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Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease

1. Spikevax approved for children 6 months to 11 years at risk. 2. FDA approval enhances trust in Moderna's vaccine for pediatric use. 3. Moderna plans updated Spikevax availability for 2025-2026 season. 4. CEO emphasizes COVID-19 threat to children underlines vaccination importance. 5. Moderna's mRNA platform underpins innovation across various therapeutic areas.

FDA Approval
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FAQ

Why Bullish?

The FDA approval strengthens market confidence in Moderna's pediatric vaccine, potentially boosting revenue.

How important is it?

The article outlines key regulatory achievements for Moderna, directly influencing its stock performance positively.

Why Long Term?

Approval sets the stage for future sales growth and market expansion over the next few years.

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PFEJNJNVAX
Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA)."COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," said Stéphane Bancel, Chief Executive Officer of Moderna. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.About ModernaModerna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.Spikevax® is a registered trademark of Moderna.INDICATIONSPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine to protect you against COVID-19. SPIKEVAX is for people who are:65 years of age and older, or6 months through 64 years of age at high risk for severe COVID-19.Vaccination with SPIKEVAX may not protect all people who receive the vaccine.IMPORTANT SAFETY INFORMATIONYou or your child should not get SPIKEVAX if you had a severe allergic reaction after a previous dose of SPIKEVAX or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.What are the risks of SPIKEVAX?There is a very small chance that SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child received your vaccine. Signs of a severe allergic reaction can include:Trouble breathingSwelling of your face and throatA fast heartbeatA rash all over your bodyDizziness and weaknessMyocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving Spikevax, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.Other side effects that have been reported include:Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and rednessGeneral side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.Fainting and febrile seizures (convulsions during a fever) were also reportedTell the healthcare provider about all of your or your child's medical conditions, including if you or your child:have any allergieshad a severe allergic reaction after receiving a previous dose of any COVID-19 vaccinehave had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)have a feverhave a bleeding disorder or are on a blood thinnerare immunocompromised or on a medicine that affects your immune systemare pregnant or plan to become pregnantare breastfeedinghave received any other COVID-19 vaccinehave ever fainted in association with an injectionThese may not be all the possible side effects of SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.Please see the SPIKEVAX Full Prescribing Information.Moderna Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the availability of an updated Spikevax vaccine for eligible populations in the U.S. for the 2025-2026 respiratory virus season. 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, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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 of this press release.Moderna ContactsMedia:Chris RidleyHead of Global Media Relations+1 617-800-3651[email protected]Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 617-209-5834[email protected]SOURCE: Moderna, Inc.

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