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What's the holdup in full FDA vaccine approval?

What’s the holdup in full FDA vaccine approval?
Tom Avril
The Philadelphia Inquirer
More than eight months ago, large studies found that both the Pfizer-BioNTech and Moderna COVID-19 vaccines reduced the risk of illness by more than 90%. Yet the U.S. Food and Drug Administration has not yet granted them full approval, to the dismay of public-health officials eager to boost vaccination rates as the delta variant sends infections skyward.
So what’s the holdup?
Part of the reason, according to experts in drug regulation, may be simply that the agency can afford to take the time.
In December, the FDA authorized the first two vaccines for emergency use, and did so for a third in February. Those authorizations, though based on extensive, rigorous research, are temporary in nature. Before granting permanent approval (“licensure”), the agency can spend months to make triply sure that all regulatory requirements are met, given that the vaccines are available ....

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'Ultrageezer' breaks 50K world record for 70-plus age group

'Ultrageezer' breaks 50K world record for 70-plus age group
dailyrepublic.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from dailyrepublic.com Daily Mail and Mail on Sunday newspapers.

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Becerra's border challenge

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Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care s morning newsletter, which is delivered to our subscribers each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. ....

New York , United States , White House , District Of Columbia , University Of Pennsylvania , Jeff Zients , Luciana Borio , Tom Avril , Scott Gottlieb , Alice Miranda Ollstein , Rym Momtaz , Jesse Naranjo , Rachel Roubein , Xavier Becerra , George Stephanopoulos , Dan Goldberg , Charles Michel , Andrew Jacobs , Europe David Herszenhorn , European Council , Jake Tapper On State Of The Union , Senate Majority Leader Chuck Schumer , Senate Finance Committee , National Institute Of Allergy , Drug Administration , Justice Department ,

19,000 Pa. voters and counting ditch the GOP | Morning Newsletter

19,000 Pa. voters and counting ditch the GOP | Morning Newsletter
Ashley Hoffman, The Philadelphia Inquirer
© TIM TAI/The Philadelphia Inquirer/TNS
From left, University of Pennsylvania junior Joey Lohmann and senior Preethi Kumaran, two of the founders of Lockdown Letters, and senior Jenny Chang, a program ambassador, on the Penn campus in West Philadelphia on Saturday, Feb. 20, 2021.
Good morning from The Inquirer newsroom.
First: Roughly 19,000 Pa. voters left the Republican party in the aftermath of the false election fraud claims.
Then: COVID-19 has led to a sharp decline in cardiac surgeries.
And: Philly will welcome new neighbors as President Joe Biden plans to resettle more of the world’s most vulnerable people to new homes in the region. ....

Montgomery County , United States , New York , Bucks County , New Jersey , University Of Pennsylvania , William Cody Anderson , Tom Avril , Joe Biden , Preethi Kumaran , Ashley Hoffman , Josephn Distefano , Joey Lohmann , Jenice Armstrong , Jenny Chang , Upenn Museum Of Archaeology , Republican Party , Society Of Thoracic Surgeons , Democratic Party , Lockdown Letters , West Philadelphia , President Joe Biden , Thoracic Surgeons , Philly The , Penn Museum , Montgomery County Through ,

Vaccine shortage may delay doses for 100,000 in Pa. | Coronavirus Newsletter

Vaccine shortage may delay doses for 100,000 in Pa. | Coronavirus Newsletter
Ellie Silverman, The Philadelphia Inquirer
© ALEJANDRO A. ALVAREZ/The Philadelphia Inquirer/TNS
A vial of Moderna COVID-19 vaccine.
TL;DR: Some Pennsylvania vaccine providers have for weeks been administering Moderna shots meant for second doses as first doses, leading to a dose shortage that could cause as many as 100,000 Pennsylvanians to have their vaccine appointments delayed. Read on for answers to some of your most pressing vaccination questions like: How long does immunity last? How do we track prevention? Does infection equal a dose of vaccine?
What you need to know: ....

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