FDA Ties 10 Child Deaths to COVID Vaccine: Report – Newsweek

Report on FDA Memorandum Regarding COVID-19 Vaccine Safety and its Implications for Sustainable Development Goals

1.0 Introduction

A memorandum from the U.S. Food and Drug Administration (FDA) has raised significant concerns regarding the safety of the COVID-19 vaccine in children. This report analyzes the memo’s contents, the subsequent reactions from the scientific community, and the potential impact on global public health objectives, particularly Sustainable Development Goal 3 (SDG 3), which aims to ensure healthy lives and promote well-being for all at all ages.

2.0 Analysis of the FDA Memorandum

2.1 Core Allegations

The non-peer-reviewed memo makes several critical claims regarding the impact of COVID-19 vaccination on children. These assertions directly challenge public health strategies aimed at achieving SDG Target 3.3 (end epidemics of communicable diseases) and Target 3.8 (achieve universal health coverage, including access to safe and effective vaccines).

• The vaccine is alleged to have contributed to the deaths of at least 10 children.
• The reported number is described as a “certainly an underestimate” due to underreporting and attribution bias.
• The memo suggests that healthy children, who faced a low risk from the virus, were coerced into vaccination through mandates.
• It states that the agency’s analysis concludes “no fewer than 10” deaths between 2021 and 2024 are related to the vaccine.

2.2 Methodological Limitations

The scientific validity of the memo’s conclusions has been questioned due to a lack of transparent methodology, which is crucial for maintaining trust in institutions as outlined in SDG 16 (Peace, Justice and Strong Institutions).

1. The document has not been subjected to peer review.
2. The specific methodology used to establish a causal link between vaccination and the reported deaths is not detailed.
3. The memo acknowledges that the agency “does not have reliable data estimating the absolute benefit” of the vaccine for children.

3.0 Implications for Sustainable Development Goal 3: Good Health and Well-being

3.1 Challenges to Vaccine Confidence and Universal Health Coverage (Targets 3.3 & 3.8)

The release of this information, regardless of its scientific validity, poses a direct threat to public trust in vaccination programs. This erosion of confidence can impede progress towards achieving universal health coverage and controlling communicable diseases.

• Public skepticism, fueled by official sources, can reduce vaccine uptake, undermining herd immunity and leaving vulnerable populations at risk.
• The controversy may disrupt established childhood immunization schedules, a key component of public health infrastructure.

3.2 Re-evaluation of Vaccine Approval and Safety Monitoring (Targets 3.b & 3.d)

In response to the memo, the FDA has announced forthcoming changes to its vaccine approval process. This development has significant implications for SDG Target 3.b (support research and development of vaccines) and Target 3.d (strengthen capacity for management of global health risks).

• The FDA’s chief medical and scientific officer, Vinay Prasad, confirmed the agency would alter its approval process, balancing the benefits and risks of medical products.
• This move follows previous FDA actions, such as requiring vaccine manufacturers to update information regarding risks of myocarditis and pericarditis in young men.

4.0 Scientific and Medical Community Response

4.1 Demand for Evidentiary Standards

Medical experts have criticized the FDA for releasing the claims without providing the requisite scientific evidence to support them. Dr. Paul Offit, Director of the Vaccine Education Center, outlined the rigorous data needed to substantiate such a claim:

1. Autopsy data confirming myocarditis as the cause of death, with no other contributing factors.
2. Evidence of an immune response specifically to the SARS-CoV-2 spike protein from the vaccine, and not from a natural infection.
3. Exclusion of other viral causes of myocarditis.

4.2 Counterarguments and Public Health Concerns

Public health professionals have highlighted the established benefits of COVID-19 vaccination and the potential harm of the FDA’s unsubstantiated claims.

• Dr. Krutika Kuppalli, of the IDSA Global Health Committee, stated there is no evidence linking the vaccines to child deaths, while there is clear evidence of harm from COVID-19 infection itself.
• Lucky Tran, Director of Science Communications at Columbia University, described the memo as “reckless,” emphasizing that scientific evidence shows COVID-19 vaccines have saved millions of lives globally.

