With Congress facing a short-term continuing resolution to keep the federal government running as it approaches the end of the fiscal year at the end of September, the White House highlighted several budget priorities, including requests for $22.4 billion in COVID-19 funding and monkeypox funding of $4.5 billion.

“..[O]ur COVID-19 response efforts continue to require additional funding,” said the White House in a September 2, 2022, press briefing. “In March [March 2022], we requested that Congress provide supplemental COVID-19 funding and repeatedly warned that without Congressional action, we would be forced to make difficult trade-offs and pull existing funding from critical efforts to meet the most pressing needs. That is precisely what has happened.”

Its now updated request for COVID-19 funding is being made in order to meet the following: immediate short-term domestic needs, including testing; accelerating research and development of next-generation vaccines and therapeutics; preparing for future variants; and supporting the global response to COVID-19.

The request to Congress for $4.5 billion in monkeypox funding is split into two areas; $3.9 billion to facilitate access to vaccinations, testing, treatment, and operational support in the US and $600 million to combat the disease spread globally.

Separately, the US Food and Drug Administration (FDA) took action to expand access to monkeypox testing. It issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. Additionally, the agency is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. These templates include recommendations—not requirements—for how a developer could validate a test to help ensure it is appropriately accurate and reliable.

This guidance follows a declaration by the Secretary of the Department of Health and Human Services justifying the emergency use of in vitro diagnostics for detection and/or diagnosis of the monkeypox virus or non-variola orthopoxviruses. Under the declaration, the FDA may issue an EUA to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics. The agency issued the first EUA for a monkeypox in vitro diagnostic, the Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR test to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens.

Source: The White House and FDA