Emergent BioSolutions’ ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions
Emergent BioSolutions Inc. (NYSE: EBS) announced that the FDA has approved ACAM2000® for prevention of mpox disease in high-risk individuals. This single-dose vaccine, originally approved for smallpox in 2007, now has an expanded indication. The approval is based on human safety data and animal studies showing effectiveness against mpox virus exposure.
Emergent is actively engaging with global health leaders to support the response to the recent mpox outbreak, which the WHO declared a public health emergency. The company plans to donate 50,000 doses of ACAM2000® for potential deployment in Central Africa. This approval comes as mpox continues to spread, with over 95,000 cases reported across 115 non-endemic countries in 2022.
Emergent BioSolutions Inc. (NYSE: EBS) ha annunciato che la FDA ha approvato ACAM2000® per la prevenzione della malattia mpox in individui ad alto rischio. Questo vaccino monodose, inizialmente approvato per il vaiolo nel 2007, ora ha un'indicazione ampliata. L'approvazione si basa su dati di sicurezza umani e studi su animali che mostrano l'efficacia contro l'esposizione al virus mpox.
Emergent sta attivamente collaborando con i leader della salute globale per supportare la risposta all'recenti focolai di mpox, che l'OMS ha dichiarato un'emergenza sanitaria pubblica. L'azienda prevede di donare 50.000 dosi di ACAM2000® per una potenziale distribuzione nell'Africa centrale. Questa approvazione arriva mentre il mpox continua a diffondersi, con oltre 95.000 casi segnalati in 115 paesi non endemici nel 2022.
Emergent BioSolutions Inc. (NYSE: EBS) anunció que la FDA ha aprobado el ACAM2000® para la prevención de la enfermedad mpox en individuos de alto riesgo. Esta vacuna de dosis única, inicialmente aprobada para la viruela en 2007, ahora tiene una indicación ampliada. La aprobación se basa en datos de seguridad en humanos y estudios en animales que muestran efectividad contra la exposición al virus mpox.
Emergent está colaborando activamente con líderes de salud globales para apoyar la respuesta al reciente brote de mpox, que la OMS declaró una emergencia de salud pública. La empresa planea donar 50,000 dosis de ACAM2000® para una posible distribución en África Central. Esta aprobación llega mientras el mpox sigue propagándose, con más de 95,000 casos reportados en 115 países no endémicos en 2022.
Emergent BioSolutions Inc. (NYSE: EBS)는 FDA가 ACAM2000®을 고위험 개인의 mpox 질병 예방을 위해 승인했다고 발표했습니다. 이 단일 접종 백신은 2007년 세계 천연두에 대해 처음 승인되었으며, 이제 사용 indication이 확장되었습니다. 이 승인은 인간의 안전성 데이터와 mpox 바이러스 노출에 대한 효과를 보여주는 동물 연구에 기반합니다.
Emergent는 최근에 WHO가 공공 보건 비상사태로 선언한 mpox 발병에 대응하기 위해 글로벌 건강 리더들과 적극적으로 협력하고 있습니다. 이 회사는 중앙 아프리카에 배포 가능성을 위해 ACAM2000®의 50,000회의 접종량을 기부할 계획입니다. 이 승인은 2022년 115개의 비토착 국가에서 95,000건이 넘는 사례가 보고됨에 따라 mpox가 계속 확산되고 있는 가운데 이루어졌습니다.
Emergent BioSolutions Inc. (NYSE: EBS) a annoncé que la FDA a approuvé ACAM2000® pour la prévention de la maladie mpox chez les individus à haut risque. Ce vaccin à dose unique, initialement approuvé pour la variole en 2007, a désormais une indication élargie. L'approbation repose sur des données de sécurité humaine et des études animales montrant l'efficacité contre l'exposition au virus mpox.
Emergent collabore activement avec des leaders de la santé mondiale pour soutenir la réponse à la récente épidémie de mpox, que l'OMS a déclarée urgence de santé publique. L'entreprise prévoit de donner 50,000 doses d'ACAM2000® pour une éventuelle distribution en Afrique centrale. Cette approbation survient alors que le mpox continue de se propager, avec plus de 95,000 cas signalés dans 115 pays non endémiques en 2022.
Emergent BioSolutions Inc. (NYSE: EBS) gab bekannt, dass die FDA ACAM2000® zur Prävention der mpox-Erkrankung bei Hochrisikopersonen genehmigt hat. Dieser Einzelimpfstoff, der ursprünglich 2007 für Pocken zugelassen wurde, hat nun eine erweiterte Indikation. Die Genehmigung basiert auf Daten zur Sicherheit beim Menschen und Tierversuchen, die die Wirksamkeit gegen die Exposition gegenüber dem mpox-Virus zeigen.
Emergent arbeitet aktiv mit globalen Gesundheitsführern zusammen, um die Reaktion auf den jüngsten mpox-Ausbruch zu unterstützen, den die WHO als öffentliche Gesundheitsnotlage erklärt hat. Das Unternehmen plant, 50.000 Dosen von ACAM2000® für eine mögliche Bereitstellung in Zentralafrika zu spenden. Diese Genehmigung erfolgt, während mpox weiterhin verbreitet wird, mit über 95.000 gemeldeten Fällen in 115 nicht-endemischen Ländern im Jahr 2022.
