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The U.S. FDA has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for adults aged 65 and older and those aged 12–64 with risk factors, marking a major step under tighter regulations.
The U.S. Food and Drug Administration has approved Moderna’s latest COVID-19 vaccine, mNEXSPIKE, for people aged 65 and above and for those aged 12 to 64 with at least one underlying risk factor, as defined by the CDC. This is the first approval following the agency’s recent tightening of vaccine requirements.
Moderna expects to distribute the updated mRNA-based vaccine during the 2025–2026 respiratory virus season. Unlike previous versions, mNEXSPIKE can be stored in regular refrigerators, simplifying distribution, particularly in low-resource settings.
“This approval adds an important tool to help protect high-risk groups,” said Moderna CEO Stéphane Bancel.
The FDA recently shifted its guidelines, requiring placebo-controlled trials for younger, healthy adults, effectively limiting new COVID-19 boosters to those at higher risk of severe disease. Regulatory tightening comes under the Department of Health and Human Services, now led by Robert F. Kennedy Jr., who has long expressed skepticism about vaccines.
Despite concerns over regulatory changes, the CDC reaffirmed that COVID vaccines remain an option for healthy children when deemed necessary by parents and doctors. Analysts say this helps maintain market stability for vaccine makers by preserving demand in core demographics.
The FDA also recently approved Novavax’s protein-based COVID vaccine Nuvaxovid, but similarly restricted its use to older and at-risk individuals. Moderna, meanwhile, is focusing on its newer mRNA pipeline to counter declining interest in its original Spikevax and lower-than-expected uptake of its RSV shot.
Trial data supporting mNEXSPIKE’s approval showed the new vaccine performed equally or better than Spikevax, particularly among adults aged 18 and older.
As the U.S. government pursues agency overhauls and budget cuts, questions remain about the long-term regulatory environment. Still, with 100 to 200 million Americans eligible for boosters under current rules, the market for COVID-19 vaccines - especially next-generation options like mNEXSPIKE - remains significant.
The world’s biggest dance music festival faces an unexpected setback as a fire destroys its main stage, prompting a last-minute response from organisers determined to keep the party alive in Boom, Belgium.
China and the Association of Southeast Asian Nations will send an upgraded ‘version 3.0’ free-trade agreement to their heads of government for approval in October, Chinese Foreign Minister Wang Yi said on Saturday after regional talks in Kuala Lumpur.
Germany's export slump since 2021 is largely driven by deep-rooted competitiveness issues, the Bundesbank warned in its latest report, calling for urgent structural reforms.
Israeli researchers have unveiled an artificial intelligence tool that can determine a person’s true biological age from tiny DNA samples with remarkable precision.
Two Harry Potter actresses, Emma Watson and Zoe Wanamaker, have each received a six-month driving ban after separate speeding offences, both sentenced on the same day at a Buckinghamshire court.
The United States has rejected a global pandemic treaty adopted by the World Health Organization, saying it threatens national sovereignty and lacks clear language.
Ukrainian President Volodymyr Zelenskyy announced on Thursday that Deputy Prime Minister Olha Stefanishyna, who currently oversees European and Euro-Atlantic integration, has been appointed as Ukraine’s next ambassador to the United States.
British researchers have announced a major scientific milestone: eight babies have been born healthy through a revolutionary technique that combines DNA from three individuals to eliminate the risk of passing on severe mitochondrial diseases.
Mozambique has reported a surge of monkey pox cases, with Niassa province the hardest hit. The northern province of Niassa in Mozambique is facing the most severe impact from the virus outbreak.
In 2024, one million more children completed the full three-dose vaccination series for diphtheria, tetanus, and whooping cough (DTP) than in the previous year, according to a new report from the World Health Organization (W.H.O.) and United Nations Children's Fund (UNICEF).
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