FDA Says No to COVID-19 Vaccine Label Updates

In 2021 and 2023, the Coalition Advocating for Adequately Labeled Medicines (CAALM) submitted formal Citizen Petitions to the FDA requesting critical updates to the official product labeling for Pfizer and Moderna COVID-19 vaccines.

The requests were reasonable and aimed at giving patients and doctors more accurate, transparent information. Among other things, CAALM asked the FDA to include clearer warnings about:

• The limited duration of protection
• Reduced ability to stop viral transmission
• Known risks such as myocarditis, neurological events, and other serious adverse events
• Updated contraindications based on emerging safety data

Despite these being well-documented issues, the FDA denied the vast majority of the requested labeling changes.

The Hill published a powerful opinion piece detailing these efforts and the FDA’s refusals. To read the full article, click here.

We tried to improve COVID vaccine labeling — the FDA said ‘no thanks’

Timeline of CAALM Citizen Petitions and FDA Responses

June 2021

CAALM Citizen Petition (FDA-2021-P-0786)

Requested that the FDA delay full approval of COVID-19 vaccines until longer-term safety and efficacy data were available.

→ View 2021 Citizen Petition (PDF)

FDA Response

→ View FDA Response to 2021 Petition (PDF)

January 2023

CAALM Citizen Petition (FDA-2023-P-0360)

Requested multiple updates to vaccine labeling, including clearer information on duration of protection, reduction in viral transmission, adverse events (including myocarditis and neurological conditions), and updated contraindications.

→ View 2023 Citizen Petition (PDF)

FDA Response (33-page letter)

The FDA denied the vast majority of the requested labeling changes.

→ View FDA Response to 2023 Petition (PDF)

Key Point from The Hill Article

The authors conclude: “Product labeling should be informative and accurate, not promotional. The law requires it, and following the law shouldn’t be optional.”