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FDA, Covid and vaccines

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

The new labels will expand that warning to certain age groups.

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FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

STAT · 2h

FDA gives Covid vaccine manufacturers instructions for next fall’s shot

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 · 9h

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

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FDA limits access to COVID-19 vaccine to older adults and other high-risk groups – a public health expert explains the new rules

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.

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

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

2don 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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,

1don MSN

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

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

20h

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

Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the drugmaker said it would withdraw its application seeking approval from the U.S.

2don 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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.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,

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

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.

STAT2d

Pharmalittle: We’re reading about Trump’s drug-pricing plan, a Moderna change of plans, and more

The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.

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Third COVID Vaccine Gets Approved for Adults 65 and Over

Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.