Moderna's Spikevax Gets Full FDA Approval for At-Risk Children Aged 6 Months to 11 Years

On July 10, 2025, Moderna, Inc. made a significant announcement regarding its COVID-19 vaccine, Spikevax®. The U.S. Food and Drug Administration (FDA) has granted approval for a supplemental Biologics License Application (sBLA) for Spikevax, specifically targeting children aged 6 months to 11 years who are at an elevated risk for COVID-19. Previously, this vaccine was available for pediatric use under an Emergency Use Authorization (EUA).

This approval marks a crucial step in safeguarding young children, especially those with pre-existing health conditions that make them vulnerable to severe COVID-19 outcomes. Moderna’s CEO, Stéphane Bancel, emphasized the continuous threat COVID-19 poses to children, particularly those with underlying conditions, and highlighted vaccination as a key defense against serious illness and hospitalization.

Moderna is preparing to make the updated Spikevax vaccine accessible for at-risk populations in the United States for the 2025-2026 respiratory virus season. This development underscores the company's commitment to using mRNA technology to address health challenges swiftly and effectively. Moderna has been a pioneer in mRNA medicine, transforming preventive and therapeutic measures for various diseases.

Spikevax is specifically indicated for individuals aged 65 and older and for those between 6 months and 64 years who are at heightened risk for severe COVID-19 outcomes. However, it is important to note that vaccination with Spikevax may not guarantee protection for every recipient.

The safety profile of Spikevax reveals some potential risks, albeit rare. Anaphylaxis, a severe allergic reaction, could occur shortly after vaccination, necessitating post-vaccination observation by healthcare providers. Symptoms of such reactions include difficulty breathing, facial swelling, rapid heartbeat, full-body rash, dizziness, and weakness.

Another concern linked to mRNA COVID-19 vaccines, including Spikevax, is myocarditis and pericarditis, particularly among males aged 12 to 24. These conditions involve inflammation of the heart muscle and surrounding lining, respectively. It is crucial to seek immediate medical attention if symptoms such as chest pain, shortness of breath, or a rapid heartbeat arise after vaccination, particularly within two weeks post-injection. In children, additional symptoms may include fainting, irritability, poor feeding, fatigue, vomiting, abdominal pain, or pale skin.

Common side effects of Spikevax include reactions at the injection site, such as pain, swelling, and lymph node tenderness. More generalized side effects can involve fatigue, headaches, muscle and joint pain, chills, nausea, fever, rash, irritability, and loss of appetite. There have also been reports of fainting and febrile seizures following vaccination.

Individuals considering Spikevax should disclose any medical conditions to their healthcare provider, including a history of severe allergic reactions, myocarditis, or pericarditis. Other factors such as current fever, bleeding disorders, immunocompromised status, pregnancy, breastfeeding, or previous COVID-19 vaccinations should also be discussed with healthcare professionals.

While this information outlines many known potential side effects of Spikevax, patients are encouraged to consult their healthcare providers with any concerns. Side effects can be reported to the Vaccine Adverse Event Reporting System (VAERS).

The approval of Spikevax for younger children at increased risk represents a significant advancement in public health efforts to combat COVID-19. Moderna’s innovative approach continues to pave the way in the fight against infectious diseases, with a focus on developing rapid and effective medical solutions.