Documents released by Sen. Ron Johnson (R-Wis.) show the FDA revised its assessment of several child deaths following Covid-19 vaccination, reducing the number of deaths considered vaccine-related from 10 to seven after reviewing autopsy findings.
According to the documents, FDA scientists initially identified 10 child deaths linked to Covid-19 vaccines in November 2025. A month later, the agency downgraded three of those cases and lowered the likelihood that several deaths were related to vaccination.
Johnson sent the records to Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas, saying the remaining seven cases alone should have prompted stronger safety warnings.
The documents also show FDA officials recommended updating the warning labels on the Pfizer and Moderna mRNA Covid-19 vaccines to include myocarditis with fatal outcomes. According to the report, that label change was never made.
Johnson, who chairs the Senate Permanent Subcommittee on Investigations, is examining whether federal health agencies failed to properly disclose vaccine safety concerns. He has requested additional CDC and FDA records related to pediatric deaths following Covid-19 vaccination and internal discussions about vaccine labeling.
The article cites comments from former FDA officials, outside scientists and medical experts questioning why some cases were reclassified.
One issue involved the presence of parvovirus B19 in two children. According to Yale pathologist Dr. James Gill, who performed two of the autopsies, the virus did not explain the pattern of heart damage observed and should not have ruled out vaccine-related myocarditis.
The report also discusses two cases reviewed by the FDA. One involved 16-year-old Micah Williamson, whose death certificate cited stress cardiomyopathy following vaccination. Another involved 13-year-old Jacob Clynick, whose death occurred three days after his second Pfizer dose. The FDA ultimately classified Clynick’s death as “probable” while disagreeing with the CDC’s assessment.
The article notes that FDA officials involved in reviewing the cases later left the agency, including former Center for Biologics Evaluation and Research Director Dr. Vinay Prasad and former acting Center for Drug Evaluation and Research Director Dr. Tracy Beth Høeg.
Several experts quoted in the article called for further investigations and legal action, while Johnson continues seeking additional records related to the agencies’ handling of the cases.
Documents released by Sen. Ron Johnson (R-Wis.) show the FDA revised its assessment of several child deaths following Covid-19 vaccination, reducing the number of deaths considered vaccine-related from 10 to seven after reviewing autopsy findings.
According to the documents, FDA scientists initially identified 10 child deaths linked to Covid-19 vaccines in November 2025. A month later, the agency downgraded three of those cases and lowered the likelihood that several deaths were related to vaccination.
Johnson sent the records to Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas, saying the remaining seven cases alone should have prompted stronger safety warnings.
The documents also show FDA officials recommended updating the warning labels on the Pfizer and Moderna mRNA Covid-19 vaccines to include myocarditis with fatal outcomes. According to the report, that label change was never made.
Johnson, who chairs the Senate Permanent Subcommittee on Investigations, is examining whether federal health agencies failed to properly disclose vaccine safety concerns. He has requested additional CDC and FDA records related to pediatric deaths following Covid-19 vaccination and internal discussions about vaccine labeling.
The article cites comments from former FDA officials, outside scientists and medical experts questioning why some cases were reclassified.
One issue involved the presence of parvovirus B19 in two children. According to Yale pathologist Dr. James Gill, who performed two of the autopsies, the virus did not explain the pattern of heart damage observed and should not have ruled out vaccine-related myocarditis.
The report also discusses two cases reviewed by the FDA. One involved 16-year-old Micah Williamson, whose death certificate cited stress cardiomyopathy following vaccination. Another involved 13-year-old Jacob Clynick, whose death occurred three days after his second Pfizer dose. The FDA ultimately classified Clynick’s death as “probable” while disagreeing with the CDC’s assessment.
The article notes that FDA officials involved in reviewing the cases later left the agency, including former Center for Biologics Evaluation and Research Director Dr. Vinay Prasad and former acting Center for Drug Evaluation and Research Director Dr. Tracy Beth Høeg.
Several experts quoted in the article called for further investigations and legal action, while Johnson continues seeking additional records related to the agencies’ handling of the cases.