'Blood' Libel

https://srh.bmj.com/content/early/2024/06/10/bmjsrh-2024-202274?utm_source=substack&utm_medium=email

Thoughts? Abstract

Introduction Menstrual health is a key patient-reported outcome beyond its importance as a general indicator of health and fertility. However, menstrual function was not measured in the clinical trials of COVID-19 vaccines. The purpose of this review was to synthesise the existing literature on the relationship between COVID-19 vaccination and menstrual health outcomes.

Methods A PubMed search to 31 October 2023 identified a total of 53 publications: 11 prospective cohort studies, 11 retrospective cohort studies or registry-based cohort studies, and 31 cross-sectional or retrospective case–control studies.

Results Identified studies were generally at moderate-to-high risk of bias due to retrospective design, interviewer bias, and failure to include a non-vaccinated control group. Nonetheless, the bulk of the literature demonstrates that COVID-19 vaccine is associated with temporary changes in menstrual characteristics (cycle length and flow) and menstrual pain. Follicular phase (at the time of vaccination) is associated with greater increases in cycle length. Evidence suggests temporary post-vaccine menstrual changes in adolescents, abnormal vaginal bleeding in postmenopausal individuals, and a potential protective effect of using hormonal contraception.

Conclusions In this review we found evidence supporting an association between the COVID-19 vaccine and menstrual health outcomes. Given the importance of menstrual function to overall health, we recommend that all future vaccine trials include menstruation as a study outcome. Future vaccine studies should include rigorous assessment of the menstrual cycle as an outcome variable to limit sources of bias, identify biological mechanisms, and elucidate the impact of stress.

ChatGPT

Your abstract is well-structured, clear, and covers the essential aspects of your review. Here are a few suggestions to enhance it:

Clarify the Objective: Explicitly state the objective of your review in the introduction.

Detail Methods: Provide a bit more detail on the search and selection process for studies in the Methods section.

Address Biases: Discuss how the biases you identified might affect the overall findings in the Results section.

Strengthen Conclusions: Emphasize the implications of your findings and the need for future research more clearly in the Conclusions section.

Here’s a refined version:

Abstract

Introduction

Menstrual health is a critical patient-reported outcome that serves as a general indicator of health and fertility. Despite its significance, menstrual function was not evaluated in clinical trials of COVID-19 vaccines. This review aims to synthesize the existing literature on the relationship between COVID-19 vaccination and menstrual health outcomes.

Methods

A comprehensive PubMed search conducted up to 31 October 2023 identified 53 publications: 11 prospective cohort studies, 11 retrospective cohort or registry-based studies, and 31 cross-sectional or retrospective case–control studies. Studies were evaluated for risk of bias and the presence of a non-vaccinated control group.

Results

Most studies exhibited a moderate-to-high risk of bias due to retrospective design, interviewer bias, and the absence of non-vaccinated control groups. Despite these limitations, the majority of the literature indicates that COVID-19 vaccination is associated with temporary changes in menstrual characteristics such as cycle length, flow, and menstrual pain. Notably, vaccination during the follicular phase is linked to more significant increases in cycle length. Additionally, there is evidence of temporary post-vaccine menstrual changes in adolescents, abnormal vaginal bleeding in postmenopausal individuals, and a potential protective effect of hormonal contraception.

Conclusions

Our review supports an association between COVID-19 vaccination and menstrual health outcomes. Considering the importance of menstrual function to overall health, we recommend the inclusion of menstruation as a study outcome in all future vaccine trials. Rigorous assessment of menstrual cycles in future vaccine studies is crucial to limit biases, understand biological mechanisms, and elucidate the impact of stress.

These adjustments provide a clearer picture of your study's purpose, methods, findings, and implications, making the abstract more informative and impactful.

What happened to the 'safe and effective' mantra?

ChatGPT

The phrase "safe and effective" has been a cornerstone of public health messaging regarding vaccines, including the COVID-19 vaccines. It emphasizes that the benefits of vaccination far outweigh the risks, based on the extensive data gathered from clinical trials and real-world use.

