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349,672 Results for "19".
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COVID-19
Vinay Prasad Overruled Reviewers on Moderna’s COVID-19 Shot for Kids
In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
July 16, 2025
·
2 min read
·
Tristan Manalac
COVID-19
Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids
The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.
July 11, 2025
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2 min read
·
Tristan Manalac
Vaccines
mRNA Helped Quell COVID-19 but COVID-19 ‘Maimed’ mRNA
Vocal skeptics of COVID-19 vaccinations gave mRNA a bad name and government funding for mRNA research is now being cut. On the flip side, at least one CEO said the pandemic also provided “elevated acceleration” for the field, which also holds promise in therapeutics for cancer and rare diseases.
May 27, 2025
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6 min read
·
Heather McKenzie
Legal
Medical Groups Sue RFK Jr. Over ‘Baseless and Uninformed’ Changes to COVID-19 Vaccine Policy
Societies, including the American Academy of Pediatrics, allege that Kennedy’s directive to remove COVID-19 from vaccination guidelines for healthy pregnant women and healthy children puts these vulnerable groups at risk of serious illness.
July 8, 2025
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2 min read
·
Tristan Manalac
Policy
Former CBER Chief Marks Decries New FDA COVID-19 Framework
Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
June 26, 2025
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3 min read
·
Tristan Manalac
Vaccines
FDA Vaccine Advisors To Meet for COVID-19 Vaccine Updates
The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.
May 8, 2025
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2 min read
·
Tristan Manalac
Vaccines
Moderna Wins FDA Approval for Next-Gen COVID-19 Vaccine Despite ‘Investor Nervousness’
Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
June 2, 2025
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3 min read
·
Nick Paul Taylor
Vaccines
FDA Vaccine Advisors Agree on COVID-19 Vaccine as New Framework Looms as ‘Elephant in the Room’
The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.
May 23, 2025
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2 min read
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Tristan Manalac
COVID-19
4 Biotechs Caught Up in Uncertain COVID-19 Vaccine Landscape
As the World Health Organization initiates a new agreement for coordinating global responses to future pandemics, the future of vaccine development in the U.S. faces growing challenges, including waning funding and regulatory changes, that threaten next-gen COVID-19 vaccine candidates and pandemic preparedness more broadly.
May 27, 2025
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7 min read
·
Ben Hargreaves
Vaccines
FDA Asks Pfizer/BioNTech, Moderna To Add Myocarditis Risk to COVID-19 Vaccines
The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
May 22, 2025
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2 min read
·
Tristan Manalac
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