Concerns over a terrorist organization using anthrax as part of an attack on a civilian population has fueled the desire to develop an effective vaccine. The research necessary to develop an anthrax vaccine is costly.
Altimmune, an immunotherapeutic company headquartered in Gaithersburg, Maryland, has been awarded what may amount to a five-year, $120.2 million contract to conduct crucial clinical trials on its experimental anthrax vaccine.
Overview of the Multi-Million Dollar Contract
Altimmune was awarded the contract from the Biomedical Advanced Research and Development Authority, or BARDA. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. BARDA is charged with providing coordinated support to develop vaccines, drugs, therapies, and diagnostic tools to be utilized in the event of a public health emergency.
BARDA contracts with private sector enterprises to further the development of resources to be used in the event of a public emergency, like it has with Altimmune in that company’s quest to bring an anthrax vaccine to market.
Pursuant to the terms of the contract, Altimmune will receive money, up to $120.2 million, as the company achieves different milestones in the clinical studies associated with the drug. The first payment from BARA to Altimmune was for $14.3 million to assist in the company’s phase one clinical studies of the experimental vaccine.
Future Clinical and Other Studies
Depending on the results of phase one of the clinical studies, Altimmune will be able to draw more money from the contract for the second part of phase one and phase two of the process. The balance of the contract will go towards these two clinical phases as well as other studies associated with the experimental vaccine that are not directly part of the clinical research process.
About the Anthrax Vaccine
Altimmune has named the experimental vaccine NasoShield. The vaccine technically is classified as intranasal anthrax vaccine. In other words, the vaccine is administered as an inhalant, the same way anthrax enters a person’s system in most cases. Preliminary, preclinical studies revealed that animals that received a dose of NasoShield were protected in the event of an inhalation of anthrax. Altimmune stressed that only one dose was required to achieve this result during the preclinical animal testing process.
NasoShield is based on a medicinal platform already in place at Altimmune. It is a part of the pharmaceutical company’s RespirVec platform. This particular platform is designed to stimulate the immune system. In the case of NasoShield, it is designed to initiate a rapid immune response to anthrax.
The FDA Approval Process
The FDA approval process for NasoShield is expected to being about midyear in 2017. This is the same time that the phase one clinical trial formally commences. The clinical trials are related closely to the FDA approval process.
The FDA does have the power to fast track the approval process for a vaccine line NasoShield if it is in the public’s interests. At this juncture, analysts can only speculate as to how the FDA will handle the approval process associated with NasoShield. Because of its potential to be of value during a major public health crisis, a strong possibility exists that the FDA may fast track approval of NasoShield, assuming clinical trials support its efficacy and safety.
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