Moderna Announces Swissmedic Authorizes Booster Dose of Moderna’s COVID-19 Vaccine
Authorization granted for particularly vulnerable individuals 12 years of age and older
In 10 years since its inception,
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.
AUTHORIZED USE IN
Spikevax ▼ (COVID-19 Vaccine Moderna) has been granted temporary marketing authorisation by
IMPORTANT SAFETY INFORMATION
Do not administer Spikevax to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of Spikevax.
Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Spikevax. Monitor Spikevax recipients for the occurrence of immediate adverse reactions according to the
Centers for Disease Control and Preventionguidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to Spikevax.
Spikevax may not protect all vaccine recipients.
Adverse reactions reported in clinical trials following administration of Spikevax include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash.
Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of Spikevax during mass vaccination outside of clinical trials.
Available data on Spikevax administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Spikevax on the breastfed infant or on milk production/excretion.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Spikevax.
The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance (https://www.adrreports.eu/) or directly to
Modernausing email EMEAMedinfo@modernatx.com.
For complete information on the safety of Spikevax, always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine against COVID-19 (mRNA-1273); the approval of mRNA-1273 for use as a booster dose and as a third dose in immunocompromised persons by
Director, Corporate Communications
Senior Vice President & Head of Investor Relations