What will happen when your child’s school reports their first case of monkeypox? It’s not a question of if, it’s a question of when. Monkeypox may not be deadly, but it is both debilitating and disfiguring. What can be done to prevent or mitigate the harm? Think about what comes next.
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Yesterday’s announcement by Dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention (CDC), that the handling of the pandemic was “wrong” from the beginning was long overdue.
Addressing the national monkeypox emergency will give CDC an opportunity to demonstrate its determination to better address public health challenges. To succeed, the CDC must immediately address the flaws in its response to the pandemic: allowing political pressure to override scientific guidance, deploying the wrong testing kits, failing to release pandemic data in a timely manner, releasing confusing and often contradictory messages, and failure to develop a focused, coordinated national pandemic strategy.
Monkeypox is not new, but the cause of its current resurgence has yet to be determined. TPOXX Antivirus is developed by SIGA Technologies Inc. (SIGA) to treat smallpox and accumulated in response to the 9/11 attacks. Expanded access to TPOXX is now available as an investigational new drug (EA-IND) for the treatment of monkeypox. However, clinicians face obstacles in obtaining TPOXX from the Strategic National Stockpile (SNS).
Monkeypox may not be as deadly as SARS-CoV-2, but it’s still a severe and debilitating disease that, at the very least, can leave victims with telltale disfiguring scars for life. The only test available for monkeypox requires analysis of fluid from skin lesions. The test is more confirmatory than diagnostic because the virus has a long incubation period. It can take 4 – 21 days for symptoms to develop after exposure. During this time, the patient unknowingly spreads monkeypox to others. Symptoms are usually flu-like; the rash develops over several days after onset of symptoms.
The importance of diagnostics
CDC must immediately focus its resources on the development, production, distribution, and administration of a presymptomatic diagnostic test for monkeypox because this is the only way to stop the spread of the disease from presymptomatic individuals. A rapid diagnostic test would detect monkeypox virus using non-lesional samples (eg, direct whole blood, urine, etc.) early after exposure. If no such test is developed, the national emergency will turn into a national epidemic.
The rapid diagnostic test for monkeypox will allow detection immediately after known or possible exposure to an infected individual. Contact tracing (as already used in Europe) will identify preclinical infections and initiate treatment. When treated early, full-blown infections can be reduced.
As has been demonstrated with the much more complex mRNA vaccine programs, this can be done in about 90 days. The advantage of monkeypox is that it is a well-studied virus. As with all such ventures, adequate funding is essential. Developers of tests for monkeypox must have easy access to clinical samples in the form of inactivated virus. For rapid commercialization, test developers must have clear guidelines leading to emergency use authorization (EUA) commercialization. They can easily be modeled after the Covid-19 diagnostic platforms.
A presymptomatic diagnostic test for monkeypox will allow testing immediately after known or possible exposure to an infected individual. Contact tracing (as already used in Europe) will identify preclinical infections and initiate treatment. When treated early, full-blown infections can be reduced.
Few people today are old enough to bear the emotional trauma or disfiguring scars of smallpox, so it is but a distant memory. With the CDC’s announcement of a new approach, the monkeypox challenge is a significant opportunity for a real-world test to show it is serious about change. To be truly successful, coordination with industry and other public health agencies will also be critical to addressing the monkeypox emergency. However, if the “new” CDC fails to address this, it won’t just be a missed opportunity; it will be a challenge to the agency’s core competence and will not soon be forgotten.
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