5.0 Conclusion and Outlook

The FDA memorandum has initiated a significant public health debate with profound implications for achieving SDG 3. The unsubstantiated claims risk undermining global efforts to combat communicable diseases by eroding public trust in vaccines. The announced changes to the FDA’s vaccine approval process will be critical in determining the future balance between rapid response to health crises and rigorous safety evaluation. Moving forward, transparent, evidence-based communication from public health institutions is essential to maintain the integrity of vaccination programs and protect community health worldwide.

Analysis of Sustainable Development Goals in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

1. SDG 3: Good Health and Well-being

   • The article’s central theme is public health, specifically focusing on the safety and efficacy of COVID-19 vaccines for children. It discusses vaccine-related deaths, potential side effects like myocarditis, and the regulatory processes of the Food and Drug Administration (FDA). These topics are directly related to ensuring healthy lives and promoting well-being for all ages.

2. SDG 16: Peace, Justice and Strong Institutions

   • The article highlights issues concerning a key public institution, the FDA. It discusses the agency’s internal memo, its lack of peer-reviewed data to support its claims, and the subsequent criticism from the scientific community. This relates to the need for effective, accountable, and transparent institutions, as the FDA’s actions and communications are being scrutinized for their scientific basis and impact on public trust.

2. What specific targets under those SDGs can be identified based on the article’s content?

1. Under SDG 3: Good Health and Well-being

   • Target 3.2: By 2030, end preventable deaths of newborns and children under 5 years of age. The article directly addresses this target by reporting on an FDA memo that claims “at least 10 children have died after and because of receiving the COVID-19 vaccination.” The entire debate revolves around whether the vaccine prevents more deaths than it may cause in children.
   • Target 3.8: Achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines and vaccines for all. The article questions the “safety” and “effectiveness” of the COVID-19 vaccine for children. The FDA’s statement that it “may have harmed more children than we saved” and the discussion of side effects like myocarditis directly challenge the safety aspect of this target.
   • Target 3.d: Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks. The FDA’s role is to manage national health risks. The article discusses the agency’s process for identifying and communicating vaccine risks, such as requiring Pfizer and Moderna to update information about myocarditis, which is a core function of health risk management.

2. Under SDG 16: Peace, Justice and Strong Institutions

   • Target 16.6: Develop effective, accountable and transparent institutions at all levels. The article raises questions about the FDA’s accountability and transparency. Critics like Dr. Paul Offit state the FDA needs to “push forward the data that backs up its claim,” and the article notes the memo “has not been peer-reviewed.” This points to a perceived lack of transparency and evidence-based decision-making within the institution.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

1. Indicators for SDG 3 Targets

   • Child Mortality Data: The article provides a specific number: “at least 10 children have died after and because of receiving the COVID-19 vaccination.” This figure, while disputed and unverified in the article, serves as a direct, albeit controversial, indicator related to child mortality (Target 3.2).
   • Incidence of Vaccine Side Effects: The mention of “myocarditis and pericarditis” as potential side effects reported in young men is an implied indicator for monitoring vaccine safety. Tracking the incidence of such adverse events is crucial for assessing the safety component of Target 3.8.
   • Regulatory Actions on Vaccine Safety: The FDA’s action to make Pfizer and Moderna “update their information” about heart condition risks is an indicator of a functioning risk management system (Target 3.d). The announced “changes to its vaccine approval process” is another indicator of the institution’s response to perceived health risks.

2. Indicators for SDG 16 Targets

   • Public Availability of Data: The criticism that the FDA has not shared the evidence for its claims implies an indicator for institutional transparency (Target 16.6). Dr. Offit’s demand to “show people the data” highlights the expectation that data backing public health announcements should be publicly available and peer-reviewed.
   • Scientific Peer Review of Government Reports: The fact that the memo “has not been peer-reviewed” is a key point of contention and serves as a qualitative indicator of the institution’s adherence to scientific standards and accountability.

4. Summary Table of SDGs, Targets, and Indicators

Source: newsweek.com