Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. FDA has placed a clinical hold on its Investigational New Drug (IND) application for COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who received the vaccine in January 2023.
The participant reported the SAE in September 2024, after the trial completed in July 2023. Novavax is working with the FDA to provide necessary information and resolve the clinical hold. The company's Chief Medical Officer, Robert Walker, MD, emphasized that safety is their top priority and that causality has not been established for this event. Previous COVID-19 and influenza trials by Novavax have shown no signals for motor neuropathy. The COVID-19 IND for Novavax's COVID-19 vaccine is not affected by this clinical hold.
Novavax, Inc. (Nasdaq: NVAX) ha annunciato che la FDA degli Stati Uniti ha imposto un fermo clinico sulla sua domanda di Nuovo Farmaco Sperimentale (IND) per i candidati vaccinali COVID-19-Influenza Combinati (CIC) e per il vaccino antinfluenzale autonomo. Il fermo è dovuto a una segnalazione spontanea di un grave evento avverso (SAE) di neuropatia motoria in un singolo partecipante alla fase 2 dello studio CIC al di fuori degli Stati Uniti, che ha ricevuto il vaccino a gennaio 2023.
Il partecipante ha segnalato il SAE nel settembre 2024, dopo che lo studio si è concluso a luglio 2023. Novavax sta collaborando con la FDA per fornire le informazioni necessarie e risolvere il fermo clinico. Il Chief Medical Officer della compagnia, Robert Walker, MD, ha sottolineato che la sicurezza è la loro massima priorità e che non è stata stabilita una causalità per questo evento. I precedenti studi di Novavax su COVID-19 e influenza non hanno mostrato segnali di neuropatia motoria. L'IND per il vaccino COVID-19 di Novavax non è influenzato da questo fermo clinico.
Novavax, Inc. (Nasdaq: NVAX) anunció que la FDA de EE. UU. ha impuesto un detención clínica sobre su solicitud de Nuevo Medicamento en Investigación (IND) para los candidatos a vacunas Combinación COVID-19-Influenza (CIC) y vacuna contra la influenza independiente. La detención se debe a un informe espontáneo de un evento adverso grave (SAE) de neuropatía motora en un solo participante del ensayo de la fase 2 de CIC fuera de EE. UU. que recibió la vacuna en enero de 2023.
El participante reportó el SAE en septiembre de 2024, después de que el ensayo finalizara en julio de 2023. Novavax está trabajando con la FDA para proporcionar la información necesaria y resolver la detención clínica. El Director Médico de la empresa, Robert Walker, MD, subrayó que la seguridad es su máxima prioridad y que no se ha establecido una causalidad para este evento. Los ensayos previos de COVID-19 e influenza por Novavax no han mostrado señales de neuropatía motora. El IND para la vacuna COVID-19 de Novavax no se ve afectado por esta detención clínica.
Novavax, Inc. (Nasdaq: NVAX)는 미국 FDA가 COVID-19-인플루엔자 조합(CIC) 및 독립형 인플루엔자 백신 후보들에 대한 새로운 연구 약물(IND) 신청에 임상 보류를 명령했다고 발표했습니다. 이 보류는 2023년 1월에 백신을 받은 미국 외부의 단일 CIC 2상 시험 참가자에서 발생한 운동신경병증의 심각한 이상사례(SAE)에 대한 자발적인 보고 때문입니다.
참가자는 2023년 7월에 종료된 시험 후 2024년 9월에 SAE를 보고했습니다. Novavax는 FDA와 협력하여 필요한 정보를 제공하고 임상 보류를 해결하기 위해 노력하고 있습니다. 회사의 최고 의료 책임자인 Robert Walker, MD는 안전성이 그들의 최우선 과제임을 강조하며, 이 사건에 대한 인과관계는 밝혀지지 않았다고 말했습니다. Novavax의 이전 COVID-19 및 인플루엔자 시험에서는 운동신경병증에 대한 신호가 나타나지 않았습니다. Novavax의 COVID-19 백신에 대한 IND는 이 임상 보류의 영향을 받지 않습니다.
Novavax, Inc. (Nasdaq: NVAX) a annoncé que la FDA américaine a imposé un arrêt clinique sur sa demande de nouveau médicament expérimental (IND) pour les candidats vaccins COVID-19-Influenza Combiné (CIC) et vaccin contre l'influenza autonome. Cet arrêt est dû à un rapport spontané d'un événement indésirable grave (SAE) de neuropathie motrice chez un participant unique à l'essai de phase 2 CIC en dehors des États-Unis, qui a reçu le vaccin en janvier 2023.
