Spikevax FDA Alerts
The FDA Alerts below may be specifically about Spikevax or relate to a group or class of drugs which include Spikevax.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Spikevax
FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
FDA Safety Communication June 25, 2025
Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine. FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.
The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.
Updated Warning for Myocarditis and Pericarditis
The warning on myocarditis and pericarditis in the Prescribing Information for Comirnaty and Spikevax has been updated to convey that the observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age and to include the following new language:
Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.
Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known.
Information about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) following vaccination with these mRNA COVID-19 vaccines has been included in the labeling since 2021. FDA closely monitors the safety of all vaccines, including the COVID-19 vaccines, during postmarket use.
About the Study on Cardiovascular Outcomes in mRNA COVID-19 Vaccine Recipients Diagnosed With Myocarditis
In a post-approval U.S. study funded and co-authored by FDA and published in September 2024, follow-up information was collected on approximately 300 people who developed myocarditis after receiving the original formula of an mRNA COVID-19 vaccine. Some people in the study reported having heart symptoms approximately 3 months after developing myocarditis. Some people in the study had cardiac MRIs (scans that show detailed images of the heart muscle) initially after developing myocarditis and again approximately 5 months later. The initial and follow-up cardiac MRIs commonly showed signs of injury to the heart muscle, with improvement over time in some but not all people. It is not known if these cardiac MRI findings might predict long-term heart effects of myocarditis.
Safety Monitoring Continues
Continuous monitoring and assessment of the safety of all vaccines, including the mRNA COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines.
In addition, as part of the approvals of Comirnaty and Spikevax, each manufacturer is required by FDA to conduct a study to assess if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine. These studies are underway.
How to Report a Suspected Adverse Event After Vaccination
Suspected adverse events may be reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the CDC.
Source: FDA
Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use in individuals 6 months through 11 years of age.
Summary of the Issue
FDA has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine. Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual. However, the volume of a single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is only 0.25 mL.
Information for Healthcare Providers
We are advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient. To provide clarification, the Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25 mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.
Healthcare providers, parents and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.
Content current as of: November 1, 2023
Source: FDA