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FDA approves monkeypox, smallpox vaccine
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Bavarian Nordic announced that the FDA has approved Jynneos, a live, nonreplicating vaccine for the prevention of smallpox and monkeypox disease in adults aged 18 years or older who are at a high risk for smallpox or monkeypox infection.
The new vaccine from Bavarian Nordic marks the only FDA-approved vaccine for the prevention of monkeypox.
“The licensure of this vaccine not only enhances domestic biodefense and global health security but also demonstrates what can be accomplished for the American people through public-private partnerships,” Rick Bright, PhD, HHS deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority (BARDA), said in a press release. “The years of dedication working with Bavarian Nordic on this vaccine ultimately mean that the U.S. is better prepared to save lives if an emergency occurs involving one of the deadliest diseases the world has ever known.”
Monkeypox is a rare zoonotic disease that naturally occurs in central and western Africa. Rodents are the primary reservoir, although human and monkey outbreaks have occurred. The traditional, replicating smallpox vaccine has been thought to have the ability to protect against monkeypox and was recommended for use among individuals with high exposure during an outbreak in 2003 in the United States.
According to the release, some people experience adverse reactions to the traditional smallpox vaccine and the NIH have been committed to developing a safer vaccine. Jynneos is the “culmination of a 15-year partnership that started with a call from the NIH for a safer smallpox vaccine, successfully transitioned to BARDA and was delivered to the Strategic National Stockpile for use in an emergency,” according to Paul Chaplin, president and CEO of Bavarian Nordic.
Jynneos, approved for broad use, can be administered to people with weakened immune systems and individuals with eczema or with household members who have eczema.
“The FDA approval of Jynneos is a tremendous milestone for both our company and the U.S. Department of Health and Human Services,” Chaplin said in the release. “Together, we have shown that it is possible to develop a safe and effective medical countermeasure for national security threats like smallpox.”
Reference:
Healio. Monkeypox, a close relative of smallpox, is still with us. https://www.healio.com/infectious-disease/zoonotic-infections/news/print/infectious-disease-news/%7B3fae1d5b-4926-41ea-924c-67c4ef4b3d2f%7D/monkeypox-a-close-relative-of-smallpox-is-still-with-us. Accessed September 25, 2019.
Disclosures: Bright is employed by HHS and BARDA. Chaplin is the president and CEO of Bavarian Nordic.
Perspective
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Thomas M. Yuill, PhD
Although smallpox has been eradicated from the world, there is a persistent concern that somewhere, somehow, it might escape from the laboratories where it is maintained under lock and key or is kept clandestinely. That would require rapid immunization of an enormous number of people to prevent its spread, with priority given to those providing care to infected individuals. A stock of vaccines for emergency use is essential. Like one’s automobile insurance, one hopes never to use it, but it is essential to have when an unlikely accident occurs. The current smallpox vaccine has some limitations for use and carries a risk, albeit small, of serious adverse effects. Having a safe and effective vaccine to replace or supplement the current vaccine would be important.
Monkeypox presents a different kind of public health problem. In Central Africa, it can cause serious disease with a case fatality rate of up to 10%. In West Africa, the virus clade present causes milder disease with few or no fatalities. In either instance, cases are sporadic and often occur in remote areas. Vaccination of people living in these remote areas for a disease that occurs sporadically would be logistically difficult and costly to administer. However, infected individuals in those foci could spread it to some other people with whom they have contact. Also, infected individuals have traveled to other countries, become ill there and infected caregivers. Having a safe and effective vaccine under those circumstances would help to protect contacts if administered preventively in time for an immune response to occur before exposure to the virus. Because it is difficult to predict where those rare exposure events may occur, should all individuals in contact with patients receive the vaccine? The same question arises with universal vaccination of all caregivers everywhere in case smallpox should reappear.
Assuming that production of the Jynneos nonreplicating smallpox vaccine can be ramped up quickly, it may provide the insurance against the reappearance of smallpox itself. Use of the vaccine in Africa to prevent monkeypox virus infections will depend on the priority given to it by ministries of health in those countries where cases occur and at a cost that can be afforded.
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