US EditionFDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE
- On May 31, 2025, Moderna received regulatory approval for its new mRNA COVID-19 vaccine, mNEXSPIKE, for use in adults aged 65 and older as well as high-risk individuals between 12 and 64 years old.
- Approval followed clinical trials showing mNEXSPIKE's improved efficacy and lower dose compared to previous vaccines, while COVID-19 remains a significant public health threat with over 47,000 deaths last year in the U.S.
- The vaccine specifically targets those with underlying conditions such as asthma, cancer, and cerebrovascular disease, and includes warnings about rare myocarditis and pericarditis cases estimated at 8 per million doses.
- Moderna CEO Stéphane Bancel highlighted that with the FDA’s authorization of mNEXSPIKE, the company now offers an additional option aimed at safeguarding individuals vulnerable to serious COVID-19 complications.
- The approval comes amid ongoing debate over COVID vaccination recommendations, with some officials withdrawing guidance for healthy children and pregnant women while emphasizing need for further safety studies and discussions.
14 Articles
14 Articles
Covid-19 Vaccine Reform Is Moving Slower Than Many Had Hoped ⋆ Brownstone Institute
Covid-19 Vaccine Reform Is Moving Slower Than Many Had Hoped by Maryanne Demasi at Brownstone Institute Just three weeks after Dr Vinay Prasad assumed oversight of vaccines at the FDA, Moderna’s latest Covid-19 vaccine, mNEXSPIKE®, received full approval. For those who had hoped the mRNA platform would be shelved, the decision landed like a gut punch. Approved on 31 May 2025, the next-generation shot is intended for adults over 65, as well as in…
Robert F. Kennedy Jr. Addresses "Anxieties" On Approval Of New Moderna COVID-19 Jab * 100PercentFedUp.com * by Danielle
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. addressed concerns regarding the FDA’s approval of a new mRNA COVID-19 jab manufactured by Moderna. “I want to address those of you who have anxieties about @US_FDA’s limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller protein…
Approval of new COVID-19 vaccine dashes hopes Trump admin would close the book on controversial shots
From LifeSiteNews By Calvin Freiburger FDA approves new mRNA-based COVID-19 vaccine from Moderna The U.S. Food & Drug Administration (FDA) approved a new mRNA-based COVID-19 vaccine from Moderna over the weekend, further dashing hopes that a new administration would close the book on the controversial shots. The new vaccine, mNEXSPIKE, is approved for “active immunization to prevent coronavirus disease 2019,” to be taken by “individuals who have…
FDA Approves Moderna’s New COVID-19 Vaccine - The Thinking Conservative
FDA licensed Moderna’s new COVID-19 vaccine for adults aged 65+ and people aged 12 to 64 who have condition putting them at risk for severe COVID-19. The post FDA Approves Moderna’s New COVID-19 Vaccine appeared first on The Thinking Conservative.
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