Claim that new flu vaccine delivers 40% relative risk reduction not justified

Does the news release adequately discuss the costs of the intervention?

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.

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

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.

Does the news release identify funding sources & disclose conflicts of interest?

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.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

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.