Doctors Group Reviews Vaccine Evidence as Rules Change

The American Medical Association, a large group of doctors, is now looking closely at the evidence for COVID-19, flu, and RSV vaccines. This is happening because rules for vaccine advice from the government seem to be changing. The AMA wants to make sure the information about vaccines is clear and based on science.
By Newsroom | Health, United States |

A significant shift in how vaccine recommendations are being handled in the United States has prompted the American Medical Association (AMA), the nation's largest physician group, to launch its own comprehensive review of the safety and effectiveness of COVID-19, flu, and respiratory syncytial virus (RSV) vaccines. This independent undertaking comes as federal health agencies appear to be altering their established processes for evaluating and issuing vaccine guidance. The AMA's move signals a potential need for clearer, more consistently applied evidence-based assessments in the face of evolving public health needs and scientific data.

Context and Timeline of Events

For decades, the Advisory Committee on Immunization Practices (ACIP), a panel advising the Centers for Disease Control and Prevention (CDC), has been the primary body responsible for recommending vaccines for influenza, COVID-19, and RSV. Their recommendations have guided public health policies and informed healthcare providers and patients across the country.

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  • Past Practice: ACIP traditionally provided recommendations for annual flu and COVID-19 vaccines for individuals aged six months and older. RSV vaccine recommendations targeted adults over 75 and those over 50 with specific underlying health conditions.

  • Recent Changes: In the lead-up to the fall vaccination season, the AMA, in partnership with the Vaccine Integrity Project at the University of Minnesota's Center for Infectious Disease Research and Policy (CIDRAP), has initiated its own review process. This review is examining the evidence for COVID-19, flu, and RSV vaccines.

  • Federal Actions: Reports indicate that federal health agencies have been ending vaccine recommendations without apparent new supporting information. Furthermore, the CDC's ACIP recently voted to cease recommending the hepatitis B vaccine for newborns and certain other routine childhood vaccines, a move that has drawn attention.

  • Industry Developments: In parallel, the U.S. Food and Drug Administration (FDA) has declined to review Moderna's application for a new mRNA flu vaccine, citing issues with the company's submitted scientific data. This decision follows previous indications of support for the vaccine's development and suggests a tightening of review standards.

Evidence and Data Points

Multiple sources highlight the AMA's decision and the surrounding circumstances:

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America's largest medical authority to launch 'safety' review of Covid and flu vaccines - 1

  • AMA's Independent Review: The American Medical Association (AMA) has launched its own independent system to review scientific evidence concerning vaccine safety and effectiveness. This initiative involves collaboration with the Vaccine Integrity Project at CIDRAP.

  • The review focuses specifically on COVID-19, influenza, and RSV vaccines.

  • This represents a departure from the AMA's traditional focus on physician reimbursement and practice issues.

  • Federal Guidance Shift: Reports suggest that federal health agencies are ending vaccine recommendations based on a lack of new information, leading to concerns about the foundation of these public health advisements.

  • States and local health departments, as well as medical organizations, have historically relied on this evidence for policy and guidance.

  • Moderna's mRNA Flu Vaccine Application: The FDA has refused to review Moderna's application for a new mRNA flu vaccine, despite prior engagement with the company regarding its Phase 3 trials.

  • The FDA cited problems with the scientific data submitted by Moderna.

  • This refusal occurred even after the agency had previously recommended specific trial designs, including testing against a high-dose flu vaccine.

  • Published Vaccine Effectiveness Data: A study published in the New England Journal of Medicine affirms the safety and effectiveness of COVID-19, RSV, and influenza vaccines.

  • The review found acceptable safety profiles when these vaccines were administered together.

  • COVID-19 mRNA vaccines targeting the Omicron XBB.1.5 subvariant showed substantial effectiveness against hospitalization in adults and children.

Federal Guidance and Shifting Recommendations

The Advisory Committee on Immunization Practices (ACIP) has historically been the linchpin for vaccine recommendations in the U.S. However, recent actions suggest a departure from established patterns.

