Smallpox

Gates Germ-Game Warning Motivates Smallpox Vaccine Discussions

Don Hackett — Mon, 08 Nov 2021 22:03:12 +0000

Reviewer:

Policy Exchange recently hosted Mr. Bill Gates, Co-Chair of the Bill and Melinda Gates Foundation, and Rt Hon Jeremy Hunt MP, Chair of the Health Select Committee, who discussed the potential of future pandemics.

In a wide-ranging discussion on November 4, 2021, Gates called for a new international Pandemic Task Force, with a budget of about $1 billion per year.

According to Microsoft's founder, governments must invest billions in research and development to prepare for future pandemics and smallpox terror strikes.

This new effort would "germ game" potential pandemics and bioterrorist attacks such as smallpox attacks on airports. The Science Times reported germ games are ‘when government agencies practice scenarios of another pandemic catastrophe.’

“You say, OK, what if a bioterrorist brought smallpox to 10 airports? You know, how would the world respond to that?

“There are naturally-caused epidemics and bioterrorism-caused epidemics that could even be way worse than what we experienced today.”

“And citizens expect their governments not to let that happen again,” Gates commented.

Gates has previously issued similar warnings.

In an April 2015 TED presentation, "The next outbreak? We're not ready," Gates warned of the hazards of a highly contagious virus and a major pandemic, stressing the importance of being prepared.

Based on recent Centers for Disease Control and Prevention (CDC) vaccine advisory committee meetings, the U.S. is focused on the threat of smallpox.

On November 3, 2021, following an introduction by Pablo Sanchez, M.D. Chair of the Orthopoxvirus workgroup, the CDC’s Advisory Committee on Immunization Practices reviewed the two presentations focused on the smallpox vaccine JYNNEOS.

Produced by Bavarian Nordic, JYNNEOS was initially approved in 2019 by the U.S. Food and Drug Administration (FDA) and is indicated for preventing smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

JYNNEOS is the only FDA-approved non-replicating smallpox vaccine and the only FDA-approved monkeypox vaccine for non-military use.

Brett Petersen, M.D., MPH, presented the new proposed ‘clinical guidance for the use of JYNNEOS as it compares to an older smallpox vaccine, ACAM2000, which the ACIP currently recommends.

Many persons with contraindications to vaccination with ACAM2000 (e.g., atopic dermatitis, immunocompromising conditions, breastfeeding, or pregnancy) may receive vaccination with JYNNEOS.

A person can be considered fully immunized two weeks following administration of the second dose of JYNNEOS when clinical studies have demonstrated maximal antibody titers.

As a replication-deficient vaccine, JYNNEOS does not produce a vaccine site lesion that can be used as a marker of successful vaccination.

And routine titer testing is not recommended following vaccination with JYNNEOS to confirm successful administration of the vaccine, given that high seroconversion rates were demonstrated in clinical trials.

However, titer testing could be considered on a case-by-case basis after consultation with public health authorities for select persons with immunocompromising conditions or those working with more virulent orthopoxviruses (variola and monkeypox) to confirm an immune response has been achieved.

Currently, the smallpox vaccine is not recommended for the general public in the USA since smallpox has been eradicated. Routine smallpox vaccination among Americans stopped in 1972.

However, U.S. health officials are prepared to use a vaccine if there were a smallpox outbreak, says the CDC.

Note: Bill Gates publishes various posts at GatesNote.com.

PrecisionVaccinations publishes fact-checked research-based vaccine news.

Sub Title:

JYNNEOS is an FDA-approved non-replicating smallpox and monkeypox vaccine

References:

Bill Gates speaks to Rt Hon Jeremy Hunt MP in exclusive Policy Exchange interview

Bill Gates Tells WHO to Do ‘Germ Games’ to Prevent Another Pandemic, Smallpox Outbreak

CDC: Clinical Guidance for the use of Jynneos

Summary of Evidence to Recommendations Frameworks for Use of JYNNEOS

ACAM2000 Smallpox Vaccine

JYNNEOS Smallpox Vaccine

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Google News Keywords:

health, vaccines, vaccinations, bill gates, gates foundation, pandemics, future pandemics, small pox, small pox vaccines,

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Tuesday, November 9, 2021 - 06:00

USA Expands Smallpox Treatment Stockpile

Don Hackett — Wed, 09 Jun 2021 16:55:59 +0000

Reviewer:

Robert Carlson, MD

The U.S. Food and Drug Administration (FDA) announced the Approval of Tembexa (brincidofovir) to treat smallpox.

