Anthrax

Will Disease X End Federalism in the U.S.

Donald Hackett — Mon, 19 Feb 2024 22:39:21 +0000

Reviewer:

At the recent World Government Summit, the World Health Organization (WHO) Director-General commented that the planet is "unprepared" for a Disease X outbreak or future pandemics.

While Dr. Tedros Adhanom Ghebreyesus did not comment on how to legally manage a Disease X pandemic, a team of experts shared some keen observations and recommendations.

A Stanford Health Policy (SHP) article by Beth Duff-Brown commented that recent state legal reforms have exacerbated rather than improved weaknesses in U.S. emergency powers, jeopardizing future public health responses.

Rather than enhancing health emergency legal infrastructures, many states have adopted reforms that make them worse, according to new research by SHP's Michelle Mello, JD, Ph.D.

Mello, a health policy and law professor, is the lead author of an analysis published by the BMJ that looks at the legal infrastructure's role in combatting the recent pandemic.

Mello and colleagues examined laws passed by state legislatures addressing the scope of public health powers held by health officials and governors.

Some legal reforms may "contort federalism" in ways that may undermine pandemic responses.

Although the U.S. Constitution grants public health powers to the federal government and the states, the national government can regulate only where it can tie its action to one of the existing federal powers.

The authors analyzed the content of 65 laws adopted in 24 states from January 2021 through April 2023. They found that many imposed important, substantive restrictions on what officials can do to combat health emergencies.

For example, four states adopted new prohibitions requiring vaccines or proof of vaccination.

Some of the procedural checks that states adopted could be helpful; the authors noted—for example, requirements that officials provide explanations for the health orders they issue.

An accompanying editorial in the BMJ notes the nation's pre-existing structural and systematic features contributed to the devastating pandemic outcomes.

Originally published by Stanford Health Policy, a joint effort of the Freeman Spogli Institute for International Studies and the Stanford School of Medicine, the unedited article was posted on February 12, 2024.

The term Disease X was included for the first time in February 2018 by the WHO Blueprint list of diseases. According to the WHO, Disease X represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease.

Sub Title:

Legal infrastructure conflict with public health pandemic responses

References:

Legal infrastructure for pandemic response: lessons not learnt in the US

Trends in US State Public Health Emergency Laws, 2021–2022

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by Herbin Isaac

Anthrax Treatment Cocktail Found Immunogenetic

Don Hackett — Thu, 30 Apr 2020 15:22:57 +0000

Reviewer:

Robert Carlson, MD

A new phase 4 study has discovered that co-administration of the monoclonal antibody raxibacumab with Anthrax Vaccine Adsorbed (AVA) does not negatively affect AVA immunogenicity.

Published in The Lancet on April 22, 2020, this finding suggests that combining the two might provide added benefit in people who may have inhaled spores containing Bacillus anthracis.

These researchers found that the geometric mean concentration (GMC) of anti-protective antigen antibodies was 26.5 micrograms (μg)/mL in the 276 participants given only AVA versus 22.5 μg/mL in the 269 given AVA plus raxibacumab.

The between-group ratio was 1.18, which met the defined noninferiority margin and supports the hypothesis that the addition of raxibacumab doesn't undermine the vaccine's efficacy.

In a related commentary by Michael Norris, Ph.D., and Jason Blackburn, Ph.D., these scientists said that raxibacumab "is an effective, safe, and valuable addition to the current AVA vaccination regimen for anthrax post-exposure prophylaxis.”

“When anthrax exposure is suspected, recommended post-exposure prophylaxis is 60 days of antibiotics (ciprofloxacin or doxycycline) combined with anthrax vaccination.

The AVA vaccine is approved for human use in the USA, and Anthrax Vaccine Precipitated (AVP) is approved in the UK.

The major antigen in these vaccines is the Bacillus anthracis protective antigen; this molecule is secreted by B anthracis and creates a pore in the host membrane that binds then separately translocates lethal factor and oedema factor into the cell.”

“Even with prompt antibiotic treatment, the toxins released can still overwhelm the host, leading to toxaemia and death; thus, development and testing of anti-toxin treatments is needed.”

On December 13, 2019, the US Centers for Disease Control and Prevention (CDC), revised recommendations that apply to both pre- and post-exposure prophylaxis of anthrax.

The risk of exposure to aerosolized B. anthracis spores in the United States is very low. Anthrax is only endemic in a few sparsely populated areas in the western United States, such as in southern Texas.

Anthrax is not contagious, which means you can’t catch it like the cold or flu, says the CDC.

The study was sponsored by the US Biomedical Advanced Research and Development Authority and GlaxoSmithKline, which produced raxibacumab. The drug is now owned by Emergent BioSolutions.

Precision Vaccinations publishes anthrax vaccine development news.

Sub Title:

Raxibacumab combines with Anthrax Vaccine Adsorbed does not negatively affect the vaccine immunogenicity

References:

Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-infer

Raxibacumab: a panacea for anthrax disease?

Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed

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$285 Million Allocated for Novel Anthrax Antibiotic

Don Hackett — Fri, 20 Dec 2019 17:13:15 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A Boston-based biopharmaceutical company announced that the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a 5-year contract, with an option to extend to 10-years, to support the development of Paratek’s NUZYRA® (omadacycline) for the treatment of pulmonary anthrax.

