mpox

WHO invites mpox vaccine manufacturers to submit dossiers for emergency evaluation

The World Health Organization (WHO) today announced it had invited mpox vaccine manufacturers to submit an Expression of Interest for Emergency Use Listing (EUL).

On August 9, 2024, the WHO stated that the EUL procedure is an emergency use authorization process specifically developed to expedite the availability of unlicensed medical products, such as vaccines, needed in public health emergencies.

This is a time-limited WHO recommendation based on a risk-benefit approach.

WHO requests manufacturers to submit data to ensure that the vaccines are safe, effective, of assured quality, and suitable for the target populations.

Granting an EUL will accelerate vaccine access, particularly for lower-income countries that have not yet issued their national regulatory approval. The EUL also enables partners, including Gavi and UNICEF, to procure vaccines for distribution.

The WHO Director-General announced on August 7, 2024, that he had triggered the process for EUL of mpox vaccines, given worrying trends in the disease's spread.

A severe and growing mpox outbreak in the Democratic Republic of the Congo (DRC) has expanded outside to other countries. A new viral mpox strain, which first emerged in September 2023, has been detected outside DRC for the first time.

Mpox is a viral illness caused by the monkeypox virus, a species of the genus Orthopoxvirus. It can be transmitted between humans through physical contact with an infectious person, contaminated materials, or infected animals.

Two vaccines against the mpox disease are currently in use globally, both of which have been recommended by the WHO Strategic Advisory Group of Experts on Immunization.

These mpox vaccines are JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) Smallpox and Mpox Vaccine, and K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine.

In the United States, JYNNEOS has been offered since May 2022.

Sub Title:

WHO recommends two mpox vaccines

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Saturday, August 10, 2024 - 05:45

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by Gerd Altmann

Mpox Vax Flops in Chicago

Donald Hackett — Fri, 12 May 2023 10:56:23 +0000

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U.S. CDC - Mpox Infections after Vaccination

When the global mpox outbreak began in May 2022, various health agencies quickly authorized a vaccine to be administered based on historical clinical data.

However, those vaccine effectiveness decisions may have been premature compared to new real-world data.

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed a cluster of mpox cases in greater Chicago, Illinois.

And more than 50% of the new mpox cases in Chicago were in previously vaccinated people.

Unfortunately, this indicates the virus is still spreading in the U.S., even among over 1.2. million vaccinated people.

The CDC stated on May 10, 2023, 'We don't know why people in this cluster of cases (Chicago) have gotten mpox after vaccination.'

And 'we don't know if immunity after vaccination has decreased in these cases or how long the vaccine protects against mpox infection.'

'We don't know if the virus has changed,' wrote the CDC.

Mpox virus variants are referred to as clades: Clade I and II. Clade II is further divided into subclades: Clade IIa and Clade IIb wrote the U.S. NIH.

During the global outbreak, Clade IIb cases have been identified outside of Africa.

Similar to influenza and SARS-CoV-2 viruses, this version of mpox may have evolved.

Scientists from the National Institute of Allergy and Infectious Diseases removed a significant roadblock in understanding mpox's Clades in February 2023.

They developed a mouse model of the disease. They used it to demonstrate differences in virulence among the genetic clades of the mpox virus..... despite similar multiplication in cell culture, this model suggests that clade IIb is evolving and/or adapting to other species.... such as humans.

These assumptions may indicate why mpox breakthrough cases were detected in South Korea and France in 2023.

The U.S. Food and Drug Administration (FDA) initially issued approved Bavarian Nordic's Jynneos® (MVA-BN, IMVANEX®, IMVAMUNE®) to prevent smallpox and mpox disease in adults determined to be at high risk for infection in 2019.

The U.S. began offering Jynneos vaccines to healthcare staff in Boston on May 24, 2022.

Data posted by the CDC on December 8, 2022, indicated the effectiveness of one Jynneos dose was 37%, two doses were 69%, but the duration of immunity was unknown.

The CDC's recent findings are juxtaposed with current U.S. government advice.

"Without renewed vaccination and prevention efforts, we are at risk for a resurgence of mpox," said Dr. Demetre Daskalakis, the deputy coordinator of the White House national mpox response," according to NBC News reporting.

"Vaccine is a really important tool, even if it's not perfect."

Another mixed message recently came from the World Health Organization (WHO) when it terminated the mpox emergency this week.

'Having considered the significant decline in the global spread of mpox and the gains achieved in the control of the outbreak in many countries, the Committee advised that the event requires a transition to a robust, proactive, and sustainable mpox response and control program, that prevents resurgence of global spread, aims to eliminate person-to-person transmission, and mitigates the impact of local spill-over effects.'

"I'm pleased to declare mpox is no longer a global health emergency," WHO Director-General Tedros Adhanom Ghebreyesus stated on May 11, 2023.

