Over the past month, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) leaders prohibited reports on the safety and effectiveness of COVID-19 and shingles vaccines from being published multiple times. Leadership says this is because of concerns about research methods. Yet those methods are widely used, well tested, and trusted in public health research.
These reports had already gone through a process known as peer-review. Peer-reviewed research that goes through a clear, careful review process helps health decision-makers recommend vaccines, which in turn helps families make informed decisions about their health. Transparency and new research methods help improve science and improving science can support new ways to protect families from infectious diseases.
In one report, researchers were going to publish their review of millions patient records. Their analysis found that serious side effects were rare.
In another report, the CDC study evaluated how well the COVID-19 vaccine worked last year, but researchers were unable to publish this study. Leaked reports show us that by comparing hospitalization rates of people who received the COVID-19 vaccine and those who did not, the vaccine reduced emergency room and hospital admissions by about 50%. This report was not approved for publication by the current leader of the CDC, even after the findings completed internal review and clearance.
CDC leadership claims it has concerns with something called the test-negative design (TND). CDC scientists say they use this method regularly, including in a study published the week before in MMWR.
Dr. Jay Bhattacharya, who currently serves as CDC’s leader, defended the decision, saying that the TND used in the study affected the conclusion that the COVID-19 vaccine was effective in preventing serious outcomes (i.e., hospitalization).
The TND is used to measure how well vaccines work in real life. One of the biggest challenges in this kind of research is outside factors that can distort the results, or bias. The TND is designed to reduce these problems, especially healthy user bias. In simple terms, it helps researchers compare people who sought care for similar symptoms, which can make the results more reliable.
The research methods used by career government scientists, namely the TND and large retrospective cohort studies, are standard practice around the world, scientifically sound, and important for public health. Reasons given by Health and Human Services (HHS) leadership for holding back these studies do not line up with how these methods are interpreted and used by independent scientific experts.
Independent reviewers said there was nothing inherently wrong with the reports and that they offered useful information. The blocked studies found results like earlier clinical trials, including rare cases of myocarditis or allergic reactions, while still concluding that vaccine benefits outweighed the risks.
Our health leaders have been saying they want to improve transparency in health decision-making. Blocking the publication of well-researched, studies that help us understand what benefits and side effects vaccines are, is not transparent. These studies have been funded by your taxpayer dollars. The public deserves to know what they say and what those findings mean for our health.