Paratek Pharmaceuticals NUZYRA is a novel, broad-spectrum, once-daily oral and intravenous (IV) modernized tetracycline, that was approved in October 2018 to treat community-acquired pneumonia and skin infections.

A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

The initial NUZYRA approval announced on December 18, 2019, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS), are for use against potential biothreats.

Under the terms of the agreement, BARDA will award initial funding of approximately $59 million for the development of NUZYRA for the treatment of pulmonary anthrax and the purchase of an initial 2,500 treatment courses of NUZYRA to add to the current SNS.

The contract provides for additional potential time-based funding including approximately $77 million for existing commitments scheduled to begin in April 2020 and approximately $20 million for manufacturing-related requirements scheduled to begin in June 2020.

The remaining staged, milestone-based funding includes the potential for approximately $13 million to support the development of NUZYRA for the prophylaxis of anthrax and a maximum of approximately $115 million to provide for three additional purchases of NUZYRA for the SNS, each of which will be triggered upon development milestones related to the anthrax treatment development program.

Anthrax vaccine news

BARDA’s Project BioShield program was created to accelerate the research, development, purchase, and availability of effective medical products against chemical, biological, radiological, or nuclear agents. Project BioShield provides the government with the authority and funding to develop, acquire, stockpile, and distribute the medical products needed to protect the United States against biothreats.

Dr. Rick Bright, BARDA Director and Deputy Assistant Secretary for Preparedness and Response, said in a press release, “This award is an important step in BARDA’s efforts to enhance our national health security preparedness.”

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.

The use of NUZYRA during the second and third trimester of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

People get infected with anthrax when spores get into the body. When anthrax spores get inside the body, they can be “activated.” When they become active, the bacteria can multiply, spread out in the body, produce toxins (poisons), and cause severe illness.

In the event of a large-scale release of B. anthracis spores, the SNS will distribute medical countermeasures to affected states, and state and local public health agencies will then dispense antimicrobials to and vaccinate numerous at-risk persons, says the HHS.

Before 2001, the last case of inhalation anthrax reported in the United States was in 1976.

Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics.

Anthrax news published by Precision Vaccinations.

Sub Title:

Paratek NUZYRA is a novel, broad-spectrum, once-daily oral and intravenous modernized tetracycline

References:

Paratek Awarded BARDA Project BioShield Contract for NUZYRA®

CDC: A History of Anthrax

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Anthrax Vaccine Guidelines Updated by the CDC

Don Hackett — Fri, 13 Dec 2019 19:39:59 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Since the publication in 2010 of the Advisory Committee on Immunization Practices (ACIP) recommendations for use of anthrax vaccine in the United States, various studies have added new insights into preventing this serious disease.

With these new studies becoming available, the ACIP was asked to revise the recommendations for use of anthrax vaccines in the United States.

Published on December 13, 2019, by the Centers for Disease Control and Prevention (CDC), these revised recommendations apply to both pre- and post-exposure prophylaxis.

Anthrax is not contagious, which means you can’t catch it like the cold or flu, says the CDC.

The possibility does exist of an intentional wide-area aerosolized release of B. anthracis spores over a densely populated area in the United States. In 2001, letters containing B. anthracis spores sent through the U.S. Postal Service led to 22 cases of anthrax, 5 of which were fatal.

This new CDC report also describes the available data for the AV7909 vaccine candidate because of its potential for prelicensure emergency use during a large-scale anthrax public health emergency, if the current anthrax vaccine supply is inadequate to meet demand.

In addition, the AV7909 vaccine phase 1 and 2 clinical trials have demonstrated the potential of AV7909 for use as the vaccine component of PEP (PEP-Vx)

The CDC says ‘this report can be used by healthcare providers to update the current practice for providing anthrax vaccine for PrEP and PEP and can be used by emergency preparedness partners to develop emergency vaccine response plans in preparation for a wide-area aerosolized release of B. anthracis spores.’

Furthermore, this CDC report

addressed the efficacy, immunogenicity, and reactogenicity of the recommended and alternate dose-sparing schedules of AVA
estimated AVA efficacy in humans from data on animal efficacy and human antibody levels by using a correlates of protection model
evaluated whether developing chronic illnesses or having adverse pregnancy outcomes are associated with previous AVA receipt

Anthrax vaccine adsorbed (AVA)

BioThrax is licensed for preexposure prophylaxis (PrEP) for adults aged 18–65 years at high risk for exposure to B. anthracis (6). The dosage approved by the U.S. Food and Drug Administration (FDA) is 0.5 mL administered intramuscularly (IM) at 0, 1, and 6 months with boosters at 6 and 12 months after completion of the primary series and at 12-month intervals thereafter.
BioThrax is also is licensed for postexposure prophylaxis (PEP) in combination with antimicrobials for adults aged 18–65 years with suspected or known exposure to aerosolized B. anthracis spores. The dosage approved by FDA is 0.5 mL administered subcutaneously (SC) at 0, 2, and 4 weeks. For persons not included in the FDA-approved indication for PEP, AVA will be available for PEP use for children, pregnant women, nursing mothers and older adults (i.e., ≥66 years) under appropriate emergency use regulatory provisions.
Although data are lacking on the immune impact of mixing the IM and SC routes of administration, as might occur when switching from PrEP to PEP, switching between routes would be unlikely to adversely impact immunity because both routes provide adequate immunity.

