John Parkinson

This article first appeared on Contagionlive.com.

World Health Organization (WHO) announced it has recommended changing the name of 

 to mpox. Both names will be used simultaneously for one year while “monkeypox” is phased out.

The organization announced several months ago they were looking to rename the virus as it had some negative connotations and stigma associated with it. The WHO will adopt the term mpox in its communications and encourages others to follow these recommendations to minimize any ongoing negative impact of the current name and from adoption of the new name.

According to a WHO statement, the organization recommends the following:

Adoption of the new synonym mpox in English for the disease.

Mpox will become a preferred term, replacing monkeypox, after a transition period of one year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak. It also gives time to complete the

International Classification of Diseases (ICD) 

update process and to update WHO publications.

The synonym mpox will be included in the ICD-10 online in the coming days. It will be a part of the official 2023 release of ICD-11, which is the current global standard for health data, clinical documentation, and statistical aggregation.

The term “monkeypox” will remain a searchable term in ICD, to match historic information.

Assigning names to new and, very exceptionally, to existing diseases is the responsibility of WHO under the ICD and the WHO Family of International Health Related Classifications through a consultative process, which includes WHO Member States.

WHO, in accordance with the ICD update process, held consultations to gather views from a range of experts, as well as countries and the general public, who were invited to submit suggestions for new names.

Back in the summer, both the Biden Administration and the WHO declared monkeypox as 

 as the incidence rates increased dramatically in different hot spots across the globe.

Although caseloads have been decreasing in the last several weeks, a public health concern remains as it is seemingly mysterious why the outbreak started earlier this year in the first place.




CDC and the Food and Drug Administration (FDA) developed a process to help clinicians secure an antiviral therapy, tecovirimat (Tpoxx), for monkeypox treatment. This falls under the expanded access investigational new drug (EA-IND). Clinicians can secure tecovirimat by going 

Tecovirimat is manufactured by SIGA Technologies, and is approved for smallpox and is being studied for monkeypox treatment. 

spoke with SIGA Technologies Chief Scientific Officer Dennis Hruby, PhD,

Articles

Because of negative connotations and stigma associated with the term "monkeypox," WHO will fade out the term and use "mpox" in its place. 

WHO Announced "Monkeypox" Will Now Be Known as "Mpox"

Moderna announced today that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) triggered a superior antibody response compared to a booster dose of mRNA-1273, also known as Spikevax, against Omicron (BA.1 and BA.4/BA.5) in phase 2/3 clinical trials.

“We are pleased to see that both of our bivalent booster vaccine candidates offer superior protection against Omicron BA.4/BA.5 variants compared to our original booster, which is encouraging given COVID-19 remains a leading cause of hospitalization and death globally. In addition, the superior response against Omicron persisted for at least three months after the mRNA-1273.214 booster," Moderna Chief Executive Officer Stéphane Bancel, said in a statement. "Our bivalent boosters also show, in research assays, neutralizing activity against BQ.1.1, an increasingly dominant emerging variant, confirming that updated vaccines have the potential to offer protection as the virus continues to evolve rapidly to escape our immunity."

In a phase 2/3 study, a 50 µg booster dose of mRNA-1273.222 elicited a superior neutralizing antibody response against Omicron BA.4/BA.5 variants when compared to a 50 µg booster dose of mRNA-1273 in 511 previously vaccinated and boosted participants (ages 19-89 years). The participants received mRNA-1273.222 and mRNA-1273 approximately 9.5 months and 4.5 months after their prior vaccination, respectively.

Pre-booster BA.4/BA.5 titers were similar between the mRNA-1273.222 and mRNA-1273 groups. The Omicron BA.4/BA.5 geometric mean titer (GMT) ratios of mRNA-1273.222 versus mRNA-1273 were 5.11 (95% CI: 4.10, 6.36) and 6.29 (95% CI: 5.27, 7.51) for participants with and without SARS-CoV-2 infection pre-booster, respectively. In all participants the GMT against Omicron BA.4/BA.5 was 4289 (95% CI: 3789.0, 4855.9) representing a 15.1-fold increase (95% CI: 13.3, 17.1) from pre-booster levels.

For participants without prior infection, the GMT was 2325 (95% CI: 1321.2, 2812.7), representing a 26.4-fold increase (95% CI: 22.0, 31.9) and for those with prior infection, the GMT was 6965 (95% CI: 6043.7, 8025.4), representing a 9.8-fold (95% CI: 8.4, 11.4), increase from pre-booster levels.

Investigators point out the results were consistent between participants aged 65 years and older and those aged 18 to 65.

This builds upon 

 that confirmed superiority of the company's BA.1 bivalent vaccine, mRNA-1273.214, neutralizing titers against multiple Omicron variants compared to a booster dose of mRNA-1273.

