COVID-19 pandemic tested CDC and FDA, exposing cracks
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Last April, Rochelle P. Walensky, MD, MPH, requested an internal and external review of the CDC’s performance during the COVID-19 pandemic.
By August, she had the results. Interviews conducted by a longtime administrator at the Health Resources and Services Administration and by three CDC leaders uncovered the same issues: The agency was too slow to share science and data, struggled to translate findings into practical policy and fell short of prioritizing public health communications, especially for the American public.
Walensky added some of her own observations, arguing that the CDC workforce was too academic, too focused on publishing and not nimble enough to keep pace with a large and complex health crisis like COVID-19.
In an email to staff, which was obtained by Healio | Infectious Disease News, Walensky announced internal changes aimed at improving how the CDC operates, which she said would require a “cultural shift” at the agency.
“For 75 years, the CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations,” Walensky said in a statement to the media.
In interviews with infectious disease physicians and public health experts that were conducted before Walensky announced she is stepping down as CDC director, we heard some of the same concerns about how the nation’s cornerstone public health agencies — the CDC and FDA — have operated during the nation’s deadliest health crisis in a century. We also heard admiration for what Infectious Disease News Editorial Board Member Gitanjali Pai, MD, AAHIVS, FIDSA, called their “tireless” work during a large and complex pandemic.
“The COVID-19 pandemic has been a unique and challenging event that has tested the capacity of public health agencies around the world,” said Pai, Oklahoma’s chief medical officer and an infectious disease physician at Memorial Hospital and Physicians Clinic in Stilwell, Oklahoma. “It has highlighted some of the challenges and exposed weaknesses in the public health system — some of which will likely continue to exist in future pandemics.”
‘Unsung heroes’
During the pandemic, the CDC and FDA have worked “under intense pressure in the most challenging circumstances,” said Infectious Disease News Editorial Board Member and infectious disease physician Krutika Kuppalli, MD, FIDSA
“People forget, these are human beings who are working their butts off,” she said. “These are some of the best scientists we have.”
Among their successes, former CDC director Tom Frieden, MD, MPH, president and CEO of the global public health organization Resolve to Save Lives, pointed to the development of multiple vaccines in record-breaking time under Operation Warp Speed — a public-private partnership led by the FDA and supported by the CDC, he noted — and the prioritization and quick vaccination of nursing home residents.
Three years into the pandemic, the country’s public health personnel are burned out, underappreciated, undercompensated and leaving for other jobs, said David W. Kimberlin, MD, chair of pediatric infectious diseases at the University of Alabama at Birmingham and codirector of the division of pediatric infectious diseases at Children’s of Alabama hospital.
“These are unsung heroes,” he said. “Did they do everything right? No, none of us do. Did they do most things right? I would say probably yes. Could they improve? Yes, as we all can.”
‘Things were very chaotic back then’
By the end of March 2020, just 2 months after reporting its first infection, the United States had surpassed China and Italy to lead all countries in confirmed cases of COVID-19. Inadequate testing capacity hampered the U.S. response early on and was commonly cited as a weak spot in the country’s pandemic defenses, with much of the blame placed on the CDC.
The agency developed a test for SARS-CoV-2 early on, submitting an emergency use authorization (EUA) request to the FDA within weeks of the first U.S. case, but a wide rollout was delayed because of a manufacturing problem with one of the reagents that prevented labs from being able to verify results.
“Testing was a fiasco,” Kuppalli said. “There was an issue with the primers, and then we could not get tests anywhere. That was a CDC issue.”
Reliable testing could have helped the U.S. better understand where SARS-CoV-2 was spreading. Without it, health officials were unable to track cases and identify and trace contacts to prevent widespread infection.
“Things were very chaotic back then,” Kimberlin said. “The World Health Organization released a much simpler test, and use of it was discouraged early on.”
It was not solely a CDC issue, according to Amesh A. Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security.
“The FDA was slow to authorize home tests, and the initial public health emergency declaration forced test makers to use the EUA pathway instead of the more rapid [laboratory developed test] pathway,” which allows for the use of tests developed and used within a single laboratory, Adalja said.
“This constrained testing greatly in the early days,” he said.
