Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older
“We recognize the need to protect immunocompromised individuals
A growing number of studies have shown the benefit of a third dose of COVID-19 vaccine in immunocompromised subjects. In particular, a recent double-blind, randomized controlled trial of 120 individuals
About Spikevax (COVID-19 Vaccine Moderna)
Spikevax (formerly known as COVID-19 Vaccine Moderna) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On
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 autoimmune diseases.
AUTHORIZED USE IN THE EU
Spikevax ▼ (COVID-19 Vaccine Moderna) has been granted conditional marketing authorisation by the
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.
The following adverse reactions have been reported following administration of Spikevax during mass vaccination outside of clinical trials:
- Severe allergic reactions, including anaphylaxis
- Myocarditis and pericarditis
- 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.
There are no data available on the interchangeability Spikevax with other COVID-19 vaccines to complete the vaccination series. Individuals
whohave received one dose of Spikevax should receive a second dose of Spikevax to complete the vaccination series.
- 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
Forward Looking Statements
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 ability of a third dose of mRNA-1273 to enhance immune response against COVID-19 in immunocompromised populations; and the safety profile for mRNA-1273 in immunocompromised populations. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the
1 Hall et al., N Engl J Med 385;13 September 23, 2021
Director, Corporate Communications
Senior Vice President & Head of Investor Relations