Read Original Release

Shingles vaccine study summary omits significant COI with sponsor GSK

Rating

3 Star

Why the latest shingles vaccine is more than 90 percent effective

Our Review Summary

vaccineThis news release describes the results of a published study that examined how well a new shingles vaccine, Shingrix, provoked immune responses during clinical trials led by researchers in Australia. The news release does a good job of describing why Shingrix offers stronger protection compared with other vaccines. However, it isn’t clear what this new information means for patients. The news release doesn’t address costs, harms, and the fact that the study was conducted by employees of GlaxoSmithKline and others holding a financial stake in the vaccine.

 

Why This Matters

Almost one-in-three people in the U.S. will develop shingles, which is caused by the herpes zoster virus, according to the CDC. Incidence increases with age as the immune system declines, so vaccines are generally recommended for people over the age of 50.

Shingrix, which was approved in October 2017, contains an adjuvant, a substance that boosts the immune system’s response, and that appears to make it more effective and longer lasting than an older vaccine, Zostavax. It would have been helpful if the release would had informed readers how well the established vaccine works in comparison.

Criteria

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

Not Satisfactory

No cost information is provided. According to GoodRx, Shingrix costs about $300 out-of-pocket for a course of two injections.

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

Satisfactory

The primary benefit being reported here is that “90% of recipients had an increased immune response sustained across the 3-year duration of the study.”  It would have been more helpful if the release had noted the actual incidence of shingles in those vaccinated with the new vaccine versus the old (or no vaccine).

The news release says the study “shows that the vaccine stimulates your immune system to produce more antibodies and it generates a 24-fold increase in T cells. This is 12 times higher than other less effective shingles vaccines.” T cells are white blood cells that kill infected cells.

We did have some concerns with a statement in the release projecting how long the vaccine protects against shingles. The release quotes a researcher saying, “We anticipate that this protection will actually last much, much longer. We are now measuring the efficacy of the vaccine over the next 10 years and are very optimistic about the results.” However, it doesn’t say when and if that will translate into a benefit for patients.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

There’s no information on harms. Most people had pain around the injection site, and a variety of other symptoms such as muscle plain, headache and nausea were reported during clinical trials.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The news release states that data encompasses more than 15,000 people in 18 countries who received two doses of the vaccine, with the doses given two months apart.

Does the news release commit disease-mongering?

Satisfactory

There’s no disease mongering. The news release states that most “Australian adults have been infected with the herpes zoster virus and are at risk of shingles, even if they do not remember having chicken pox. By age 85, approximately 50% of the population will develop shingles. Vaccination is the only way to protect against shingles.”

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

Not Satisfactory

The study was funded by the manufacturer of Shingrix, GlaxoSmithKline, and many of the authors are listed in the study as being GSK employees or having other financial interests in shingles vaccines. None of that is mentioned.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release states:

Shingrix is different from most other vaccines. Many vaccines are made from a weakened form of the virus, but Shingrix is made from just a single protein–known as glycoprotein E–that comes from the outer shell of the herpes zoster virus.

As noted above, it would have been helpful if the release had stated how the established vaccine compared in the rate of effectiveness.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

There’s no mention of whether Shingrix is widely available. It is, including in the US where it received FDA approval in October 2017.

Does the news release establish the true novelty of the approach?

Satisfactory

It states:

The vaccine also contains an adjuvant–a substance that helps your body fight off the virus. It is the first shingles vaccine to combine a non-live antigen with a specifically designed adjuvant.

However, there are non-shingles vaccines that use this approach in vaccines recommended for older adults. According to a report in the American Osteopathic Association:

Strategies that may improve vaccine effectiveness in older individuals include using higher doses, adding extra boosters, changing the route of vaccination, or combining vaccine antigens with adjuvants (adjuvanted vaccines) or a more immunogenic protein (conjugated vaccine). Adjuvanted and conjugated vaccines, as well as altering the vaccine dose, have all been applied to 3 vaccines currently recommended for older adults: influenza virus, Streptococcus pneumonia, and VZV vaccines.

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

Satisfactory

There’s no unjustifiable language.

However, the news release would have been stronger if it had given data to back up this statement:

“This is quite remarkable because there are no other vaccines that perform nearly so well for people in their 70s and their 80s. We are seeing results comparable to those of childhood vaccinations.”

Total Score: 6 of 10 Satisfactory

Comments (1)

We Welcome Comments. But please note: We will delete comments left by anyone who doesn’t leave an actual first and last name and an actual email address.

We will delete comments that include personal attacks, unfounded allegations, unverified facts, product pitches, or profanity. We will also end any thread of repetitive comments. Comments should primarily discuss the quality (or lack thereof) in journalism or other media messages about health and medicine. This is not intended to be a forum for definitive discussions about medicine or science. Nor is it a forum to share your personal story about a disease or treatment -- your comment must relate to media messages about health care. If your comment doesn't adhere to these policies, we won't post it. Questions? Please see more on our comments policy.

chas beach

March 8, 2018 at 10:19 am

Excellent follow-up. There are always questions when new drugs are introduced. Would appreciate hearing more about RA, strepp and cancer interactions and effectiveness timeframe.

Reply