AV7909

AV7909 is an investigational 2nd-generation anthrax vaccine that is under development for PEP of inhalation anthrax in conjunction with appropriate antimicrobials. AV7909 consists of the licensed AVA combined with a novel adjuvant, CpG 7909, a synthetic immunostimulatory oligodeoxynucleotide. CpG 7909 is a Toll-like receptor 9 agonist that has been demonstrated to augment Th1 responses in humans and enhance innate and adaptive immunity.
The CDC has submitted a pre–Emergency Use Authorization (EUA) request to FDA to allow potential emergency use of AV7909, in conjunction with appropriate PEP-Abx, for PEP of inhalation anthrax when the supply of the currently licensed AVA is inadequate. EUA is an authority given to the FDA commissioner to legally permit the use of an unapproved medical product or unapproved use of an approved medical product.
Under the proposed EUA, AV7909 would be administered by the IM route as a 2-dose series 2 weeks apart in conjunction with PEP-Abx for adults aged 18–65 years. Pregnant or nursing mothers, older adults (aged ≥66 years), and children (aged <18 years) should receive AVA until data to adequately support AV7909 use in these additional populations under EUA become available.
Available data indicate that AV7909 might provide the following advantages over AVA, such as: Two IM doses of AV7909 administered 2 weeks apart might provide protective immunity 1–2 weeks sooner than the licensed 3-dose PEP-Vx regimen of AVA.

The CDC says ‘This report can be used by health care providers to update the current practice for providing anthrax vaccine for PrEP and PEP and can be used by emergency preparedness partners to develop emergency vaccine response plans in preparation for a wide-area aerosolized release of B. anthracis spores.’

The U.S. government’s Strategic National Stockpile (SNS) stores anthrax vaccine to be used with antimicrobials for PEP of persons with known or potential exposure to B. anthracis spores, as well as therapeutics and supplies for anthrax treatment.

Recent anthrax vaccine news

Animal models have shown that although 5–30 days of antimicrobials might be insufficient to prevent anthrax after single exposures or reexposures to B. anthracis spores, the addition of vaccine substantially enhances efficacy.

Antimicrobials are given long enough (up to 60 days) to prevent infection until the vaccine can elicit a protective immune response, says the CDC.

Recently, the U.S. government’s preparedness program progressed into a new stage, real-world testing in St. Louis, Missouri.

According to the St. Louis Public Radio (SLPR) news article on November 7, 2019, emergency volunteers in St. Louis are among the 1st to receive an anthrax vaccine, as part of a 2-year pilot program to inoculate local personnel.

If this program is deemed a success, then the anthrax vaccination program could be implemented across the USA.

Anthrax Vaccine news published by Precision Vaccination

Sub Title:

Emergent BioSolutions AV7909 anthrax vaccine may be needed on an emergency basis in the event of a wide-area release of aerosolized Bacillus anthracis

References:

CDC: Use of Anthrax Vaccine in the United States

CDC: What is anthrax?

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St. Louis Prepares For Potential Anthrax Event

Don Hackett — Fri, 08 Nov 2019 15:20:24 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

The U.S. government’s extensive and ongoing investments in the development of anthrax vaccines have progressed into a new stage, real-world testing in St. Louis, Missouri.

According to a recent St. Louis Public Radio (SLPR) news article on November 7, 2019, emergency responder volunteers in St. Louis are among the 1st to receive an anthrax vaccine, as part of a 2-year pilot program to inoculate local personnel.

In 2016, the U.S. Congress voted to launch a pilot program in 2 cities that would inoculate emergency responders. The Department of Homeland Security selected St. Louis for this program.

If this program is deemed a success, then the anthrax vaccination program could be implemented across the USA.

This is an important step in preparing for a potential bioterrorism event.

Emergency responders such as firefighters and police are especially at risk of contracting the illness in the event of a bioterrorism event.

Thomas Zink, M.D., senior medical adviser to St. Louis Mayor Lyda Krewson, said to STPR, “They (1st responders) are put into situations not really knowing where the safe zone ends and the hot zone begins.”

‘Previously, 5 people died and 17 people were sickened on the East Coast in 2001 when powdered anthrax was sent through the mail. In that event, even 1st responders wearing hazmat suits produced anthrax antibodies, which indicates they were put at risk,’ Dr. Zink said.

Anthrax is listed as a Category A priority pathogen, indicating the biological agent poses the highest possible risk to national security and public health.

When introduced to the body through inhalation, ingestion or cuts in the skin, anthrax-causing bacteria can cause severe illness and death. The disease poses a massive threat in situations such as bioterrorism, says the U.S. Centers for Disease Control and Prevention (CDC)..

Public health officials already know the anthrax vaccine is effective, said Stacey House, M.D., Ph.D., director of the Emergency Care Research Core at Washington University, in St. Louis.

“We’re trying to figure out how do you actually implement this type of program in the emergency personnel community,” said Dr. House.

‘There is no imminent threat of anthrax bioterrorism in St. Louis,’ Dr. House said.

The anthrax vaccine used in the United States does not contain any bacteria, either live or killed. It cannot cause anthrax disease.

But, there is evidence indicating the current anthrax vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women, says the CDC.

“Anthrax vaccines require multiple doses. If someone is vaccinated for the first time after an event, it might not be protective. The worst time to give a vaccine is when it has to work within 10 days,” Dr. Zink concluded.

Recent anthrax vaccine news

October 23rd, 2019 – Michigan-based BlueWillow Biologics® announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, a next-generation anthrax vaccine candidate.
August 1st, 2019 – Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a contract option valued at $261 million to procure doses of the AV7909 anthrax vaccine.

