Estoy muy satisfecho con la postura que ha adoptado la compañía de cara a la FDA. Con hechos y no solo promesas, transmitiendo confianza y sin complejos, ASÍ, SI!!
Si quieres le echo un ojo y comento. Yo estuve recopilando información sobre la vacuna hace unos meses por si tenía que enviarla para que me permitieran usarla pero no hizo falta y ahora está un poco obsoleta, con la presentación del otro día y las estadísticas de uso en Asia y los efectos secundarios creo que no hace falta mucho más.
La clave es la presentación y los datos de protección frente a las variantes,en contraste a las mRNA que son más específicas y bajan los NAbs antes. Destacar que esta protección amplia bajará infecciones, hospitalizaciones y muertes y la necesidad de booster específicos cada poco tiempo con las mRNA. Con lo que las olas tendrán un impacto menor en la salud de los ciudadanos, en coste de la Sanidad y de las empresas que no tendrán tantas bajas.
También se pueden añadir algunos de los comentarios de los miembros de la VRBPAC que quedaron impresionados con los datos (con una breve bio para destacar sus credenciales).
"The most compelling thing that I've seen today is the data from Novavax, showing that their protein vaccine can elicit neutralizing antibodies to the prototype strain, to BA.1, BA.2, and BA.5," said Dr. James Hildreth, president and CEO of Meharry Medical College. "Their data seems more impressive to me than the data presented by either Pfizer or Moderna. I just wonder whether or not it might be timely for the agency to quickly review the data and make a decision to approve the Novavax vaccine."
Novavax Covid vaccine data impresses FDA committee experts, and outshines Moderna and Pfizer at the all-day FDA meeting to strategize the fall booster campaign
At the all-day meeting Tuesday of the FDA's expert committee on vaccines, Novavax was 1 of just 3 vaccine companies invited to participate. This participation included extensive presentations by each company. Novavax was given as much time as Moderna and Pfizer were.
Here is a link to the full Novavax presentation live-streamed on YouTube. This link is cued up to the exact start of the presentation: https://youtu.be/BFdzNUus_CE?t=11446In it, Novavax presented strong evidence that its current vaccine produces excellent cross-protection against all variants, including the new BA.5 variant that is taking over the US. Some experts said the Novavax vaccine data was the most impressive data of the three companies, while zero experts said the Moderna or Pfizer data was the most impressive.The data from Moderna and Pfizer was much weaker in comparison and showed that RNA vaccines have a very tough time protecting against new variants.
For example, Pfizer's BA.1 vaccine had dramatically lower immune responses against BA.5 than Pfizer's BA.4/5 vaccine had. So even though BA.5 is only a few months removed from BA.1, Pfizer's BA.1 vaccine already has trouble with it. Moderna's BA.1 vaccine also had major trouble with BA.5.It has become apparent that unless an RNA vaccine is matched almost exactly with the currently dominant variant, it usually doesn't offer good protection. The big problem with this is that usually a new variant becomes dominant every 3 to 5 months.The lag time between when a new variant is becoming dominant and when the RNA companies can master the manufacturing process, receive FDA approval, and roll the vaccine out is about 4 to 4 1/2 months.
This was covered in detail during the FDA meeting. For example, the BA.4/5 variants became dominant in South Africa in April, had spread in numerous countries in Europe and North America by early May and took over in much of the world by early June. They had become the primary variants in the US by late June.
At the meeting Tuesday, Moderna said if they were told on June 28 that they needed to do a BA.5 vaccine (or BA.4/5 vaccine), it would take them 3 months to figure out the commercial scale manufacturing process and get it working fine. Then they'd submit the manufacturing data and other data to the FDA. After that, assuming a quick review and approval process, they'd be able to start rolling it out somewhere between the end of October and mid-November.That's 4 to 4 1/2 months.
Because BA.5 had become dominant in so many places in early June, Pfizer said it had already done a good amount of work on BA.5 manufacturing. Even with that, it said it would not be able to start delivering the vaccine until October, and FDA review and approval mean it could be mid-to-late October before it's rolled out. Start to finish, that's about 4 1/2 months. Put that 4 to 4 1/2 months timeline alongside new variants taking over every 3 to 5 months and it means: By the time the new vaccine rolls out, a new variant usually will have already taken over, or will take over within another month.
Most people won't even have gotten the booster in the first 4 weeks it's rolled out.To add to the problem further, it takes about one month for a person to reach peak antibodies after a booster dose. So even if a person gets an RNA booster dose in week 2 of the roll-out, by the time the immune response has heavily kicked in, most of the time a new variant will already be dominant. And the RNA vaccine won't be matched to it and will have subpar protection.By contrast, even though BA.5 is about two years removed from the Wuhan strain, the Novavax vaccine for Wuhan has very strong immune responses against BA.5. In a nutshell, the Novavax Wuhan vaccine is stronger against BA.5 than the Pfizer BA.1 vaccine is or the Moderna BA.1 vaccine. That's a very impressive feat.
