FDA Approves New Smallpox, Monkeypox Vaccine: What Is It For?

You may not wake up every morning and say, “I hope I don’t get monkeypox or smallpox.” In fact, right now, the risk of you getting smallpox or monkeypox may seem lower than the risk of getting smothered by cabbage. Nevertheless, the U.S. Food and Drug Administration’s (FDA’s) approval of the Jynneos Smallpox and Monkeypox Vaccine is significant in various ways. Bavarian Nordic will be manufacturing the vaccine.

Smallpox used to be a huge problem around the world. According to Colette Flight writing for the BBC, it killed an estimated 300 million people “in the 20th century alone.” About a third of those who got infected by the variola virus did not survive.

In fact, smallpox was so significant that it changed the course of history on many an occasion. For example, the virus may have helped the Spanish, British, and other European countries colonize the Americas. High school history books may not mention the fact that smallpox brought over by European settlers helped weaken and wipe out many of the Aztecs, Incas, and Native Americans who had been occupying the Americas and had never been previously exposed to the virus.

Indeed, not too long ago, smallpox was a major killer disease, with “killer” in this case being a very bad thing. That’s why the global eradication of smallpox that was declared complete in 1980 was such a big public health achievement. That’s also why any event that combines the words “accident” and “existing smallpox laboratory samples,” quickly results in worldwide news. This happened just last week when an explosion occurred in Vector, a Russian building that’s one of two facilities in the world housing the remaining samples of the smallpox virus. Fortunately, the explosion did not seem to affect the samples.

However, smallpox could always return from a more unfortunate accident or the use of the virus for bioterrrorism, as I have described previously for Forbes. There is even concern that climate change will eventually reveal smallpox virus that has so far remained frozen in colder climes. With smallpox eradicated before Justin Timberlake was born, not that the two are related in any way, at least two generations of people have developed no immunity to smallpox. A return of the virus could mean rapid spread across a sea of smallpox virgins, so to speak.

That’s why government agencies like the Biomedical Advanced Research and Development Authority (BARDA) continue to support the development of new ways to prevent and treat smallpox. Even though smallpox was successfully eradicated, major gaps remain in smallpox prevention and treatment. The major gap in treatment has been a lack of treatments, at least, until last year. That’s when the FDA approved TPOXX, the first real treatment for smallpox, an approval that I covered for Forbes.

Then there are the limitations of the long-used smallpox vaccines. These vaccines have contained live versions of the vaccinia virus, which is nowhere near as dangerous as the variola virus but still on some occasions can cause problems. A vaccinia virus can result in an infection that is typically mild but, in rare situations can be life-threatening. This is why the Centers for Disease Control and Prevention (CDC) web site warns against touching your injection site soon after you get the smallpox vaccination. Touching the area and then your best friend could help spread the live vaccinia virus to your friend, which may mean that you no longer will be besties. The risk of bad stuff happening goes up if you have certain chronic skin conditions such as eczema or a weakened immune system such as from HIV, cancer, or medications. Therefore, such conditions can be contraindications to getting the traditional smallpox vaccine.

The Jynneos vaccine does include the vaccinia virus, but it’s a modified version. This version is called the Modified Vaccinia Ankara and apparently “does not cause disease in humans and is non-replicating, meaning it cannot reproduce in human cells,” according to the FDA announcement. That means compared to the traditional smallpox vaccine, this new vaccine poses less risk and can be administered to a wider range of people.

Then there’s the vaccine’s ability to protect against monkeypox, which is a first. Monkeypox is not as bad as smallpox, and it isn’t exactly a common disease. Nonetheless, the virus can kill. According to the CDC, in Africa, up to one in 10 people who have developed monkeypox disease have ended up not surviving.

In 1958, scientists first discovered the monkeypox virus in, surprise, surprise, monkeys. That’s why it’s called monkeypox and not ferretpox. But this virus doesn’t just monkey around. Other mammals can be infected if the virus comes into contact with their broken skin, respiratory tracts, or mucous membranes. The first reported human case of monkeypox appeared in the Democratic Republic of Congo in 1970. Since then here’s the tally of reported cases by country, according the the CDC:

• Cameroon has had a total of seven cases with two in 1979, four in 1989, and one in 2018.
• The Central African Republic has had 55 cases with a high of 14 cases in 2018.
• Côte d’Ivoire (Ivory Coast) had one case in 1971 and another in 1981
• The Democratic Republic of Congo has by far had the most with over 1000 cases each year.
• Gabon had five cases in 1987
• Israel registered one case in 2018
• Liberia had four cases in 1970 and two in 2017
• Nigeria, after having three before 2017 since then they have had 115 cases
• Republic of Congo has had 101 since 2003 with 88 in 2017.
• Sierra Leone has had a total of three cases
• Sudan had 19 cases in 2005
• The United Kingdom experienced three cases in 2018
• The United States had an outbreak of 47 cases in 2003 after a shipment of “exotic” animals arrived from Ghana.

Here’s a CDC Foundation video on the 2003 U.S. outbreak:

So, monkeypox is nowhere near as common as cabbage, but cases still continue to occur and as Joe Cocker and Jennifer Warnes sang, who knows what tomorrow brings.

Nevertheless, chances are you won’t be getting the Jynneos vaccine anytime soon unless you are a member of the military or someone else at higher risk to be exposed to bio-terrorism, frequent certain parts of the Democratic Republic of Congo, or work with smallpox or monkeypox viruses. However, just because a medical advance isn’t necessarily needed today doesn’t mean that it isn’t important. Some advances are good just to have around, just as insurance, just in case.