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posted by martyb on Tuesday August 16 2016, @07:47AM   Printer-friendly
from the live-and-let-live? dept.

A new study has found that the FluMist nasal delivery system is just as reliable as other forms of a vaccine:

It came as a surprise this June when the Centers for Disease Control and Prevention recommended against using the nasal flu vaccine for the 2016-2017 flu season, citing a lack of evidence that it works. Now, findings from a Canadian study [DOI: 10.7326/M16-0513] appear at first blush to contradict the research that led the Advisory Committee on Immunization Practices [ACIP] to recommend against that live attenuated vaccine.

But things aren't so simple. In fact, the conflicting evidence about the live nasal flu vaccine offers an excellent case study on how complex the task of analyzing flu vaccine data and making recommendations really is. "Sometimes the public wants a very simple message, and unfortunately life's not like that," Mark Loeb, the new study's lead author and director of the division of infectious diseases at McMaster University in Ontario, tells Shots. "Things change as the evidence grows and we understand more. Unfortunately, that's how science and clinical medicine work. The challenge is to be able to help the public understand the shades of gray here."

[...] CDC data consistently showed the live nasal vaccine to be very effective in children until 2013, when the vaccine went from including three strains (trivalent) to including four strains (quadrivalent). And therein lies the rub: The new Canadian study used the trivalent vaccine, while ACIP analyzed data using the quadrivalent vaccine, and among U.S. children. "Many of us felt very strongly that the LAIV [live attenuated influenza vaccine] was a better vaccine than the inactivated for children, and the data supported that," says Pedro Piedra, a professor of virology and microbiology at Baylor College of Medicine and one of the investigators involved in the nasal vaccine clinical trials in the late 1980s. "But something happened when it became a quadrivalent vaccine."

Previously: CDC Advisory Panel Recommends Against "FluMist" Nasal Spray Vaccine System


Original Submission

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CDC Advisory Panel Recommends Against "FluMist" Nasal Spray Vaccine System 23 comments

A CDC panel has concluded that a spray version of the influenza vaccine is ineffective and shouldn't be used during the 2016-2017 flu season:

What led to the abrupt fall of FluMist — the nasal spray version of influenza vaccine — which until recently was considered the first choice for younger children? On Wednesday, an advisory panel to the Centers for Disease Control and Prevention concluded that the spray version was so ineffective, it shouldn't be used by anyone during the 2016-2017 flu season.

Just two years ago, that same Advisory Committee on Immunization Practices [ACIP] recommended FluMist as the preferred alternative for most kids ages 2-8, after reviewing several studies from 2006-2007 that suggested the spray was more effective in kids than the injectable forms of the vaccine.

What changed to make the spray so much less effective than studies had shown it to be in the past? The bottom line is that right now "we don't understand what it is," said David Kimberlin, a professor of pediatrics at the University of Alabama, Birmingham, who said academic researchers and those at MedImmune, the subsidiary of Astra Zeneca that makes FluMist, are working to get answers.

AstraZeneca, the maker of FluMist, says its own numbers conflict with the CDC's. The ACIP recommendation must be reviewed by the CDC's director before it can become official policy. The FluMist spray comprises 8% of the projected vaccine supply for the upcoming flu season.


Original Submission

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  • (Score: 1, Funny) by Anonymous Coward on Tuesday August 16 2016, @10:33AM

    by Anonymous Coward on Tuesday August 16 2016, @10:33AM (#388637)

    Yes, which is precisely the sort of thing we need to know. I mean, do people want flu that can be fitted nasally?

  • (Score: -1, Offtopic) by Anonymous Coward on Tuesday August 16 2016, @12:05PM

    by Anonymous Coward on Tuesday August 16 2016, @12:05PM (#388646)

    I think we should look at the link between corporations that only want profit forcing vaccines on the people. There has been an alarming rise in autism. Some question whether there is a link, this man included.

  • (Score: 1, Interesting) by Anonymous Coward on Tuesday August 16 2016, @01:35PM

    by Anonymous Coward on Tuesday August 16 2016, @01:35PM (#388666)

    This is just bizarre...look at "Appendix table 2" in the paper (http://annals.org/article.aspx?articleid=2543271). This paper reports data indicating that neither vaccine does much of anything, but they just don't discuss that aspect at all. I suppose one way of spinning their result is that the two methods "work just as well" as one another. Actually the people who got vaccinated had a higher chance of testing positive for influenza (6% vs 5 %).

