3rd Generation Anthrax Vaccine Moves Forward
Emergent BioSolutions Inc. submitted an application to the U.S. Food and Drug Administration (FDA) for potential emergency use of the anthrax vaccine NuThrax in the event of a public health emergency involving Bacillus anthracis.
Anthrax is a serious infectious disease caused by gram-positive, bacteria known as Bacillus anthracis, says the Centers for Disease Control and Prevention (CDC).
This is important news, as anthrax cases have been reported in Kenya, Africa.
Three Tharaka-Nithi residents have been admitted in critical condition after eating the meat of cow believed to have been infected with anthrax, reported AllAfrica.com
County Health Director, Dr. Tony Njoka, told the Nation that the situation was worsening as people were still eating the meat of cows that had been sick.
Although it is rare, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products.
While the ingestion or skin exposure to anthrax can sometimes be treated, inhalation is highly fatal, with a mortality rate of at least 80 percent, according to the FDA.
The biological attack conducted through the U.S. postal system in 2001 broadened the threat posed by anthrax, and how we vaccinate against Bacillus anthracis.
NuThrax, also known as AV7909, is an anthrax vaccine adsorbed with CPG 7909 adjuvant. NuThrax is comprised of Anthrax Vaccine Adsorbed in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909.
NuThrax was designed to have a two-dose schedule and may elicit a faster immune response than currently available anthrax vaccines.
Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of NuThrax.
A Phase 3 Study is scheduled for 1st subject enrollment targeted for 2019, says Emergent.
Currently, FDA has not approved the BioThrax vaccine for use after exposure for the general public.
This FDA submission is anticipated to undergo review through the first half of 2019.
“We are pleased with engaging in early discussions with the FDA regarding NuThrax, which has been identified as a potential critical component of the nation’s anthrax preparedness strategy,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions, in a press release.
“NuThrax is designed to have attractive features, including the potential to have a shorter dosing schedule and to elicit a faster immune response, that may make it a more appropriate candidate for an effective response to a large-scale public health emergency involving anthrax.”
Additionally, on December 19th, 2018, Health Canada approved a New Drug Submission for BioThrax.
The FDA submission package was completed under the company’s 2016 contract with the Biomedical Advanced Research and Development Authority (BARDA) that includes a 5-year base period of performance valued at approximately $200 million to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile an initial 3 million doses following pre-approval by FDA.
Contract HHSO100201600030C for the advanced development and delivery of NuThrax is funded by BARDA, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats.