“The policies we adopted during the COVID-19 pandemic still reverberate and shape many of our public health debates and challenges today,” said David Grande, MD, MPA, “It’s essential to take stock of how data and evidence, communication strategies and political dynamics shaped pandemic decisions. What lessons have we learned? And perhaps most importantly, how can we apply what we learned to prepare more effectively for future public health threats?”

Grande, LDI Director of Policy and Professor of Medicine at the Perelman School of Medicine was opening the Sept. 19 Penn LDI seminar designed to assess the continuing aftermath of that national emergency.

The event featured two academics who have been heavily involved in analyzing the logistics of the pandemic response at the national and state level: Frances Lee, PhD, Professor of Politics and Public Affairs at Princeton and Paul Offit, MD, Director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Lee is the co-author of the book published earlier this year, “In COVID’s Wake: How Our Politics Failed Us” that analyzes how measures including school closures, lockdowns, and masking were adopted in ways that often contradicted both pre-pandemic government guidance and sound evidence, disproportionately impacting children and disadvantaged families.

Offit is an internationally respected vaccine scientist, pediatrician, and educator, best known as co-inventor of the rotavirus vaccine RotaTeq. A Professor at the Perelman School of Medicine, he also directs the Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP). He has long served on FDA, CDC, and national vaccine policy boards. But last month, he was dismissed from the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) by Health and Human Service Secretary Robert F. Kennedy Jr.

A Range of Topics

The seminar discussion ranged over topics that included:

• COVID mRNA vaccines were a major success in being a safe way to prevent hospitalizations and death.
• The evidence on non-pharmaceutical interventions (NPIs) — masking, social distancing, lockdowns, and school closures, etc. — is inconclusive. NPIs slowed transmission but did not clearly reduce mortality rates.
• The reluctance of policymakers to acknowledge that prior COVID infection conferred immunological protection to an individual like vaccines.
• A major communications mistake was the overselling of the idea that vaccines could stop transmission and achieve herd immunity.
• Both state and federal government offices often departed from, or did not fully implement, established federal pandemic response plans, resulting in a fragmented national response and large differences in the policies and measures instituted by individual states.
• The lack of a centralized, orderly and comprehensive collection of evidence during the pandemic now makes the task of assessing what did and did not work during that emergency more difficult.

Corroded Public Trust

A bottom line of it all is that political animosity, organizational confusion, a chaotic communications environment, and broad misinformation campaigns significantly corroded public trust in government health officials and medical professionals at the same time they strengthened the anti-science, anti-vaccine movement that has gained such political traction in conservative circles today.

Offit cited the 2020 hydroxychloroquine incident as an example of government action that seriously eroding the public’s trust. The opening months of the pandemic witnessed the sudden rise of a misinformation campaign hyping the anti-malarial drug hydroxychloroquine as a COVID cure. Without evidence of the drug’s effectiveness, the Trump administration ordered 29 million doses at the same time it was reported to have pressured FDA to approve that through emergency use authorization (EUA). After three months on the market and, as studies and clinical reports showed hydroxychloroquine was useless against COVID, the FDA withdrew its authorization.

“The FDA wasn’t doing its job, which was to stand between the pharmaceutical company and the American public to make sure that we were getting products that were safe and at least effective,” said Offit. “It scared people that now the government can really twist the arm of the FDA to do what it wants despite what evidence does or does not exist. As a result, at least ten states formed their own advisory committees. They no longer trusted the FDA.”

Ignored Established Guidance

Lee pointed out that from the start, the U.S. federal and state governments seemed to be adrift and unwilling to follow established guidance for managing pandemics like this one. She pointed out that in 2019, the World Health Organization had published a comprehensive review of recommendations for a whole range of non-pharmaceutical interventions (NPIs) during a pandemic. Its researchers had systematically gone through the evidence base for each NPI and recommended which should or should not be used.

“But when you look back at the early period the pandemic in the spring of 2020, it’s quite remarkable that what was being considered across the U.S. states was quite at odds with the new WHO recommendations,” said Lee.

Looking back at vaccine development operations, Offit characterized Operation Warp Speed as “an enormous success” and “one of the greatest scientific or medical advances in my lifetime. Within 11 months you had data suggesting this vaccine was highly effective at preventing what you wanted to prevent — keeping people out of the hospital, out of the ICU, and from dying. And the safety price paid — myocarditis — was pretty small. We haven’t seen that from mRNA vaccines in the last few years.”