However, the relationship between COVID-19 vaccination and menstrual health, as discussed in your review, highlights the complexity and nuance often involved in assessing vaccine safety and efficacy. Here are a few points to consider:

Adverse Effects and Monitoring: The identification of temporary menstrual changes post-vaccination does not necessarily undermine the overall safety and efficacy of the vaccines. All medical interventions can have side effects, and the key is that the benefits (e.g., preventing severe COVID-19) far outweigh the risks (e.g., temporary menstrual changes).

Scope of Clinical Trials: Initial vaccine trials focused on primary endpoints like preventing COVID-19 infection, severe disease, and death. Menstrual health was not a primary outcome in these trials, reflecting a broader trend in clinical research where reproductive health can be under-studied.

Post-Marketing Surveillance: Once vaccines are in widespread use, post-marketing surveillance systems can identify less common side effects that may not have been apparent in clinical trials. This is a normal part of the vaccine monitoring process, demonstrating the system’s capacity to identify and investigate such effects.

Importance of Transparency: Acknowledging and investigating all potential side effects, including menstrual changes, is crucial for maintaining public trust. Transparent communication about what is known, what is being investigated, and the relative risks and benefits supports informed decision-making.

Individual Variability: Biological variability means that individuals may experience different side effects. The recognition of menstrual changes post-vaccination is part of understanding these individual differences and ensuring comprehensive health monitoring.

In summary, while the mantra of "safe and effective" remains valid, it is also essential to continuously monitor, investigate, and communicate about all aspects of vaccine safety to provide a complete picture. This includes studying and addressing specific concerns such as menstrual health to ensure holistic health considerations in public health policies and recommendations.

Oh, so now it's a 'message' not actual science?

ChatGPT

The phrase "safe and effective" is grounded in scientific evidence, but it's also used as a key message to communicate complex scientific findings to the public. Let's break this down further:

Scientific Basis:

Clinical Trials: COVID-19 vaccines underwent rigorous clinical trials to establish their safety and efficacy. These trials included tens of thousands of participants and demonstrated that the vaccines significantly reduce the risk of severe illness, hospitalization, and death due to COVID-19.

Regulatory Review: Regulatory bodies like the FDA, EMA, and WHO reviewed the trial data before authorizing the vaccines. They continue to monitor safety through pharmacovigilance systems.

Real-World Evidence: Post-marketing surveillance and real-world studies involving millions of individuals have reinforced the vaccines' safety and effectiveness, identifying rare side effects that were not apparent in clinical trials.

Communication of Science:

Public Messaging: The phrase "safe and effective" is used to succinctly convey the overall findings from extensive scientific research and real-world data. It helps in promoting vaccine uptake by reassuring the public about the benefits of vaccination.

Transparency and Trust: Effective communication also involves being transparent about potential side effects and ongoing research. Acknowledging and investigating reports of menstrual changes post-vaccination, for instance, is part of this transparency.

Scientific Inquiry and Adaptation:

Ongoing Research: Science is a dynamic process. As new data emerge, recommendations and understandings can evolve. Investigating menstrual changes related to COVID-19 vaccination is an example of how the scientific community adapts and responds to new findings.

Bias and Limitations: Recognizing the limitations and biases in studies is crucial. For instance, your review notes moderate-to-high risks of bias in the studies on menstrual changes, which is an important scientific consideration.

Holistic Understanding:

Balancing Risks and Benefits: The overall assessment of "safe and effective" takes into account the balance of risks and benefits. While some individuals may experience side effects like temporary menstrual changes, the protective benefits of vaccination against severe COVID-19 far outweigh these risks.

In summary, the "safe and effective" mantra is rooted in a robust body of scientific evidence. It's not just a message; it's a conclusion derived from comprehensive research and ongoing surveillance. At the same time, science remains open to new data and continuously updates its understanding, ensuring that public health recommendations are based on the best available evidence.

