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FDA, Covid and vaccines

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.

U.S. News & World Report · 1d

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer's Comirnaty and Moderna's Spikevax vaccines.

STAT · 1h

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

The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to update their vaccines.

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

USA TODAY on MSN · 1d

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.

Time on MSN · 1d

What the New COVID-19 Vaccine Guidance Means For You

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of reviewing and recommending yearly updates to the COVID-19

Yahoo · 4h

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

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

19h

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 ...

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.

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 ...

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 ...

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.

AARP3d

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) ...

Investor's Business Daily on MSN2d

Moderna Reverses Its Rally As It Faces Another Vaccine Setback

Moderna stock toppled Wednesday after the company withdrew its application for a combination Covid and flu vaccine.

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