FDA Blocks Publication of COVID-19 and Shingles Vaccine Safety Studies: What Pharmacists Need to Know

According to new reports, federal health officials at the FDA blocked the publication of multiple vaccine safety studies for COVID-19 and recombinant zoster (shingles) vaccines in late 2025 and early 2026. The development has sparked debate across the medical and regulatory communities, particularly as vaccine confidence remains a critical public health priority.¹

Reported Suppression of Safety Data

According to a report from The New York Times, FDA staff scientists conducted or reviewed analyses that did not identify significant safety concerns for either COVID-19 vaccine or the recombinant zoster vaccine (RZV, Shingrix; GSK). However, the publication of these findings in a peer-reviewed journal was allegedly halted or delayed by agency leadership.¹

Two of the COVID-19 vaccine studies were withdrawn in October 2025 after scientists were directed to pull them. In February 2026, top FDA officials declined to approve submission of RZV-related study abstracts to a major drug safety conference.¹

The rationale for the decision has not been fully detailed publicly, but the move has drawn scrutiny, given longstanding FDA norms supporting transparency and timely dissemination of scientific data. Public availability of safety data is widely considered essential for maintaining trust in vaccination programs and informing clinical decision-making.¹

A spokesperson for the Department of Health and Human Services (HHS), which oversees the FDA, confirmed the withdrawals to multiple outlets. The official rationale offered was that the studies' conclusions exceeded what the underlying data could support.¹

The withdrawals are taking place under HHS Secretary Robert F. Kennedy Jr, a prominent vaccine skeptic who has repeatedly expressed doubt about the safety and efficacy of several vaccines, including COVID-19 and childhood immunization schedules.¹

Established Safety Profile of COVID-19 and Shingles Vaccines

Extensive evidence continues to support the safety and efficacy of both COVID-19 and RZV vaccines. Postmarketing surveillance systems, including the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, have consistently demonstrated that serious adverse events are rare and that benefits outweigh risks.^2,3

For COVID-19 vaccines, large-scale observational studies and ongoing CDC monitoring have reinforced favorable safety profiles across diverse populations, even as booster recommendations evolve. Similarly, the recombinant zoster vaccine has shown high efficacy in preventing shingles and related complications, with a well-characterized safety profile supported by clinical trials and real-world data.^2,4

Implications for Pharmacists on the Front Lines

Pharmacists play a central role in vaccine delivery and patient education, making transparency in safety data particularly important. Reports suggesting delayed publication of reassuring safety findings may complicate conversations with vaccine-hesitant patients.

In practice, pharmacists are often asked to interpret emerging news and address concerns in real time. Situations like this underscore the importance of relying on the totality of evidence rather than individual reports. Pharmacists should be prepared to contextualize such developments by emphasizing the robust body of existing safety data and the multiple independent systems that continuously monitor vaccine safety.

Additionally, pharmacists may need to clarify the distinction between regulatory processes and scientific consensus. Although internal agency decisions can affect how and when data are released, they do not necessarily reflect changes in the underlying evidence regarding vaccine safety.

Transparency and Public Trust

Transparency has long been a cornerstone of successful immunization programs. Public confidence can be influenced not only by the data itself but also by how openly the data are communicated. Experts note that delays in publishing reassuring findings may inadvertently contribute to misinformation or skepticism, particularly in an environment already shaped by heightened scrutiny of vaccines.¹

Professional organizations, including the CDC and FDA, have emphasized their commitment to ongoing safety monitoring and data sharing. However, the current controversy may prompt renewed calls for clearer policies around publication practices and scientific independence within federal agencies.²

Maintaining Evidence-Based Practice

Despite the concerns raised in the report, current clinical recommendations for both COVID-19 and shingles vaccination remain unchanged. The CDC continues to recommend COVID-19 vaccination based on age and risk factors, as well as routine use of recombinant zoster vaccine in adults 50 years and older.^2,4

For pharmacists, the priority remains delivering evidence-based care while addressing patient concerns with clarity and accuracy. Reinforcing known safety data, explaining how vaccine monitoring systems work, and acknowledging uncertainties transparently can help sustain patient trust.

Looking Ahead

The reported actions by the FDA may lead to further investigation or policy clarification regarding the handling and publication of internal research. In the meantime, health care providers, including pharmacists, will continue to play a key role in bridging the gap between evolving regulatory developments and patient understanding.

As vaccine discourse continues to evolve, timely and transparent communication of scientific findings will remain essential to supporting informed decision-making and maintaining confidence in public health interventions.

REFERENCES

1. Jewett C. FDA blocked publication of research on COVID-19 and shingles vaccine safety. New York Times. May 5, 2026. Accessed May 6, 2026. https://www.nytimes.com/2026/05/05/us/politics/fda-covid-vaccine-studies.html?unlocked_article_code=1.gFA.XH5g.f1ZrCLsixpj4&smid=nytcore-ios-share&login=email&auth=login-email

2. COVID-19 vaccine safety reporting systems. CDC. January 31, 2025. Accessed May 6, 2026. https://www.cdc.gov/vaccine-safety-systems/monitoring/covid-19.html

3. COVID-19 vaccine safety surveillance. FDA. January 10, 2025. Accessed May 6, 2026. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance

4. Clinical considerations for Shingrix use in immunocompromised adults aged ≥19 years. CDC. July 9, 2024. Accessed May 6, 2026. https://www.cdc.gov/shingles/hcp/vaccine-considerations/immunocompromised-adults.html