Tembexa, an oral antiviral, was developed in conjunction with the U.S. Biomedical Advanced Research and Development Authority (BARDA).

The FDA granted Approval of Tembexa to Chimerix Inc.

Although the World Health Organization declared smallpox eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon.

Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an essential component of the U.S. medical countermeasures response, says the FDA.

Recently, BARDA exercised the final $12 million option under the $202 million order for the JYNNEOS vaccine. JYNNEOS is the only FDA-Approved non-replicating smallpox and monkeypox vaccine.

Before its eradication in 1980, the variola virus was mainly spread by direct contact among people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache.

Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. Effectiveness was determined by measuring animals’ survival at the end of the studies.

Safety information to support Approval of Tembexa was derived from clinical trials of the drug for a non-smallpox indication, primarily from patients who received hematopoietic stem cell transplants. The most common side effects when using Tembexa are diarrhea, nausea, vomiting, and abdominal pain.

Previously, Tembexa received Priority Review, Fast Track, and Orphan Drug Designations by the FDA.

PrecisionVaccinations publishes research-based news.

Sub Title:

Tembexa antiviral and Jynneos vaccine are essential components of the USA medical countermeasures

References:

Tembexa

JYNNEOS Smallpox Vaccine

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Thursday, June 10, 2021 - 05:00

Canada Expands Smallpox Vaccine Indications

Don Hackett — Sun, 15 Nov 2020 16:04:30 +0000

Reviewer:

Robert Carlson, MD

A Denmark-based vaccine producer announced that Health Canada has expanded the approval of the Company’s non-replicating smallpox vaccine, IMVAMUNE® to include indications for monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure.

IMVAMUNE is currently approved in Canada under the Extraordinary Use New Drugs Pathway.

Announced by Bavarian Nordic A/S on November 12, 2020, the extended approval was granted following an assessment of additional clinical and non-clinical data, generated since IMVAMUNE received approval as a smallpox vaccine by Health Canada in 2013.

Smallpox is a systemic viral disease caused by the variola virus, a species of the Orthopoxvirus.

Because the monkeypox virus is closely related to the virus that causes smallpox, the smallpox vaccine can also protect people from getting monkeypox.

These data include among others a Phase 3 study which demonstrated that, in terms of efficacy, IMVAMUNE was non-inferior to replicating smallpox vaccines, while also confirming its favorable benefit/risk profile.

IMVAMUNE is a non-replicating vaccine that, unlike traditional vaccines, cannot spread in the vaccinated person. Therefore, none of the serious side effects normally associated with traditional vaccines have been seen with IMVAMUNE, says the company.

Paul Chaplin, CEO of Bavarian Nordic said in a press release, “While monkeypox is endemic to certain parts of Africa, orthopoxvirus infections may occur from animals to humans all over the world. Although cases are rare, no vaccine has previously been approved for these indications, and we are pleased to receive this extended approval of IMVAMUNE.”

Bavarian Nordic has collaborated with the Canadian authorities since 2008 on supplying IMVAMUNE, initially for the Canadian Department of National Defence. Subsequent to the initial Canadian approval in 2013, Bavarian Nordic has also collaborated with the Public Health Agency of Canada for stockpiling of the vaccine for the general population.

In 2003 and 2004, Bavarian Nordic received contracts from the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the clinical development of IMVAMUNE. In 2007, BARDA awarded the company a procurement contract to supply 20 million doses of the vaccine.

The U.S. CDC’s website indicates JYNNEOS (also known as Imvamune or Imvanex), has been licensed in the United States to prevent monkeypox and smallpox.

Past data from Africa suggests that the smallpox vaccine is at least 85% effective in preventing monkeypox. The effectiveness of JYNNEOS against monkeypox was concluded from a clinical study on the immunogenicity of JYNNEOS and efficacy data from animal studies. Experts also believe that vaccination after a monkeypox exposure may help prevent the disease or make it less severe.

Smallpox vaccines licensed in the United States include ACAM2000, which contains a live vaccinia virus, and JYNNEOS, a live non-replicating vaccine.

Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture, and commercialization of life-saving vaccines.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

IMVAMUNE vaccine indications include monkeypox and related orthopoxvirus infections

References:

HEALTH CANADA EXTENDS APPROVAL OF IMVAMUNE TO IMMUNIZATION AGAINST MONKEYPOX AND ORTHOPOX VIRUSES

BAVARIAN NORDIC COMPLETES DELIVERY OF 20 MILLION DOSES OF IMVAMUNE® SMALLPOX VACCINE TO THE U.S. STRATEGIC NATIONAL STOCKPILE

Smallpox vaccine: Canadian Immunization Guide

WHO Advisory Committee on Variola Virus Research

Monkeypox and Smallpox Vaccine

MVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo

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GoodRx Vaccine:

jynneos

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Smallpox Biodefense Therapeutic Awarded $67.4 Million Dollars

Don Hackett — Sat, 28 Sep 2019 17:39:19 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Maryland based BioFactura, Inc. announced a contract valued at up to $67.4 million for the advanced development of its Smallpox Biodefense Therapeutic.

This Biomedical Advanced Research and Development Authority (BARDA) award announced on Septemeber 26, 2019, is for a potential medical countermeasure for the treatment of smallpox.

Smallpox is one of the most devastating diseases with a mortality rate as high as 30 percent, says the World Health Organization (WHO). Smallpox is caused by the variola virus, a member of the Orthopoxvirus family.

This BioFactura product has the potential to fulfill an unmet need in preparedness for a 2nd anti-viral therapeutic with a different mechanism of action to the current stockpile to guard against potential host resistance.

To fill the need for additional treatment options, BioFactura, in partnership with BARDA, is advancing the development of its monoclonal antibody-based Smallpox Biodefense Therapeutic in a stepwise approach building upon years of early product research and development and a strong foundation of a cell line, process, analytical and manufacturing development experience, and expertise.

Although TPOXX® received FDA approval for smallpox treatment in 2018, Variola Virus, the causative agent for smallpox infections in humans, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics.

Dr. Darryl Sampey, President, and CEO of BioFactura, stated in a press release, “This government contract for the development of a novel smallpox therapeutic countermeasure is the result of years of cutting edge biotechnology research, the perseverance of forward-thinking scientific entrepreneurs, the risk appetite of loyal investors, and the dedication of the Department of HHS/BARDA to maintain the safety and security of the United States population.”

Smallpox vaccines have been foundational to the U.S. government’s preparedness and response efforts as documented in the Project BioShield Act of 2004 and its predecessor the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

In 2015, the Centers for Disease Control and Prevention issued clinical guidance for smallpox vaccine use in a post-event scenario stating that surveillance and containment activities including vaccination with replication-competent smallpox vaccine, such as ACAM2000, will be the primary response strategy for achieving epidemic control.

While smallpox was declared eradicated in 1980 by the WHO after an extensive vaccination campaign, the threat of bioterrorism and/or inadvertent release remains.

Smallpox vaccine news

This new smallpox project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00054.

BARDA is part of the HHS Office of the Assistant Secretary for Preparedness and Response, which was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza and emerging infectious diseases.

To-date, BARDA has supported 42 FDA approvals for products addressing various threats.

Smallpox Vaccine news published by Precision Vaccinations

Sub Title:

BioFactura contracts with BARDA for the advanced development of its Smallpox Biodefense Therapeutic

References:

BioFactura Awarded $67.4 Million Advanced Development Contract for its Smallpox Biodefense Therapeutic

Biomedical Advanced Research and Development Authority

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Smallpox and Monkeypox Combo Vaccine Approved by the FDA

Don Hackett — Wed, 25 Sep 2019 01:13:58 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The U.S. Food and Drug Administration announced the approval of Jynneos, a Smallpox and Monkeypox Vaccine, produced by Bavarian Nordic A/S.

This is important news since Jynneos is the only approved non-replicating smallpox vaccine in the USA and the only approved monkeypox vaccine anywhere in the world.

UPDATE: in a September 30th press release, Col. E. Darrin Cox, commander of the U.S. Army Medical Research Institute of Infectious Diseases said, "In addition to its public health importance, this vaccine will have a direct impact on improving force health protection for U.S. service members who are required to be immunized against smallpox."