According to investigators, the frequency of adverse reactions with mRNA-1273.222 and mRNA-1273.214 were similar or lower than that of either a second or third dose of the original vaccine.

Additionally, they did not identify any new safety concerns after approximately one month and three months of follow-up. According to Moderna, these safety and immunogenicity data will be submitted for peer-reviewed publication and shared with regulators globally.

No new safety concerns with this COVID-19 vaccine were reported. 

Spikevax Booster’s Efficacy Falling Behind Omicron-Targeting Booster Candidates

A picture of a Pfizer sign (Adobe Stock) 

Because of the risks that newborns face from respiratory syncytial virus (RSV), the news from Pfizer today is encouraging. While monoclonal antibodies have been around for decades, a more 

 is needed.Pfizer announced this morning topline data for its RSVpreF investigational vaccine for expecting mothers demonstrating a high efficacy in its phase 3 trial. Specifically, when looking at severe medically attended lower respiratory tract illness (severe MA-LRTI) the efficacy for the vaccine was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. In addition, substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period.

“We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer, Vaccine Research & Development, Pfizer, said in a statement.

The results are from its phase 3 MATISSE trial



RSV continues to be a challenge for the youngest in the pediatric population. Hospitals and clinicians in some areas of the United States are reporting overcapacity at their facilities.

Pfizer said in the statement that the pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period.

Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period.

The vaccine was considered to be well-tolerated.

At the recommendation of the DMC, and after consultation with the FDA, Pfizer stopped enrollment in the study. With these positive results, the company plans to submit a Biologics License Application (BLA) to the FDA by the end of this year for the RSVpreF vaccine.

“We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants,” Anderson said in the same statement.

 by GlaxoSmithKline is demonstrating promise also.

Respiratory syncytial virus (RSV) can be deadly for newborns and young infants. The newest information from Pfizer about its RSCpreF investigational vaccine is promising for new mothers and infants through the first 90 days of life.  


Pfizer Announces Encouraging Data on RSV Vaccine for Pregnant Persons

According to some data, as much as 35% of patients treated for an initial episode of 

 (CDI) develop a recurrence, and up to 65% of these patients experience multiple episodes of it, and it can become recurrent (r)CDI .

Therefore, in understanding the reoccurring frequency, some serious health effects associated with rCDI can manifest, as well as a severely diminished quality of life. In the latter capacity, some patients can become housebound, fearful for leaving their homes due to concerns of having a CDI episode.

Currently, there are different forms of investigational treatments and therapies being developed to help these patients. For example, RBX2660, an investigational microbiota therapeutic has been in clinical trials. In fact, last month the FDA's Vaccines and Related Biological Products Advisory Committee's (VRBPAC) committee voted to recommend a Biologics License Application (BLA) for RBX2660 for rCDI.

In the lead-up to that vote, investigators looking at RBX2660 developed an 8-week health-related quality of life (HRQL) questionnaire with results measured using the 

 Health-related Quality-of-Life Questionnaire (Cdiff32)—a validated, disease-specific instrument— from RBX2660’s randomized, double-blinded, placebo-controlled phase 3 trial PUNCH CD3.

The investigators had two objectives for the questionnaire:

1. To summarize Cdiff32 total and domain-specific (ie, physical, mental, social) scores for patients with rCDI at baseline and weeks 1, 4, and 8 separately for patients randomized to RBX2660 or placebo (PBO)

2. To compare differences in changes from baseline to week 8 in Cdiff32 total and domain-specific scores between rCDI patients randomized to RBX2660 and to placebo.

Participants completed the questionnaire that looked at 32 items related to the physical, mental, and social health of patients with CDI. The total score and three domain scores (ie, physical, mental, and social relationships) were calculated and rescaled to range from 0 to 100 (100 best possible).

“Cdiff32 scores improved significantly from baseline to weeks 1, 4, and 8 for both arms, with numerically greater improvements for RBX2660 through week 8,” investigators wrote.

The results were presented as a poster, “Significant Improvement in Health-Related Quality of Life (HRQL) with RBX2660: Results from a Phase 3 Randomized, Placebo-Controlled Trial in Recurrent 

, held October 19-October 23, 2022 in Washington DC.

“Although improvements were observed for both treatment arms, RBX2660-treated patients had more profound and sustained improvements than patients treated with PBO with statistically significant differences in total and mental domain Cdiff32 scores at week 8,” the investigators wrote.

The Clostridioides difficile Health-related Quality-of-Life Questionnaire responses demonstrated patients handled the situation better with specific investigational treatments. 