Le participant a signalé le SAE en septembre 2024, après que l'essai se soit terminé en juillet 2023. Novavax collabore avec la FDA pour fournir les informations nécessaires et résoudre l'arrêt clinique. Le médecin-chef de l'entreprise, Robert Walker, MD, a souligné que la sécurité est leur priorité absolue et qu'aucune causalité n'a été établie pour cet événement. Les études antérieures de Novavax sur COVID-19 et la grippe n'ont montré aucun signe de neuropathie motrice. La demande IND pour le vaccin COVID-19 de Novavax n'est pas affectée par cet arrêt clinique.
Novavax, Inc. (Nasdaq: NVAX) gab bekannt, dass die US-FDA eine klinische Aussetzung für den Antrag auf ein Neues Arzneimittel (IND) für die COVID-19-Influenza-Kombination (CIC) und eigenständige Influenza-Impfstoffkandidaten verhängt hat. Die Aussetzung erfolgt aufgrund eines spontanen Berichts über ein schwerwiegendes unerwünschtes Ereignis (SAE) einer motorischen Neuropathie bei einem einzelnen CIC-Teilnehmer der Phase 2 außerhalb der USA, der den Impfstoff im Januar 2023 erhalten hat.
Der Teilnehmer berichtete von dem SAE im September 2024, nachdem die Studie im Juli 2023 abgeschlossen wurde. Novavax arbeitet mit der FDA zusammen, um die erforderlichen Informationen bereitzustellen und die klinische Aussetzung zu beheben. Der Chief Medical Officer des Unternehmens, Robert Walker, MD, betonte, dass Sicherheit ihre oberste Priorität sei und dass eine Ursächlichkeit für dieses Ereignis nicht festgestellt wurde. Frühere COVID-19- und Influenza-Studien von Novavax zeigten keine Hinweise auf motorische Neuropathie. Der IND-Antrag für den COVID-19-Impfstoff von Novavax ist von dieser klinischen Aussetzung nicht betroffen.
- Novavax's COVID-19 vaccine IND is not impacted by the clinical hold
- Previous COVID-19 and influenza trials showed no signals for motor neuropathy
- FDA placed a clinical hold on Novavax's CIC and stand-alone influenza vaccine candidates
- Serious adverse event of motor neuropathy reported in a Phase 2 trial participant
- Potential delay in starting Phase 3 trial for CIC and influenza vaccines
Insights
The FDA's clinical hold on Novavax's COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates is a significant setback for the company's pipeline development. This delay in the Phase 3 trial could impact Novavax's competitive position in the evolving vaccine market.
Key points to consider:
- The hold is due to a single case of motor neuropathy reported 9 months after trial completion, which may not establish causality.
- Previous trials showed no signals for motor neuropathy, suggesting this could be an isolated incident.
- The company's existing COVID-19 vaccine IND is not affected, which is important for ongoing operations.
For investors, this news introduces uncertainty regarding the timeline for Novavax's combination vaccine development. While the company is working to resolve the issue, the duration of the clinical hold is unknown, potentially delaying market entry and affecting future revenue projections.
This clinical hold presents a material risk to Novavax's near-term growth prospects. The company's market cap of
Financial implications to consider:
- Potential delays in revenue diversification from the combination vaccine program
- Increased R&D expenses to address FDA concerns
- Possible impact on partnership negotiations and future funding opportunities
While the standalone COVID-19 vaccine remains unaffected, the combination vaccine was seen as a key differentiator in a crowded market. Investors should monitor the company's cash position and burn rate, as prolonged delays could necessitate additional capital raising. The stock price may experience volatility as the market reassesses the risk profile and timeline for Novavax's pipeline development.
"We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold," said Robert Walker, MD, Chief Medical Officer, Novavax. "It is important to note that safety is our top priority, and while we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA. Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible."
Data from Novavax's previous COVID-19 and influenza trials have shown no signals for motor neuropathy. Investigators have been informed of this action. The COVID-19 IND for Novavax's COVID-19 vaccine is not impacted by the clinical hold.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in
Forward-Looking Statements
Statements herein relating to the potential resolution of the clinical hold placed on Novavax's IND for its CIC and stand-alone influenza vaccine candidates and the timing of the initiation of the Phase 3 trial for Novavax's CIC and stand-alone influenza vaccine candidates are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.
FAQ
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