Frieden said the FDA “could and should have encouraged laboratories to develop tests locally, as is routinely done,” and that HHS “should — as South Korea did — have convened larger private labs” to quickly scale up testing capacity.
“CDC’s tests were never intended for broader use than in public health laboratories, and the problem with primers was fixed within weeks,” he said. “But those weeks were costly, in both lives and in CDC’s reputation.”
Surveillance silos
In addition to testing problems, experts identified the country’s outdated, unreliable and siloed disease surveillance and data systems as a major reason the U.S. was limited in its ability to respond to COVID-19.
The CDC is responsible for tracking and gathering data on emerging health threats, Pai noted, but the agency’s surveillance and data systems are subpar, lacking the capacity and sensitivity of more modern systems in other countries, which can provide more comprehensive data, experts said.
“When we want to understand vaccine effectiveness and boosters, or if we want to know surveillance trends, we often turn to the United Kingdom, Israel or other nations with strong health data systems and universal health coverage,” said Lawrence O. Gostin, JD, director of the O’Neill Institute for National and Global Health at Georgetown University.
The issue, Frieden said, is that the information comes from many places, diminishing its accuracy.
“We don’t really have sensitive information about what’s happening — a reflection of our very heterogenous and often inadequate disease surveillance systems,” he said.
The CDC in December announced that it awarded $3.2 billion to state, local and territorial jurisdictions to improve and grow the public health workforce and bolster an initiative to modernize data systems, with most of the money going to workforce development.
The money earmarked for the data modernization initiative, which the CDC launched in 2020, is meant to make it easier for various public health systems in the U.S. to exchange and use data, giving everyone access to better and more information to improve the response to health threats, a CDC spokesperson told Healio | Infectious Disease News.
To modernize the CDC even more, Frieden said he supports a bipartisan proposal for a more sustainable structure for funding the agency through the Health Defense Operations budget designation, which would exempt core public health agencies from spending caps using the same type of classification that exempted U.S. overseas operations in the global war on terror after 9/11 from spending limits.
He also recommended that CDC embed thousands more staff in state and local health departments, with those staff rotating to the CDC in Atlanta over time to “harmonize federal, state and local public health.”
“Fixing data systems is going to take 5 or 10 years. This is not a quick fix,” Frieden said. “These are data systems that need sustained investment for many years to get much better.”
Kimberlin said investing in public health is the main issue and agreed that the money should be spent on staffing and improving surveillance systems so they can communicate better with each other.
“We get what we pay for, and if we pay for a Yugo instead of a Chevy, we’re going to get an unreliable vehicle,” he said.
Communication breakdown
The CDC’s lack of access to robust real-time data, and “cumbersome oversight by HHS and the White House,” meant many of the CDC’s recommendations were “delayed or confusing,” Frieden said.
Experts also criticized the agency for being inconsistent and unclear in its messaging, including on the issue of masks. One of the issues, Gostin said, is that the CDC “hires academic scientists and doesn’t have a skilled staff of nonmedical professionals, such as in health communication,” echoing some of what Walensky herself noted in her own criticisms of the agency’s response.
“CDC has been a poor health communicator,” Gostin said. “Its health messages on vaccines and isolation have been inconsistent and confusing. It has also been slow to understand and communicate basic information such as asymptomatic transmission and aerosolized spread of the virus.”
Regarding masks, Kuppalli pointed to the color-coded, county-level map for SARS-CoV-2 transmission that the CDC unveiled in the summer of 2021. States that appeared orange or red on the map — the colors that represented the highest levels of transmission — ostensibly fell under new guidance recommending that even vaccinated people wear masks.
“That was hard because everyone was doing their own thing. I think the narrative was very confusing for people and very politicized,” Kuppalli said.
Pai noted the confusion over whether masks were necessary or effective. The CDC, which recommended against buying them early on amid a shortage, was encouraging everyone to wear masks by July 2020 after reviewing increasing evidence that showed they could prevent infection.
In a recent essay published in The Wall Street Journal, Frieden noted that masks have been shown to reduce SARS-CoV-2 infections from 10% to 80% but that protection depends on consistent use, especially in high-risk situations. "As the pandemic progressed and we learned more about asymptomatic spread of the virus, it became clear that masks are an important tool. I think many of us were surprised at how effective masks were, including me,” he said.