The anthrax vaccines to be used in St. Louis come from the U.S. Strategic National Stockpile (SNS), a federal government repository for antidotes, vaccines, and other emergency medical supplies.

Vaccines against anthrax were first developed as early as 1880 and used in livestock. An acellular product for human use was developed in 1954 and used in the first U.S. efficacy study of a human anthrax vaccine.

To protect the nation against the potential risk of an anthrax attack, the U.S. Department of Health and Human Services currently stores tens of millions of doses of injectable anthrax vaccine in the SNS, the nation’s largest supply of potentially life-saving medical products for emergency use.

The currently licensed injectable anthrax vaccine requires 3 immunizations in addition to antimicrobial therapy as a medical countermeasure following potential anthrax exposure.

The CDC says the current anthrax vaccine is recommended for adults 18 through 65 years of age who are at risk of exposure to anthrax bacteria and for unvaccinated people of all ages who have been exposed to anthrax.

The anthrax vaccine has not been studied or used in children less than 18 years of age, says the CDC.

Anthrax Vaccine news published by Precision Vaccinations

Sub Title:

Emergency responders are at high risk of contracting anthrax during a bioterrorism event

References:

St. Louis Emergency Personnel Get Anthrax Vaccine In Federal Test

H. Rept. 115-948 - DEPARTMENT OF HOMELAND SECURITY APPROPRIATIONS BILL, 2019

Development of a novel multiepitope chimeric vaccine against anthrax

CDC: Anthrax VIS

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Next-Gen Anthrax Vaccine To Launch Phase 1 Study

Don Hackett — Wed, 23 Oct 2019 19:14:11 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Michigan-based BlueWillow Biologics® announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, a next-generation anthrax vaccine candidate.

The development of the intranasal anthrax vaccine BW-1010 is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL).

The BW-1010 vaccine combines BlueWillow’s novel intranasal NanoVax system with a recombinant protective antigen for anthrax from PBL.

The NanoVax platform employs a proprietary oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immunity, uniquely enabling protection against challenging respiratory infections, such as anthrax.

The Phase 1 clinical study is expected to begin enrollment during 2020 and is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH).

Anthrax is listed as a Category A priority pathogen by NIAID, indicating the biological agent poses the highest possible risk to national security and public health.

To protect the nation against the potential risk of an anthrax attack, the U.S. Department of Health and Human Services currently stores tens of millions of doses of injectable anthrax vaccine in the U.S. Strategic National Stockpile, the nation’s largest supply of potentially life-saving medical products for emergency use.

The currently licensed injectable vaccine requires 3 immunizations in addition to antimicrobial therapy as a medical countermeasure following potential anthrax exposure. Evidence indicates the current vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women.

BlueWillow’s CEO Dave Peralta, said in a press release, “Animal studies have demonstrated BW-1010 is safe and elicits protection against anthrax after just one or two vaccinations.”

“In addition, informal stability studies have shown that our vaccine has a shelf life of over five years, compared to three years for the current injectable vaccine.”

“The improved stability of BW-1010 would allow for longer-term storage, potentially saving the U.S. government over $100 million annually.”

BlueWillow Biologics® is a clinical-stage, privately-held biopharmaceutical company focused on developing and commercializing prophylactic and therapeutic vaccines. Visit BlueWillow for details on the company’s vaccine pipeline and studies completed to date.

Anthrax Vaccine news published by Precision Vaccinations

Sub Title:

BlueWillow Biologics BW-1010 is an intranasal anthrax vaccine candidate

Reference:

BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

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BARDA Exercises $261 Million Dollar Option for Innovative Anthrax Vaccine

Don Hackett — Thu, 01 Aug 2019 15:52:01 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Emergent BioSolutions announced today that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a contract option valued at $261 million to procure doses of the AV7909 anthrax vaccine.

This announcement on July 31, 2019, calls for delivery of the AV7909 anthrax vaccine to the Strategic National Stockpile (SNS) over 12 months.

AV7909 is designed to offer a 2-dose schedule that elicits a rapid immune response especially advantageous during an anthrax event.

This contract option includes a 5-year base period of performance to develop AV7909 for post-exposure prophylaxis of anthrax disease and to deliver an initial 3 million doses to the SNS, as well as contract options for procurement of up to an additional 50 million vaccine doses.

Robert G. Kramer Sr., president, and chief executive officer of Emergent BioSolutions, said in a press release, “Emergent continues its longstanding history of successfully meeting the U.S. government’s anthrax preparedness strategy."

“As the US government initiates the transition from BioThrax to AV7909 in the SNS, Emergent remains responsive to their needs.”

“We look forward to maintaining the BioThrax capability for pre-exposure vaccination for military and other high-risk personnel.”

The vaccine candidate AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure, in conjunction with the recommended course of antimicrobial therapy.

AV7909 is a combination of BioThrax and CPG 7909, an adjuvant.

CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen.

Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of AV7909. The lot consistency, safety, and immunogenicity of AV7909 are currently being evaluated in a Phase 3 trial, which is expected to complete in late 2020.

Recent anthrax vaccine news

Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis. Although it is rare, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products, says the CDC.

The type of illness a person develops depends on how anthrax enters the body. Typically, anthrax gets into the body through the skin, lungs, or gastrointestinal system. All types of anthrax can eventually spread throughout the body and cause death if they are not treated with antibiotics.