    • (Score: 2) by maxwell demon on Tuesday August 16 2016, @01:44PM

      by maxwell demon (1608) Subscriber Badge on Tuesday August 16 2016, @01:44PM (#388672) Journal

      Hey, that's a great marketing idea.

      "Buy my new medicine! It works just as well as snake oil, at half the prize!"

      And the best, nobody can sue for false claims, as the statement is absolutely true (assuming the prize statement is)! ;-)

      --
      The Tao of math: The numbers you can count are not the real numbers.
      • (Score: 2) by Osamabobama on Tuesday August 16 2016, @07:17PM

        by Osamabobama (5842) on Tuesday August 16 2016, @07:17PM (#388800)

        Competing on price is a difficult business model to sustain. It ends up being a race to the bottom, where, pretty soon, you end up selling commodity placebos for commodity prices. Look to homeopathy for a better marketing plan. (Hint: it involves bullshit for added value)

        --
        Appended to the end of comments you post. Max: 120 chars.
    • (Score: 0) by Anonymous Coward on Tuesday August 16 2016, @08:04PM

      by Anonymous Coward on Tuesday August 16 2016, @08:04PM (#388814)

      People tested positive for influenza after squirting "live" influenza viruses up their noses? Impossibru!

      • (Score: 0) by Anonymous Coward on Tuesday August 16 2016, @10:58PM

        by Anonymous Coward on Tuesday August 16 2016, @10:58PM (#388882)

        The primary outcome was reverse transcriptase polymerase chain reaction–confirmed influenza A or B virus in all participants (vaccinated children and persons who did not receive the study vaccine).

        Since testing positive for influenza was the primary endpoint, I would hope they accounted for that somehow. Too bad it is behind a paywall...

  • (Score: 2) by maxwell demon on Tuesday August 16 2016, @01:36PM

    by maxwell demon (1608) Subscriber Badge on Tuesday August 16 2016, @01:36PM (#388668) Journal

    People love shades of gray — as long as there are 50 of them.

    --
    The Tao of math: The numbers you can count are not the real numbers.
  • (Score: 0) by Anonymous Coward on Tuesday August 16 2016, @02:54PM

    by Anonymous Coward on Tuesday August 16 2016, @02:54PM (#388687)

    Unfortunately, that's how science and clinical medicine work. The challenge is to be able to help the public understand the shades of gray here.

    That may be how clinical medicine works, but not science. In science you design things so the result of your study is to get an ever closer approximation of reality. The NHST approach to research, used here (and is standard in clinical research), has been well known to automatically lead to apparently conflicting evidence for many, many years. The only reason this pandemic of conflicting evidence isn't more apparent are the institutionalized resistances to replication studies and publishing "negative" results.

    The second interpretation is as follows: In 63% of the studies, the drug had no effect. However, in 37% of the studies, the drug did have an effect. (Moreover, when the drug did have an effect, the effect was quite large, averaging .89.) Research is needed to identify the moderator variables (interactions) that cause the drug to have an effect in some studies but not in others. For example, perhaps the strain of rat used or the mode of injecting the drug affects study outcomes. This interpretation is also completely erroneous. In addition, it leads to wasted research efforts to identify nonexistent moderator variables.

    Both traditional interpretations fail to reveal the true meaning of the studies and hence fail to lead to cumulative knowledge. In fact, the traditional methods based on significance testing make it impossible to reach correct conclusions about the meaning of these studies. This is what is meant by the statement that traditional data analysis methods militate against the development of cumulative knowledge.

    Schmidt, F. L. (1996). Statistical significance testing and cumulative knowledge in psychology: Implications for training of researchers. Psychological Methods, 1, 115– 129. http://psycnet.apa.org/journals/met/1/2/115.pdf [apa.org]

    • (Score: 2) by darkfeline on Tuesday August 16 2016, @03:42PM

      by darkfeline (1030) on Tuesday August 16 2016, @03:42PM (#388697) Homepage

      Protip: the results of studies always represent reality correctly. The problem lies in trying to induct general models from those results.

      --
      Join the SDF Public Access UNIX System today!
      • (Score: 0) by Anonymous Coward on Tuesday August 16 2016, @04:30PM

        by Anonymous Coward on Tuesday August 16 2016, @04:30PM (#388711)

        Thanks. I meant to say "models that are ever better approximations of reality".