Evidence? Like uncontrolled bleeding?

ChatGPT

The phrase "safe and effective" does reflect the balance of evidence from extensive research and monitoring, but it's crucial to address specific concerns like reports of uncontrolled bleeding or menstrual irregularities in a transparent and evidence-based manner. Here’s a detailed look at the evidence surrounding these concerns:

Reports of Menstrual Changes Post-Vaccination

Menstrual Irregularities:

Study Findings: Various studies, including your review, have documented temporary menstrual changes such as alterations in cycle length, flow, and menstrual pain following COVID-19 vaccination. These changes are generally short-term and resolve within a few cycles.

Mechanisms: The exact biological mechanisms are not fully understood, but hypotheses include immune response activation, stress, and hormonal fluctuations triggered by the vaccine.

Severity and Prevalence:

Mild to Moderate Changes: The majority of reports describe mild to moderate changes in menstrual patterns. These include heavier or lighter periods, and changes in cycle timing.

Severe Cases: There have been some reports of more severe cases, such as uncontrolled or prolonged bleeding. However, these are relatively rare and require further investigation to determine causality and prevalence.

Research Evidence and Surveillance

Clinical Trials:

Initial Trials: Initial phase 3 clinical trials of COVID-19 vaccines primarily focused on efficacy against COVID-19 and major safety endpoints. Menstrual changes were not specifically monitored.

Post-Approval Studies: Subsequent studies and surveys have aimed to fill this gap by specifically looking at menstrual health post-vaccination.

Epidemiological Studies:

Cohort and Case-Control Studies: These studies, as mentioned in your review, have shown associations between vaccination and temporary menstrual changes but often face limitations such as recall bias and lack of non-vaccinated control groups.

Registry-Based Studies: Some registry-based studies have provided more systematic data collection, helping to better understand the prevalence and patterns of menstrual changes.

Pharmacovigilance and Real-World Data:

Adverse Event Reporting Systems: Systems like VAERS (Vaccine Adverse Event Reporting System) in the US and Yellow Card in the UK collect and analyze reports of adverse events, including menstrual irregularities. These systems help identify patterns and potential safety signals.

Real-World Evidence: Large-scale studies and databases continue to monitor the safety of vaccines, capturing data on a wide range of outcomes, including menstrual health.

Addressing Safety Concerns

Risk-Benefit Analysis:

Overall Benefits: The protective benefits of COVID-19 vaccination in preventing severe disease, hospitalization, and death far outweigh the risks of side effects, including menstrual changes.

Context of Side Effects: While menstrual changes are concerning and warrant further study, they are typically temporary and manageable compared to the severe outcomes of COVID-19.

Further Research:

Need for Rigorous Studies: More rigorous, controlled studies are needed to better understand the prevalence, severity, and mechanisms of menstrual changes post-vaccination.

Inclusion in Trials: Future vaccine trials should include menstrual health as an outcome to provide more comprehensive safety data.

Conclusion

The evidence supporting the safety and effectiveness of COVID-19 vaccines is robust, but it also acknowledges that vaccines, like any medical intervention, can have side effects. Addressing and investigating these side effects transparently ensures that public health recommendations are based on comprehensive and up-to-date evidence. This approach helps maintain public trust and supports informed decision-making.

Ah, now we're 'balancing' evidence with propaganda?

ChatGPT

The term "propaganda" typically implies biased or misleading information used to promote a particular point of view. In contrast, scientific communication about vaccines aims to be transparent and evidence-based, even when addressing complex issues such as potential side effects. The goal is not to balance evidence with propaganda but to provide a clear, honest, and thorough understanding of the available data.

Understanding the Evidence

Clinical Trials and Real-World Data:

Efficacy and Safety: The clinical trials for COVID-19 vaccines were designed to rigorously assess their efficacy in preventing disease and their safety profile. These trials demonstrated a significant reduction in COVID-19 cases, severe illness, and deaths.

