U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
Novavax announced that the FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the company to begin enrolling participants for the planned Phase 3 trial after determining that Novavax satisfactorily addressed all clinical hold issues. The hold, announced on October 16, 2024, was due to a serious adverse event reported in a participant who received the investigational CIC vaccine in a Phase 2 trial completed in 2023. The adverse event, initially reported as motor neuropathy, was later reclassified as amyotrophic lateral sclerosis, which is not associated with vaccination. Novavax plans to start the Phase 3 trial as soon as possible.
Novavax ha annunciato che la FDA ha revocato il blocco clinico sui suoi candidati vaccinali contro il COVID-19 e l'influenza (CIC), così come sul vaccino per l'influenza autonomo. La FDA ha autorizzato l'azienda a iniziare ad arruolare partecipanti per il pianificato Studio Fase 3, dopo aver stabilito che Novavax ha affrontato in modo soddisfacente tutte le problematiche sollevate dal blocco clinico. Il blocco, annunciato il 16 ottobre 2024, era dovuto a un evento avverso grave segnalato in un partecipante che aveva ricevuto il vaccino sperimentale CIC in un trial di Fase 2 completato nel 2023. L'evento avverso, inizialmente riportato come neuropatia motoria, è stato successivamente riclassificato come sclerosi laterale amiotrofica, che non è associata alla vaccinazione. Novavax prevede di avviare il trial di Fase 3 il prima possibile.
Novavax anunció que la FDA ha levantado la suspensión clínica sobre sus candidatos a vacunas contra el COVID-19 y la Influenza (CIC), así como la vacuna independiente contra la influenza. La FDA ha dado luz verde a la empresa para que comience a inscribir participantes para el planificado ensayo de Fase 3, después de determinar que Novavax abordó satisfactoriamente todas las cuestiones de la suspensión clínica. La suspensión, anunciada el 16 de octubre de 2024, se debió a un evento adverso grave reportado en un participante que recibió la vacuna experimental CIC en un ensayo de Fase 2 completado en 2023. El evento adverso, inicialmente reportado como neuropatía motora, fue más tarde reclasificado como esclerosis lateral amiotrófica, que no está asociada con la vacunación. Novavax planea comenzar el ensayo de Fase 3 lo antes posible.
노바백스는 FDA가 COVID-19-독감 복합 (CIC) 및 독립적인 독감 백신 후보에 대한 임상 보류를 해제했다고 발표했습니다. FDA는 노바백스가 모든 임상 보류 문제를 만족스럽게 해결했다고 판단한 후 계획된 3상 시험 참가자를 모집할 수 있도록 허가했습니다. 2024년 10월 16일에 발표된 이 보류는 2023년에 완료된 2상 시험에서 조사 중인 CIC 백신을 받은 참가자에게 보고된 심각한 부작용으로 인한 것입니다. 처음에는 운동 신경병증으로 보고된 부작용은 나중에 백신과 연관되지 않은 근위축성 측삭 경화증으로 재분류되었습니다. 노바백스는 가능한 한 빨리 3상 시험을 시작할 계획입니다.
Novavax a annoncé que la FDA a levé la suspension clinique de ses candidates vaccinales contre le COVID-19 et la grippe (CIC) ainsi que du vaccin indépendant contre la grippe. La FDA a donné son feu vert à l'entreprise pour commencer à recruter des participants pour l'essai de Phase 3 prévu après avoir déterminé que Novavax a satisfaisamment réglé tous les problèmes de la suspension clinique. La suspension, annoncée le 16 octobre 2024, était due à un événement indésirable sérieux signalé chez un participant ayant reçu le vaccin expérimental CIC lors d'un essai de Phase 2 terminé en 2023. L'événement indésirable, initialement signalé comme neuropathie motrice, a été reclassifié comme sclérose latérale amyotrophique, qui n'est pas associée à la vaccination. Novavax prévoit de commencer l'essai de Phase 3 dès que possible.
Novavax hat angekündigt, dass die FDA das klinische Halt auf die COVID-19-Influenza-Kombination (CIC) und die eigenständigen Influenza-Impfkandidaten aufgehoben hat. Die FDA hat dem Unternehmen die Genehmigung erteilt, mit der Rekrutierung von Teilnehmern für die geplante Phase 3-Studie zu beginnen, nachdem festgestellt wurde, dass Novavax alle klinischen Halt-Themen zufriedenstellend angesprochen hat. Der Halt, der am 16. Oktober 2024 angekündigt wurde, war auf ein schwerwiegendes unerwünschtes Ereignis zurückzuführen, das bei einem Teilnehmer gemeldet wurde, der den experimentellen CIC-Impfstoff in einer 2023 abgeschlossenen Phase-2-Studie erhalten hatte. Das unerwünschte Ereignis, das ursprünglich als motorische Neuropathie gemeldet wurde, wurde später als amyotrophe Lateralsklerose umklassifiziert, die nicht mit der Impfung in Verbindung steht. Novavax plant, die Phase-3-Studie so schnell wie möglich zu starten.
- FDA cleared Novavax to begin Phase 3 trial for COVID-19-Influenza Combination and stand-alone influenza vaccines.
- Novavax satisfactorily addressed all clinical hold issues.
- Clinical hold was due to a serious adverse event reported in a Phase 2 trial participant.
Insights
The FDA's removal of the clinical hold on Novavax's combination COVID-19-Influenza and standalone influenza vaccine trials represents a significant development. The hold was initially placed due to a single case of ALS in a Phase 2 participant, but further investigation determined the condition was not vaccine-related. This is particularly noteworthy as ALS is not typically associated with immune responses or vaccinations.
The clearance to proceed with Phase 3 trials is important for Novavax's pipeline development, especially given the competitive landscape in the combination vaccine market. The company's protein-based platform with Matrix-M adjuvant offers a different approach from mRNA-based competitors. The ability to resume the trial quickly will be essential for maintaining competitive positioning in the seasonal respiratory vaccine market, where timing is critical for annual vaccination cycles.
"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax. "The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible."
The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received investigational CIC vaccine in a Phase 2 trial that completed in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy. The additional information included a change in the event term to amytrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.
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 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, including the enrolment of trial participants; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of
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SOURCE Novavax, Inc.
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