Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the European Medicines Agency (EMA) has authorized a third dose of the Moderna COVID-19 vaccine (Spikevax) given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.

“We recognize the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease. It is promising to see recent trials demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in this important population,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain committed to helping to end the COVID-19 pandemic with our mRNA vaccine.”

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 who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo¹. In the study, the third dose was generally well tolerated.

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 December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

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. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

AUTHORIZED USE IN THE EU

Spikevax ▼ (COVID-19 Vaccine Moderna) has been granted conditional marketing authorisation by the European Commission for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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 Prevention guidelines (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
  • Syncope
• 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 who have 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 Moderna using 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 European Union on the EMA website.

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 U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

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¹ Hall et al., N Engl J Med 385;13 September 23, 2021

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