Exaggerated Public Messaging

He did fault the promotional campaigns designed to increase the public’s vaccine uptake.

“The COVID-19 virus — SARS-CoV-2 — had a short incubation period and we knew you weren’t going to protect against mild disease for long,” Offit said. “Once you’re four or six months past either your natural infection or vaccination, the antibodies in your circulation system will start to decline and protection against mild to moderate disease wasn’t going to be very good. So, while the vaccine was remarkably effective at preventing transmission, it certainly didn’t eliminate it. And because we were all so desperate to get people vaccinated, I think that we may have oversold this vaccine to the public a little bit.”

Not a “Breakthrough”

Those not-well-understood characteristics of the vaccine led to erroneous reports of alarming “breakthrough” infections among people who had been vaccinated. The case that generated national headlines involved a group of 300 people attending a 2021 July 4th celebration in Provincetown, Massachusetts.

“This term, ‘breakthrough’ really bugged me during the pandemic,” Offit said. “It was so frustrating that even the CDC reported that Provincetown case as a ‘breakthrough.’ That term implies failure. But this was not a failure. Only about one percent of the infected people in Provincetown were hospitalized. I remember elsewhere around that same time that Lindsey Graham reported he had a mild case but that it would have been much worse if he hadn’t been vaccinated. He got it right. The vaccine kept him out of the hospital and that was the goal.”

Impact of Social Measures a Mystery

According to Lee, the available evidence is that the introduction of effective vaccines in December 2020 played a major role in reducing mortality in the states that strongly promoted vaccination. At the same time there’s not a correlation between excess deaths and the use of non-pharmaceutical interventions like social distancing, masking, lockdowns and school and business closings.

“Looking back, it is not clear which of the NPIs made a difference,” said Lee. “There’s good evidence that they slowed transmission, but we don’t have good evidence that mortality rates differed in places that instituted them and places that did not. This is something that needs a lot more retrospective study. NPIs were enormously disruptive and costly. They had many secondary harms. The evidence is not that we’re sure they did not work, instead, it’s that we just don’t have strong evidence that they did achieve their goals.”

Controversy Over “Natural Immunity”

Another area of broad misunderstanding by public health officials and employers was related to the natural immunity created when a person catches and survives a COVID infection. That natural immunity was widely not “counted” as being like a vaccination. As a result, large numbers of people who had natural immunity and declined to follow employer vaccination mandates were fired from their jobs or otherwise stigmatized — situations that generated anger and resentment.

“I just think we miscommunicated about that, and it wasn’t fair,” said Offit. “When you’re vaccinated, you’re getting an immune response to one viral protein, the spike protein, but when you’re infected and survive you’re actually making immune response to all four viral proteins of the virus. You could argue that it’s better being naturally infected, assuming you live.”

He noted that in a February 2022 Zoom meeting of eight top HHS officials and virologists, he voted for the agency to recognize natural immunity as being equal to vaccination, but he said he was outvoted. He also said he didn’t like the term “natural immunity” and wanted to call it “survivor immunity.”

COVID is With Us Forever

Offit also pointed out it’s still not generally appreciated that because, like flu or RSV, the characteristics of COVID-19 are such that the disease cannot be eliminated as we once did with diseases like measles or mumps.

“Even if the whole world was vaccinated every year, this virus is going to continue to circulate,” Offit said. “We knew that because we had decades and decades of experience with this kind of virus in the pathogenesis of this kind of virus. I just don’t think we communicated it right.”

Need for a Government Commission

Because of the lack of evidence about NPIs and other aspects of the pandemic, Lee emphasized that the country isn’t well prepared for the next pandemic. She suggested there should have been — and should still be — a government commission established to objectively analyze the COVID pandemic response.

“I think certainly one is warranted,” said Lee. “But there has been hesitancy and a reluctance to look back. For instance, there have been very few conferences held at universities where you would have evidence systematically analyzed. If we are going to handle this in a responsible way, we need to look at what we did, what worked, what were the harms, and what were the costs. Even if we can’t reach official consensus, it could help to generate a more mutual understanding about what can be learned from the experience so that we can do better next time.”

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