In the fight against monkeypox, the government is not learning from past experiences.

Monkeypox has gripped the country at an alarming rate. About 7000 cases were reported. As early as August. In response, the Biden administration has declared the monkeypox outbreak a national health emergency. Unlike COVID-19, monkey pox is not one. A new disease And two are Food and Drug Administration-approved vaccines.

Unfortunately, the administration has made several critical mistakes that show it has not learned the lessons from the COVID-19 pandemic.

President Joe Biden assured Americans in May That we had vaccines for everyone who needed them. Weeks later, we learned of a severe shortage of monkeypox vaccine, putting many people at risk. This was the first mistake.

The doses that Biden proposed were part of the Strategic National Stockpile, which is managed by the Assistant Secretary for Response and Preparedness in the United States. Department of Health and Human Services. The stockpile contained about 100 million doses of an old vaccine. (ACAM2000)who has Rare but serious side effects. it was Only 2,400 doses The latest and safest vaccine, Jynneos, manufactured by Bavarian Nordic in Denmark. It is not clear why a safer vaccine is not included in the stockpile.

Similarly, in 2020, the same stock failed to provide enough protection. N95 mask. To clarify the role in such decisions, the office was recently transformed into an independent agency. Management of strategic preparedness and response.

Another management mistake: the FDA It took a long time to inspect A Bavarian Nordic facility. As the outbreak began in May 2022, there was an application for approval of the facility. fast. The facility was pre-inspected. European Medicines Agency, but the FDA does not cooperate with them on vaccines. The FDA has completed its inspection. Mid Julyand it took another two weeks to release about 800,000 doses.

FDA He said he sped up This timeline. However, two months are critical to contain a rapidly spreading outbreak. The Department of Health and Human Services also made some Strategic miscalculations in planning. HHS and FDA should reconsider what procedures should be in place to enable them to act quickly in times of crisis.

Sadly, the FDA’s actions mirrored its previous handling. Baby formula crisis. The FDA took months to inspect the Michigan plant after receiving reports of adverse events and a whistleblower complaint about food safety violations at the nation’s largest baby formula plant. Inspections are one of the FDA’s key safeguards, and the agency seems ill-equipped to act quickly on information about emerging risks.

A wake up call

The administration’s third mistake is in the monkeypox vaccine rollout strategy, which is not how they handled the COVID-19 vaccine rollout. In early 2021, the Centers for Disease Control and Prevention was criticized for its rollout strategy. First, during the Trump administration, Other doses were held. – For every 100 doses in stock, only 50 people were vaccinated. As of early January 2021, there were other doses. No longer being held, but the CDC still didn’t prioritize the first dose. In contrast, countries that preferred the first diet, e.g Canada and the United Kingdomreduction in infection.

For monkeypox, state and local public health agencies, including those in Colorado, San Francisco, Washington, D.C., and New York City, have postponed other doses of Jynneos until they have enough inventory. be The FDA has issued statements “against deviations from product labeling.”

The decision about whether to vaccinate more people with a single dose or fewer people with the full regimen is not straightforward because of uncertainty and risk-benefit trade-offs. This requires a value trade-off, often a challenge Government agencies. Decision analysis tools can be used to clarify these trade-offs.

There does not appear to be a deliberate process for agencies to learn from past experience. Strategic preparedness and response management structures can help address the leadership problem, but they cannot address agencies’ failure to learn from the past. We hope to see learning and adaptation as part of this agency infrastructure.

It is disappointing to see that the CDC and FDA have not learned from the past. We hope this situation will serve as a wake-up call for them to rethink and retool emergency response policies and practices and develop a framework for decision-making that It is the first of many emerging threats in the coming decades.

Tinglong Dai is a professor of operations management and business analytics at Johns Hopkins University’s Cary Business School and a core faculty member of the Hopkins Business of Health Initiative.

Cara Morgan is a Principal at Quant Policy Strategies and Chair of the Advocacy and Governance Committee at INFORMS (Institute for Operations Research and the Management Sciences).

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