GSK on track to file regulatory applications in 2016
This news release summarizes the findings of a phase III clinical trial of an investigational vaccine for shingles, a painful skin rash that can affect anyone who has ever had chickenpox. The study, described in a NEJM article, involved 13,900 adults 70 or older from 18 countries in North America, Europe, Latin America and the Asia-Pacific region. The study results showed that the new vaccine reduced the likelihood of developing shingles by nearly 90% and decreased by nearly 89% the likelihood that those who did develop shingles despite the vaccine would experience the lingering, sometimes severe, pain that affects about one-in-five people who have shingles.
The release generally did a good job of quantifying the benefits and acknowledging side effects without using sensational language. It neglected to note that many financial ties exist between numerous researchers involved and GSK . In addition, the release didn’t mention that another vaccine (though less effective) is already in use or that the study excluded individuals with compromised immune systems, who are at the greatest risk of developing shingles.
Shingles, a virus that results in a painful skin rash, is common in the United States, affecting about one-in-four adults at some point in their lifetime. Caused by varicella zoster, the same virus that causes chickenpox in children, shingles produces a line of blisters that can be extremely painful. Although the rash usually clears up within two to four weeks, about one in five shingles sufferers will experience lingering pain, sometimes severe, known as post-herpetic neuralgia. The likelihood of developing shingles and of suffering continuing pain after the rash clears increases with age. A vaccine to prevent shingles has been available since 2006, however its effectiveness depends on age and it is not very effective in the older age groups. According to the CDC, the current vaccine prevents shingles for 51% of those who receive it but prevents post-rash pain for two-thirds of the recipients.
With the widespread adoption of varicella (chickenpox) vaccine in kids, we are probably going to see a lot less shingles in seniors in the future, and consequently a lower demand for the vaccine in 30-40 years.
The vaccine in question has not yet been submitted to the FDA for approval, so we wouldn’t expect to have a specific price for the vaccine. The price GSK will charge for the vaccine will vary by country. Still, GSK ought to have some idea of how much this vaccine would cost in one of the largest global markets. The release never mentions cost at all.
The news release, like the original article on which it reports, states that the vaccine effectively prevented shingles in 90% of participants, including preventing the pain often associated with shingles.
Absolute numbers in addition to or rather than relative reductions would have been a more meaningful quantification for readers.
The news release notes that serious adverse reactions occurred with about equal frequency among study participants who received the vaccine and those who had placebo injections. Although the release acknowledges the most common injection site and systemic adverse reactions, most commonly mild-to-moderate pain at the injection site and fatigue, it could have been more forthcoming about how common these reactions were. The article on which the release is based states that 79% of participants who received the vaccine, versus 29.5% of placebo recipients, reported local and/or systemic side effects.
This was a large multi-site study that included evaluations of 13,900 participants 70 and older from 18 countries worldwide, according to the published study. Overall. the release warrants a satisfactory for describing the study and evidence. However, it slightly overstates the number of participants, saying it involved 14,800 adults, but the lower number used in the study article reflects participants who actually were evaluated; thus, the lower number would have been more appropriate to use in the news release. The release calls this an “observer-blind” study, but the study article states that investigators, participants and other observers were all blind to whether specific participants had received the vaccine or a placebo. One important, and missing, bit of information was that the study excluded immune-compromised individuals, who are at the greatest risk of developing shingles.
Shingles is a common problem, and it can be severe. The news release avoids overstating either the frequency of shingles’ occurrence or the severity of its symptoms.
The news release was issued by GSK so it’s assumed that GSK provided the funding for the study.
The release makes no mention of numerous potential conflicts of interest between the many researchers involved in the study and GSK. These include holding GSK stock, employment with GSK, serving on a GSK board, grant support, lecture fees, consulting fees, travel fees, honoraria, and royalties from a zoster vaccine patent.
The news release does not acknowledge that another shingles vaccine has been in use in the United States since 2006. Although the study results do suggest that GSK’s vaccine is likely to be more effective than the currently used vaccine, the release could easily give a casual reader the impression that no other vaccine exists.
It is clear from the press release that GSK has not yet applied for regulatory approval of the vaccine in any country. Thus, it should be obvious that the vaccine is not yet available for use.
The release acknowledges that the “headline results” of this trial were reported in October 2015. That earlier release focused on the apparent efficacy of the vaccine but did not include any information about safety or side effects. The new PR release provides information about adverse reactions and also notes that the GSK vaccine retains its effectiveness for at least four years, representing an apparent fix to a shortcoming of the already available vaccine.
The language in the news release is straightforward and matter-of-fact. The closest it comes to hyping the study results is a quote from the GSK senior vice president for vaccine research calling the findings “remarkable.”