Bavarian Nordic’s Jynneos is a live, non-replicating 2-dose vaccine for adults 18 years of age and older, who are determined to be at high-risk for smallpox or monkeypox infection.

“Routine vaccination of the American public was stopped in 1972 after the smallpox disease was eradicated in the USA and, as a result, a large proportion of the global population has no immunity,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a September 24, 2019 press release.

“Therefore, although naturally occurring smallpox disease is no longer a global threat, the intentional release of this highly contagious virus could have a devastating effect.”

“Today’s approval reflects the U.S. government’s commitment to preparedness through support for the development of safe and effective vaccines, therapeutics, and other medical countermeasures,” said Dr. Marks.

The Jynneos vaccine is also part of the Strategic National Stockpile (SNS), the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency that is severe enough to cause local supplies to be depleted.

The availability of this vaccine in the SNS will help ensure that the vaccine is accessible in the U.S. if needed.

Jynneos does not contain the viruses that cause smallpox or monkeypox. It is made from a vaccinia virus, a virus that is closely related to, but less harmful than, variola or monkeypox viruses and can protect against both of these diseases.

Jynneos contains a modified form of the vaccinia virus called Modified Vaccinia Ankara, which does not cause disease in humans and is non-replicating, meaning it cannot reproduce in human cells.

Smallpox, which is caused by the variola virus, emerged in human populations thousands of years ago and is a highly contagious and often fatal infectious disease. A person infected with smallpox typically develops a rash characterized by raised pocks on the face and body, says the FDA.

The smallpox virus is spread through saliva and droplets from the respiratory tract or by direct or indirect contact with the virus as it is shed from skin lesions. The virus can also be spread through other body fluids and contaminated clothing or bed linen.

If a person is infected with smallpox and they are in close contact with others, the virus can spread quickly.

Monkeypox, which does not occur naturally in the USA, is a rare disease caused by infection with the monkeypox virus, which causes symptoms similar to, but milder than, smallpox.

Monkeypox begins with fever, headache, muscle aches, and exhaustion and can be fatal, even though it is typically milder than smallpox. It is transmitted to people from various wild animals, such as rodents and primates.

In 2003, the USA experienced an outbreak of monkeypox, which was the 1st time human monkeypox was reported outside of Africa.

The effectiveness of Jynneos for the prevention of smallpox was determined in a clinical study comparing the immune responses in study participants who received either Jynneos or ACAM2000, an FDA-approved vaccine for the prevention of smallpox.

The study included approximately 400 healthy adults, 18 through 42 years of age who had never been vaccinated for smallpox, in which half of the study participants received two doses of Jynneos administered 28 days apart, and half received one dose of ACAM2000.

The group vaccinated with Jynneos had an immune response that was not inferior to immune responses to ACAM2000. Vaccine effectiveness for the prevention of smallpox was also inferred from supportive animal studies that showed prior vaccination with Jynneos protected non-human primates who were exposed to viruses related to the smallpox virus.

The effectiveness of Jynneos for the prevention of monkeypox disease is inferred from the antibody responses in the smallpox clinical study participants and from studies in non-human primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.

Monkeypox vaccine news

The safety of Jynneos was assessed in more than 7,800 individuals who received at least one dose of the vaccine.

The FDA granted the application Priority Review and with this approval, the FDA issued a material threat medical countermeasure (MCM) priority review voucher to Bavarian Nordic A/S.

The Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act, authorizes the FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria.

Bavarian Nordic has received significant support during the development of JYNNEOS from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), the Department of Defense and the Centers for Disease Control and Prevention.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against infectious diseases and cancer.

Published by Precision Vaccinations

Sub Title:

Bavarian Nordic Jynneos smallpox and monkeypox vaccine approved for adults 18 years of age and older

References:

FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox

Bavarian Nordic Announces U.S. FDA Approval of JYNNEOS™ for Prevention of Smallpox and Monkeypox Disease in Adults

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Google News Keywords:

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U.S. Government Expands Smallpox Vaccine Supply

Don Hackett — Sat, 19 Jan 2019 11:01:29 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Kelley Lu, PharmD

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has exercised another option under an ongoing contract for freeze-dried MVA-BN® smallpox vaccine.

