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COVID, FDA and Moderna

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.

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· 2d · on MSN

FDA expands COVID vaccine warning about heart side effect risk for young males

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FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

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.

MIT Technology Review · 1d

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Uncertainty loomed as FDA advisors met to discuss this year’s COVID shot

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Here's what to know about the FDA's COVID-19 vaccine changes

COVID shots should target newer strains of JN.1 variant, US FDA advisers say

The House budget bill that narrowly passed in an early morning vote on Thursday would effectively put the brakes on a clean energy production boom in the United States spurred by subsidies enacted in ...

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

Arizona PBS · 23h

FDA ends routine COVID shots for healthy young Americans

FDA, COVID-19 vaccine

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Changes are happening around COVID-19 vaccines: Here's what to know

COVID-19 vaccine recommendations could be changing, according to the U.S. Food and Drug Administration.

· 1d · on MSN

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FDA to restrict COVID vaccine access

Boise State Public Radio · 1d

Vaccine advisers to the FDA recommended changes to COVID vaccines

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.

19hon MSN

Moderna files application for updated COVID vaccine

Moderna said on Friday it had filed a marketing application for an updated COVID vaccine to the U.S. Food and Drug Administration.

The Manila Times on MSN11m

Moderna's updated Covid vaccine for review

The company said the submission for the vaccine, branded as Spikevax, is based on guidance from the FDA, which advised that the shots should be updated to target strains that are a part of JN.1 lineage,

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

Moderna withdraws application for COVID-flu combination vaccine

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine,

BioPharma Dive2d

Moderna pulls application for combo COVID, flu shot

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.

4don 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.

3don MSN

Moderna pulls application for COVID-flu combination shot

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,