Contract HHSO100201600030C for the advanced development and delivery of AV7909 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, deliberate, and naturally occurring public health threats.

Sub Title:

Emergent BioSolutions AV7909 anthrax vaccine being added to the Strategic National Stockpile

References:

Emergent Announces Exercise by BARDA of the First Contract Option, Valued at $261 Million, to Procure Doses of AV7909

CDC: Types of Anthrax

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2nd Anthrax Case Confirmed in Texas Animals

Don Hackett — Sat, 29 Jun 2019 12:21:03 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Health and animal authorities in Texas have confirmed 2 anthrax cases from 18 recent animal deaths in Uvalde County.

The initial anthrax case in Uvalde County was confirmed in an antelope on June 19, 2019. The second case involved an adult sheep from Edwards County.

The locations where these animals were found have been placed under quarantine.

Uvalde County is located west of San Antonio, in southwest Texas. Edwards County is northwest of Uvalde.

Diagnostic testing was performed by the Texas Veterinary Medical Diagnostic Laboratory.

As of June 27th, the Texas Department of State Health Services (DSHS) has not reported any human anthrax cases.

Texas DSHS said in a press release that ‘anthrax in humans is rare but, people can contract the disease by handling dead or sick animals infected with anthrax.’

‘Typically humans contract anthrax by skin contact or consuming the meat of an infected animal. A skin anthrax infection requires treatment with antibiotics prescribed by a physician.’

Unreliable reporting makes it difficult to estimate with accuracy the true incidence of human anthrax.

In more recent years, anthrax in animals has been reported from 82 countries, and in the United States, the annual incidence of human anthrax has steadily declined to about 1 per year for the past 10 years.

During May 2018, the FDA issued final guidance Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.

‘Anthrax is a bacterial disease caused by Bacillus anthracis, which is a naturally occurring organism found in the soil around the world,’ stated the Texas Animal Health Commission (TAHC).

‘Deer, sheep, goats, cattle, horses, and other animals can contract anthrax when they swallow or inhale anthrax spores while grazing," stated the DSHS. "Animals usually die within two days of showing signs of anthrax infection."

Anthrax can enter the human body through the skin, lungs, or gastrointestinal system. All types of anthrax can eventually spread throughout the body and cause death if they are not treated with antibiotics.

A human case of skin anthrax typically starts out itchy and resembles an insect bite that within 2-6 days progresses into a painless sore with a depressed black center.

People should contact a healthcare provider if they develop an unusual-looking sore on their hands, arms or other exposed skin.

There is a vaccine that can help prevent anthrax, however, it is not typically available for the general public. It is only recommended for people who are at an increased risk of coming into contact with or have already been exposed to B. anthracis, says the Centers for Disease Control and Prevention (CDC).

The CDC says ‘ The anthrax vaccine was developed from an attenuated strain of B. anthracis. The vaccine derives from the cell-free culture filtrate of this strain and, in its final formulation, is adsorbed onto an aluminum salt.’

The only licensed anthrax vaccine, Anthrax Vaccine Adsorbed (AVA) or BioThrax is indicated for active immunization in persons 18 – 65 years of age who are at risk of exposure to anthrax.

BioThrax has been purchased by the federal government and is stored in the Strategic National Stockpile.

Next-generation anthrax vaccines are under development by multiple manufacturers, such as:

According to Texas DSHS, basic precautions can effectively reduce the risk of people contracting anthrax from animals, such as:

Avoid direct contact with dead animals, including their bones, horns or antlers.
Keep pets and children away from dead animals.
Do not harvest animals that appear ill or are acting abnormally.
Wear long-sleeved garments and gloves when handling, dressing, and processing game.
Wash hands with soap and water and launder clothes immediately after animal exposure.
Minimize contact with animal fluids, brain, and spinal tissues.
Cook all meat until well done before consuming.

Dr. Susan Rollo, Texas State Epidemiologist said, “There is an effective anthrax vaccine available for use in susceptible livestock in high-risk areas. Livestock or animals displaying symptoms consistent with anthrax should be reported to a private veterinary practitioner.”

“We encourage you to consult with your local veterinary practitioner.”

Sub Title:

Anthrax vaccine and medications reduce illness and mortality risks from anthrax

References:

TVMDL confirms second case of anthrax in West Texas

Texas DSHS

DSHS reminds Texans to avoid sick or dead wildlife

Anthrax Confirmed on Uvalde County Premises

FDA: Anthrax

CDC: Anthrax

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Anthrax Vaccine Candidate NanoVax Awarded Patent

Don Hackett — Wed, 05 Jun 2019 21:35:19 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A privately-held biopharmaceutical company headquartered in Michigan announced the issuance of U.S. patent number 10,138,279, covering an intranasal NanoVax® anthrax vaccine.

BlueWillow’s intranasal NanoVax platform employs a novel oil-in-water emulsion adjuvant that elicits both systemic and mucosal immunity, thereby uniquely protecting against challenging respiratory infections.

‘The NanoVax nanoemulsion platform is unique because when administered intranasally, the vaccine can elicit both a systemic and mucosal response. Most vaccines are injected (intramuscular) and fail to provide mucosal immunity.’

‘By being able to generate an immune response that can respond to mucosal pathogens like anthrax, the platform may be able to provide more effective protection against the deadly disease,’ said BlueWillow in a press release.