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  • Decreased Routine Recommendations: ACIP has voted to stop recommending the birth dose of the hepatitis B vaccine and other routine childhood immunizations, such as the measles, mumps, rubella, and chickenpox vaccine.

  • Reliance on Existing Data: Concerns have been raised that current federal recommendations for respiratory virus vaccines may not be based on new scientific evidence, prompting the need for independent assessment.

  • Impact on Policy: Traditionally, ACIP's recommendations have served as the bedrock for vaccination policies adopted by states, local health departments, and various medical organizations. A shift in this process could have wide-ranging implications.

Independent Review and Collaboration

The AMA's decision to collaborate with the Vaccine Integrity Project underscores a commitment to a rigorous, evidence-based approach to vaccine assessment.

  • Partnership with CIDRAP: The Vaccine Integrity Project, housed at the University of Minnesota's CIDRAP, is a key collaborator in this independent review.

  • Scope of Review: The project has also undertaken reviews of evidence for the hepatitis B vaccine's birth dose and HPV vaccination data, demonstrating a broad interest in vaccine evidence.

  • Addressing Information Gaps: This independent effort aims to ensure that recommendations are robustly supported by scientific data, especially during periods of changing federal practices.

FDA's Stance on New Vaccine Technologies

The FDA's decision regarding Moderna's mRNA flu vaccine highlights the agency's evolving approach to evaluating novel vaccine technologies and submitted data.

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  • Data Scrutiny: The FDA's refusal to review Moderna's application, citing data issues, suggests a heightened level of scrutiny for new vaccine submissions, particularly those utilizing mRNA technology.

  • Tightened Standards: This follows the FDA's setting of stricter approval standards and narrowed use for COVID-19 vaccines.

  • Technological Promise: mRNA technology holds the potential for more precisely targeted flu vaccines, offering an alternative to traditional egg-based methods that can have production and matching challenges. The FDA's decision in this instance, however, signals that the pathway for approval requires meeting stringent data requirements.

Expert Analysis and Observations

  • Dr. Robert Rasmussen, quoted in reports, has suggested that the FDA's decision regarding Moderna's vaccine aligns with a broader pattern of changing agency stances. This implies that the refusal may not be an isolated incident but part of a larger trend in regulatory review.

  • Concerns exist among some experts that federal agencies might be "abdicating responsibility" for providing clear, evidence-based vaccine guidance. This sentiment underpins the motivation for independent reviews.

  • The established efficacy and safety of current COVID-19, flu, and RSV vaccines are supported by published research, including findings in the New England Journal of Medicine. This highlights the contrast between existing data and the current evaluation landscape.

Conclusion and Implications

The American Medical Association's decision to initiate an independent review of COVID-19, flu, and RSV vaccine evidence marks a significant development in the landscape of vaccine recommendations. This action appears to be a response to perceived shifts in federal guidance processes and the FDA's stricter review of new vaccine applications.

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  • Enhanced Scrutiny: The AMA's review, in partnership with the Vaccine Integrity Project, suggests a need for continued and thorough evaluation of vaccine data to ensure public trust and informed decision-making.

  • Potential for Divergent Guidance: If the AMA's independent review yields different conclusions or emphasizes different data points than future federal guidance, it could create confusion among healthcare providers and the public.

  • Focus on Evidence: The move underscores the critical importance of transparent, evidence-based recommendations, particularly for widely used public health interventions like vaccinations against common respiratory viruses.

  • Future of Vaccine Guidance: The AMA's proactive step may influence how vaccine recommendations are developed and disseminated, potentially leading to more robust oversight mechanisms in the future. The impact of the FDA's decision on future vaccine development, particularly using mRNA technology, remains to be seen.

Sources

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Frequently Asked Questions

Q: Why is the American Medical Association reviewing vaccines?
The AMA is reviewing COVID-19, flu, and RSV vaccines because they see changes in how the government gives advice about vaccines. They want to make sure the information is clear and correct.
Q: What vaccines are being reviewed?
The review is looking at vaccines for COVID-19, the flu, and RSV (a breathing illness).
Q: What does this mean for people?
This review helps make sure that the advice given about vaccines is based on good science. It aims to provide clear and trustworthy information for everyone.