Monkeypox has swept the country at an alarming rate, with nearly 7,000 cases reported as of early August. In response, the Biden administration has declared the monkeypox outbreak a national health emergency. Unlike COVID-19, monkeypox is not a novel disease and has two Food and Drug Administration-approved vaccines.
Unfortunately, the administration has made several key mistakes that show it has not learned from the COVID-19 pandemic.
President Joe Biden assured Americans in May that we had vaccines for anyone who needed them. Weeks later, we learned of a severe shortage of monkeypox vaccines, which has left many at risk. This was the first mistake.
The doses Biden touted were part of the Strategic National Stockpile, which has been managed by the assistant secretary of response and preparedness in the U,S. Department of Health and Human Services. The stockpile had about 100 million doses of an older vaccine (ACAM2000), which has rare but severe side effects. It had only 2,400 doses of the newer and safer vaccine, Jynneos, manufactured by Bavarian Nordic in Denmark. It is unclear why the stockpile does not include more of the safer vaccine.
Similarly, back in 2020, the same stockpile failed to supply enough of the highly protective N95 masks. To clarify roles in decisions like these, the office was recently elevated to an independent agency, the Administration of Strategic Preparedness and Response.
The administration’s second mistake: The FDA took too long to inspect a Bavarian Nordic facility. As the outbreak began in May 2022, the application for approval of this facility was expedited. The facility had previously passed inspection by the European Medicines Agency, but the FDA does not have reciprocity with them on vaccines. The FDA completed its inspection by mid-July, and it took another two weeks to release nearly 800,000 doses.
The FDA said it accelerated this timeline. However, two months are crucial in containing an accelerating outbreak. The Department of Health and Human Services also made some strategic miscalculations in planning. The HHS and FDA should rethink 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 of the baby formula crisis. It took months for the FDA to inspect the Michigan plant involved after receiving adverse event reports and a whistleblower’s complaint about food safety violations in the country’s largest baby formula plant. Inspections are a key FDA safety tool, and the agency does not seem well-prepared to move quickly on information about emerging risks.
A wake-up call
The administration’s third mistake is in the rollout strategy of the monkeypox vaccine, which is not unlike the way they handled the COVID-19 vaccine rollout. In early 2021, the Centers for Disease Control & Prevention was lambasted for its rollout strategy. First, during the Trump administration, second doses were held — for every 100 doses in stock, only 50 people were vaccinated. By early January 2021, second doses were no longer being held, but the CDC still did not prioritize first doses. By contrast, countries that prioritized first doses, such as Canada and the United Kingdom, reduced infections.
For monkeypox, state and local public health agencies, including in Colorado, San Francisco, Washington, D.C., and New York City, have postponed giving second doses of Jynneos until they have enough inventory. The FDA issued statements “against departing from the product labeling.”
The decision about whether to vaccinate more people with one dose or fewer people with the full regimen is not straightforward, due to uncertainty and risk-benefit trade-offs. It requires value trade-offs, often a challenge for government agencies. The tools of decision analysis could be used to bring clarity to those trade-offs.
A deliberate process does not seem to exist for the agencies to learn from past experience. The creation of the Administration of Strategic Preparedness and Response may help solve the leadership problem, but it may not address agencies’ failure to learn from the past. We hope to see learning and adaptation as part of the core structure of this agency.
It is disappointing to see the CDC and FDA have not learned from the past. We hope this situation serves as a wake-up call for them to rethink and re-tool their emergency response policies and practices and create a framework for decision-making to address what is just the first of many emerging risks over the coming decades.
Tinglong Dai is professor of operations management and business analytics at Johns Hopkins University’s Carey Business School and a core faculty member of the Hopkins Business of Health Initiative.
Kara Morgan is principal at Quant Policy Strategies and chair of the INFORMS (Institute for Operations Research and the Management Sciences) advocacy and governance committee.
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