Can The “New” CDC Meet The Monkeypox Challenge?

What will happen when your child’s school reports their first case of monkeypox? It is not a question of if, it is a question of when. Monkeypox may not be lethal, but it is both debilitating and disfiguring. What can be done to prevent or mitigate the harm? Consider what follows.

Yesterday’s announcement by Dr. Rochelle P. Wallensky, the director of the Centers for Disease Control and Prevention (CDC), that the handling of the pandemic has been “botched” from the start was long overdue.

Dealing with the national emergency of monkeypox will afford the CDC an opportunity to demonstrate its resolve to handle public health challenges better. To succeed, the CDC must promptly address the failings of its pandemic response: letting political pressure supplant scientific guidelines, deploying faulty testing kits, failing to publish pandemic data in a timely fashion, releasing confusing, and often contradictory, messaging, and failing to develop a targeted, coordinated national pandemic strategy.

Monkeypox is not new but the reason for its current resurgence is yet to be determined. The anti-viral TPOXX, was developed by SIGA Technologies Inc. (SIGA) to treat smallpox and stockpiled in response to the September 11 attacks. Expanded access to TPOXX is now available as an Investigational New Drug (EA-IND) for treatment of monkeypox. However, clinicians face hurdles in obtaining TPOXX from the Strategic National Stockpile (SNS).

Monkeypox may not be as lethal as SARS-CoV-2, it is nonetheless a severe and debilitating illness that at a minimum can leave victims with telltale disfiguring pockmarks for life. The only available test for monkeypox requires analysis of fluid from skin lesions. The test is more confirmatory than diagnostic since the virus has a long incubation period. It can take 4 – 21 days to develop symptoms after exposure. During that time, the patient is unknowingly spreading monkeypox to others. Symptoms are usually flu-like; the rash develops a few days after the onset of symptoms.

The Importance of Diagnostics

The CDC must immediately concentrate its resources for the development, manufacture, distribution, and administration of a pre-symptomatic monkeypox diagnostic test, because that is the only way to stem the spread of the disease by pre-symptomatic individuals. A rapid diagnostic test would detect the monkeypox virus using non-lesion samples (e.g., direct from whole blood, urine, etc.) early after exposure. Failure to develop such a test will turn a national emergency into a national epidemic.

A rapid monkeypox diagnostic test will allow for detection immediately after known or possible exposure to an infected individual. With contact tracing (as already employed in Europe), pre-clinical infections will be identified, and treatment initiated. When treated early, full-blown infections can be reduced.

As was demonstrated with the much more complex mRNA vaccine programs, this could be done in about 90 days. The advantage with monkeypox is that it is a well-researched virus. As with all such endeavors adequate funding is essential. Monkeypox test developers must have easy access to clinical specimens in the form of inactivated virus. For rapid commercialization, the test developers must have clear guidelines leading to commercialization under emergency use authorization (EUA). These could easily modeled after the Covid-19 diagnostic platforms.

A pre-symptomatic monkeypox diagnostic test will allow for testing immediately after known or possible exposure to an infected individual. With contact tracing (as already employed in Europe), pre-clinical infections will be identified, and treatment initiated. When treated early, full-blown infections can be reduced.

Few people today are old enough to have borne the emotional trauma or disfiguring scars of smallpox, so it is only a remote memory. With the CDC’s pronouncement of a new approach, the monkeypox challenge is a meaningful opportunity for a real-world test to show that it is serious about change. To really be successful, coordinating with industry and other public health care agencies also will be critical to address the monkeypox emergency. If, however, the ‘new’ CDC fails to rise to this occasion, it will not just be a missed opportunity; it will be a challenge to the agency’s core competence and it will not soon be forgotten.