Recurrent C Difficile: Evaluating Patients’ Physical, Mental, Social Outlooks 

The Centers of Disease Control and Prevention (CDC) 

The Centers for Disease Control and Prevention (CDC) announced today that polio viruses found in New York state meet the World Health Organization's (WHO) criteria for circulating vaccine-derived poliovirus (cVDPV). This announcement stems from both a single case of paralytic polio in an unvaccinated adult in Rockland County, NY, as well the viruses being found in several wastewater samples from communities near the patient’s residence. The cVDPV declaration means that polio continues to be transmitted in Rockland County, NY, and surrounding areas.

 of federal investigators to New York State to investigate.

The Centers for Disease Control and Prevention (CDC) announced om September 13 that polio viruses found in New York state meet the World Health Organization's (WHO) criteria for circulating vaccine-derived poliovirus (cVDPV). This announcement stems from both a single case of paralytic polio in an unvaccinated adult in Rockland County, NY, as well the viruses being found in several wastewater samples from communities near the patient’s residence. The cVDPV declaration means that polio continues to be transmitted in Rockland County, NY, and surrounding areas.

Back in August, the CDC sent a small team of federal investigators to New York State to investigate. The single case of polio is reported to be an 

 who contracted the virus and is said to have suffered paralysis. No other information is available about the patient’s condition.

Over the past weekend, New York Governor Kathy Hochul declared a state of emergency after this case of paralytic polio was determined. In the state of emergency declaration, it was stated that “local health departments are actively responding to the poliovirus outbreak through investigation support, contact identification and monitoring, vaccine administration for exposed contacts and focused current high-risk populations, and education and outreach…the State government must support the municipalities, localities, and counties in their efforts to facilitate and administer vaccinations and tests for poliovirus, and to prevent the disease from continuing to spread.”

This is the first case here in the United States since 2013. The last case to originate here was in 1979. Polio can originate from different countries and travelers can bring it back to the US.

And, genetically related polioviruses were detected in wastewater samples collected in Orange, Rockland, and Sullivan counties in New York in April, May, June, July, and August 2022.

The United States now joins a list of about 

 where cVDPVs have been identified. Circulating vaccine-derived poliovirus occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine.

As the virus circulates and more genetic changes occur, the virus can regain its ability to infect the central nervous system and cause paralysis. It’s important to note that cVDPVs are not caused by a child receiving the polio vaccine. The oral polio vaccine has not been used or licensed in the US since 2000 but continues to be used in some countries.

As part of a larger investigation, CDC is working with the WHO, the Pan American Health Organization (PAHO), and other international public health organizations in looking at wastewater samples outside the US. The virus’ genetic sequences from the patient from Rockland County, NY, and wastewater specimens collected in New York have been linked to wastewater samples in 

, thus indicating community transmission. The viral sequences from the patient and from three wastewater specimens had enough genetic changes to meet the definition of a vaccine-derived poliovirus (VDPV).

“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” José R. Romero, MD, director of CDC’s National Center for Immunization and Respiratory Diseases, said in a statement. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

CDC said there have been no other additional cases of polio reported in the United States, and that today’s update does not impact the current CDC recommendations for polio vaccination for children or adults.

With this declaration the United States is put on a list of countries circulating the viruses, specifically noted in Rockland County, NY, where the vaccination rate is low and surrounding areas.

CDC: Vaccine-Derived Polio Is Circulating in the United States

This article was originally published in 

US Health Secretary Xavier Becerra declared a national public health emergency for monkeypox.

“In light of evolving circumstances on the ground, I am declaring a public health emergency on #monkeypox. We are prepared to take our response to the next level in addressing this virus. We urge every American to take monkeypox seriously," Becerra, tweeted on August 4.

The declaration mobilizes the response and opens up federal funding to address the virus.

As of yesterday, there has been 6617 confirmed cases with California and New York having the most cases. Earlier this week, 

declared a state of emergency with regards to the monkeypox outbreak. This came on the heels of 

San Francisco and New York City declaring states of emergency 

along with New York State’s declaration that monkeypox is an "imminent threat to public health," over the last week. Shortly before that, World Health Organization declared monkeypox a 

The US federal agencies are making vaccines and treatment available. For example, CDC and FDA have developed a process to help clinicians secure an antiviral therapy, tecovirimat (Tpoxx), for treatment for patients with monkeypox. This falls under the expanded access investigational new drug (EA-IND). Clinicians can begin the process to secure tecovirimat by going here.

Tecovirimat is manufactured by SIGA Technologies, and is approved for smallpox and is being studied for monkeypox treatment. 

 recently about the therapy.

The federal government has also been sending out vaccines to prevent the spread of monkeypox. At this point in time, it has been reported that only people who are close personal contacts of people who have contracted the virus are eligible to get access to the vaccines.

 gives details about monkeypox, what it is and how it is spread, 

The declaration will allow more funds for control of and resources for the disease. 