Latest news with #SPIKEVAX
Time of India
10-07-2025
- Health
- Time of India
Moderna's COVID vaccine gets full US approval for at-risk children aged 6 months and older
US regulators have granted Moderna Inc. full approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years, but only for those at increased risk from the virus. Tired of too many ads? go ad free now The move marks a shift in federal policy under Health and Human Services Secretary Robert F. Kennedy Jr., who has led a controversial effort to scale back universal access to pediatric COVID shots. The Food and Drug Administration's decision, announced Thursday, means that healthy children in this age group will no longer have routine access to the vaccine unless it is prescribed off-label. Moderna's shares rose more than 4% in early trading in New York following the announcement. Under emergency use authorization during the pandemic, COVID-19 vaccines from Moderna and Pfizer were made widely available to all children. But Kennedy, a longtime vaccine skeptic, has reversed course. In 2021, he petitioned the FDA to revoke temporary approval for children's vaccines, citing low risk of severe illness in healthy children. Now, the vaccine's full approval ensures it remains available for high-risk kids, but also restricts broader access. What are the risks of SPIKEVAX? For most people, getting the SPIKEVAX COVID-19 vaccine is safe and simple. But like any vaccine, there are some rare risks you should know about. There's a very small chance of having a serious allergic reaction, usually within a few minutes to an hour after the shot. That's why your doctor or nurse may ask you or your child to wait for a short time after getting vaccinated—just to be safe. As per the official website of Moderna, signs of a serious allergic reaction may include: Difficulty breathing Swelling of the face or throat A fast or racing heartbeat A rash all over the body Dizziness or weakness In rare cases, some people—mostly boys and young men between 12 and 24 years old—have developed myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) after getting an mRNA COVID-19 vaccine like SPIKEVAX. Tired of too many ads? go ad free now If you or your child experiences any of the following symptoms within two weeks of the vaccine, it's important to see a doctor right away: Chest pain Shortness of breath A fast, fluttering, or pounding heartbeat In children, signs to watch for can include chest pain, shortness of breath, pounding heartbeat, fainting, being unusually tired or irritable, poor feeding, stomach pain, vomiting, or cool, pale skin. What are the possible side effects of SPIKEVAX? Common side effects around the injection site: pain or tenderness, redness, swelling or firmness, and swollen lymph nodes in the same arm or sometimes in the groin General side effects: feeling tired or sleepy, headache, muscle or joint pain, chills or fever, nausea or vomiting, rash, irritability or crying (especially in young children) and loss of appetite. In some cases, people have also reported fainting or febrile seizures (seizures caused by a fever). While these are less common, it's helpful to be aware of them.
Yahoo
10-07-2025
- Business
- Yahoo
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
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 CAMBRIDGE, MA / / July 10, 2025 / 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 Moderna Moderna 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 and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Spikevax® is a registered trademark of Moderna. INDICATION SPIKEVAX (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, or 6 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 INFORMATION You 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 breathing Swelling of your face and throat A fast heartbeat A rash all over your body Dizziness and weakness Myocarditis (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 redness General 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 reported Tell the healthcare provider about all of your or your child's medical conditions, including if you or your child: have any allergies had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever have a bleeding disorder or are on a blood thinner are immunocompromised or on a medicine that affects your immune system are pregnant or plan to become pregnant are breastfeeding have received any other COVID-19 vaccine have ever fainted in association with an injection These 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 Please see the SPIKEVAX Full Prescribing Information. Moderna 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 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 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 Contacts Media:Chris RidleyHead of Global Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire
Miami Herald
10-07-2025
- Business
- Miami Herald
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
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 CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / 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 Moderna Moderna 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 and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Spikevax® is a registered trademark of Moderna. INDICATION SPIKEVAX (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 INFORMATION You 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 and febrile seizures (convulsions during a fever) were also reported Tell 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 injection These 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 Please see the SPIKEVAX Full Prescribing Information. Moderna 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 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 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 Contacts Media:Chris RidleyHead of Global Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 SOURCE: Moderna, Inc.
Time of India
31-05-2025
- Health
- Time of India
New COVID vaccine approved by US FDA: Here's all about it
Just new variants of the coronavirus causing COVID are emerging, the US Food and Drug Administration (US FDA) has approved a new vaccine against COVID. The vaccine has been manufactured by Moderna. "Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC)," the pharma maker has said in a press release. COVID killed 47,000 Americans in 2024. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Buy Brass Idols - Handmade Brass Statues for Home & Gifting Luxeartisanship Buy Now Undo " What is mNEXSPIKE? mNEXSPIKE is a COVID-19 vaccine meant for folks who've already had a previous COVID shot. It's mainly for people aged 65 and older, or anyone between 12 and 64 who's at high risk of getting really sick from the virus. Just a heads-up though—like all vaccines, it's not a guaranteed shield for everyone, but it does offer an extra layer of protection for those who need it most. "You should not get mNEXSPIKE if you hada severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines," Moderna has warned. The side effects are trouble breathing, swelling of face and throat, fast heart beat, rashes, dizziness and weakness. Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the Company's approved respiratory syncytial virus (RSV) vaccine. One step to a healthier you—join Times Health+ Yoga and feel the change
Miami Herald
23-05-2025
- Health
- Miami Herald
Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine
CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant. About Moderna Moderna 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 and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. AUTHORIZED USE IN THE U.S. INDICATION (U.S.) SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. IMPORTANT SAFETY INFORMATION Contraindications Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX. Warnings and Precautions Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of and Pericarditis: Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 years through 24 years of (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX. Procedures should be in place to avoid injury from Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients. Adverse Reactions The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, swelling at the injection site, erythema at the injection site, and fever. Reporting Adverse Events and Vaccine Administration Errors The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at or by calling 1-800-822-7967. Please see the SPIKEVAX Full Prescribing Information. Please see the Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine for more information. 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 statements regarding: Moderna's regulatory submission to the U.S. FDA for its Spikevax 2025-2026 formula, including the potential for approval in the U.S. 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 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 Contacts Media:Chris RidleyGlobal Head of Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 SOURCE: Moderna, Inc.