This patent issued to the University of Michigan on May 29, 2019, under exclusive license to BlueWillow, is based on research conducted by the University demonstrating the vaccine’s ability to elicit long-term protection against lethal anthrax challenge in animals.

To date, the NanoVax anthrax vaccine has demonstrated safety, immunogenicity, and protection in multiple, non-human, animal studies. In contrast, animals exposed to anthrax without first receiving the NanoVax vaccine did not survive the study.

Vaccine development is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) of the United Kingdom. The vaccine combines BlueWillow’s novel intranasal adjuvant with PBL’s recombinant protective antigen (rPA) for anthrax.

The currently available vaccination schedule for anthrax consists of 5 intramuscular injections at months 0, 1, 6, 12 and 18, followed by annual booster injections thereafter. Evidence indicates that the current vaccine can cause acute side effects and may provide only partial protection against some strains of B. anthracis.

BlueWillow is supplying its NE adjuvant for use with Public Health England (PHE)’s rPA antigen to enable the development of an intranasal vaccine that requires fewer doses than current treatments.

The National Institute of Allergy and Infectious Diseases (NIAID) lists Bacillus anthracis (anthrax) as a Category A pathogen, indicating the biological agent poses the highest possible risk to national security and public health.

Anthrax exposure can cause severe illness and death when spores enter the body through inhalation, ingestion or cuts in the skin. The disease poses an immense threat in situations such as bioterrorism, says the NIAID.

PBL holds a contract (#HHSN272201600045C) from NIAID for the development of a next-generation NanoVax anthrax vaccine. Phase one clinical studies are expected to begin in the second half of 2019.

BlueWillow Biologics is a privately-held biopharmaceutical company headquartered in Ann Arbor, Michigan, focused on developing and commercializing vaccines using its patented NanoVax® technology platform.

In 2012, BlueWillow Biologics partnered with Public Health England (PHE) to develop an intranasal anthrax vaccine.

Sub Title:

BlueWillow’s NanoVax vaccine platform employs a novel oil-in-water emulsion adjuvant that elicits both systemic and mucosal immunity

References:

BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

Our Science

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BARDA to Purchase Anthrax Vaccine for Strategic Stockpile

Don Hackett — Fri, 17 May 2019 20:31:36 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The Biomedical Advanced Research and Development Authority (BARDA) announced it will procure the anthrax vaccine candidate AV7909 into the Strategic National Stockpile (SNS).

The AV7909 development and procurement contract with BARDA, valued at up to $1.5 billion dollars, was signed in 2016.

AV7909 is being developed by Emergent BioSolutions for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure, in conjunction with the recommended course of antimicrobial therapy.

AV7909 is an anthrax vaccine adsorbed with CPG 7909 adjuvant, designed to elicit a faster immune response than the currently available anthrax vaccine.

AV7909 is made up of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown in clinical studies to accelerate and enhance the immune response, the company said.

The AV7909 vaccine candidate is currently in a Phase 3 trial, which is expected to be completed in late 2020.

Abbey Jenkins, senior vice president at Emergent BioSolutions said in a press release, “AV7909 is designed to offer a 2-dose schedule that elicits a rapid immune response. We are now one step closer to delivering the initial 3 million doses of AV7909 into the SNS.”

Emergent submitted an application for AV7909 in December 2018 to the U.S. Food and Drug Administration (FDA) for the potential emergency use in the event of a public health emergency involving Bacillus anthracis, a bacteria that can cause a serious infectious disease.

The SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency.

Additionally, Jenkins said ‘this action marks an important advancement in the company’s goal to protect public health through its decade-long partnership with BARDA.’

BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

Sub Title:

Emergent Anthrax Vaccine AV7909 consists of Anthrax Vaccine Adsorbed drug substance and CPG 7909 adjuvant

References:

BARDA will procure Emergent BioSolutions’ AV7909 anthrax vaccine in Strategic National Stockpile

VELOCITY: An Anthrax Vaccine Clinical Study

emergent: AV7909 Overview

Therapeutic Anthrax Vaccine Candidate Launches Phase 3 Study

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Therapeutic Anthrax Vaccine Candidate Launches Phase 3 Study

Don Hackett — Fri, 03 May 2019 15:40:25 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

John Paul Sanchez, PharmD

A Phase 3 clinical trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 anthrax vaccine candidate launched on April 23, 2019.

The AV7909 vaccine is being developed by Emergent BioSolutions Inc. for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.

AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine.

Abbey Jenkins, senior vice president at Emergent said in a press release, “Dosing the first subject in this large clinical study is a milestone achievement and we look forward to continuing to execute on our development and procurement contract for AV7909.”

AV7909 is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909.

The addition of CPG 7909 to AVA has been shown, in previous Phase 1 and Phase 2 studies, to safely accelerate and enhance the immune response.

This Phase 3 randomized, double-blind, parallel-group study plans to enroll 3,850 adults across 35 sites within the U.S. with an overall study duration of approximately 20 months.

The advanced development and delivery of AV7909 is funded by the Biomedical Advanced Research and Development Authority, 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.

Additional information about the company may be found here.

Sub Title:

AV7909 vaccine is being developed for post-exposure prophylaxis of disease resulting from Bacillus anthracis exposure

References:

VELOCITY: An Anthrax Vaccine Clinical Study

Emergent BioSolutions Initiates Phase 3 Clinical Study to Evaluate AV7909 for Post-Exposure Prophylaxis of Anthrax

3rd Generation Anthrax Vaccine Moves Forward

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Featured:

3rd Generation Anthrax Vaccine Moves Forward

Don Hackett — Wed, 02 Jan 2019 16:49:59 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

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.