As of May 12, 2023, the FDA continues authorizing Jynneos vaccination for mpox prevention and supports the use of TPOXX® (Tecovirimat) once a person is infected.

Other sexually transmitted disease vaccine news and mpox research are posted by Precision Vaccinations.

Sub Title:

Mpox breakthrough cases in Chicago

References:

Mpox Emergency Officially Ends

US FDA Mpox Response

The Vital Role of Research in Mpox Response

Virulence differences of mpox clades I, IIa, and IIb.1

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Monday, May 15, 2023 - 15:15

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WHO May 2023 - Fifth Meeting of the International Health Regulations Emergency Committee on the Multi-Country Outbreak of mpox

Mpox Outbreaks Continue in 2023

Karen McClorey Hackett — Mon, 08 May 2023 12:09:57 +0000

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Mpox in the WHO European Region update 25 April 2023

According to new data, the U.S. government and various countries may have prematurely ended their Mpox outbreak activity.

Recent Mpox outbreaks in Chicago, Paris, and Seoul indicated Mpox resurged in 2023.

The U.S. Centers for Disease Control and Prevention (CDC) forewarned in April 2023 that if Mpox reintroduction occurs and no additional vaccination or sexual behavior adaptations arise, the risk of a Mpox resurgence was greater than 35% in most jurisdictions in the U.S.

Moreover, resurgent Mpox outbreaks could be as large or more extensive as the 2022 outbreak in the U.S., which reached 30,361 cases and 42 related fatalities as of late April 2023.

In Chicago, Illinois, Howard Brown Health confirmed on May 5, 2023, a resurgence in Mpox cases in the Chicago area, with seven cases reported in the last three weeks.

"We urge sexually active members of our community to receive the mpox vaccine. For example, unvaccinated people planning to attend International Mr. Leather at the end of May should receive their first dose of the mpox vaccination as soon as possible," said Dr. Patrick Gibbons, Chief Medical Director, in a press release.

And in South Korea, Yonhap reported on May 4, 2023, sixteen new Mpox cases were confirmed in early May 2023, increasing the country's total to 60 cases this year.

Furthermore, France reported a Mpox outbreak with 17 cases, including Breakthrough cases, since the beginning of 2023 in CentreVal de Loire.

Previously, the World Health Organization (WHO) published specific activities derived from the temporary recommendations issued by the WHO Director-General about the multi-country outbreak of Mpox following the fourth meeting of the International Health Regulations Emergency Committee on February 15, 2023.

The WHO wrote, 'With significant Mpox transmission still occurring in endemic and newly affected countries, it is likely that new localized or dispersed outbreaks may occur."

"The risk of resurgence in previously affected groups will be further compounded as large and mass-gathering events that involve elements of sexual contact commence again in Spring 2023.'

Mpox is an infectious disease caused by the Mpox virus, an orthopoxvirus that can spread from person to person through close contact, including sexual contact.

As of May 8, 2023, Mpox vaccines and oral treatments remain available in most cities in the U.S. However, the therapeutic benefits are being evaluated in various research studies.

Sub Title:

Jynneos and TPOXX Mpox therapies are authorized

References:

Howard Brown Health Identifies Mpox Resurgence

S. Korea reports 16 new mpox infections

Mpox Outbreak Global Map U.S. CDC May 2023

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U.S. CDC Mpox map April 26, 2023

Sexually Transmitted Disease Vaccine Development Remain Underwhelming

Karen McClorey Hackett — Fri, 28 Apr 2023 18:08:14 +0000

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National Strategic Plan for the US 2021–2025

The U.S. Sexually Transmitted Infections (STI) National Strategic Plan includes, but is not limited to, vaccine and treatment research focused on chlamydia, gonorrhea, and Mpox.

According to recent STI reports, additional clinical evaluations and research are needed for these diseases.

For example, the U.S. Centers for Disease Control and Prevention (CDC) today announced a report describing New York City patients with Mpox who developed new lesions after completing oral treatment.

This CDC report suggests that post-treatment lesions might occur more commonly than previously reported.

During the 2022 Mpox outbreak in the U.S., TPOXX® (tecovirimat), an antiviral medication approved for the treatment of smallpox, was used as an investigational treatment for severe mpox.

However, efficacy and optimal treatment duration are still being investigated in 2023.

All ten patients received outpatient treatment from their healthcare provider with oral dosing of TPOXX, and all completed the recommended 14-day course.

Unfortunately, new Mpox lesions appeared a median of 13 days after completion of TPOXX treatment (range = 2–30 days).

In eight patients, the provider rated post-treatment lesions as less severe than initial lesions (median severity score = 3 [range = 3–7]).

One received a positive result among six patients for whom orthopoxvirus testing of post-treatment lesions was conducted.

One possibility to explain this analysis is that the Mpox virus, like other viruses, can recur, but the recurrent viral load might be too low for test detection.

