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Brief but informative report from AP on newly approved shingles vaccine

Rating

3 Star

Categories

FDA approves better vaccine against painful shingles virus

Our Review Summary

This breaking news coverage of the FDA’s approval of a new shingles vaccine, GlaxoSmithKline’s Shingrix, does a good job of comparing the vaccine’s costs and benefits to those of an established competitor, Merck’s Zostavax.

However, the story lacks perspective from independent experts. Also, it doesn’t report more meaningful data such as the absolute number of patients who would benefit from receiving the vaccine or how many patients must receive the vaccine for one patient to benefit, known as the number needed to treat (NNT). That’s information patients might consider in determining whether the vaccine is worthwhile.

Also, while some aspects of the new vaccine appear to be superior, proclaiming it “better” as this headline does is too vague. Better in what way?

[Editor’s note: This review has been corrected and star score changed from 4 to 3 stars. See the “Benefits” criterion below for explanation.]

 

Why This Matters

Almost one in three people in the U.S. will develop shingles, a painful rash that can affect anyone who’s had chicken pox, according to the CDC. The rash can lead to ulcers and scars, and a few patients develop postherpetic neuralgia, severe nerve pain that can last for months or years. Shingles can strike anyone with a compromised immune system, but about half of all cases occur in people 60 and older. Zostavax, available since 2006, was shown to be 51 percent effective at preventing shingles and 67 percent effective at preventing post-herpetic neuralgia.

The availability of a vaccine with close to 90 percent reported efficacy is significant news that could prompt more patients to be vaccinated. A MedScape provider survey suggested Shingrix will likely replace Zostavax, given its higher efficacy and the fact that it can be given to more patients because it does not contain a live virus. News stories should strive to provide independent viewpoints and data that will help patients weigh weigh the costs and benefits.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does a good job here:

GlaxoSmithKline PLC said the price of its shingles vaccine, called Shingrix, will be $280 for the required two shots. Merck & Co.’s one-shot Zostavax costs $223. Most insurance plans cover it.

A couple of caveats aren’t addressed. For one, it’s unclear to what extent insurers will cover Shingrix. Also, shingles vaccines aren’t fully covered under Medicare, which means Medicare patients often pay significant out-of-pocket costs.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

[Editor’s note: As pointed out in the comments section of this post, this story uses only relative risk measures to quantify the benefit of the vaccine. To earn a Satisfactory rating, news stories are typically required to describe benefits in absolute terms if possible. Accordingly, we have changed the rating here to Not Satisfactory and reduced the star score for the story from 4 to 3 stars. Learn more about the importance of reporting absolute numbers in this primer.]

The story states studies found the vaccine prevents shingles in about 90 percent of people, while Merck’s product is about 50 percent effective. It also states that the vaccine “reduces the risk of nerve pain by nearly 90 percent.”

It also said: “Glaxo studies also show it retains about 90 percent of its effectiveness for four years, and follow-up studies indicate it lasts years longer, according to Dr. Leonard Friedland, Glaxo’s vaccines director for North America.” The story should have stressed that the long-term efficacy is unknown.

It also would have been useful to include the number of patients who would need to be treated to prevent one bad outcome. The company didn’t put that figure in its news release or published research. However, outside experts have crunched the numbers. According to shared calculations, about 34 patients would need to be given Shingrix over three years to prevent one case of shingles, and about 260 would have to receive the vaccine to prevent one case of post-herpetic neuralgia.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No potential harms are mentioned. According to GSK’s news release: “The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.” GSK’s research reported 79 percent of those who received the vaccine, versus 29.5% of placebo recipients, reported local and/or systemic side effects, as HealthNewsReview.org reported in a 2016 news release review.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story doesn’t say anything about the reliability of the research behind this vaccine, except to say that it was company-funded. A line or two about the how many patients were in the trial and the selection criteria would have been useful. Some of that data is in our news release review.

Does the story commit disease-mongering?

Satisfactory

The story doesn’t engage in disease mongering, and gives useful data about the prevalence of shingles:

Anyone who’s had chickenpox — nearly everyone over 40 — harbors the varicella-zoster virus that causes the disease. The virus can resurface decades later, triggering painful sores on one side of the body. About 10 to 20 percent of those who get shingles also develop debilitating nerve pain that can last for months, even years.

