Global Health Emergency Declared Over Monkeypox Outbreak as Vaccine Stocks Surge
The World Health Organization declares Monkeypox a public health emergency as an outbreak in the DRC spreads beyond borders.
The World Health Organization (WHO) has once again declared Monkeypox a public health emergency under the International Health Regulations (2005) following an outbreak in the Democratic Republic of the Congo that has now spread beyond the country's borders. This announcement from the WHO regarding Monkeypox, or mpox, comes on the heels of Africa’s CDC announcing that a public health emergency was declared for the entire continent of Africa.
Director-General of the WHO Dr. Tedros Adhanom Ghebreyesus stated during a briefing on Wednesday, “The detection and rapid spread of new clade of mpox in Eastern DRC’s detection in neighboring countries that have not previously reported mpox and the potential for further spread within Africa and beyond is very worrying. In addition to other outbreaks of other clades of mpox in other parts of Africa, it’s clear that a coordinated international response is essential to stop these outbreaks and save lives.”
Tedros added, “We are not dealing with one outbreak of one clade; we are dealing with several outbreaks of different clades in different countries with different modes of transmission and different levels of risk.”
According to the WHO’s press release on Wednesday, the IHR Emergency Committee Chair Professor Dimie Ogoina explained their decision, “The current upsurge of mpox in parts of Africa, along with the spread of a new sexually transmissible strain of the monkeypox virus, is an emergency, not only for Africa but for the entire globe. Mpox, originating in Africa, was neglected there, and later caused a global outbreak in 2022. It is time to act decisively to prevent history from repeating itself.”
From January 1st to May 26th, 2024, the Congo reported more than 7,851 suspected mpox cases and just under 300 deaths, tripling the amount recorded in the same period in 2023. Between 700 and 1000 cases globally (with an average of 866 cases per month), were confirmed by the WHO between January 1st and June 30th, 2024. Most patients reported finding lesions on their genitals whereas previously they were found mostly on their hands, feet, and chest.
As of the latest Africa CDC Epidemic Intelligence Weekly Report from August 9th, 2024, there have been 2,822 confirmed cases of mpox since January 12th, 2024. Additionally, 14,719 suspected cases have been identified, and 517 confirmed deaths have been reported across 13 African Union Member States. Further, 2,542 new cases and 56 new deaths of mpox were reported from five African Union Member States: Burundi, Central Africa Republic (CAR), the Democratic Republic of Congo (DRC), and South Africa.
What is Monkeypox & Where Did it Originate?
The scientific name for the virus that causes mpox is MPXV, of the Poxvirdae family which also includes variola, vaccinia, and cowpox. While mpox was discovered in Denmark in 1958 with two different cases spreading amongst a colony of monkeys, according to the CDC, the first case of mpox in humans was found in a 9-month-old boy in 1970.
Monkeypox is from a species of the genus Orthopoxvirus, which is the same family of viruses that cause smallpox. Most who find themselves to be infected first show symptoms of a fever and rash. While it is generally less severe than smallpox, the disease has garnered increased attention due to recent outbreaks. Smallpox was eradicated in 1980, but mpox later emerged in East, Central, and West Africa. Then, just two years ago there was a global outbreak in over 70 countries that had not previously reported any infections. This was also the first time mpox was confirmed to spread through sexual partners.
In August of 2022, NBC News reported, “…an expanding cadre of experts has come to believe that sex between men itself — both anal as well as oral intercourse — is likely the main driver of global monkeypox transmission. The skin contact that comes with sex, these experts say, is probably much less of a risk factor.”
The Associated Press reported at the time, “Unlike in previous mpox outbreaks, where lesions were mostly seen on the chest, hands and feet, the new form of mpox causes milder symptoms and lesions on the genitals.” Another difference from the 2022 outbreak was that the 2023 mpox outbreak reported children under 15 accounting for more than 70% of cases with 85% of the deaths being in Congo.
The first cluster of cases were identified in the UK on May 6, 2022, with the initial case being detected in London in a patient who had recently returned from Nigeria. By May 16th, 2022, the UK Health Security Agency (UKHSA) confirmed four new cases of mpox in individuals who had not traveled to Africa, where the epidemic was rapidly spreading.
Shortly after, Director General of the WHO, Tedros Adhanom Ghebreyesus declared a Public Health Emergency of International Concern (PHEIC) on July 23rd. The PHEIC would continue until May of 2023 when an end was proclaimed by the WHO.
Symptoms & Transmission of Monkeypox
WARNING: *GRAPHIC IMAGES BELOW*
The otherwise flat rash quickly fills with liquid and blisters and can be found all over the body, including arms, legs, feet, faces, and even the anus and genitals.
