The number one spot of the 2016 Top Ten Medical Innovations goes to the scientists, physicians and public health officials who are developing safe, efficient and effective vaccines faster than ever to prevent disease epidemics. These efforts were given new urgency by the 2014 Ebola epidemic in Africa and of bacterial meningococcal (Meningococcal B) outbreaks in the United States. In both cases, physicians, scientists, companies and government agencies innovated with unprecedented speed to move new vaccines from laboratories to clinical testing in large populations.
“The rapid scientific response to recent epidemics indicates that we’ve achieved new level of sophistication in the area of vaccine development,” says Steven Gordon, MD, chair of the Department of Infectious Disease at Cleveland Clinic. “It was a global effort involving thousands of people, aided by information technology and instant communication.”
Ebola went epidemic for the first time in 2014. More than 10,000 people died in Sierra Leone, Guinea and Liberia. Reported case mortality rates were 70-90%. The disease spreads through direct contact with an infected person's bodily fluids. Caregivers, family members, and burial parties were struck down. The World Health Organization declared it a public health emergency of international concern.
The most promising Ebola vaccine was developed in only 12 months. It isolates a surface protein from the Ebola virus and places it inside a harmless cattle virus for delivery into the host. The Ebola fragment is too small to trigger an infection, but it retains enough of the full virus’s genetic identity to flip the immune switch and flood the bloodstream with antibodies. A Phase III trial of the vaccine involving 4,000 people who’d had direct exposure to the Ebola virus showed 100% protection after 10 days. If this vaccine should be proven impracticable for some heretofore -unknown reason, there are at least five other candidates in other phases of testing, ready to take its place. No Ebola vaccine has yet been licensed for use in humans, but Cleveland Clinic experts estimate that a safe and effective vaccine should be available by 2016.
Two effective vaccines for Meningococcal B received “breakthrough” designation from the Food and Drug Administration in 2014. Meningococcal B is an aggressive disease spread by airborne particles. It is highly contagious and can lead to death within 24 hours. Ten percent of cases are fatal, and others lead to loss of limbs, and sensory or neurological deficits. Outbreaks of meningitis can take place in schools, colleges, prisons, and other close-quarter environments. While there are vaccines to prevent other forms of meningococcal, up until recently, there have been none for Meningococcal B.
Outbreaks at two American universities (one on the east coast and one on the west coast) fueled the race to bring an effective meningitis B drug to market in 2014. Thousands of students at both universities were successfully vaccinated in clinical studies. Today, the Meningococcal B vaccines are available to all.
Where Are They Now
Two vaccines for Meningococcal B are FDA approved and have been circulating in several countries for some time – a three-dose series approved in October 2014 and a two-dose series approved in January 2015. Work toward vaccines for the Ebola virus has also made significant headway, with the leading candidate demonstrating over 90% effectiveness.
Efforts regarding vaccination solutions for the Zika virus have also ramped up in the past year, with novel Zika vaccines in various phases of testing. A DNA-based vaccine for Zika entered phase II clinical trials in March of 2017, while a purified inactivated Zika vaccine remains in phase I testing. Most recently, a live, attenuated Zika vaccine entered a phase I clinical trial in August 2018. An oral vaccination for rotovirus is also in development, with positive results from a phase III trial released early 2017. Other novel vaccine breakthroughs include a respiratory syncytial virus (RSV) vaccine in phase I/II testing and the FDA approval of (2017) and CDC recommendation of (2018) the new, more effective shingles vaccine.