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Moderna, COVID and FDA

Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine

The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

· 6h · on MSN

Moderna files application for updated COVID vaccine

· 1d

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

MIT Technology Review · 18h

The FDA plans to limit access to covid vaccines. Here’s why that’s not all bad.

Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk.

Alaska Dispatch News · 17h

Opinion: The FDA’s new covid vaccine policy is clear as mud

· 1d

FDA panel recommends keeping COVID shots targeted to same strain as last year

· 1d

US FDA Advisers to Weigh Composition of COVID Vaccines for 2025-2026

Public health experts say that there is no certainty on which strains are going to be dominant.

· 1d

With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations

· 1d

FDA panel debates COVID vaccine recipe as questions swirl about fall shots

2don MSN

FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.

Moderna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign

Moderna isn’t giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options.

3don MSN

Covid vaccine rollout for healthy kids and adults likely delayed by new FDA rule

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it will require another clinical trial.

Live Science on MSN4d

2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayed

Late-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect the shot's approval may be delayed.

MySuncoast.com on MSN5d

New Novavax Covid -19 vaccine tailored for patients 65 and older

After a six-week long delay, The Food and Drug Administration (FDA) has finally approved a more traditional protein-based covid vaccine produced by pharmaceutical giant Novavax.