Although not yet approved in the USA, MVA-BN is currently stockpiled by the U.S. Government for emergency use in people for whom replicating smallpox vaccines are contraindicated, such as people with HIV and atopic dermatitis.

This option, valued at USD 44 million, will cover qualification of the new fill-finish facility, currently being established at the Bavarian Nordic A/S manufacturing site in Denmark, as well as transfer and validation of the freeze-drying process.

This new facility has been designed with a potential annual capacity of up to 40 million doses of liquid vaccines and 8 million doses of freeze-dried vaccines.

This is the 2nd option exercised under an existing contract.

During 2017, BARDA exercised an option of USD 37 million to cover development costs associated with the Phase 3 study required for the eventual approval of the freeze-dried MVA-BN smallpox vaccine.

This Phase 3 will be initiated in the first half of 2019.

Since 2010, Bavarian Nordic has manufactured its liquid-frozen MVA-BN smallpox vaccine for the U.S. government and has supplied 28 million doses to the U.S. Strategic National Stockpile (SNS) for emergency use.

Concurrently, BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the current stockpile that has expired.

This project has been funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.

Recent smallpox vaccine news articles:

MVA-BN is approved in Canada (marketed under the trade name IMVAMUNE®) and in the European Union (marketed under the trade name IMVANEX®).

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safer therapies against cancer and infectious diseases.

Sub Title:

Bavarian Nordic MVA-BN is a non-replicating smallpox vaccine distributed in liquid-frozen formulation

References:

BAVARIAN NORDIC ANNOUNCES EXERCISE OF USD 44 MILLION OPTION BY THE U.S. GOVERNMENT UNDER CONTRACT FOR FREEZE-DRIED MVA-BN®

NON-REPLICATING SMALLPOX VACCINE

A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine

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First Smallpox Medication Approved by FDA

Don Hackett — Fri, 13 Jul 2018 20:03:21 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The U.S. Food and Drug Administration (FDA) today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.

Smallpox is a serious, highly contagious, and sometimes fatal infectious disease. Complications of smallpox include encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye) and blindness.

Though the World Health Organization (WHO) declared smallpox, eradicated in 1980, there have been long-standing concerns that smallpox could be used as a bioweapon.

This FDA approval is important since there is no proven treatment for smallpox disease. Variola virus, the virus that causes smallpox, was mainly spread by direct contact between people.

Additionally, smallpox can be prevented by the smallpox vaccine. Currently, there is one licensed smallpox vaccine; ACAM2000, licensed on August 31, 2007, which is manufactured by Sanofi Pasteur Biologics Co.

If you get the vaccine:

Before contact with the virus, the vaccine can protect you from getting sick.
Within 3 days of being exposed to the virus, the vaccine might protect you from getting the disease. If you still get the disease, you might get much less sick than an unvaccinated person would.
Within 4 to 7 days of being exposed to the virus, the vaccine likely gives you some protection from the disease. If you still get the disease, you might not get as sick as an unvaccinated person would.

During February 2018, a biotechnology company announced positive results from a Phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE.

TPOXX’s effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox and was based on measuring survival at the end of the studies.

TPOXX was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

The safety of TPOXX was evaluated in 359 healthy human volunteers without a smallpox infection.

“This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D.

"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”

The FDA granted this application Fast Track and Priority Review designations. TPOXX also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases and a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.

TPOXX was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Sub Title:

TPOXX (tecovirimat) is the first medication with an indication for treatment of smallpox

References:

FDA approves the first drug with an indication for treatment of smallpox

Prevention and Treatment

WHO Smallpox

FDA Smallpox

Smallpox Treatment TPOXX Benefits Outweigh Risks, says FDA

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Smallpox Treatment TPOXX Benefits Outweigh Risks, says FDA

Don Hackett — Thu, 03 May 2018 18:07:18 +0000

Reviewer:

Smallpox is a naturally occurring, highly contagious, and sometimes fatal infectious disease.

The last case of wild smallpox occurred in Somalia in 1977.

Yet, it remains as one of the highest priority pathogens due to its potential as a biological weapon.

There is not a specific treatment for smallpox disease available today, but the Food and Drug Administration (FDA) is taking action to remove this shortcoming.

SIGA Technologies, Inc. announced a favorable outcome of the FDA Antimicrobial Drugs Advisory Committee meeting on oral TPOXX®, a small molecule antiviral treatment for smallpox.

