The World Health Organization officially declared the current monkeypox outbreak to be a Public Health Emergency of International Concern (PHEIC) on July 23rd, 2022.
With more than 38,000 confirmed cases and limiting testing sites, it’s hard to say with certainty how widespread monkeypox is. But one thing can be certain: it’s taken the world by storm.
Monkeypox: An Overview
What is monkeypox?
Monkeypox (MPXV) is an orthopoxvirus that is pathological and affects both animals and plants. It’s part of the same family of viruses as the variola virus, which is the same virus that causes smallpox.
Although both of these viruses have similar symptoms, including fever, swollen lymph nodes, and skin lesions, monkeypox tends to be milder — lasting two to four weeks. In contrast, a typical smallpox case takes five or more weeks to resolve.
There are two types of monkeypox, including:
- West African
- Congo Basin
The current global health emergency is related to the West African strain, which is rarely fatal and has a 99% recovery rate.
How did monkeypox start?
Although it’s hard to pinpoint when and where monkeypox originated, researchers first discovered it in 1958. During this time, two “pox-like outbreaks” began spreading between monkey colonies kept for research. The first human case was reported 22 years later, in 1970.
Researchers believe rodents and non-human primates are likely the culprits that carry the virus and infect humans. Over the years, outbreaks sporadically popped up in central and west African countries.
There are more than 38,000 monkeypox cases related to the current outbreak, according to recent CDC data.
How is monkeypox transmitted?
Monkeypox spreads through close contact with an infected person, animal, or material contaminated with the virus.
However, the risk factors associated with exposure appear to vary depending on the type of contact. Recent research suggests monkeypox primarily spreads through bodily fluids released during close personal contact.
What are the symptoms of monkeypox?
The first monkeypox symptoms are typically flu-like in nature and may include fever, chills, swollen lymph nodes, muscle aches, headaches, sore throat, nasal congestion, and fatigue.
Not everyone who gets monkeypox will experience these symptoms. Some people only get a rash, which usually appears within four days of exposure to the virus.
Monkeypox Vaccine: What to Expect
Is there a monkeypox vaccine?
Currently, there is no specific monkeypox vaccine. However, recent studies show that smallpox vaccines offer some protection against monkeypox because the two viruses are genetically similar.
As a result, the Food and Drug Administration (FDA) recently approved MVA-Bavarian Nordic, more commonly known as Jynneos, a smallpox vaccine, to help treat and prevent monkeypox. Jynneos isn’t made using the live virus so it’s safer than the other vaccine used to treat smallpox, ACAM2000.
“The FDA recently approved the first, live non-replicating vaccine to prevent monkeypox, known as the Jynneos Smallpox and Monkeypox Vaccine. It is wonderful to see that this vaccine has already been approved and is a Priority Review application.”
— Satya Salvi, Senior Sales Executive, Apprentice
However, ACAM2000 is available in certain cases under the Expanded Access Investigational New Drug (EA-IND) protocol to protect against monkeypox. According to CDC guidelines, the EA-ING allows people “aged one and older who have been determined to be at high risk for [monkeypox] infection” to receive this immunization.
How does the monkeypox vaccine work?
The smallpox vaccine works by triggering the body’s natural defense system to produce antibodies against the virus. In using the smallpox vaccines, the expectation is for these antibodies to also protect against monkeypox.
Is the monkeypox vaccine safe?
Researchers are actively studying the safety and efficacy of the smallpox vaccines used to treat monkeypox. Recent FDA reports indicate healthy adults generally experience mild side effects after the Jynneos jab, including:
- Injection site pain
- Redness, swelling, and itching
- Muscle pain
In rare cases (2.1%), recipients of the Jynneos vaccine experienced cardiac issues.
The CDC recently stated it expects people receiving the immunization to reach peak immunity 14 days after the second jab.
How Is the Monkeypox Vaccine Manufactured?
Is there a unique monkeypox vaccine in development?
At this time, Moderna is considering creating an mRNA vaccine to treat monkeypox, but research is at the preclinical level. Currently, the company is prioritizing COVID booster shots due to the associated health risks.
Moderna’s exploration of potential vaccines to treat monkeypox follows their March 2022 plan to advance vaccines targeting pathogens of 15 major health risks by 2025.
Does the smallpox vaccine protect against monkeypox?
Currently, the Jynneos smallpox vaccine is the only treatment that has been FDA-approved to treat monkeypox. As the CDC explains,
“Because Monkeypox virus is closely related to the virus that causes smallpox, the smallpox vaccine can protect people from getting monkeypox. Past data from Africa suggests that the smallpox vaccine is at least 85% effective in preventing monkeypox.”
— Centers for Disease Control and Prevention (CDC)
In short, the smallpox vaccine is currently the best available protection against smallpox, monkeypox, and other diseases resulting from orthopoxviruses.
How is the monkeypox vaccine made?
