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The vaccine makers must expand information about the age groups at risk and warn that myocardial damage has commonly been long-lasting among those who suffer vaccine-related myocarditis, the FDA said Wednesday.<\/p>\n
Pfizer<\/a>\u00a0and\u00a0Moderna<\/a>\u00a0must\u00a0revise their COVID-19 vaccine labels<\/a>\u00a0to include more detailed warnings about the risks of heart damage, the U.S. Food and Drug Administration (FDA) said Wednesday.<\/p>\n Letters issued to both companies state that\u00a0post-marketing analysis<\/a>\u00a0shows greater risks than previously indicated for\u00a0myocarditis<\/a>, or inflammation of the heart muscle, and pericarditis, which refers to inflammation of the sac-like membrane surrounding the heart.<\/p>\n The\u00a0companies<\/a>\u00a0must expand the age group they say is at risk for vaccine-related myocarditis and pericarditis and warn that myocardial injury can be lasting among those who suffer it, the agency said.<\/p>\n Both\u00a0COVID-19<\/a>\u00a0vaccines<\/a>\u2019 labels previously warned that the shots posed a risk of post-vaccination myocarditis and pericarditis for young men \u2014 Moderna\u2019s Spikevax label specified that 18- to 24-year-olds were at risk, while Pfizer\u2019s Comirnaty warning targeted 12- to 17-year-olds.<\/p>\n The new labels must state that the known rate of myocarditis and pericarditis is about 8 cases per million doses for children and adults under 65 years old. They must also warn that the \u201chighest estimated incidence was in males 16 through 25 years of age,\u201d among whom the rate was 38 cases per million.<\/p>\n Last month, researchers for the Centers for Disease Control and Prevention (CDC) told the agency that acute myocarditis \u201ctends to resolve quickly<\/a>\u201d after vaccination.<\/p>\n However, the new labeling cites data showing that five months following vaccination, \u201cmyocardial injury was common.\u201d The FDA said the vaccine makers must add that information to their labels.<\/p>\n A spokesperson for the U.S. Department of Health and Human Services (HHS) said Wednesday that the labeling change was intended to increase \u201cradical transparency.\u201d<\/p>\n Neither Pfizer nor Moderna responded to The Defender\u2019s request for comment.<\/p>\n Label changes announced as Senate held contentious hearing on COVID vaccines and myocarditis<\/strong><\/p>\n The FDA issued the letters the same day the U.S. Senate\u2019s\u00a0Permanent Subcommittee on Investigations<\/a>\u00a0issued a report showing that public health officials under the Biden administration\u00a0failed to warn the public<\/a>\u00a0of the myocarditis risk associated with COVID-19 vaccines and actively downplayed that risk.<\/p>\n The report<\/a>\u00a0compiled previously redacted information from government records recently obtained by subpoena and information gathered from\u00a0earlier requests made by The Defender<\/a>\u00a0and other news organizations under the Freedom of Information Act (FOIA).<\/p>\n The records show how HHS officials under Biden avoided issuing a formal warning to the American public despite a safety signal that the COVID-19 vaccines could cause myocarditis and pericarditis, especially in young men.<\/p>\n For example, the report included internal emails showing that the CDC and FDA discussed issuing a\u00a0Health Alert Network<\/a>\u00a0that would warn practitioners nationwide about the heart risks in May 2021, but ultimately decided against it.<\/p>\n It also showed that top\u00a0health<\/a>\u00a0officials at HHS were warned that\u00a0V-safe<\/a>, another safety surveillance system, could miss \u201cpossible cases of cardiac adverse events\u201d because it failed to include cardiac symptoms in its pre-programmed list of\u00a0vaccine<\/a>\u00a0side effects for individuals to check off.<\/p>\n Yet, officials chose not to update the program to include those events.<\/p>\n Senators discussed the report and heard expert testimony in a contentious\u00a0hearing<\/a>\u00a0on Wednesday.<\/p>\n Lawmakers and invited witnesses \u2014 including\u00a0Dr. Peter McCullough<\/a>,\u00a0Dr. Joel Wallskog<\/a>, and\u00a0attorney Aaron Siri<\/a>\u00a0\u2014 shared heated exchanges around a wide range of topics related to COVID-19 and beyond, including what \u201cthe science\u201d shows, whether federal health officially intentionally concealed COVID-19 vaccine adverse events data, how the vaccine-injured have been ignored and abandoned, why lockdowns harmed children and the potential impact of recent funding cuts to federal health\u00a0agencies<\/a>, The Defender reported.<\/p>\n Also this week, the\u00a0FDA unveiled plans<\/a>\u00a0to\u00a0limit approvals for updated COVID-19 vaccines<\/a>\u00a0to people over age 65 and people with one or more health conditions that put them at high risk for the virus, and require new clinical trials for the vaccines for children and teens. Experts continue to debate the implications of this shift.<\/p>\n The FDA\u2019s vaccine advisory committee is also meeting today to decide on the composition of the fall COVID-19 shots.<\/p>\n Related articles in The Defender\u00a0<\/strong><\/p>\n \n\t<\/div>\n