Claim that new flu vaccine delivers 40% relative risk reduction not justified
Rating
Superior Protection by Flublok® Influenza Vaccine in Seniors Documented in New England Journal of Medicine
Our Review Summary
The news release, which comes from flu vaccine manufacturer Protein Sciences Corporation, highlights a recent study published in the New England Journal of Medicine on the effectiveness of its vaccine in older adults. The news release does a fair job of describing the study, when the drug will be widely available, and addressing potential harms. However, there are two significant shortcomings: first, the release does not address cost — which is problematic, given that the release comes from the company itself; and second, the release only tells readers about the benefits of the vaccine in terms of relative risk, as opposed to absolute risk. This is an important distinction — which we’ve discussed quite a bit — and we’ll address it at greater length below. Furthermore, the release seems to inflate the reduction in relative risk from 30 percent to 40 percent. Data in the study itself only supports a 30 percent relative risk reduction.
Why This Matters
The CDC estimates that “influenza has resulted in between 9.2 million and 60.8 million illnesses, between 140,000 and 710,000 hospitalizations and between 12,000 and 56,000 deaths annually since 2010.” What’s more, the CDC also notes that: “While influenza seasons can vary in severity, during most seasons people 65 years and older experience the greatest burden of severe influenza disease.” In other words, the flu is a big deal — and especially so for older adults. This news release is focused on a study that examined the effectiveness of a new flu vaccine in adults aged 50 years and older compared to the conventional flu vaccine in adults of the same age. Even an incremental improvement in efficacy of a vaccine so commonly used and central to prevention of illness is important. This is useful information, and could help older adults — and their doctors — make informed decisions about how they choose to protect themselves against the flu. However, in order to make truly informed decisions, older adults (and their doctors) need to truly understand the difference in protection provided by the two types of vaccine — and they also need to know the difference in cost. Informed decisions can’t be made without a clear understanding of costs and benefits, and this release doesn’t quite meet the bar.
Criteria
Not Satisfactory
Costs aren’t discussed at all. Given that this release comes from the manufacturer, and that the drug was approved by the FDA in October 2016, it’s not clear why this information isn’t available.
Not Satisfactory
This is very problematic. The release tells readers that “People who were given [the new vaccine] Flublok Quadrivalent were over 40% less likely to develop culture-confirmed influenza [compared to those who took conventional, egg-based inactivated vaccine].” If you look at the numbers reported in the NEJM article, you’ll see that 96 of the 4303 people who received the new vaccine (or 2.2 percent) were later diagnosed with the flu. That compares to 138 of 4301 study participants who received the conventional vaccine (or 3.2 percent). So the benefit is a reduction of risk from 3.2 to 2.2 percent. That’s a 1 percentage point difference in terms of absolute risk. So where does that “40% less likely” language come from? Theoretically, it refers to the relative reduction in risk between the experimental vaccine group and the conventional vaccine group. But that doesn’t really work either. Here’s how the study authors describe the relative risk reduction in the NEJM article: “thus, in the modified per-protocol population, the probability of influenza-like illness was 30% lower with [the experimental vaccine] than with [the conventional vaccine].” So, where does that “40% less likely” language come from? We don’t know, and the release doesn’t tell us.
Satisfactory
The release includes a section on the safety of the new vaccine that offers substantial relevant information, as well as how to obtain more detailed information if desired.
Satisfactory
The release includes a concise, but effective, overview of the study.
Satisfactory
No disease mongering here.
Not Satisfactory
The release is clearly from Protein Sciences Corporation and clearly identifies its own chief medical officer when she is quoted in the piece. The release does not explicitly state that the study was funded by Protein Sciences, but hat can be deduced from the text.
But omitting conflicts of interest disclosures in the release is another matter. According to the disclosure in NEJM, journal article authors “Drs. Dunkle, Izikson, and Cox report being employed by and holding stock in Protein Sciences.” That financial connection should have been included in the news release.
Satisfactory
The release does not list other flu vaccines by name, but does clearly describe the conventional vaccine that was compared to Flublok Quadrivalent in this study. The release also articulates what distinguishes Flublok from conventional vaccines in terms of its manufacturing and components (e.g., Flublok is made without using eggs, etc.).
Satisfactory
The release explicitly states that: “Flublok Quadrivalent was approved by the FDA in October 2016 and will be available nationwide in prefilled syringes for the upcoming flu season.”
Satisfactory
As noted above, the release clearly describes how Flublok Quadrivalent differs from other flu vaccines. The release also addresses the novelty of the clinical study in shedding light on the efficacy of Flublok Quadrivalent to a conventional vaccine in older adults.
Not Satisfactory
In addition to the findings that inflated the relative risk reduction from 30 to 40 percent (described under benefits), the chief medical officer’s statement includes the following: “Clearly, Flublok represents a major step forward in combating influenza on a global scale.” Stating the the findings are “a major step forward” and “on a global scale” are broad, unjustified claims. This is an incremental improvement, not a major step forward.
Total Score: 6 of 10 Satisfactory
Comments (2)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Donald Weinshank
July 3, 2017 at 4:38 pmWe need comparison to conventional egg-based vaccine.The issue is risk analysis of different approaches. Of course, this approach may be of significant help to people who have anyphylactic shock to vaccines made in eggs,
Alison Fujito
March 10, 2018 at 8:52 pmYou might want to look more closely at the safety studies on this flu shot, and on every other vaccine. You might not be aware that vaccines are classified as biologicals, and are thus exempt from the standard of safety testing required of all other pharmaceutical products. They are not required to be safety-tested against a true placebo; typically, adverse event data is compared with either another vaccine (which may have a poor safety record itself), or with the most reactive ingredients in the vaccine, minus the actual antigen, Since the adjuvant’s entire purpose is to elicit a stronger immune response, it hardly qualifies as a placebo, but it’s usually given — sometimes in large amounts — to the “placebo” group.
Data on long-term effects, such as autoimmune and neurological disorders, is rarely, if ever, sought.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like