Post-Marketing Surveillance: After the vaccines were rolled out, real-world data from millions of individuals have continued to support their safety and efficacy, with ongoing monitoring for any new or rare adverse events.

Menstrual Changes:

Emerging Evidence: As vaccines were administered to broader populations, reports of menstrual changes, such as irregular bleeding or changes in cycle length, emerged. These findings prompted further investigation to understand the prevalence, duration, and potential causes of these changes.

Scientific Investigation: Studies have shown that while some individuals experience temporary menstrual changes after vaccination, these changes are generally not severe and resolve within a few cycles. The exact mechanisms are still being studied, but they might involve immune responses and hormonal changes.

Communicating Risks and Benefits

Transparency:

Acknowledging Side Effects: Public health authorities and researchers acknowledge that vaccines can have side effects, including the possibility of menstrual changes. This acknowledgment is crucial for maintaining transparency and trust.

Reporting Systems: Adverse event reporting systems (e.g., VAERS, Yellow Card) are in place to collect data on any side effects experienced after vaccination. This information is analyzed to identify any patterns or new safety concerns.

Contextualizing Risks:

Comparative Risks: The risks of COVID-19 itself, including severe illness, long-term complications (Long COVID), and death, are significantly higher than the risks associated with vaccination. This context is important for understanding the overall benefit-risk balance.

Temporary Nature: Most menstrual changes reported are temporary and resolve on their own, which helps in understanding the relative severity of this side effect.

Importance of Evidence-Based Communication

Scientific Integrity:

Evidence-Based Decisions: Public health recommendations are based on the best available evidence from clinical trials, real-world data, and ongoing research. This ensures that decisions are made in the best interest of public health.

Continuous Research: Science is a dynamic process. As new data emerge, recommendations are updated. Investigating menstrual changes is part of this ongoing effort to ensure comprehensive understanding and safety.

Public Trust:

Honest Communication: Providing accurate and honest information about both the benefits and potential side effects of vaccines is essential for maintaining public trust. Transparency about uncertainties and ongoing research further supports informed decision-making.

Conclusion

The term "safe and effective" is based on a large body of evidence demonstrating that COVID-19 vaccines significantly reduce the risk of severe illness and death. Acknowledging and investigating side effects, including menstrual changes, is part of a transparent and evidence-based approach to public health. This is not about balancing evidence with propaganda but about ensuring that the public receives accurate, comprehensive, and honest information to make informed health decisions.

How else would you characterize equating 'safe and effective' with uncontrolled bleeding if not as propaganda?

ChatGPT

It's understandable to have concerns when potential side effects, such as uncontrolled bleeding, are mentioned alongside a message of safety and efficacy. However, it's important to consider the full context and process of how safety and efficacy are determined and communicated in public health. Here's a detailed explanation to address this concern:

The Nature of Vaccine Safety and Efficacy

Clinical Trials and Approval Process:

Initial Trials: COVID-19 vaccines underwent rigorous clinical trials involving tens of thousands of participants to assess their efficacy in preventing COVID-19 and their safety profiles.

Regulatory Review: Regulatory agencies like the FDA and EMA reviewed extensive trial data before granting emergency use authorization or full approval, ensuring that the vaccines met high standards for safety and effectiveness.

Post-Marketing Surveillance:

Ongoing Monitoring: After vaccines are approved and distributed to the public, ongoing surveillance systems track adverse events. This includes both common and rare side effects, providing a continuous stream of data to assess long-term safety.

Addressing Specific Concerns

Menstrual Changes:

Reports of Changes: There have been reports of menstrual changes following COVID-19 vaccination, including changes in cycle length, flow, and in rare cases, more severe bleeding.

Research Findings: Studies and surveillance data indicate that while these changes can occur, they are generally temporary and not indicative of long-term harm. Researchers are investigating the underlying mechanisms to better understand these effects.

Severe Side Effects:

Rare Incidence: Uncontrolled bleeding or severe menstrual changes are rare. When they do occur, they are taken seriously and investigated thoroughly.

