resistance, foodborne infections like E. Coli, salmonella, norovirus, influenza, and the emerging fungal pathogen Candida Auris.”

Critical Surveillance Tool for Microbiology Laboratories

Independent of the nation’s network of public health laboratories, expansion of this program may give microbiology and clinical laboratories in smaller cities and rural towns an opportunity to test wastewater specimens in support of local wastewater monitoring programs.

As the CDC develops this surveillance network into a more formal program, microbiology labs may find it useful to learn which infectious diseases are showing up in their localities, often days or weeks before any patients test positive for the same infectious agents.

That would give pathologists and clinical laboratory leaders an early warning to be on the alert for positive test results of infectious diseases that wastewater monitoring has confirmed exist in the community.   

JP Schlingman

Related Information:

Studies Finding Remnants of SARS-CoV-2 in Sewage Suggest COVID-19 May Not Have Originated at Wuhan Market, Some Scientists Dispute the Findings

CDC Turns to Poop Surveillance for Future COVID Monitoring

National Wastewater Surveillance System (NWSS)

Transcript for CDC Media Telebriefing: COVID-19 Wastewater Surveillance

CDC, HHS Create National Wastewater Surveillance System to Help Monitor and Track Spread of COVID-19