Shingles vaccine study summary omits significant COI with sponsor GSK

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 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 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 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.”