So in case anyone’s been living under a rock recently or has just been doing their very best to avoid any Ebola news (which is almost impossible here in the US), there has been news coverage stating that leading drug makers across the world have been working together and with the WHO to expedite Ebola vaccine testing and manufacturing in hopes of being able to stop the outbreak in West Africa. Now a lot of questions have been floating around about who gets the first doses of the vaccine, why didn’t we have a vaccine already, is this expedited testing safe, do we even know if these vaccines will work in people, etc? All of that information can probably be found somewhere else on the internet. What I want to cover today is what this vaccine testing will look like as far as how vaccines are tested before being deemed safe, and why, if Ebola has been around since 1976, do we not have a vaccine already?
Vaccine development is a costly and time consuming process. In the US here the FDA has ultimate say over drug and vaccine licensing so companies need to prove that the vaccine is safe and effective in people. Below is a little infograph from the CDC about how vaccines are developed and tested. While this is referencing childhood vaccines, the basic approval principles apply to all vaccines used here in the US. This is not to say that the FDA will immediately have to license any vaccines used to fight Ebola if the vaccines are not used here in the US.
The current status of many of these vaccines is that some are in the beginning stages of human trials (Phase 1), with plans to expand to larger populations as soon as the data comes in that the vaccines so far as safe. These trials are important not only to determine if there are any bad side effects from the vaccines, but also to determine how strong the vaccines should be to protect people. We obviously want the vaccines strong enough to provide protection against Ebola infection but we also don’t want them too strong as sometimes that can lead to undesirable side effects. Also, if the lower strength vaccine works well there would be more vaccine immediately available because they could just dilute the highest strength to the lower strength without having to make more from scratch. There is also hope that even if the vaccines aren’t available for widespread use until January and might only be available in limited quantities, methods could be used to vaccinate people in areas where the outbreak is headed so we can stem the expansion.
So if Ebola’s been on this planet and infecting humans since 1976, why just now is it a priority to have a vaccine or treatment for this life threatening disease? Truth be told, when only a few people in Africa are sporadically being infected and dying, vaccine and drug development for that disease is just not a top priority for US pharmaceutical companies. The NIH (National Institutes of Health) began working on Ebola vaccines/treatment after 9/11 when there was huge interest in potential biological weapons being used. “With limited resources to test vaccines, et cetera, one always has to pick and choose what are the highest priorities,” said Dr. Myron Levine, an infectious disease specialist at the University of Maryland School of Medicine, and who has been working on vaccines (including one for Ebola) for 44 years. There’s just not a financial incentive for pharmaceutical companies to put money into Ebola research when there are everyday threats like cancer and influenza that affect many more people and are a more lucrative target for making money. The NIH budget has been roughly the same since 2003, around 29 million, but this has not kept pace with inflation so in reality the budget has actually decreased about 21%. NIH Director Francis Collins has said that we’d likely have an Ebola vaccine already if not for the budget cuts.
Ebola is just something that didn’t matter much to the US until it had the potential to, and then did, cross our borders.