Sub Title:

Emergent BioSolutions NuThrax anthrax vaccine adsorbed with CPG 7909 Adjuvant is being studied for use as a third-generation anthrax vaccine

References:

Emergent BioSolutions Announces Submission to FDA of Application Covering Emergency Use Authorization for NuThrax™

Anthrax

BARDA Securing Anthrax Immunity For the Elderly (B-SAFE)

The Threat

Anthrax Vaccine Stockpile is Reloading

Anthrax Outbreak in Animals Near Southeastern France

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Anthrax Vaccine BioThrax Expands Into Canada

Don Hackett — Wed, 19 Dec 2018 20:25:27 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Health Canada has approved Emergent BioSolutions’ New Drug Submission (NDS) for its anthrax vaccine, BioThrax®.

BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure.

BioThrax is administered in a 3-dose primary schedule (0, 1 and 6 months) with boosters at 3-year intervals recommended thereafter.

BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis.

Anyone who has come in contact with anthrax spores could be at risk of getting sick.

Over 14 million doses of BioThrax have been administered to more than 3 million individuals, said the company.

BioThrax is designated by Health Canada as an innovative drug, giving it market exclusivity for 8 years.

“With the growing awareness of biological and chemical threats around the globe, Emergent is committed to partnering with allied governments and providing preparedness solutions to meet their national security needs,” said Abbey Jenkins, senior vice president, at Emergent BioSolutions, in a press release.

During April 2018, Emergent completed the Mutual Recognition Procedure for BioThrax expanding licensure of BioThrax in five European countries, namely, the U.K., Poland, France (marketed as BaciThrax), Italy, and the Netherlands, in addition to Germany, where BioThrax received market authorization in 2013.

BioThrax has also received market authorization from the Health Sciences Authority in Singapore and the Paul-Ehrlich Institut in Germany.

Where approved in Europe, BioThrax is indicated for the prevention of disease caused by Bacillus anthracis in adults at risk of exposure.

In the USA, BioThrax is also licensed by the U.S. Food and Drug Administration for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age for both pre-exposure and post-exposure prophylactic use.

Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis, says the Centers for Disease Control and Prevention (CDC).

Visitors to countries where anthrax is common can get sick with anthrax if they have contact with infected animal carcasses or eat meat from animals that were sick when slaughtered.

People can also get sick if they handle animal parts, such as hides, or products made from those animal parts, such as animal hide drums, says the CDC.

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.

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.

Sub Title:

Emergent BioSolutions anthrax vaccine BioThrax now approved for Canada

References:

Emergent BioSolutions Receives Health Canada Approval of BioThrax® (Anthrax Vaccine Adsorbed)

BioThrax® (Anthrax Vaccine Adsorbed)

Anthrax

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Dual Protection Vaccine Candidate Against Anthrax & Plague Advances

Don Hackett — Wed, 17 Oct 2018 20:25:36 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Bioterrorism remains one of the biggest challenges to global security and public health, says the Food and Drug Administration (FDA).

But, there are no FDA-approved vaccines for mass vaccination to protect the general public against either anthrax or the plague, which are tier 1 agents that pose serious threats to US national security.

However, researchers announced today that they have now engineered a virus nanoparticle vaccine candidate against Bacillus anthracis and Yersinia pestis.

B. anthracis and Y. pestis are the pathogens that cause anthrax and plague, respectively.

Using bacteriophage T4, the scientists developed the vaccine by incorporating key antigens of both B. anthracis and Y. pestis into one formulation.

Two doses of this vaccine provided complete protection against both inhalational anthrax and pneumonic plague in animal models.

Even when animals were threatened with lethal doses of both anthrax lethal toxin and Y. pestis CO92 bacteria, the vaccine was shown to be effective.

The study is published in mBio, an open-access journal of the American Society for Microbiology. Their results demonstrate that T4 nanoparticle is a novel platform for developing multivalent vaccines against pathogens of high public health concern.

“This dual anthrax-plague vaccine is a strong candidate for stockpiling against a potential bioterror attack involving either one or both of these biothreat agents,” the researchers noted in the study.

Vaccine development historically relied on the whole pathogen-containing either the inactivated organisms or live attenuated organisms.

Several such vaccines have been developed against anthrax and plague in the past.

However, these whole-pathogen vaccines produce severe side effects. Hence, these vaccines have either been discontinued or used only in a limited way to protect at-risk military and laboratory personnel.

Subunit vaccines containing only the target antigen(s) of a pathogen are safer alternatives to whole-pathogen vaccines. Numerous recombinant vaccines against anthrax or plague have been under investigation, but none have yet been licensed.

This new vaccine candidate is important since following the deadly anthrax attacks of 2001, the Centers for Disease Control and Prevention (CDC) determined that Bacillus anthracis and Yersinia pestis that cause anthrax and plague were named as Tier-1 biothreat agents.

Both cause rapid death, in 3 to 6 days, of exposed individuals.

This study was conducted in accordance with the Guide for the Care and Use of Laboratory Animals recommended by the National Institutes of Health.

This work was supported by NIAID/NIH grant AI111538 (V.B.R.) and in part by grant AI064389 (A.K.C.) and the intramural research program of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

The American Society for Microbiology is the largest single life science society, composed of more than 30,000 scientists and health professionals.