Symptoms include:
Chills
Fever
Sore throat
Pimple-like rash that turns into pustules
Exhaustion
Muscle aches, including backaches
Headaches
Swollen lymph nodes
While sore throat, fever, and muscle aches tend to appear first, mpox rashes almost always start on the face before spreading to the palms of hands and the bottom of feet. According to the WHO, this evolution happens in: “2-4 weeks in stages – macules, papules, vesicles, pustules. Lesions dip in the center before crusting over. Scabs then fall off.”
Transmission occurs primarily through direct contact with bodily fluids, contaminated materials, or close contact with those who are already infected. Individuals can contract the virus simply by coming into contact with linens or clothing that has been contaminated, through sharp tools used in a medical setting, from needles used in tattoo parlors, and from a sexual partner. Those who have multiple sex partners are at a much higher risk of contracting the mpox virus. In addition, mpox is zoonotic, meaning it can pass from animals to humans under natural conditions.
The virus can enter the body in a variety of ways including through the respiratory tract, broken skin, or mucosal surfaces (ocular, oral, pharyngeal, anorectal, or genital).
As of April 2024, the CDC recognizes two main clades of the Monkeypox virus, Clade I, and Clade II.
“Clade I causes more severe illness and deaths. Some outbreaks have killed up to 10% of the people who get sick, although more recent outbreaks have had lower death rates. Clade I is endemic to Central Africa.
“Clade II is the type that caused the global outbreak that began in 2022. Infections from clade II mpox are less severe. More than 99.9% of people survive. Clade II is endemic to West Africa.”
NIAID clarifies that there are also subclades of Clade II, “Clade II is further divided into subclades: Clade IIa and Clade IIb. According to the World Health Organization, cases identified as part of the ongoing global outbreak are largely caused by Clade IIb.”
On its website, the WHO explains, “Key audiences should be identified, including health professionals, key populations including commercial sex workers, men who have sex with men, trans and gender-diverse individuals, people working at or attending venues and events where sexual activity takes place, and people at risk of more serious illness (including persons living with untreated or poorly controlled HIV infection).”
The CDC echoed the WHO in April 2024 confirming people with advanced HIV are more likely to have severe symptoms of mpox, including death due to being immunocompromised. Sub-Saharan Africa has the highest concentration of people living with HIV, accounting for roughly two-thirds of the global total. Sub-Saharan Africa constitutes East and Southern Africa as well as West and Central Africa. According to UNAIDS, in 2023, women and girls of all ages in sub-Saharan Africa made up 62% of all new HIV infections. 3,100 out of 4,000 new infections each week occurred in this region among females aged 15 to 24.
The WHO Calls for Emergency Use Vaccines
Just last Friday, the WHO announced to mpox vaccine manufacturers to submit an Expression of Interest for Emergency Use Listing (EUL), after WHO Director-General Dr. Tedros Adhanom Ghebreyesus triggered the EUL process due to concerns of mpox spreading throughout the globe, and specifically the Democratic Republic of the Congo (DRC).
The press release reads in part: “The EUL procedure is an emergency use authorization process, specifically developed to expedite the availability of unlicensed medical products like vaccines that are needed in public health emergency situations. This is a time-limited recommendation, based on a risk-benefit approach.”
Also included in the August 9th press release: “Granting of an EUL will accelerate vaccine access particularly for those lower-income countries which have not yet issued their own national regulatory approval. The EUL also enables partners including Gavi and UNICEF to procure vaccines for distribution.”
Currently, there are two approved Monkeypox vaccine manufacturers: LC16 by KM Biologics, which is manufactured and stockpiled in Japan but not commercially available, and Jynneos by Bavarian Nordic in Denmark. The WHO press release last week highlighted Gavi and UNICEF's roles in procuring new mpox vaccines. Tim Nguyen, MPH, head of the WHO’s High Impact Events Preparedness unit said there are only around 500,000 doses of Jynneos’s MVA BN vaccine, but another 2.4 million doses could be produced by the end of the year if orders are received.
Further, Bavarian Nordic said it would be able to produce another 10 million doses in 2025. As of Tuesday, Bavarian Nordic announced it has committed to procuring 175,420 doses for immediate use in Africa and will donate 40,000 doses to HERA, which will be distributed to Africa CDC. The press release from Bavarian Nordic declares, “This larger donation follows a recent pledge from the Company for 15,000 doses as part of the coordinated response in the African region by Gavi, WHO, and UNICEF.”
Gavi, whose founding partner is the Bill & Melinda Gates Foundation says they’ve accelerated engagement with manufacturers, including Bavarian Nordic to produce new mpox vaccines. The Bill & Melinda Gates Foundation committed to $1.55 billion for Gavi’s 2016-2025 strategic period, up from $241 million during the 2015-2018 time period.
On Thursday, Gavi publicly welcomed the call to action from the WHO and African CDC stating on their website:
“Gavi, the Vaccine Alliance continues to be deeply concerned about the escalating mpox emergency on the African continent. We welcome recently announced measures by our partners at the African Centres for Disease Control and Prevention (Africa CDC) and World Health Organization (WHO) which will help create an enabling environment in support of a comprehensive region-led response, and join partners in emphasizing the importance of international coordination following a declaration of a Public Health Emergency of Continental Security by Africa CDC and a Public Health Emergency of International Concern by WHO.
