PaxVax is modernizing a pneumonia virus vaccine that hasn’t been updated in 30 years, partly to help protect military recruits.
Because the virus often impacts recruits, the armed forces is blessing PaxVax’s effort, and the company has obtained government funding for the development effort.
The virus, known as adenovirus serotypes 4 and 7 (Ad 4/7), is a common cause of acute respiratory distress in recruits. Although the vaccine reduces rates of the condition — which often leads to severe pneumonia — it is made according to procedures developed in the 1960s.
PaxVax has dubbed its improved vaccine the Modernized Production Adenovirus Vaccine (MPAV) Prototype A.
The company submitted an Investigational New Drug Application for the vaccine to the U.S. Food and Drug Administration in January 2017, and is preparing for Phase 1 clinical trials.
The trials will be held at the Larner College of Medicine at the University of Vermont and the Cincinnati Children’s Hospital.
“Our military continues to be at risk from acute respiratory disease,” Jonathan F. Smith, executive vice president of PaxVax, said in a press release.
“We are thrilled to be initiating our clinical development program for the Ad 4/7 vaccine, as this milestone enables us to advance our mission of developing specialty vaccines and contribute to military readiness,” he said. “We are honored to undertake the modernization of adenovirus vaccine production in order to help support the health and wellbeing of our U.S. troops.”
In addition to pneumonia, the two types of adenovirus can cause high fever, headache, sore throat, and eye infections. Patients are often hospitalized and occasionally die from an infection.
The virus spreads like the common cold, by sneezing and coughing. While anyone can become infected, compact living quarters and the stressful conditions of military training make recruits particularly vulnerable.
Among problems with the current vaccine is that its production depends on products derived from animals. In addition to difficulties obtaining animal-based material, it is difficult to control the quality of such products.
Without addressing the existing technical limitations of the vaccine, its continued supply cannot be guaranteed, PaxVax contended.
It has received funding for the vaccine’s development through the Small Business Innovation Research (SBIR) program.
“Pending successful conclusion of Phase I trials, we look forward to further evaluating the efficacy and safety of this vaccine, and are committed to bringing this vaccine to licensure,” Smith said.
“The current vaccine, which is safe and efficacious, has been in use for a number of years and is given to more than 200,000 enlisted military trainees every year,” said Dr. Cliff Snyder, product manager for adenovirus vaccine at the U.S. Army Medical Materiel Development Activity unit.
“We are always looking for ways to better protect our military service members,” he said. “Modernization of production processes offers the opportunity to reduce risks to sustainment and the likelihood of capturing cost savings that result from increasing the efficiencies of processes used in vaccine production.”