TPOXX, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug, that targets orthopoxvirus infections.

This FDA panel voted unanimously, 17 to 0, that the benefits of TPOXX outweigh its risks. The FDA had previously announced that its target final action date was August 8, 2018.

The U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) funded the advanced development of oral TPOXX in partnership with SIGA.

Additionally, under Project Bioshield, BARDA has already acquired two million courses of oral TPOXX and such courses have been delivered to the Strategic National Stockpile.

Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies said, “We believe that safety and efficacy data support TPOXX’s future use as a medical counter-measure in response to a smallpox outbreak.”

Variola major is the severe form of smallpox, with a more extensive rash and higher fever. It is also the most common form of smallpox. Historically, variola major has a case-fatality rate of about 30 percent.

There are four types of variola major smallpox: ordinary (the most frequent); modified (mild and occurring in previously vaccinated persons); flat, and hemorrhagic.

And, the only smallpox prevention is vaccination, says the FDA.

Dryvax, a smallpox vaccine, originally licensed in 1944 was manufactured until the mid-1980s when the World Health Organization declared that smallpox had been eradicated.

Currently, there is one licensed smallpox vaccine; ACAM2000, which is based on the same strain of virus as Dryvax.

On May 2, 2005, CBER licensed Vaccinia Immune Globulin, Intravenous to treat rare serious complications of smallpox vaccination.

Recently, during February 2018, a biotechnology company announced positive results from a Phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE®.

Additionally, IMVAMUNE recorded a statistically superior immune response (2x) and the majority of volunteers achieved primary vaccination, requiring no need for re-vaccination.

This clinical study demonstrated IMVAMUNE’s non-inferiority, which means not worse than ACAM2000, the current U.S. licensed, replicating smallpox vaccine.

For more information about SIGA, please visit www.siga.com.

Sub Title:

TPOXX is an oral small molecule antiviral treatment for smallpox

References:

SIGA Technologies Announces Favorable Outcome of Advisory Committee In Support of TPOXX®

Development of the small-molecule antiviral ST-246® as a smallpox therapeutic

Smallpox

Disease Eradication

Smallpox Vaccine IMVAMUE Found Successful in Phase 3 Clinical Study

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Smallpox Vaccine IMVAMUE Found Successful in Phase 3 Clinical Study

Don Hackett — Wed, 07 Feb 2018 07:32:00 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A biotechnology company announced positive results from a Phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE®.

This is the second positive Phase 3 study demonstrating the safety and efficacy of IMVAMUNE.

This clinical study demonstrated non-inferiority, which means not worse than ACAM2000, the current U.S. licensed replicating smallpox vaccine.

Additionally, IMVAMUNE recorded a statistically superior immune response (2x) and the majority of volunteers achieved primary vaccination, requiring no need for re-vaccination.

IMVAMUNE is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis (AD) and HIV.

IMVAMUNE, delivered via an intramuscular injection, is based on a strain of the Modified Vaccinia Ankara virus that is incapable of replicating in the body. It elicits an immune response without the post-vaccination complications associated with traditional smallpox vaccines that are administered via pricking the skin.

IMVAMUNE has been given to more than 7,800 subjects in 21 clinical studies, including two Phase 3 studies that have supported a favorable safety profile and efficacy in comparison to replicating smallpox vaccines.

"These and earlier study results validate the promise of IMVAMUNE for the prevention of smallpox and support product registration with the U.S.FDA," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

The IMVAMUNE Smallpox Vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX® as the only non-replicating smallpox vaccine approved for use in the general population.

The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200700034C.

Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile for emergency use. The Company has ongoing contracts the Biomedical Advanced Research and Development Authority (BARDA) to replenish the stockpile with a freeze-dried formulation of the vaccine, which offers improved shelf life.

Bavarian plans to file its U.S. marketing application under Fast Track status.

If approved, it will receive a Priority Review voucher for accelerated review of a future application or it can be sold to a third party.

For more information visit www.bavarian-nordic.com

Sub Title:

Non-replicating smallpox Vaccine IMVAMUE met both primary endpoints

References:

A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®

Bavarian Nordic Announces Positive Results of Pivotal Phase 3 Study of IMVAMUNE® Smallpox Vaccine

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