“Working in collaboration with countries and partners, Gavi has been closely monitoring the mpox situation since 2022. As a result, considerations related to mpox have helped inform both the design of Gavi’s new innovative health security mechanisms, aimed at addressing systemic gaps exposed during the COVID-19 vaccine response, as well as Gavi’s next five-year strategy. When the assessment process for Gavi’s next five-year Vaccine Investment Strategy (VIS) began in 2023, mpox vaccines were included for consideration. Special sessions of the VIS Steering Committee were convened in Q1 2024 to ensure the approach took into account developments in the Democratic Republic of the Congo (DRC), where the outbreak has spread rapidly, primarily impacting children (in terms of both morbidity and mortality), and resulting in a high case fatality ratio.”
Further, the August 15th press release outlined the measures that were approved in June 2024 by the Gavi Board:
“In its next five-year strategic period, beginning 2026, Gavi will establish a global stockpile of mpox vaccines – similar to its existing stockpiles for cholera, Ebola, meningitis and yellow fever vaccines. Establishment of a stockpile is pending the availability of WHO Emergency Use Listing or prequalification of a recommended vaccine, and subject to fundraising for Gavi’s next strategic period. A critical goal will be ensuring the design of the stockpile is informed by a robust assessment of the long-term public health need.
“In the interim, Gavi will support outbreak response in the DRC and surrounding countries.
“In parallel, Gavi will make critical investments in a learning agenda that will ensure the current response will help inform and improve future vaccination efforts against the disease, including the design of a global stockpile.”
The Gavi press release also outlines the final terms of the First Respond Fund, a $500 million initiative dedicated to vaccine procurement, delivery systems, and immunization programs. According to Gavi, this funding becomes available if the WHO declares a Grade 2 or Grade 3 emergency or a Public Health Emergency of International Concern (PHEIC).
Shares of Mpox Vaccine Manufacturers Surge After PHEIC Declaration
Forbes reported on Thursday that shares of mpox vaccine manufacturers surged significantly after the WHO declared a Public Health Emergency of International Concern (PHEIC):
“Shares of Danish company Bavarian Nordic jumped as much as 17% during early trading in Copenhagen on Thursday, though gains fell to around 11% as trading continued.
“The rally extends a climb of around 12% from the day before, when the WHO joined Africa’s top public health body in declaring a growing mpox outbreak a public health emergency.
“Bavarian Nordic is one of the only companies in the world with an approved mpox vaccine and in practice it is the only company as the shot it manufactures is the preferred choice of global health authorities by far on account of the much lower risks of negative outcomes associated with it.
“Bavarian Nordic sells the vaccine under three brand names worldwide—Jynneos, Imvamune and Imvanex—and U.S.-traded shares of the company were up nearly a third (33%) during premarket trading early Thursday morning.
“Shares for Maryland-based Emergent BioSolutions, which acquired smallpox vaccine ACAM2000 from French pharma giant Sanofi in 2017—smallpox is related to mpox and the shot is believed to protect against it as well—had soared nearly 12% by market close on Wednesday, though shares dipped more than 3.5% during premarket trading Thursday.
“Tonix Pharmaceuticals, a U.S. firm with an experimental shot in early-stage trials for horsepox with the potential for further applications to smallpox and mpox, also dipped 3.6% during premarket trading, paring gains of 2.7% from the day before.”
The zoonotic MPXV (mpox) virus, initially suspected to originate from monkeys and rodents in Africa, has evolved into more deadly strains and now poses a global threat to humans, according to the WHO and the CDC. Recent genetic mutations have led to infections outside Africa, particularly among homosexual men and sex workers. Alarmingly, there is a rising number of cases in children under 15 in the Congo. The high prevalence of HIV/AIDS in Africa exacerbates the risk, as immunocompromised individuals, like those with HIV/AIDS, face a much higher mortality rate from contracting MPXV. This underscores the urgent need for increased attention and resources for Africa's HIV-positive population. With mpox vaccines priced at around $100 per dose and Africa being home to 23 of the world’s 28 poorest countries, it's crucial to provide assistance to help prevent the virus from spreading to other regions.
This. "Forbes reported on Thursday that shares of mpox vaccine manufacturers surged significantly after the WHO declared a Public Health Emergency..."
Call me a conspiracy theorist, or overly skeptical, but the hairs on the back of my neck are tingling with that "this ain't a coincidence" feeling. #FollowTheMoney ?
"Africa home to 23 or the 28 poorest countries in the world" Maybe, just maybe, if we invested money into abetting the poverty ie sanitation that breeds disease we wouldn't need to declare health emergencies.