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HHS Rejects Study: COVID Vaccines Prevent Hospitalization, ER Visits

A new study indicating that COVID-19 vaccines significantly reduced hospitalization and ER visits for US adults last fall and winter was reportedly blocked from publication by the CDC. Sources claim CDC Director Dr. Jay Bhattacharya halted the publication in the MMWR, citing methodological concerns. Critics argue this rejection is unusual because the study used the standard, established 'test-negative design' via the CDC-led VISION network. The controversy occurs against a backdrop of recent, notable policy shifts by the HHS regarding vaccine recommendations for various demographics.

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HHS Rejects Study: COVID Vaccines Prevent Hospitalization, ER Visits

A new study indicates that COVID-19 vaccines significantly reduced the risk of hospitalization and emergency room visits for US adults last fall and winter, yet the CDC has reportedly blocked its publication.

CDC Blocks Publication of Vaccine Efficacy Study

Sources familiar with the findings revealed that COVID-19 vaccines roughly halved the chances that a US adult would require an ER visit or hospitalization due to infection during the previous fall and winter season. However, the Centers for Disease Control and Prevention (CDC) allegedly prevented the publication of these findings in its flagship journal, the Morbidity and Mortality Weekly Report (MMWR).

  • The current CDC Director, Dr. Jay Bhattacharya, is reported to have blocked the publication.
  • The authors of the study reportedly received an official rejection letter from the journal on Tuesday, despite the research having passed internal reviews and being scheduled for publication.
  • Andrew Nixon, deputy assistant secretary for media relations at the US Department of Health and Human Services (HHS), confirmed the rejection, stating the MMWR’s editorial assessment found concerns regarding the methodological approach to estimating vaccine effectiveness.

Methodological Concerns and Scientific Process

The rejection is considered unusual by experts because the study employed standard methodologies and utilized the CDC-led VISION collaboration.

  • VISION Network: This collaboration uses electronic health records from nine US health systems to monitor vaccine effectiveness across various age groups season over season.
  • Test-Negative Design: The study used this established method, which compares vaccination status between individuals who test positive for an infection versus those who test negative. This design helps minimize bias known as the 'healthy user effect.'
  • Industry Standard: This test-negative design is the standard approach for measuring vaccine effectiveness for not only COVID-19 but also for seasonal viruses like influenza and RSV.
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Dr. Fiona Havers, a former senior vaccine policy adviser at the CDC, described the rejection as "pretty problematic in general, because it’s a very standard, well-established study design that has been used for a long time."

Expert Criticism of the Rejection

Several former CDC officials and experts voiced concern over the process:

  • Dr. Havers noted that the VISION network has a history of publishing in top-tier journals, including The New England Journal of Medicine and The Lancet.
  • Dr. Deb Houry, a former CDC chief medical officer, stated that the methodology was appropriate and rarely rejected at such a late stage in the review process.

Context: HHS Policy Shifts on Vaccines

The controversy emerges amid notable shifts in vaccine policy from the HHS under current leadership. These changes include:

  • Pregnancy and Children: In June, HHS announced that COVID-19 vaccines would no longer be recommended for pregnant women and children.
  • General Recommendations: In September, new vaccine advisers removed the CDC's blanket recommendation for all individuals aged six months and older, shifting the guidance to require shared clinical decision-making (i.e., a recommendation or prescription from a doctor or pharmacist).
  • Political Statements: During recent congressional hearings, HHS officials disputed claims that their views on vaccines influenced declining vaccination rates.
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