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Stay Alert | FDA Updates
Title of the regulatory update One
Stay Alert | FDA Updates
August 2025

Title of the regulatory update One

Covid-19 Updates
On March 1, 2024 the CDC updated their guidelines. An additional dose of the Covid-19 202324 vaccine has been approved for individuals over the age of 65. This dose can be administered 4 months after the previous dose.

The FDA issued a new Emergency Use Authorization (EUA) on March 22, 2024 for Pemgarda (pemivibart). This medication can be used for the prevention of Covid-19 as a pre-exposure prophylaxis treatment.

This is the first treatment to be used a “pre exposure medication” Pemgarda is for individuals over the after of 12 or at least weighing 40kg, who are not infected with the virus AND have not had recent exposure to Covid-19. It is only to be considered for individuals that are moderate to severe immune compromised where vaccine will likely not provide adequate immune response.


How statins reduce mortality

Statins are the first line treatment for cardiovascular disease-atherosclerosis, more simply put, the high cholesterol. However, since these medications also have known associated risks in the elderly, the effects of it in older patients with multiple comorbidities, including dementia was not available and it was broadly recommended to avoid statins.

Recently, after extensive review in this population, the use of statins has been associated with improved mortality in the elderly, including those with dementia
The take home message is that these medications might improve the quality of life by reducing the risk for cardiovascular events in the elderly including those with dementia and this is something to consider in the nursing home setting. Perhaps it is important to look at the bigger picture of the benefit these medications can provide before recommending to de-prescribe statins. 

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