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Tuesday, October 26, 2021
Following expert advice, FDA authorizes boosters for people 65+, high risk

Following expert advice, FDA authorizes boosters for people 65+, high risk

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Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Covid-19 Coverage View more stories The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also eligible for boosters will be those ages 18 to 64 who are at high risk…
Tension over boosters rises as FDA regulators quit and publicly blast Biden’s plan

Tension over boosters rises as FDA regulators quit and publicly blast...

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Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Two leading vaccine regulators who had previously announced their resignations from the Food and Drug Administration have now come out against the Biden administration's plan to offer COVID-19 booster shots. In a viewpoint article published in The Lancet on Monday, Marion Gruber, the…
Unvaccinated are 5X more likely to catch delta, 11X more likely to die

Unvaccinated are 5X more likely to catch delta, 11X more likely...

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Enlarge / The Centers for Disease Control and Prevention (CDC) headquarters stands in Atlanta, Georgia, on Saturday, March 14, 2020. COVID-19 vaccines are largely holding up against the hyper-transmissible delta coronavirus variant, particularly when it comes to preventing severe disease and death, according to three studies published Friday by the Centers for Disease Control and…
Pressure mounts over COVID vaccines for kids; docs warn against off-label use

Pressure mounts over COVID vaccines for kids; docs warn against off-label...

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Enlarge / PALOS VERDES ESTATES, CA - AUGUST 24: A father helps his 4-year-old son with the swab for a rapid COVID-19 test. After Pfizer's COVID-19 vaccine earned full regulatory approval Monday, pressure is mounting to have the vaccine available to children under 12 years old—and so are concerns that it will be given to…
Report: Pfizer’s COVID-19 vaccine may get full FDA approval Monday

Report: Pfizer’s COVID-19 vaccine may get full FDA approval Monday

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Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. The Food and Drug Administration is aiming to issue full regulatory approval of Pfizer/BioNTech's COVID-19 vaccine as early as Monday, according to a report by the New York Times. The regulatory agency had previously set an unofficial…
What to know about the US COVID booster plan—and why WHO hates it

What to know about the US COVID booster plan—and why WHO...

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Covid-19 Coverage View more stories US officials on Wednesday formally announced plans to offer COVID-19 vaccine booster shots to Americans—and the plans are already under fire from experts at the World Health Organization. US officials are recommending that all Americans vaccinated with two doses of an mRNA vaccine (either the Moderna or Pfizer/BioNTech vaccine) get…
FDA expected to authorize 3rd COVID vaccine dose for immunocompromised

FDA expected to authorize 3rd COVID vaccine dose for immunocompromised

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Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. Covid-19 Coverage View more stories The Food and Drug Administration is expected to announce Thursday (or soon after) that it is authorizing a third COVID-19 vaccine dose for some people with compromised immune systems, according to people familiar with the FDA's…
Pandemic of unvaccinated rages with delta’s spread; cases up in all 50 states

Pandemic of unvaccinated rages with delta’s spread; cases up in all...

Enlarge / Anthony Church says goodbye through glass windows to his daughter, who is recovering from COVID-19 at Johnston Memorial Hospital's ICU on June 16, 2021, in Abingdon, Va. Covid-19 Coverage View more stories With the rapid rise of the highly transmissible delta variant and national vaccination efforts largely stalled, the COVID-19 pandemic continues to…
Expert panel says new $56K Alzheimer’s drug is unproven—and worth $8,400 max

Expert panel says new $56K Alzheimer’s drug is unproven—and worth $8,400...

Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts. Biogen's new Alzheimer's drug Aduhelm continues to face opposition after its contentious approval by the Food and Drug Administration last month—which the FDA now says should be independently investigated. Some insurers say they won't pay for the drug, some hospitals say…
Amid firestorm of criticism, FDA narrows use of $56,000 Alzheimer’s drug

Amid firestorm of criticism, FDA narrows use of $56,000 Alzheimer’s drug

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Less than five weeks after granting a highly controversial approval for the Alzheimer's drug Aduhelm, the Food and Drug Administration has updated its recommendation for who should receive the drug. The update narrows the recommended patient pool from all those with Alzheimer's disease…

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