US Declares Monkeypox a Public Health Emergency; Ups Vaccine Supply

The US government has declared the spread of monkeypox virus in the US a public health emergency and has taken action to increase the supply of monkeypox vaccines in the US.

“Ending the monkeypox outbreak is a critical priority for the Biden-Harris Administration,” said US Department of Health and Human Services (HHS) Secretary Xavier Becerra in an August 4, 2022 statement. “We are taking our response to the next level by declaring a public health emergency.”

The declaration of a public health emergency follows the appointments by President Joe Biden of Robert Fenton of the Federal Emergency Management Agency as White House National Monkeypox Response Coordinator and Dr. Demetre Daskalakis of the Centers for Disease Control and Prevention as White House National Monkeypox Response Deputy Coordinator.

The declaration of a public health emergency is in concert with the Food and Drug Administration’s (FDA) work to explore new strategies to increase monkeypox vaccine supply, including using a new dose-sparing approach that could increase the number of doses available, up to five-fold.

Earlier this week (August 9, 2022), the FDA issued an emergency use authorization (EUA) for Bavarian Nordic’s monkeypox vaccine, Jynneos, to allow the vaccine to be administered by intradermal injection, an upper skin level injection that requires smaller dosage levels. The vaccine was previously approved for administration by subcutaneous injection, a deeper injection that goes through the fat layer of the skin and requires a higher dosage than an intradermal injection. The FDA estimates that the change in administration would increase existing vaccine supply by five-fold.

Bavarian Nordic’s vaccine, Jynneos, is a non-replicating smallpox vaccine that the FDA approved in 2019 for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. It later authorized the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection using standard subcutaneous dosing. The authorization for intradermal administration of the vaccine only applies to adults 18 years of age and older determined to be at high risk of monkeypox infection.

To date (as of August 9, 2022), the HHS has distributed more than 670,000 Jynneos vaccines to states and jurisdictions from the Strategic National Stockpile (SNS). In addition, the SNS is preparing to distribute approximately 400,000 additional vials to states and jurisdictions as part of the next phase of the US national vaccine strategy. Jurisdictions that administer 90% of their current vaccine supply may request additional doses sooner. With the authorization of intradermal administration of the vaccine, the 400,000 vials of vaccine in the SNS’s inventory that have been allocated but not yet distributed hold the potential to provide up to 2 million doses using intradermal administration. Additionally, vaccines that have been received by jurisdictions, but not yet administered, are eligible for intradermal administration. In addition, the HHS has allocated 1.1 million doses to states and jurisdictions in total and is making more doses available as jurisdictions use their current supply. It is accelerating delivery of an additional 150,000 doses, originally slated to arrive in November (November 2022), to arrive in the US next month (September 2022).

The declaration of a public health emergency carries implications for data sharing with the federal government. Fifty-one jurisdictions have already signed data-use agreements that will provide the US Centers for Disease Control and Prevention with information related to vaccine administration. Additionally, it provides authorities to the US Centers for Medicare & Medicaid Services to collect testing and hospitalization data.

US exercises procurement options for Siga’ antiviral drug
In a separate development, the US government exercised procurement options to secure supplies of Siga Technologies’ Tpoxx (tecovirimat), a small-molecule antiviral drug approved for treating monkeypox. The HHS exercised its option for the delivery of an intravenous formulation of treatment courses valued at approximately $26 million, with product delivery slated for 2023. The procurement options, which were exercised by the Biomedical Advanced Research and Development Authority part of the office of the Administration for Strategic Preparedness and Response at the HHS, include the manufacture of bulk drug substance and the use of such substance to manufacture and deliver final drug product of IV Tpoxx.

The company also has an oral version of the drug and announced last month (July 2022), that it has received $56 million of international orders for the drug with Canada and two jurisdictions respectively in Europe and Asia-Pacific. The FDA approved oral Tpoxx for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack, and the oral version of the drug was approved for the same indication by Health Canada in December 2021. The oral version was approved by the European Medicines Agency in January 2022 with a broader label that covers the treatment of smallpox, monkeypox, cowpox, and complications from vaccination for smallpox.

Source: Siga Technologies, The White House, US Department of Health and Human Services and US Food and Drug Administration