It Is Time to Separate Food Safety from the FDA?

Between the baby formula debacle and longer-than-expected review periods for COVID-19 vaccines, it’s been a rough year for the Food and Drug Administration (FDA).  The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and tobacco products to pharmaceutical drugs […]

What Happened, What You Missed: July 4-8

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FDA Allows Pharmacists to Prescribe Paxlovid Authorized state-licensed pharmacists can now prescribe the COVID-19 antiviral Paxlovid to eligible patients, according to a revised emergency use authorization (EUA) from the Food and Drug Administration (FDA).  The revision will increase access to the medication, which has been a priority of the Biden administration for the past few weeks.  While Paxlovid has […]

What Happened, What You Missed: June 20-24

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Moderna Says Updated Vaccine Effective against Omicron Subvariants Moderna announced on Wednesday that an updated version of its COVID-19 vaccine provides strong protection against a symptomatic infection of the Omicron subvariants BA.4 and BA.5, which are rapidly spreading worldwide.  The updated vaccine candidate is bivalent, meaning it targets both the original version of COVID-19 and the Omicron […]

What Happened, What You Missed: May 23-27

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Pfizer’s COVID-19 Vaccine Is 80% Effective in Kids under 5 This week, Pfizer finished submitting clinical trial data to the Food and Drug Administration (FDA) to seek emergency approval of its three-dose COVID-19 vaccine for children ages six months to five years.  On Monday, the company announced that its vaccine is 80.3% effective in preventing against symptomatic […]

What Happened, What You Missed: May 16-20

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FDA Authorizes Pfizer COVID-19 Booster Shots for Kids Ages 5-11 On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third “booster” dose of Pfizer’s COVID-19 vaccine for children ages 5 to 11 at least five months after their most recent shot.  The FDA decided to authorize a third […]

What Happened, What You Missed: May 2-6

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E&C Leaders Release FDA User Fee Package On Wednesday, bipartisan leaders of the House Energy and Commerce Committee released a legislative proposal to reauthorize the Food and Drug Administration’s (FDA) ability to collect fees from drug, biosimilar, and device manufacturers for five years.  Additionally, the bill contains several policy riders that would give the FDA more control […]

Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

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Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal. Anger among parents hit a boiling point last week when […]

Will We Need More Booster Shots?

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People will only need annual COVID-19 booster shots after getting their third vaccine dose, according to a top Food and Drug Administration (FDA) official at the 2022 Innovation in Regulatory Science Summit in January 2022.  Since then, however, mounting evidence over waning immunity plus the potential of a new wave of COVID-19 are feeding calls for people to […]

What Would the End of the Public Health Emergency Mean for EUAs?

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The current public health emergency (PHE) is set to expire on April 16.  While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans.  Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire […]

When Can Kids Under 5 Get Vaccinated?

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An average 672 children per day last week were admitted to the hospital with COVID-19 last week, the highest number since the COVID-19 public health emergency began.  Surging case numbers are also causing schools to close and temporarily revert to virtual learning.  While children ages 5-17 can be vaccinated for protection against COVID-19, this currently isn’t an […]