And the proportions of patients not tested for STIs at initial Mpox diagnosis and the assessment of post-treatment lesions represent missed opportunities to identify potential coinfections or alternative diagnoses.

Two patients received repeat STI testing; one received a positive syphilis test result.

The immunocompromised patient with untreated HIV received positive post-treatment orthopoxvirus and positive syphilis test results.

TPOXX was restarted for two patients (one treated for seven additional days and one treated for 14 additional days), both of whom had resolved their lesions.

Among the seven patients who did not receive a second course of tecovirimat, six had a resolution of lesions.

Furthermore, Mpox vaccine breakthrough cases have been confirmed in 2023.

Public Health France published an update on March 23, 2023, confirming multiple cases of Mpox in previously JYNNEOS® (MVA-BN) vaccinated men in the Centre-Val de Loire region.

And The Lancet published a clinical episode of a second Mpox virus infection in a fully vaccinated man.

Recently, a study published in February 2023 concluded that chlamydia and gonorrhea cause substantial lifetime quality-adjusted life-years lost among infected women.

As of April 27, 2023, no U.S. Food and Drug Administration vaccines are approved to prevent chlamydia or gonorrhea infection. But researchers are evaluating vaccine candidates in development.

Blue Water Vaccines Inc. announced the signing of a Sponsored Research Agreement with The University of Texas Health Science Center at San Antonio on April 12, 2023, to fund a non-human primate study to evaluate the efficacy of BWV-401, a live attenuated, orally delivered chlamydia vaccine candidate.

And regarding gonorrhea, the NEJM journal published Original Research on April 6, 2023, that found the incidence of gonorrhea was low with doxycycline postexposure prophylaxis.

And a study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. In France, MenB-4C vaccination is currently recommended against gonorrhea.

In summary, STI cases increased between 2020 and 2021, impacting millions.

To reverse this trend, the CDC calls for more local, healthcare, industry, and public health groups to contribute to STI prevention and treatment efforts.

Updated: Corrected headline, trademark, and related links on May 11, 2023.

Sub Title:

Mpox, Chlamydia, Gonorrhea vaccine and treatment research April 2023

References:

Sexually Transmitted Disease Vaccines April 2023

CDC - Notes from the Field: Posttreatment Lesions After Tecovirimat Treatment for Mpox

CDC: STI Epidemic Showed No Signs of Slowing in 2021

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More Mpox Vaccine Breakthrough Cases Confirmed

Karen McClorey Hackett — Sun, 09 Apr 2023 09:11:44 +0000

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Mpox in France April 2023

While the global outbreak of Mpox has steadily declined, recent reports indicate a resurgence of local and vaccine breakthrough cases.

For example, Public Health France reported 17 confirmed Mpox cases in the Centre-Val de Loire region in April 2023.

An investigation showed six of these cases received no smallpox vaccination, one reported having a non-complete vaccination schedule with a 1st generation smallpox vaccine, such as ACA2000, and ten reported complete vaccinations: five with a 1st generation smallpox vaccine in childhood plus one dose of 3rd generation vaccine in 2022, and five with two doses of 3rd generation vaccine in 2022.

This data indicates 59% were vaccine breakthrough cases in this cluster in southwest Paris.

And is significantly greater than what has been observed at France's national level (25%) between October and February 2023 in France concerning vaccinated men.

In summary, Public Health France says there is a minimal perspective on the efficacy of 3rd generation vaccines against Mpox infection.

And there are no data on long-term protection after a full vaccination course, nor in population subgroups.

Moreover, to date, no signal has been issued on the quality or safety of these vaccines.

As of April 9, 2023, this episode suggests that the localized Mpox transmission in the Touraine sector indicates at-risk contacts and exposures in other regions, particularly in Ile-de-France.

In other mpox developments, the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO) European regional office posted a joint update on April 5, 2023, which reported 28 new Mpox cases from 7 countries over the past month.

Six were from Spain, with Mpox cases in Portugal, the Netherlands, Switzerland, Greece, and Malta.

In the United States (U.S.), communities can monitor the presence of the Mpox virus in wastewater samples. This data offers an early warning of local mpox activity.

The U.S. Centers for Disease Control and Prevention (CDC) began offering Bavarian Nordic's Jynneos® vaccine on May 24, 2022. Since then, over 1.2 million vaccine doses have been administered as of April 4, 2023.

The CDC recently updated the U.S. National Mpox Vaccination Strategy on February 6, 2023, and recommends that people exposed to the Mpox virus and those more likely to contract Mpox should be vaccinated.

Unfortunately, it's unknown whether Jynneos's protection might decrease over time, says the CDC.

The good news is next generation Mpox vaccine candidates are conducting clinical studies.

Article Updated on April 28, 2023, with corrected citation link.

Sub Title:

Jynneos vaccinations recommended pre and post Mpox infection

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ECDC and the WHO European regional office mpox update

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