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posted by martyb on Tuesday August 24 2021, @02:43AM   Printer-friendly
from the it's-worth-a-shot! dept.

Pfizer's COVID-19 vaccine wins full approval from the FDA:

Pfizer's COVID-19 vaccine is now fully approved by the US Food and Drug Administration, making it the first shot against the coronavirus to get all the way through the regulatory review.

The FDA on Monday approved the mRNA vaccine against COVID-19 developed by Pfizer and its partner BioNTech for two doses, given three weeks apart, in people 16 years of age and older. The vaccine was previously being given under an emergency use authorization, which is still in place for the Moderna and Johnson & Johnson vaccines.

"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," said acting FDA Commissioner Janet Woodcock in a release. "Today's milestone puts us one step closer to altering the course of this pandemic in the US."

Full approval is expected to make it easier for local governments, schools and businesses to require vaccinations and may encourage people who are hesitant to get a shot. Three in 10 unvaccinated adults said they'd be more likely to get a vaccine if one moved from emergency authorization to full approval by the FDA, according to a June poll by the Kaiser Family Foundation.

[...] The Pfizer vaccine will now be marketed as Comirnaty, said the FDA.

Also at Washington Post and CNN.


Original Submission

 
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  • (Score: 3, Insightful) by c0lo on Tuesday August 24 2021, @03:05AM (7 children)

    by c0lo (156) Subscriber Badge on Tuesday August 24 2021, @03:05AM (#1170130) Journal

    Comirnaty, Illuminati and Vaxzevria - WTF is wrong with the marketing heads?

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    https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
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  • (Score: -1, Offtopic) by Anonymous Coward on Tuesday August 24 2021, @03:16AM

    by Anonymous Coward on Tuesday August 24 2021, @03:16AM (#1170136)

    Look at this.

    Aussie, i.e., criminal, can't handle anything.

    Nuke it from the orbit is the only option.

  • (Score: 5, Informative) by takyon on Tuesday August 24 2021, @06:39AM (4 children)

    by takyon (881) <{takyon} {at} {soylentnews.org}> on Tuesday August 24 2021, @06:39AM (#1170180) Journal

    Requirements from FDA and equivalents, zillions of pre-existing drug names, etc.

    Why drug names are so increasingly weird [chicagotribune.com]

    With thousands of drugs on the market, the No. 1 reason drug names are rejected by the Food and Drug Administration is that the agency doesn't want names to be too similar when prescriptions are filled, said Brannon Cashion, global president of branding firm Addison Whitney.

    The concern is that the prescribed drug will be confused with another, which could cause serious medical problems or even death. "Letters get transposed, letters get confused," Cashion said. "The pharmacist is often scrolling down an alphabetized list."

    Proposed drug names also can't elicit an air of superiority. Superbeststatin, for instance, would be a no-go with the FDA.

    And names should avoid eliciting any cultural confusion or sensitivity around the world.

    What's In A Drug Name? Sometimes, Enough To Cause Mix-Ups [npr.org]

    There are nearly 800 pairs of drugs like Clindesse and Clindets that look or sound alike, according to the Institute for Safe Medication Practices, or ISMP, a patient safety group that compiled a list of them. And the ISMP says all of these similarly named drugs are a big problem, because name mix-ups are responsible for about 25 percent of all medication errors.

    "We see errors all the time," Michael Cohen, president of ISMP, tells Shots. "And though it's rare, some of these mix-ups are fatal."

    The Food and Drug Administration has a name review process that's supposed to prevent pharmaceutical companies from using a name that's too close to another one already on the market. And they have forced drug companies to change the names of about a dozen drugs over the years, says Cohen.

    --
    [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
    • (Score: 2) by c0lo on Tuesday August 24 2021, @06:55AM (2 children)

      by c0lo (156) Subscriber Badge on Tuesday August 24 2021, @06:55AM (#1170186) Journal

      That's... relatable, I sorta can understand.

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
      • (Score: 1, Informative) by Anonymous Coward on Tuesday August 24 2021, @08:13AM (1 child)

        by Anonymous Coward on Tuesday August 24 2021, @08:13AM (#1170212)

        Then this will tear off the band-aid again. Moderna's SARS-CoV-2 vaccine's name once it gets approved in the US will be "Spikevax."

    • (Score: 2) by hendrikboom on Thursday August 26 2021, @09:53AM

      by hendrikboom (1125) on Thursday August 26 2021, @09:53AM (#1171132) Homepage Journal

      Drug names can be a real problem.
      My wife was once given a fertility drug instead of a birth control drug because the names were too similar.

  • (Score: 2) by DannyB on Tuesday August 24 2021, @03:40PM

    by DannyB (5839) Subscriber Badge on Tuesday August 24 2021, @03:40PM (#1170356) Journal

    Comirnaty, Illuminati and Vaxzevria - WTF is wrong with the marketing heads?

    They took their own vaccines.

    --
    Satin worshipers are obsessed with high thread counts because they have so many daemons.