WHO Declares Monkeypox a Public Health Emergency; US, EU Update Vaccine Supply

Facing rising incidence of monkeypox globally, the World Health Organization (WHO) has declared monkeypox a public health emergency of international concern, the highest alert level that can be given by WHO, and the US and European Union (EU) have provided supply updates for a monkeypox vaccine.

Between January 1, 2022 and July 20 2022, 14,533 probable and laboratory-confirmed cases of monkeypox were reported to WHO from 72 countries across all six WHO Regions, up from 3,040 cases in 47 countries at the beginning of May 2022.

WHO issued a series of temporary recommendations to fight monkeypox, including the following:

  • Calling on WHO member states who have manufacturing capacity for smallpox and monkeypox diagnostics, vaccines, or therapeutics to raise production and availability of medical countermeasures;
  • Calling on manufacturers to work with WHO to ensure that diagnostics, vaccines, therapeutics, and other necessary supplies are made available based on public health needs and at reasonable cost to countries where they are most needed to stop the onward spread of monkeypox;
  • Using a framework of collaborative clinical efficacy studies that apply standardized design methods and data collection tools for existing or new therapeutics and antiviral agents to increase evidence generation on efficacy and safety;
  • Strengthening laboratory capacity and international specimen referral capacities for the diagnosis of monkeypox virus infection and related surveillance; and
  • Strengthening genomic-sequencing capacities and international specimen referral capacities to determine circulating virus clades and their evolution and sharing genetic sequence data through publicly accessible databases.

US, EU ramp up monkeypox vaccine supplies
Both the US and EU have provided updates regarding supply and regulatory approvals for a monkeypox vaccine. To date (as reported on July 21, 2022), the US Department of Health and Human Services (HHS) has made 374,000 monkeypox vaccine doses available for ordering and delivered over 191,000 of those doses to state and city health departments. When factoring in doses already delivered to the Strategic National Stockpile, those pending at the supplier, and replacement doses, the US federal government will have access to more than 6.9 million doses by mid-2023.

The US government is mainly working with Bavarian Nordic, a Copenhagen, Denmark-based vaccine company, for the supply of the company’s monkeypox vaccine, a non-replicating smallpox vaccine marketed under the name Jynneos in the US and Imvanex outside the US. The vaccine is approved for use against monkeypox in the US, Canada, and Europe, where it received approval for monkeypox this past week (July 25, 2022) in European Union member states as well as in Iceland, Liechtenstein, and Norway.

This past week (July 27, 2022), Bavarian Nordic received approval from US and EU regulatory authorities to manufacture the Jynneos/Imvanex smallpox and monkeypox vaccine at the company’s fill–finish facility in Denmark. The US approval followed a successful pre-approval inspection of the facility by the Food and Drug Administration (FDA) earlier this month (July 2022). The inspection included the final drug production of Jynneos, which was previously performed at a contract manufacturer. The inspection was successfully completed with no observations made, which has led to the approval of Bavarian Nordic as the new drug product manufacturer of the vaccine. The EU approval followed submission of a Type II-variation application in June 2022, which, similar to the FDA approval, acknowledges Bavarian Nordic as the new drug product manufacturer of the vaccine.

Earlier this month (July 2022), Bavarian Nordic agreed to supply an additional 1.5 million doses of the vaccine to an undisclosed European country. While deliveries under this contract will start in 2022, the majority of the doses will be delivered during 2023.

UK increases research efforts for monkeypox vaccine
In the UK, the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that develops vaccines against infectious diseases, is funding up to $375,000 to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Security Agency (UKHSA) to support the development of laboratory tools to advance and standardize assessment of vaccines used to protect against monkeypox, including the currently approved smallpox vaccines.

The tools CEPI is supporting the development are for: (1) assays, with the UKHSA, to test for the presence of specific antibodies—indicative of an immune response to monkeypox—following either natural infection or vaccination and (2) a reference antibody standard, with the UK MHRA, to harmonize how different laboratories assess the strength and duration of immune responses generated by current vaccines and those in development against monkeypox.

Source: World Health Organization, US Department of Health and Human Services, Bavarian Nordic, and The Coalition for Epidemic Preparedness