How are US stockpiles prepared for monkeypox outbreaks?

In the midst of a new monkeypox outbreak, the U.S. government Launch of vaccine Provides protection against monkeypox from strategic national stockpiles for use in high-risk adults.

Vaccines that prevent smallpox and monkeypox are not available to the general public, but the US government has signed numerous multi-year contracts for procurement and supply with businesses over the past few decades. As the number of confirmed and suspected monkeypox cases continues to grow, we will outline the major supply contracts for treatment and vaccines and the US government’s preparations for this new monkeypox outbreak.

Procurement of smallpox and monkeypox vaccines

Due to travel, high contact between human and animal hosts in deforested areas, and the decline of herd immunity after the end of regular smallpox vaccination, the monkeypox virus is no longer confined to the West African region. Since the eradication of smallpox, monkeypox virus is now considered the most pathogenic poxvirus that can be transmitted by two routes. Animal-human (zoonoses) or human-human infections.

Bavarian Nordic JYNNEOS vaccine Is a US-approved smallpox vaccine that also provides 85% protection against the monkeypox virus. Also known as Jynneos, Imvamune or Imvanex. FDA approved As a preventive vaccine against monkeypox for adults over 18 years of age and high-risk individuals in September 2019. However, the United States began a supply contract with Bavarian Scandinavia long before that.

Bavarian Nordic has supplied about 30 million liquid frozen vaccines so far. In November 2009, the Biomedical Advanced Research and Development Authority (BARDA) released a liquid-frozen version of the Jynneos vaccine stockpile with a longer shelf life, resulting in a vaccine.

Eight years later, BARDA signed a $ 359 million contract with Bavarian Nordic for the supply of lyophilized vaccines. In light of the increasing number of cases of monkeypox, on May 18, BARDA released a previously manufactured bulk vaccine for the production and supply of lyophilized vaccine doses billed and delivered in 2023 and 2024. You have exercised the $ 119 million value option of your existing contract to convert. On the same day, a traveler from Canada was identified as the first case of monkeypox in the United States. Another option, worth $ 180 million in contracts to support the supply of 13 million lyophilized vaccines in 2024 and 2025, remains unexercised.

Antiviral agents against smallpox and monkeypox

TPOXX (tecovirimat) and Tembexa (cydofovir) are two antiviral drugs used to treat smallpox and are also effective in treating monkeypox. SIGA Technologies’ Tpoxx The first drug approved for the treatment of smallpox In July 2018, and a few months later, the company won a multi-year contract to supply oral and intravenous drugs for strategic national stockpiles in the United States. The deal is worth $ 629 million and was designed to maintain a drug stockpile of 1.7 million treatment courses.

Tpoxx works by inhibiting the formation and release of the intracellular envelope containing the orthopoxvirus.both Monkeypox Smallpox virus belongs to the genus Orthopoxvirus.

Over the last two years, BARDA has exercised $ 213.8 million worth of options for the delivery of Tpoxx. More recently, the US Department of Defense (DoD) has signed a new contract with SIGA for approximately $ 7.5 million, of which approximately $ 3.6 million worth of oral TPOXX will be delivered in 2022. Supplying and Procuring the Remaining $ 3.9 Million Oral TPOXX Depends on the Pentagon’s decision to exercise superior options. On May 19, SIGA received supplemental approval for intravenous antiviral medication in the United States.

Tembexa manufactured by Chimerix was designated by the FDA as an orphan drug for smallpox in June 2018, and was approved three years later in June 2021.To date, the U.S. government has not signed a supply contract for Tembexa with Chimerix, but on May 16 Chimerix will sell Tembexa. Emergent BioSolutions He said it would continue to lead ongoing negotiations with BARDA to raise supply transactions.

Limit the occurrence of monkeypox with current stockpiles

According to the judgment of 2022 national stockpiling experts listed in the Ministry of Health, Social Welfare Emergency Fund, the maximum budget for procuring medicines for smallpox is $ 363.2 million. Smallpox and monkeypox remain a high concern at national and global levels, so the Public Health and Social Welfare Emergency Fund document states that BARDA aims to ensure adequate vaccine supply for all Americans. I am saying. However, the number of cases of monkeypox continues to increase (as of May 21, WHO confirmed in a total of 92 laboratories and 28 suspicious cases), and a stockpile of existing treatments for smallpox and monkeypox. In addition to maintaining, important, Development of specific treatments You also need monkeypox.

According to GlobalData, there are only two effective pipeline preventative vaccines in the preclinical stage of smallpox and monkeypox development. Both TNX-1200 and TNX-801m by Tonix Pharmaceuticals.

Monkeypox is currently managed by supportive care and treatment that applies only to patients with symptomatic treatment. In addition, regular population vaccination against smallpox was discontinued after it was eradicated in 1980, so currently available treatments are to spread the monkeypox virus from asymptomatic individuals to others. Cannot be prevented.

Visualization by Andrew Hillman