About one-third of people who have had chickenpox get shingles. That’s about 1 million Americans a year. But once someone has recovered from shingles, it rarely reoccurs.

It would have been informative to also include that only about one-third of adults 60 and older have ever received the Zostavax vaccine.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story doesn’t use any independent sources, which is a major weakness.

Does the story compare the new approach with existing alternatives?

Satisfactory

This is a strength of the story, which states near the top that Shingrix will be the second shingles vaccine in the U.S. market. It compares available data on efficacy, duration, and cost and notes that they are “made differently.”

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The news here is that the vaccine was approved by the FDA, which indicates it’s going to be available soon. The story alludes to Shingrix’s two-dose requirement, but doesn’t specifically point out that it could inconvenience some patients.

Does the story establish the true novelty of the approach?

Satisfactory

The lead states that Shingrix is “more effective” than the existing vaccine for shingles. Further along the story points out that unlike its competitor, Shingrix doesn’t contain a live virus, which makes it appropriate for people with compromised immune systems. We would have liked more specificity about how the vaccine is made, rather than the statement that it “is genetically engineered and includes an ingredient that boosts effectiveness.”

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not appear to rely on the news release.

Total Score: 6 of 10 Satisfactory

Comments (5)

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Alan Cassels

October 25, 2017 at 1:28 pm

It is just me or does it seem you’re a little too nice on this AP report of this new shingles vaccine? Repeating the “90% efficacy rate” of this new vaccine is very misleading and exaggerates its benefits. We saw the exact same thing when Zostavax was being reported in the media a decade ago. The 2005 study of Zostavax published in the New England Journal of Medicine enrolled more than 38,000 people over 60. It found that over three years, the vaccine “reduces the occurrence of herpes zoster by 51.3 per cent.” And that’s the number the newspapers unfortunately trumpeted. This study found 315 shingles cases among those vaccinated and 642 among placebo recipients, –hence the conclusion that it reduced the rate of shingles by 51.3 per cent.

The absolute effects of the vaccine was measured in “1,000-person years” and found that the vaccine dropped the rates of shingles per 1,000 person-years from 11.12 (those on placebo) to 5.42 (those given the vaccine). In absolute terms, the vaccine “helps” (prevents from developing shingles) about 5.7 people per thousand per year (11.12 minus 5.42 equals 5.7). What can’t we similarly see a headline that tells us what the “90% reduction” in this new vaccine means in thousand-person years? Please tell me it’s not too hard to find that number.

The 90% reduction when presented to readers of this article will think that the vaccine helps 90 people out of a hundred but like the previous vaccine which helped five people per thousand per year. (and not 50) this number similarly exaggerates those effects. I’m glad you found outside experts who crunched the numbers in terms of NNT, but a 3% or 0.2% difference is VERY different than 90%. Giving them a ‘satisfactory’ score on ‘quantifying the benefits’ is letting them off a bit easy, wouldn’t you say? That’s the crux of the story and you let them off the hook on this key issue.

Reply

    Kevin Lomangino

    October 25, 2017 at 4:14 pm

    Alan,

    Although the review did call attention to the lack of absolute numbers, the story should have been rated Not Satisfactory on this point as you note. We’ve changed the rating, corrected the star score, and updated the review comments with an editor’s note. Thanks for the close read.

    Kevin Lomangino
    Managing Editor

    Reply

      Stephen Cox, MD

      October 30, 2017 at 11:14 am

      This is more confusing after reading Alan Cassels comment. So is the added cost of this new vaccine, especially for those of us already vaccinated with Zostavax, (for whom it is also recommended), advisable? What is the bottom line?

      Kevin Lomangino

      October 30, 2017 at 11:58 am

      I’m sorry to give an answer that probably won’t satisfy here, but we don’t offer medical advice or bottom line recommendations on what people should or shouldn’t do. Whether the cost is advisable or not is something patients should discuss with their doctors. Our point is that stories about the vaccine should include information that would help people make these decisions. In this case, the difference between 50% and 90% effectiveness should have been explained in more detail. Hopefully, our comments and provision of NNT description will help fill this information gap.

      Kevin Lomangino
      Managing Editor

Stephen Cox, MD

October 31, 2017 at 12:07 pm

Thank you for emphasizing the need for better transparency from authors of clinical studies who should always print ABSOLUTE percentages rather than relative( misleading).

Reply