      • (Score: 2) by bob_super on Tuesday August 16 2016, @05:46PM

        by bob_super (1357) on Tuesday August 16 2016, @05:46PM (#388747)

        > Protip: the results of studies always represent reality correctly.

        They represent the answer to the exact question arising from the setup, which is too often unrelated to the actual intent and/or interpretation.
        Like most computer bugs.

  • (Score: -1, Flamebait) by Anonymous Coward on Tuesday August 16 2016, @03:38PM

    by Anonymous Coward on Tuesday August 16 2016, @03:38PM (#388694)

    "t came as a surprise this June when the Centers for Disease Control and Prevention recommended against using the nasal flu vaccine for the 2016-2017 flu season"

    yeah right! it was only a suprise to dumbasses or liars. the cdc recommends against using a method where your body might be able to keep their soft kill weapons from working. how are they going to inject cancer viruses and god knows what else straight into your baby's blood if you don't let them start shooting them up with bioweapons as soon as some demented quack cuts them out of the mother's belly like a fish? It's no suprise the vaccines didn't work either. Anyone with any sense already knows it's not about stopping any disease.

    • (Score: 2, Interesting) by Anonymous Coward on Tuesday August 16 2016, @03:43PM

      by Anonymous Coward on Tuesday August 16 2016, @03:43PM (#388698)

      Is there a -1 batshit crazy mod available yet?

      • (Score: 0) by Anonymous Coward on Tuesday August 16 2016, @04:48PM

        by Anonymous Coward on Tuesday August 16 2016, @04:48PM (#388720)

        By the inject cancer viruses, I think they are referring to the HPV vaccine.

        Though I guess they never read "The Red Queen" by Matt Ridley or
        they would have a slightly different take on vaccines and their role in our genetic diversity.

        • (Score: 0) by Anonymous Coward on Wednesday August 17 2016, @01:38AM

          by Anonymous Coward on Wednesday August 17 2016, @01:38AM (#388944)

          i'll read it, thanks for the recommendation. i'll be more than happy to learn i've been focusing on negatives that are a small percentage of the overall wonderful picture, but you'll have to forgive me if i'm skeptical until then.

          • (Score: 0) by Anonymous Coward on Wednesday August 17 2016, @03:15PM

            by Anonymous Coward on Wednesday August 17 2016, @03:15PM (#389142)

            "The Red Queen" doesn't directly cover vaccines, and it is good to keep skepticism.

      • (Score: 2) by butthurt on Tuesday August 16 2016, @09:59PM

        by butthurt (6141) on Tuesday August 16 2016, @09:59PM (#388858) Journal

        Some polio vaccines prepared from 1954 to 1961 were contaminated with infectious SV40.

        -- https://www.ncbi.nlm.nih.gov/pubmed/16288015 [nih.gov]

        Studies in the 1960s showed that SV40 could produce certain cancers in newborn hamsters. More recent studies reported finding SV40 genes in several types of human tumors. These findings have raised the question of whether SV40 may cause, or contribute to causing, some types of cancer in humans. Several epidemiological studies found no link between exposure to SV40 contaminated vaccines and development of cancer. However, a study of immunization of pregnant women showed an increase in certain cancers in the offspring of women immunized with IPV compared to women immunized with either OPV or influenza vaccine. However, a recent report by the Institute of Medicine of the National Academy of Sciences concluded that "the evidence is inadequate to accept or reject a causal relationship between SV40 containing polio vaccines and cancer."

        -- William Egan, Ph.D., Acting Director, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration on Hearing: SV40 in Polio Vaccine before the Subcommittee on Wellness and Human Rights, Committee on Government Reform, US House of Representatives, November 13, 2003 http://www.hhs.gov/asl/testify/t031113.html [hhs.gov]

      • (Score: 0) by Anonymous Coward on Wednesday August 17 2016, @01:20AM

        by Anonymous Coward on Wednesday August 17 2016, @01:20AM (#388936)

        sv40 is just one small example where their absurd stupidity and arrogance got them noticed.
        watch Silent Epidemic - The Untold Story of Vaccines for one thing. i'm not against the idea of vaccines, btw. just sick of the medical industry and the prostitutes (at best) at the cdc.