The Jynneos smallpox vaccine, which is approved to treat monkeypox, uses Chicken Embryo Fibroblast cells. It’s made with Modified Vaccinia Ankara (MVA), a live attenuated vaccinia virus. This means when the vaccine is administered, it won’t replicate in the human body resulting in a viral outbreak. Instead, it will work to prevent infection and create long-lasting immunity.
In contrast, ACAM2000 is made from a live, pox-type virus that’s related to smallpox but milder. As such, the vaccine can’t cause smallpox or monkeypox (as it doesn’t contain these viruses). Recipients of this vaccine are directed to be mindful of the vaccination site because it is possible to spread this “pox-type” virus to other people, as well as other parts of the body.
Who makes the monkeypox vaccine?
A Danish company called Bavarian Nordic is currently the sole manufacturer of the smallpox vaccine. In an unfortunately ill-timed move, they decided to close their bulk manufacturing facility in the spring of 2022 to focus on other vaccine products.
Hindsight’s 2020, and shortly after this decision it became clear that there would need to be a major ramp-up of Jynneos vaccine manufacturing.
In August of 2022, Bavarian Nordic announced a partnership with Michigan-based Grand River Aseptic Manufacturing Inc. (GRAM) to help meet the global demand for monkeypox vaccines. While this type of technology transfer would ordinarily take 8 months, they anticipate having this transfer completed in as soon as three months.
“Rapidly increasing the supply and safe delivery of the monkeypox vaccine to Americans at the highest risk of contracting the virus is a top priority for President Biden. This partnership between Bavarian Nordic and GRAM will significantly increase the capacity to fill and finish government-owned doses – for the first time in the U.S. – and allow us to deliver our current and future supply more quickly to locations nationwide.”
— Bob Fenton, Coordinator of the White House National Monkeypox Response
To further accelerate production, Bavarian Nordic is considering moving to a 24/7 production cycle to meet this unexpected demand. They are also considering partnering with additional CDMOs to boost their manufacturing capacity.
Vaccine Manufacturing: Learnings from COVID
If COVID has taught us anything, it’s the need to expect — and prepare for — the unexpected. The rapid scale-up of the COVID vaccine has shown that when push comes to shove, pharmaceutical manufacturers are able to pivot and adapt to unplanned obstacles.
However, COVID hasn’t turned out to be the wake-up call we needed to respond to the monkeypox crisis. In a familiar turn of events, scientists are lamenting the lack of coordination, funding, and resources needed to respond to this global pandemic.
“Without even finishing the COVID pandemic, we’re already facing monkeypox.”
— Dr. Caitlin Rivers, Senior Scholar, Johns Hopkins University’s Center for Health Security
It’s clear that there needs to be a continued effort made towards public education around monkeypox transmission and available treatment options.
In addition, scale-up of manufacturing should remain a core focus to bridge the gap between the 400,000 available U.S. doses and the estimated 1.7 million Americans at high risk of contracting the disease.
Closing Thoughts: Scale-Up Is Now a Necessity
There are enough viruses in the world to “assign one to every star in the universe 100 million times over.”
In a world with frequent global outbreaks, repeatable, rapid manufacturing scale-up is no longer a nice to have. It’s a necessary capability to meet evolving demands to keep the world’s patient population — in other words, all of humanity — protected.
In the coming months, we’ll learn more about monkeypox including how it reacts to the smallpox vaccines, and whether immunity wanes over time. Additionally, biotech companies may begin to tweak the existing vaccines and create more targeted immunizations.
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Our Featured Thought Leader
When it comes to R&D and vaccine development, Satya Salvi is our in-house expert. Read on to learn about his career background and insights on vaccine development.
Satya Salvi is a Senior Sales Executive at Apprentice, experienced in spearheading innovative AI and AR-centered SaaS and cloud enterprise solutions for life sciences customers across the entire ecosystem from biopharma manufacturers to CDMOs/CMOs. Leveraging a cross-functional and strategic style, he is able to work closely with Solutions Engineering, Product Management, Customer Success, and executive leadership teams to build novel MES, LES, and AR-centered remote collaboration use-cases for clientele.
Satya has a successful history of achieving and engaging Fortune 500 biotech and pharmaceutical clients, through his experience at Top 10 automation and technology companies in the past. He has managed multi-million dollar books of businesses at leading Fortune 500 automation and software organizations. In his tenure, he has configured and managed complex engineer-to-order and large multi-million dollar capital projects for multiple system integrators, distributors, and clients.
In the past, Satya has worked in investment banking, consulting and in commercial R&D capacity. His R&D experience at top-tier academic institutions has resulted in commercialization of new technology, multiple awards, and multiple publications in top-tier biomedical journals.
Vaccine Development: Satya’s Point of View
“Vaccine development is an extensive process, requiring enormous capital investment as it can take 10-15 years for biopharma manufacturers and their partners to bring their therapeutics to market. Within this duration there is a preclinical stage that can take 2-4 years, and consequently there are numerous phases during the clinical development stage before a vaccine can be licensed, marketed, and manufactured to broader consumers.”