PIDS Rejects Claims of Harm Due to Tested, Approved Vaccines

PIDS strongly rejects the claim by US Food and Drug Administration that vaccine regulatory processes are lax and that there is evidence that COVID-19 vaccines for children are unsafe or ineffective. Furthermore, claims such as those from the leaked memo, which diverge from the standard scientific process of data sharing, peer review, and evidence-based conclusions, fail to live up to rudimentary best practices and should have no basis in determining public health policy.

Here is what we, the PIDS community, have found from exhaustive study of millions of vaccine administrations:

1. Scientific evidence continues to support pediatric vaccination. The data presented by the Centers for Disease Control and Prevention (CDC) during Advisory Committee on Immunization Practices (ACIP) meetings confirm that healthy children — including infants — remain at significant risk of severe disease, hospitalization, and death from COVID-19.
2. Regulatory language ≠ evidence of harm. The fact that vaccine prescribing information may state that safety and efficacy “have not been established” for some pediatric age groups does not mean the vaccines are unsafe. This is a technicality tied to regulatory licensing — not a conclusion about actual risk. Independent experts emphasize that such language is often misunderstood or misused to sow doubt.
3. Rare adverse events are extremely uncommon and far outweighed by benefits. Serious events like post-vaccination inflammatory heart conditions or allergic reactions are exceptionally rare in children, while the risk of hospitalizations, complications (including MIS-C) and death from COVID-19 remains real.
4. Removing or limiting access undermines longstanding evidence-based vaccine policy. The recent decision by the FDA to down-rate broad availability of COVID-19 vaccines for children runs counter to the “immense scientific evidence” accumulated over the pandemic.
5. Public-health decisions must remain guided by science, not fear or politics. PIDS continues to advocate that all children 6 months–23 months, children with high-risk conditions, and any child whose family wishes vaccination should have access to COVID-19 vaccines. We urge insurers to continue covering them and policymakers to support their availability.

In summary: claims suggesting that recent regulatory findings signal a “vaccine-safety failure” are misleading. The weight of evidence continues to support COVID-19 vaccination for children as a safe, effective, and essential tool to safeguard them and protect the communities around them.