- FDA approval of ACAM2000® for mpox prevention expands product portfolio
- Potential for increased global demand due to ongoing mpox outbreaks
- Donation of 50,000 doses may lead to future contracts and goodwill
- Positioning as a key player in addressing global health emergencies
- Efficacy data based on animal studies, not human trials
- Competition from other mpox vaccines in the market
- Potential side effects or safety concerns not mentioned in the PR
Insights
The FDA's approval of ACAM2000® for mpox prevention marks a significant milestone in infectious disease control. This expanded indication comes at a important time, addressing the ongoing global mpox outbreak. Key points to consider:
- The vaccine's efficacy against mpox was demonstrated through animal studies, building on existing human safety data.
- ACAM2000® is a single-dose vaccine, which could streamline vaccination efforts in high-risk populations.
- The approval strengthens Emergent's portfolio, potentially positioning the company as a key player in the global mpox response.
However, investors should note that the real-world effectiveness and demand for this vaccine in mpox prevention remain to be seen, especially given the existence of other mpox vaccines in the market.
The approval of ACAM2000® for mpox prevention is a critical development in global health security. Several factors underscore its importance:
- The ongoing mpox outbreak in Africa, with the more severe clade I variant, necessitates expanded vaccine options.
- Emergent's commitment to donate
50,000 doses to Central African countries demonstrates corporate social responsibility and could enhance the company's reputation. - The vaccine's potential inclusion in WHO's Emergency Use Listing could significantly boost its global reach and adoption.
However, investors should consider the competitive landscape and potential challenges in vaccine distribution and administration, particularly in resource- settings. The percutaneous administration method may require specialized training, potentially impacting widespread adoption.
The FDA approval of ACAM2000® for mpox prevention presents a potentially significant revenue opportunity for Emergent BioSolutions. Key financial considerations include:
- Expanded market potential due to the ongoing global mpox outbreak and the vaccine's dual indication for smallpox and mpox.
- Potential for increased government contracts and stockpiling orders, given the public health emergency status of mpox.
- The donation of
50,000 doses, while impacting short-term revenue, could lead to longer-term contracts and goodwill.
However, investors should be cautious about overestimating the immediate financial impact. The actual revenue boost will depend on factors such as pricing, competition from other mpox vaccines and the scale of government and international organization orders. The company's ability to ramp up production and meet potential demand will be important for capitalizing on this opportunity.
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000® vaccine was shown to be effective in protecting against mpox virus exposure.
ACAM2000® is a single-dose vaccine administered percutaneously via a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine.
The vaccine was first approved by the FDA in 2007 for active immunization for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. Mpox, previously called monkeypox, is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus. The virus is a member of the Orthopoxvirus genus in the Poxviridae family, related to the virus which caused smallpox, which was eradicated in 1980.
“The FDA approval of ACAM2000® for immunization against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV® and TEMBEXA®, said Joe Papa, president and CEO of Emergent. “This expanded indication for ACAM2000® comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”
This approval follows Emergent’s announcement that it filed an Expression of Interest (EOI) with the World Health Organization (WHO) for the WHO’s assessment of ACAM2000® vaccine to be added as an Emergency Use Listing in connection with the mpox outbreak. Emergent also is in discussions with other global public health leaders to help address the current mpox outbreak in response to the WHO’s Director-General’s August 14 statement declaring that the upsurge of mpox is a public health emergency of international concern under the International Health Regulations. As part of its support to the response, Emergent announced that it will donate 50,000 doses of ACAM2000® for potential deployment across impacted countries in Central Africa.
“Mpox has progressed to become an uncontrolled epidemic in Africa — prompting the WHO to declare a second public health emergency of international concern — creating an enormous need to use all effective tools to extinguish it as a threat,” said Dr. Amesh A. Adalja, FIDSA FACP FACEP & health security and emerging infectious diseases expert, Johns Hopkins Center for Health Security. “ACAM2000®, a direct descendant of the Jenner vaccine (humanity’s first) which was used to eradicate smallpox, and now with the broadened indication, will be an invaluable tool in this endeavor.”
In 2022, the world experienced a global outbreak of clade II mpox, which led to more than 95,000 cases across 115 non-endemic countries.
The clade I variant of mpox is characterized by more severe clinical outcomes and a higher case fatality rate. The recently identified clade Ib variant, exhibiting enhanced transmissibility through close contact, has led to an increase in cases, particularly in Central Africa, and a sizable impact on children and families. According to the WHO, clade I mpox tends to cause a higher number of severe infections and have a higher mortality rate than clade II mpox.
About ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live)
ACAM2000® is the primary smallpox vaccine designated for use in a bioterrorism emergency, with doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000® is also licensed in Canada, Australia and Singapore and is currently stockpiled both in the U.S. and internationally.
ACAM2000® is indicated in the U.S. for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox and mpox infection.
The labeling for ACAM2000® contains a contraindication for individuals with severe immunodeficiency. Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000®. The risk for experiencing severe vaccination complications must be weighed against the risk for experiencing a potentially severe or fatal smallpox or mpox infection.
Additionally, there are warnings and precautions for myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson Syndrome), eczema vaccinatum resulting in permanent sequelae or death, accidental eye infection (ocular vaccinia), which can cause ocular complications that may lead to blindness, and fetal death. These may occur following either primary vaccination or revaccination with live vaccinia virus vaccines, including ACAM2000®. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequalae and/or death.
Please see the Prescribing Information for ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) Vaccine for full Boxed Warning and additional safety information.
The full U.S. Prescribing Information for ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) Vaccine can be found here. If it is not currently available via this link, it will be visible as soon as possible as the company works to finalize the document. Please check back for the full information shortly.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we help protect public health, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Safe Harbor Statement
This communication includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the expected timing for delivery of the ACAM2000® vaccine and Emergent’s ability to increase inventories of ACAM2000® vaccine to meet requested levels within specified time frames, if needed, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this communication and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause our actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements.
Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com
FAQ
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