Yo estoy alcista en el valor, pero estoy empezando a mosquearme tal y como me pasó cuando no veía envíos de vacunas.
PR del 15 de Junio:
- Novavax preparada para entregar la XBB.
- Desarrollada la XBB y manufacturándose a escala comercial, OJO, "con la intención" de estar en el mercado en otoño. ¿Cómo que con la intención?
- Si se autoriza será la única no-mRNA XBB en USA. ¿Pero habéis pedido la autorización? ¿O la habéis pedido en secreto (cosa que dudo mucho)? Moderna y Pfizer la pidieron hace más de un mes y a la vez. ¿Cuál es el puto problema de pedir la autorización si en la PR ya decís que lo tenéis todo de puta madre? No lo entiendo.
Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall
- Novavax has developed a protein-based monovalent XBB.1.5 COVID vaccine candidate and is manufacturing at commercial scale with the intent to be in market during the fall vaccination campaign
- Novavax shared data demonstrating that its XBB.1.5 COVID vaccine candidate induces functional immune responses to XBB subvariants including XBB.1.5, XBB.1.16 and XBB.2.3
- If authorized, Novavax's protein-based vaccine candidate would be the only non-mRNA XBB.1.5 vaccine available in the U.S.
- Novavax intends to supply vaccine globally, consistent with FDA, WHO and EMA recommendations
GAITHERSBURG, Md., June 15, 2023 /
PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, participated in today's U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting, which resulted in a unanimous vote recommending updating the current COVID vaccine composition to a monovalent XBB-lineage.
"Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today's VRBPAC recommendation," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In partnership with regulators and public health authorities, Novavax has been developing and manufacturing this vaccine candidate, and now that we are nearing harmonization on guidance from the FDA, the World Health Organization and European Medicines Agency, we believe we are in a better position to offer an alternative vaccine choice for individuals worldwide."
Novavax presented data at the VRBPAC meeting that supports the recommendation to vaccinate this fall with a monovalent XBB strain. Novavax data showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.
Novavax will seek updated FDA labeling for its XBB COVID vaccine candidate with the goal of it being available and accessible on par with other COVID vaccines.
PR del 13 de Julio
El HHS les envía una carta a Pfizer, Moderna y Novavax pidiendo que tengan listo todo para la segunda parte de septiembre. Pues queda 1 mes y medio y yo no veo que hayan pedido la autorización. Ha pasado poco más de 1 mes y a Pfizer y Moderna todavía no le han dado suatutorización. Así que, que tarden un poco más, que no llegan...
"Novavax se compromete a seguir asociándose con el HHS y sus agencias para cumplir el objetivo compartido de proteger a las personas en riesgo de infección y reinfección por COVID y maximizar el acceso a las opciones de vacunas contra la COVID esta temporada de otoño".
"Novavax tiene la intención de entregar la vacuna XBB COVID basada en proteínas como se especifica en la carta del HHS de EE. UU. a los fabricantes de COVID"
Está muy bien COMPROMETERSE y tener INTENCIONES.
A mí ésto me huele a chamusquina hasta que no vea que piden autorización formal.
Novavax Intends to Deliver Protein-based XBB COVID Vaccine as Specified in U.S. HHS Letter to COVID Manufacturers
Today the U.S. Department of Health and Human Services (HHS) issued a
letter to COVID vaccine manufacturers, including Novavax, requesting that updated vaccines are ready for Food and Drug Administration (FDA) regulatory action and the Centers for Disease Control and Prevention (CDC) recommendations on vaccination by the latter part of September 2023. Novavax has developed an updated protein-based monovalent XBB.1.5 COVID vaccine candidate and is manufacturing at commercial scale with the intent to meet HHS’ September timeline, pending FDA regulatory action and CDC recommendations on vaccination.
“Upon authorization, Novavax's XBB.1.5 protein-based vaccine would be the only non-mRNA vaccine available in the U.S.,” said John C. Jacobs, President and Chief Executive Officer, Novavax. "Novavax is committed to continuing to partner with HHS and its agencies to meet the shared goal of protecting those at risk of COVID infection and re-infection and maximizing access to COVID vaccine options this fall season.”
In addition, Novavax is in discussions with HHS and leading pharmacy retailers regarding the “Bridge Access Program For COVID-19 Vaccines and Treatments” to provide access to Novavax’s protein-based vaccine option for adults in the U.S. without other sources of coverage. Novavax is committed to protecting consumers' vaccine options and will continue to work with HHS on program participation.
