The U.S. Food and Drug Administration (FDA) has approved Jynneos, a vaccine designed to prevent smallpox and monkeypox disease.

Smallpox afflicted thousands in the early part of the 20th century but was eradicated in the 1980s following an aggressive vaccination campaign worldwide. Today however, there is a new generation of people who have not been vaccinated and therefore are not immune to this disease if it were to strike again – most likely as a biological weapon by enemies of the state. To that end, the approved vaccine will be stored by the U.S. government in the event of an emergency.

In a news release, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research said, “although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect. Today’s approval reflects the U.S. government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures.”

Smallpox is caused by the variola virus and is a highly contagious and deadly disease that no longer occurs naturally. Approximately 30% of those infected with smallpox die from the illness.

Monkeypox is also caused by the variola virus but unlike smallpox, monkeypox infection is less transmissible between humans and also less deadly. Most cases of monkeypox infections in humans have been limited to central and western regions of Africa, where the virus is naturally occurring.

The vaccine was developed by Bavarian Nordic A/S and the FDA granted the company a priority review voucher following approval. A priority review voucher means the company can apply the voucher towards any drug under review by the FDA and give that drug a priority review (i.e., speed up the review process from 10 months to 6 months). The voucher is also transferable and the company has stated in a press release they plan to sell the voucher. Earlier this year, GW Pharmaceuticals sold their voucher for $105 million.

The approval of Jynneos for smallpox was based data from 22 clinical trials involving 7871 individuals while the approval for monkeypox was based on data using studies in non-human primates.

The most common (>10%) adverse reactions associated with Jynneos were injection site reactions (pain, redness, swelling, induration, itching) and systemic adverse reactions such as muscle pain, headache, fatigue, nausea, myalgia and chills.

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