The monkeypox vaccine underscores the value of U.S. investments in preparedness

After living through the Covid-19 epidemic, many people around the world reacted to the sudden spread of monkeypox with understandable dismay. But while researchers and public health experts are still learning more about this outbreak, there is one critical distinction between monkeypox and Covid-19: a safe and effective vaccine has been ready and on the shelf from the start, thanks to a long-standing U.S. public-private partnership aimed at preparing for the worst biological threats, whether naturally occurring or deliberate.

The U.S. government’s engagement in the development of medical countermeasures began in earnest after the September 11 attacks on the United States. In September and October 2001, at least five envelopes containing spores of Bacillus anthracis, a species of bacteria, were mailed to the offices of U.S. senators in Washington D.C. and to journalists in New York and Boca Raton, Florida. These spores cause anthrax, a deadly disease. The resulting infections killed five people, including two postal workers, a hospital employee, a journalist, and a 94-year-old woman who was exposed by cross-contaminated mail.

The events of 9/11 largely overshadowed the anthrax attacks. But the realization that a deliberate biological attack had struck the country prompted the U.S. government to begin investing in creating and stockpiling vaccines and treatments for dangerous pathogens that posed a national security risk.

Smallpox was included in this effort, even though it had been declared eradicated in 1980. U.S. intelligence agencies suspected several countries of having smallpox weaponization programs — suspicions that remain today. Russia also holds stocks of the smallpox virus for research purposes. And in recent years, synthetic biology and other developments have dramatically lowered the bar for those who may seek to weaponize this disease.

While the U.S. owns a large stockpile of an older smallpox vaccine derived from the 1970s-era technology that was used to eradicate smallpox, that product can cause severe side effects, making it a particular concern for people with compromised immune systems. As a result, in 2003, the United States government partnered with Bavarian Nordic, which I now lead, to develop a safer vaccine using the company’s proprietary and patented vaccine platform technology. The vaccine that emerged from the subsequent research and development process, called Jynneos in the U.S., was approved by the Food and Drug Administration in 2019.

Jynneos uses a live virus that Bavarian Nordic modified so it cannot replicate in the body. This means that it still produces a potent immune response to the smallpox virus but has a strong safety profile. Clinical trials and studies of the vaccine in the elderly, people with HIV, eczema, and other immunocompromised populations have all demonstrated the vaccine’s safety.

The U.S.’s investment was prescient. Not only can the new vaccine be used to fight smallpox, but it also provides a platform for fighting other pathogens. Part of the technology behind Jynneos is a key component of a vaccine created to confront the Ebola crisis in 2014. And when the FDA approved this vaccine for use in the U.S., the approval included use against monkeypox. Jynneos is currently the only vaccine in the world approved for vaccination against monkeypox.

Few people outside of West and Central Africa had heard of monkeypox until it began appearing in headlines this year in early May. Monkeypox causes painful rashes and lesions, fever, and swollen lymph nodes, and can lead to death. According to the Centers for Disease Control and Prevention, as of July 1st there have been nearly 5,800 confirmed cases in 52 locations around the world.

This year’s outbreak is worrisome and atypical of previous episodes, especially given the number of countries now reporting cases and the ongoing public health burden of the Covid-19 pandemic. Fortunately, a vaccine, testing, and effective antivirals are all available. Their existence illustrates three lessons for the future of health security.

First, a monkeypox vaccine exists because the U.S. government invested in preparedness nearly two decades ago. Funding from the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield supported the development, manufacturing, and stockpiling of Jynneos. Congress should ensure that these critical health security programs have adequate funding to prepare for the threats facing the country, both known and unknown.

Second, other countries should follow the lead of the U.S. and make long-term investments in preparedness. The creation of the Health Emergency Preparedness and Response Authority in the European Union is a promising development, as is the new World Bank and WHO Fund for Pandemic Prevention, Preparedness and Response.

Third, it’s not enough to invest in just creating new vaccines and treatments — this investment must be carried through to manufacturing and stockpiling. That is a critically important lesson from Covid-19: it takes time to vaccinate large groups of people, even when a vaccine is immediately available.

The U.S. government’s investment in preparedness represents forward-thinking science and policy. Readiness for future outbreaks of dangerous pathogens, whether they spread naturally or are spread by nefarious actors, requires other global leaders to see the wisdom of similar long-term funding for medical countermeasure development and stockpiling strategies. It also requires leaders in the U.S. to stay the course and continue funding efforts to prepare for the next biological threat.

I hope that the swift response to monkeypox will provide leaders with the proof they need to make the case for investing in the future.

Paul Chaplin is the CEO of Bavarian Nordic.