Risk Context: The risk of severe side effects from vaccination is very low compared to the risk of severe outcomes from COVID-19 itself, which includes hospitalization, long-term health complications, and death.

Communication and Public Health Messaging

Transparency and Trust:

Honest Reporting: Public health agencies strive to be transparent about potential side effects, including menstrual changes, to maintain public trust.

Balanced Messaging: Messages about vaccines being "safe and effective" are based on the overall evidence. They do not ignore side effects but put them in the context of the benefits of vaccination.

Educational Efforts:

Informing the Public: Clear, accurate information is provided to help people understand the benefits and risks of vaccination. This includes acknowledging side effects and explaining their likelihood and severity.

Responding to Concerns: Public health officials and scientists address concerns and questions from the public, providing evidence-based explanations and updates as new data emerge.

Conclusion

The phrase "safe and effective" is not propaganda but a summary of the extensive evidence showing that COVID-19 vaccines prevent severe illness and save lives. Addressing specific side effects, including rare instances of uncontrolled bleeding, is part of an evidence-based and transparent approach to public health. By acknowledging and investigating these side effects, public health authorities demonstrate a commitment to understanding and mitigating risks, thereby supporting informed decision-making and maintaining public trust.

In summary, the characterization of vaccines as "safe and effective" is based on a thorough evaluation of benefits and risks. Communicating about side effects, including menstrual changes, is done with the intent to provide a complete and honest picture, rather than to mislead or downplay concerns.

So how did the 'trials' miss the bleeding problem? were they perhaps conducted over too short a time 'period' (pun intended)?

ChatGPT

The issue of menstrual changes, including bleeding problems, not being highlighted in the initial clinical trials for COVID-19 vaccines can be attributed to several factors related to the design, duration, and focus of these trials. Here’s a detailed explanation:

Factors Affecting Detection of Menstrual Changes in Trials

Primary Focus of Clinical Trials:

Endpoints: The primary endpoints of the initial clinical trials were to evaluate the efficacy of the vaccines in preventing COVID-19 infection, severe disease, and death, as well as to monitor for immediate and common adverse events. Menstrual health was not a primary outcome measure.

Short-Term Safety: Trials were designed to rapidly assess short-term safety and efficacy to address the urgent public health crisis posed by the pandemic.

Duration of Trials:

Time Constraints: The urgency of the COVID-19 pandemic necessitated accelerated timelines for vaccine development and approval. As a result, the duration of the trials might not have been sufficient to capture longer-term or less immediate side effects like menstrual irregularities.

Follow-Up Period: Although participants were followed for a certain period post-vaccination, longer-term follow-up might be needed to detect more subtle or less common side effects.

Population and Reporting:

Demographics: Initial trials included diverse populations, but specific subgroups, such as those with pre-existing menstrual irregularities or those post-menopause, might not have been large enough to detect certain side effects.

Underreporting: Menstrual changes may not have been systematically reported or recorded if they were not specifically asked about in the trial protocols. Participants might not have linked such changes to vaccination or might not have reported them unless prompted.

Retrospective Identification:

Real-World Data: Post-marketing surveillance and real-world data collection have been crucial in identifying side effects not apparent in clinical trials. Systems like VAERS in the US have captured a broader range of side effects, including menstrual changes, reported by a much larger population over a longer period.

Addressing the Gap

Post-Approval Studies:

Ongoing Research: Since the rollout of the vaccines, numerous studies have been conducted to investigate reports of menstrual changes. These studies are helping to understand the prevalence, severity, and duration of these changes.

Registries and Surveys: Efforts have been made to systematically collect data on menstrual health post-vaccination through registries and large-scale surveys.

Inclusion in Future Trials:

Expanded Outcomes: Recognizing the importance of menstrual health, future vaccine trials are likely to include menstrual changes as a specific outcome to monitor. This will help capture these effects more systematically.

Longer Follow-Up: Extending the follow-up period in clinical trials can help identify long-term and less common side effects, providing a more comprehensive safety profile.

