Moderna's COVID-19 vaccines for the 2026-2027 season have received approval from the U.S. Food and Drug Administration (FDA). The approved products are 'Spikevax' and 'mNEXSPIKE,' both updated to target currently circulating SARS-CoV-2 lineages.

Moderna announced on the 27th that the FDA has approved supplemental biologics license applications for the 2026-2027 formulations of Spikevax and mNEXSPIKE.

◆ XFG Variant Incorporated... "U.S. Supply Within Days"

Both vaccines incorporate XFG, a subvariant of the JN.1 lineage, following the FDA's guidance to develop this season's COVID-19 vaccines as monovalent J.1 lineage XFG formulations.

The approved age groups and vaccination criteria differ by product.

▲ Spikevax: Individuals aged 6 months to 64 years with at least one underlying condition that increases the risk of severe COVID-19, plus all adults aged 65 and older ▲ mNEXSPIKE: Individuals aged 12 to 64 years with risk factors for severe COVID-19, plus adults aged 65 and older

Following the FDA approval, Moderna expects to supply the updated vaccines to the U.S. market within days.

Moderna CEO Stephane Bancel explained that COVID-19 continues to pose a significant public health burden. According to the company, COVID-19 caused up to 2.3 million outpatient visits and approximately 250,000 hospitalizations in the United States last year.

◆ Approvals Follow in South Korea, Europe, Japan, and Elsewhere

Regulatory procedures are also underway outside the United States. The 2026-2027 formulation of Spikevax has already received regulatory approval in Europe, South Korea, Singapore, Switzerland, and the United Kingdom. The new formulation of mNEXSPIKE has also been approved in Japan. Moderna stated that it is pursuing additional approvals in other countries ahead of the upcoming respiratory virus season.

These products are based on Moderna's mRNA platform. Beyond COVID-19 vaccines, the company is developing mRNA-based vaccines and therapeutics targeting infectious diseases, cancer, and rare diseases.

◆ Adverse Reaction Information to Know Before Vaccination

However, COVID-19 vaccination does not completely prevent all infections.

According to Moderna, clinical trials of Spikevax and mNEXSPIKE reported injection site pain and swelling, swollen lymph nodes, as well as fatigue, headache, muscle pain, joint pain, chills, fever, nausea, and vomiting. Cases of myocarditis and pericarditis have also been reported after mRNA COVID-19 vaccination, particularly at relatively higher rates among males aged 12 to 24.

If symptoms such as chest pain, difficulty breathing, or a fast or irregular heartbeat appear after vaccination, medical attention is required. Those who have previously experienced severe allergic reactions to Moderna's COVID-19 vaccines or their components should consult a healthcare professional before vaccination.

◆ Annually Updated Vaccine Formulations... Focus on Expanding Sales

This approval demonstrates the ongoing trend of adjusting vaccine formulations annually to match variant changes as the COVID-19 vaccine market shifts toward a seasonal respiratory infection response framework. Moderna plans to expand sales of its 2026-2027 season COVID-19 vaccines depending on additional regulatory review results in each country and actual vaccine supply conditions.

[Vaccine effectiveness and adverse reactions may vary depending on an individual's age, health status, and underlying conditions. Whether and when to get vaccinated should be decided in consultation with a healthcare professional, and this article is not intended to recommend the use or administration of any specific medication. For information on drug approval scope and safety, please refer to the latest official materials from regulatory authorities and manufacturers in each country. This article was written with AI assistance.]