However, like seatbelts, masks work only if they are worn, Frieden said. Mask mandates have been shown in many studies to reduce infections, including in schools, but the widely implemented precaution became one of the most politically divisive topics during the pandemic.
“We do need to do a better job of communicating the evolving science and our understanding particularly in a rapidly evolving situation, as was the case during the pandemic. I think this is something that the lay public has a hard time understanding,” Kuppalli said. “This is where the situation with masks became difficult, and then when you add the politics in there, it became even trickier.”
Adalja described other CDC guidelines during the pandemic as being imprecise and favoring “one-size-fits all solutions.”
“For example, lumping people with prior infection together with those who are unvaccinated” — considering previously infected people as being unprotected — “really was not supported by the science, even if there are differences in that group. This type of categorization did diminish trust,” Adalja said.
“When guidance was considered to be inconsistent, it often was because it wasn’t issued with the caveat that the context of knowledge may broaden and require adjustments. This was also coupled with overvaluing certain nonrepresentative anecdotes such as the events in Provincetown,” Adalja said, referring to an MMWR report about breakthrough COVID-19 cases among vaccinated people associated with large gatherings in the Massachusetts town during the delta surge, which motivated the CDC to update its guidance to say that even vaccinated people needed them in some places. The update coincided with the creation of the color-coded map and came just 2 1/2 months after the CDC said that fully vaccinated people no longer had to wear masks or distance indoors.
Frieden described the Provincetown report as “a game-changer” — evidence that vaccination was not sterilizing.
“The recommendations for vaccinated people to mask weren’t wrong, they just weren’t clearly communicated,” he said. “This isn’t about flip-flopping. It’s about learning and improving as we learn.”
Because masking was divisive, it was difficult to satisfy everyone with guidelines about it, said Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and director of the immunocompromised host infectious diseases program at the University of California, San Francisco.
“The CDC’s reputation has been so damaged that they could say anything about these nonpharmaceutical interventions and people would criticize it,” he said.
Public health messaging on vaccines also has not always been clear, according to Pablo J. Sánchez, MD, a professor of pediatrics at The Ohio State University and physician at Nationwide Children’s Hospital.
The main message should have been that COVID-19 vaccines prevent serious disease, said Sánchez, who is a voting member on the CDC’s Advisory Committee on Immunization Practices. He indicated that clearer messaging could have cut down on some vaccine hesitancy.
People saw vaccinated people still getting sick and thought, “Yeah, bye,” Sanchez said. “But if it kept them out of the hospital, kept them out of the ICU, kept them from having multisystem inflammatory syndrome in children, if it kept them from dying, then the vaccine was working. I think that message was not made clear from the beginning.”
Chin-Hong called the CDC’s communications strategy during much of the pandemic “tremendously flawed,” especially in the first couple of years, and said it will be more difficult to issue guidance in future pandemics.
“That’s because they weren’t actionable recommendations, and they weren't specific enough,” Chin-Hong said. “For example, seeing all the ways you can potentially get COVID when it’s really one to three things people can do to cut down on the bulk of transmission.”
‘Unconscionable political pressure’
Political interference, especially early in the pandemic, made it difficult to fully evaluate how the CDC and FDA have performed, according to Kuppalli, who said both agencies struggled with interference, which affected the credibility of their decisions in the eyes of the public.
“The agencies have had to undergo unconscionable political pressure,” Gostin said.
Others echoed the concern that politics has played too large a role in pandemic-related decisions. The interference has come from both sides, Adalja said, citing the FDA’s EUA for hydroxychloroquine during the Trump administration and decisions made regarding boosters during the Biden administration.
“When the FDA gave hydroxychloroquine emergency use authorization for COVID, I think everyone was shocked, because at that point, we already had agents available, and it really was seen as a political move,” Chin-Hong said.
Adalja noted that two FDA vaccine experts decided to leave their jobs in the wake of the Biden administration declaring in August 2021 that booster shots would be available the following month, before the FDA had even authorized them.
“What the pandemic showed us, after all, is that science is political, even though it shouldn't be, and as long as our country remains divided, you're never going to have CDC and FDA guidance that really appeals to everyone,” Chin-Hong said.