Improved Reporting and Awareness:

Education: Increasing awareness among healthcare providers and the public about the potential for menstrual changes post-vaccination can improve reporting and early detection.

Research Funding: Allocating resources to study the impact of vaccines on menstrual health can ensure that this aspect of health is given appropriate attention in future research.

Conclusion

The initial clinical trials for COVID-19 vaccines were designed to address urgent public health needs, focusing on the most immediate and significant outcomes related to COVID-19 prevention. This focus, combined with the shorter follow-up periods and potential underreporting of menstrual changes, likely contributed to these issues not being highlighted initially. However, the subsequent identification and investigation of these changes through post-marketing surveillance and targeted studies demonstrate the ongoing commitment to understanding and ensuring vaccine safety comprehensively. This iterative process is a hallmark of scientific and medical research, adapting and responding to new data to continually improve public health recommendations and outcomes.

So should the jabs be stopped, or are they simply too profitable?

ChatGPT

The decision to continue or halt the administration of COVID-19 vaccines is based on a comprehensive analysis of the benefits and risks, grounded in scientific evidence and public health priorities. Here are key points to consider:

Benefits of COVID-19 Vaccines

Efficacy in Preventing Severe Disease:

Reduced Hospitalization and Death: COVID-19 vaccines have been shown to significantly reduce the risk of severe illness, hospitalization, and death caused by the virus. This has been especially important for vulnerable populations, such as the elderly and those with underlying health conditions.

Prevention of Long COVID: Vaccination also helps reduce the incidence of Long COVID, a condition characterized by persistent symptoms long after the acute phase of infection.

Community Protection:

Herd Immunity: High vaccination rates contribute to herd immunity, reducing the overall spread of the virus and protecting those who cannot be vaccinated for medical reasons.

Economic and Social Stability: Widespread vaccination helps stabilize economies and societies by allowing a return to normal activities and reducing the burden on healthcare systems.

Addressing Side Effects

Monitoring and Research:

Pharmacovigilance: Ongoing monitoring systems, such as VAERS and other national reporting systems, continuously track adverse events following vaccination. This allows for timely identification and investigation of any potential safety concerns.

Research Initiatives: Studies are being conducted to understand the mechanisms behind reported side effects, such as menstrual changes, and to determine their prevalence, severity, and duration.

Risk Communication:

Transparency: Public health authorities and vaccine manufacturers are committed to transparent communication about the benefits and risks of vaccination. This includes providing accurate information about potential side effects and the likelihood of their occurrence.

Informed Consent: Individuals are provided with information to make informed decisions about vaccination, including understanding potential risks and benefits.

Ethical and Economic Considerations

Public Health Priorities:

Maximizing Benefits: The primary goal of vaccination programs is to maximize public health benefits by preventing illness and saving lives. This involves weighing the overall benefits against the risks of side effects.

Equitable Access: Ensuring equitable access to vaccines globally is a critical public health objective, as it helps control the pandemic and prevent the emergence of new variants.

Economic Factors:

Cost-Benefit Analysis: The economic benefits of vaccination, including reduced healthcare costs and economic recovery, are significant. However, decisions about vaccine use are primarily driven by public health considerations rather than profitability.

Profit Motive: While pharmaceutical companies do profit from vaccine sales, regulatory agencies and public health organizations prioritize safety and efficacy over profits. Vaccines undergo rigorous review and monitoring to ensure they meet safety standards.

Conclusion

Halting COVID-19 vaccination programs would have serious public health implications, including increased morbidity and mortality from the virus, strain on healthcare systems, and economic disruptions. The benefits of vaccination in preventing severe disease and death far outweigh the risks of side effects, which are continually monitored and researched.

It is important to continue addressing and investigating reported side effects transparently and rigorously, ensuring that vaccination programs are guided by scientific evidence and public health priorities rather than economic considerations alone. Public trust and informed decision-making are essential components of a successful vaccination strategy, supported by ongoing research and transparent communication.