This article really doesn't seem to understand our situation when dealing with a malignant brain tumor. Every patient that goes through our patient navigation program is given a vaccine as one of the suggested options. There are a few clinical trials for vaccines, but they are very difficult to get into. The vast majority of these patients can not get into these trials, and if they do get in, then they have to contend with a placebo control on most of them, so they might not even get the vaccine. One of my friends started the foundation named in the article to help solve this problem. We had many patients going outside the USA to get access to vaccines, which is not only expensive but difficult for many brain tumor patients. Ideally, this foundation would find a way to get funding for these patients but right now there is no funding other than requiring the patient to pay the costs. Under FDA rules, unapproved treatments accessed under expanded access can only charge the actual cost of the treatment. This was not meant to be for profit. All of the available vaccines were evaluated and they selected the personalized neoantigen synthetic long peptide vaccine which was created at the Washing University School of Medicine. Based on your molecular pathology report, a team of experts figure out which of the markers are most likely the drivers of the tumor, and create a unique vaccine just for your particular case. This is an expensive process and undergoes a lot of quality control before a patient can get it.
So it brings up an ethical dilemma: Is it fair to provide a promising experimental treatment only to those that can afford it? Or is it better not to do it at all? Keep in mind this is no more expensive that most other treatments that are being used - the problem comes up because insurance usually does not pay this and it does pay for the other treatments. So it is a problem with our system, not with the vaccine. This is the reason I am supporting the Promising Pathway Act. Under the current system, the cost to take this vaccine into the standard (or even accelerated) FDA approval pathway would take at least 7-10 year and cost anywhere from $500 million to over a billion dollars. Under the Promising Pathway Act, we could cut that down to maybe 2-4 years and $5 to $10 million. Still expensive but much easier to raise than under the standard pathway.
Bottom line: This is a promising treatment and it is better to have access than not have access, even if it cost a lot of money. We need to find a way to help patients pay treatments like this.