Sub Title:

T4 nanoparticle is a novel platform for developing multivalent vaccines against pathogens of high public health concern

References:

A Bacteriophage T4 Nanoparticle-Based Dual Vaccine against Anthrax and Plague

Researchers engineer dual vaccine against anthrax and plague

A Bivalent Anthrax–Plague Vaccine That Can Protect against Two Tier-1 Bioterror Pathogens, Bacillus anthracis & Yersinia pestis

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Anthrax Outbreak in Animals Near Southeastern France

Don Hackett — Tue, 21 Aug 2018 13:33:11 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Since June 28, 2018, more than 50 animals have died of anthrax in the Hautes-Alpes region of France, reported the Regional Health Agency Provence-Alpes-Côte d'Azur (ARS).

This is France's most serious anthrax outbreak in cattle, sheep, and equines in over two decades, according to ARS, who is located in southeastern France.

The ARS identified 103 people potentially in contact with the disease.

As a precaution, preventive antibiotic treatment has been prescribed for 54 people and to date, no human anthrax case has been identified, reported ARS.

“Cases of anthrax being passed on to humans are extremely rare, but in its rarest forms, it can be deadly,” said Christine Ortmans, a doctor with ARS.

As of August 20th, 13 municipalities in the Hautes-Alpes have been impacted: Montgardin, La Batie-Neuve, La Rochette, Chorges, Théus, La Freissinouse, Romette, Ancelle, Saint-Léger-les-Mélèzes, Sainte-Eusebe-en-Champsaur, Rambaud, Saint- Etienne-le-Laus and Buissard.

Senior Hautes-Alpes official Serge Cavalli said ‘animals were being vaccinated at affected farms in the region. Those affected have been banned from production for at least 21 days while the farms are disinfected and to provide time for the vaccinated animals to become immune.’

Anthrax cases are fairly rare, although more than 100 cases have been registered at French farms since 1999, said ARS.

Anthrax is transmitted by spores that can stay inactive in the ground for decades, including in the bodies of dead animals.

When anthrax spores get into the skin, usually through a cut or scrape, a person can develop cutaneous anthrax. This can happen when a person handles infected animals or contaminated animal products like wool, hides, or hair.

Cutaneous anthrax is most common on the head, neck, forearms, and hands. It affects the skin and tissue around the site of infection, says the US Centers for Disease Control and Prevention (CDC).

Cutaneous anthrax is the most common form of anthrax infection, and it is also considered to be the least dangerous. Infection usually develops from 1 to 7 days after exposure. Without treatment, up to 20% of people with cutaneous anthrax may die.

However, with proper treatment, almost all patients with cutaneous anthrax survive says the CDC.

Starting therapy immediately before the anticipated or potential exposure can reduce the risk of illness and reduce mortality from inhalational anthrax, says the Food and Drug Administration (FDA).

After years of refinement, the FDA has issued final guidance for Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.

FDA Commissioner Scott Gottlieb, M.D. said in a press release, “Since the 2001 anthrax attacks, the U.S. government’s efforts to protect the nation from bioterrorism threats have continued to evolve.”

“We now know that a comprehensive preparedness plan for potential anthrax threats must account for both pre- and post-exposure scenarios.”

The final FDA guidance revises the indication to “prophylaxis of inhalational anthrax” for the reduction of disease risk in those who have inhaled, or are likely to inhale, aerosolized B. anthracis spores, but who do not yet have established disease.

Obiltoxaximab, known as Anthim, was FDA approved during March 2016 and is an antibody-based therapeutic that can complement antibiotics by neutralizing the toxins produced by Bacillus anthracis, the bacteria that cause anthrax disease.

While antibiotics can be effective in treating bacteria like anthrax, antibody-based therapeutics, such as Anthim, treat the toxins released by the anthrax bacteria that can lead to illness and death.

In April 2018, the USA government announced it would purchase an anthrax treatment for $25.2 million.

Anthim will be delivered to the Strategic National Stockpile (SNS), the nation’s largest supply of potentially life-saving medical countermeasures, such as vaccines, therapeutics, and diagnostics.

The SNS contains more than $7 billion worth of medicines and medical supplies referred to as the ‘formulary.’

While many SNS items are readily available, some are not available in the commercial marketplace.

For potential consumer use, there are anthrax vaccine candidates in development.

On March 13th, 2018, Altimmune announced data from a pre-clinical study comparing SparVax-L and BioThrax against anthrax infection.

This limited study showed a 67 percent survival rate in animals challenged with a lethal dose of anthrax, after a single dose of SparVax-L.

Additionally, SparVax-L reported a 100% survival rate after two doses on day 0 and day 14 when challenged at Day 28, which was comparable to BioThrax’s 96% survival rate after two doses.

SparVax-L is being developed as a second generation, highly purified recombinant anthrax vaccine requiring only two vaccinations for protection.

SparVax-L is further differentiated by its ability to be stored at room temperature, making it well-suited for stockpiling in the Strategic National Stockpile.

Sub Title:

Altimmune SparVax-L anthrax vaccine candidate showed positive comparison against BioThrax in preclinical study

References:

Case of anthrax in the department of Hautes-Alpes: the state services take the necessary measures to contain the disease

Cutaneous Anthrax

Developing Preventive Anthrax Medicines Now Has a Plan

Anthrax Vaccine Program Advances

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