Below the leadership levels, vaccine advisors on the ACIP and FDA’s Vaccines and Related Biological Products Advisory Committee have done “what they were meant to do, which is to provide scientific advice” to help guide authorizations and recommendations, Chin-Hong said. He said those expert panels, which have met dozens of times to discuss and make recommendations on vaccines, “continued to maintain scientific integrity throughout the process.”
Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia and voting member on the ACIP, said the committee is back to working mainly on nonpandemic vaccines with “absolutely no political interest.”
“It's fantastic, because we make decisions and look at the data unfettered that the president possibly could announce a White House plan pre-emptively or a public health policy ... that is not based solely on ACIP’s due diligence,” Long said.
‘We really ought to do a postmortem’
An issue that comes up frequently in discussions about pandemic preparedness in the U.S. is the country’s unwillingness to prepare appropriately.
“During the pandemic, we did not do a good job of anticipating problems and ended up being reactive to problems that arose,” Kuppalli said. “We need to look back at the COVID-19 pandemic and think about the lessons learned and how we can be better prepared for the future.”
Frieden and Gostin both recommended that the U.S. pursue an independent assessment of how the CDC and FDA performed during the pandemic — something akin to the 9/11 Commission that investigated the attacks on Sept. 11, 2001 — suggesting it could help the country prepare for next the one.
“There should be strong recommendations for reform,” Gostin said.
Pai said many of the public health shortcomings laid bare by COVID-19 — the lack of funding, proliferation of misinformation, political interference and supply chain limitations — could make it difficult to respond to the next pandemic.
“All aspects of our response really ought to be looked at with clear eyes,” Kimberlin said. “We really ought to do a postmortem on what we did, what worked and what did not work. That's not going to happen, because everybody's yelling at each other still ... but that's what we should do.”
References:
- Brown C, et al. MMWR Morb Mortal Wkly Rep. 2021;doi:10.15585/mmwr.mm7031e2.
- CDC calls on Americans to wear masks to prevent COVID-19 spread. https://www.cdc.gov/media/releases/2020/p0714-americans-to-wear-masks.html. Published July 14, 2020.
- CDC. CDC moving forward summary report. https://www.cdc.gov/about/organization/cdc-moving-forward-summary-report.html. Last reviewed Sept. 1, 2022. Accessed April 25, 2023.
- CDC. Science brief: Community use of masks to control the spread of SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-sars-cov2.html. Updated Dec. 6, 2021. Accessed April 27, 2023.
- Congressional Research Service. FY2022 NDAA: Overseas contingency operations. https://crsreports.congress.gov/product/pdf/IN/IN11839. Published Jan. 14, 2022. Accessed April 27, 2023.
- Cowger TK, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2211029.
- FDA. Laboratory developed tests. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests. Updated Sept. 27, 2018. Accessed April 27, 2023.
- Frieden T. What worked against Covid: Masks, closures and vaccines. The Wall Street Journal. March 17, 2023. Accessed April 27, 2023. https://www.wsj.com/articles/what-worked-against-covid-masks-closures-and-vaccines-aff2bafc.
- Prevent epidemics. Health Defense Operations. https://preventepidemics.org/health-defense-operations-hdo/. Accessed April 27, 2023.
- Statement from CDC Director Rochelle P. Walensky, MD, MPH, on today’s MMWR. https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html. Published July 30, 2021. Accessed April 27, 2023.
For more information:
- Amesh A. Adalja, MD, can be reached at aadalja1@jhu.edu.
- Peter Chin-Hong, MD, can be reached at peter.chin-hong@ucsf.edu.
- Tom Frieden, MD, MPH, can be reached at press@resolvetosavelives.org.
- Lawrence O. Gostin, JD, can be reached at gostin@georgetown.edu.
- David W. Kimberlin, MD, can be reached at dkimberlin@peds.uab.edu.
- Krutika Kuppalli, MD, can be reached at krutika.kuppalli@gmail.com.
- Sarah S. Long, MD, can be reached at sl58@drexel.edu.
- Gitanjali Pai, MD, AAHIVS, FIDSA can be reached at gpai@stilwellmemorial.com.
- Pablo J. Sánchez, MD, can be reached at mediarelations@nationwidechildrens.org.
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