The Novavax vaccine also has strong immune responses for BA.1, BA.2 and other prior variants. During the Novavax presentation, Dr. Gregory Glenn said the data indicates the Novavax vaccine is "universal-like." Furthermore, trials proved that it had very high efficacy against the Wuhan, Alpha and Delta strains and a few of the shorter-lived variants like Iota.A few prominent experts on the committee said they were very impressed by the Novavax vaccine and evidence. Two of them flat-out said the Novavax data was stronger than the RNA data. Here is a quote during the meeting from committee member Dr. James Hildreth, who is an expert in immunology and also president of Meharry Medical College in Nashville:
“The most compelling thing that I’ve seen today is the data from Novavax, showing that their protein vaccine can elicit neutralizing antibodies to the prototype strain, to BA.1, BA.2, and BA.5.
Their data seems more impressive to me than the data presented by either Pfizer or Moderna. I just wonder whether or not it might be timely for the agency to quickly review the data and make a decision to approve the Novavax vaccine.
… and there are tens of millions of people who have not been vaccinated, many of whom would accept a protein vaccine who would not otherwise accept an RNA vaccine.
So to me, I think that it’s very compelling that we move forward on the Novavax vaccine for all of those reasons.
And again I want to say the most impressive data that I saw today was presented by Dr. Glenn from Novavax.
These comments weren't made just after the morning Novavax presentation, but rather near the end of the day during the period to discuss overall FDA strategy. Here is the point in the video where he begins speaking, and a half-minute in the quotes above start:
During the same discussion, Dr. Wayne Marasco, professor of medicine at Harvard Medical School and founder of the National Foundation of Cancer Research (NFCR) Center for Therapeutic Antibody Engineering (CTAE), also praised the Novavax vaccine. Marasco is one of the top people in the country on infectious diseases. In addition to the things above, he founded and runs an important research and development lab in the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute.
The Marasco Lab focuses on areas such as targeted immunotherapy and the treatment of emerging infectious diseases including SARS, highly pathogenic H5N1 avian influenza (bird flu), West Nile Virus (encephalitis) and Denge virus, as well as HIV/AIDS and cancer. His lab has made important breakthroughs that you can read a summary of here: https://hsci.harvard.edu/people/wayne-marasco-md-phd
He is also professor of Cancer, Immunology, and Virology at the Dana-Farber Cancer Institute and supervises fellows and residents in the Division of Infectious Diseases at Brigham and Women's Hospital. Dana-Farber is the 37th largest nonprofit in the US and receives funding from the National Institute of Allergy and Infectious Diseases. Its annual budget of about $2 billion allows it to hire some of the best people from around the world, including Dr. Marasco. This is what he said at the meeting:
"So, I don’t know if the rest of the committee is as impressed by this data as I was, but the Novavax data was pretty significant in that the ancestral strain in their formulation was able to give pretty good protection against Omicron 5 (BA.5) and they also showed in their cartography work that the antigenic distance had been lessened with that booster. So that essentially means that the antigen itself, presented properly in an adjuvanted protein form, is able to produce antibodies that have that broader capability.
And I am wondering after seeing this data, if we are not witnessing some of the limitation that there may be with the mRNA vaccines. Yes, they were first out of the gate, but they don’t appear to be able to have that kind of, um, breadth of protection.
Dr. Marasco was so impressed by the Novavax vaccine that he brought it up again at the end of the day. Here's part of what he said. Note that the only data presented during the day that wasn't RNA was Novavax, so that's what he is talking about here:
"But I will say that I was pretty interested today that we can do better, and I am not sure that the mRNA vaccines as they have presented so far, are giving us the best kind of immunity that we can get here. So I think this is a step in the right direction, but we have to reevaluate this as we move forward, because I think there’s something to be said about a trans-presentation versus a cis, and I mean that antibodies elicited to be able to bridge more than one variant ....
Also during the meeting, committee member Hayley Altman-Gans, an expert in infectious disease and professor at Stanford University Medical Center, said: "I would agree that the data presented from our colleagues at Novavax was very impressive …" She also talked about the benefit of having people who have received RNA doses get the Novavax vaccine.
At the end of the day in the final comments, she said she felt compelled to again talk about having RNA recipients get the Novavax vaccine in order to broaden their protection:
"Hopefully as sort of the process moves forward and maybe we have a third vaccine option, well actually a fourth at this point, vaccine option for us with Novavax, that we really ought to consider mix and-match as we have in the past. I brought that up earlier, but I thought I should bring it up again because it really does broaden our ability to get to these Omicron and the BA4/BA5, which are starting to take over faster, then that might be an option to bridge us."
Other experts spoke positively about the Novavax vaccine and data during the meeting. To see the information, we recommend watching Novavax's presentation to the expert committee and the positive discussion that follows. Here is a link to a copy of the YouTube live stream of the meeting cued up to the exact start of the Novavax presentation: https://youtu.be/BFdzNUus_CE?t=11446Please note that only some of the discussion and comments about Novavax came just after the presentation., which was in the morning. A lot of it came later in the day. The livestream above has the whole meeting.If you are a Novavax investor or thinking of becoming one, or are simply interested in vaccines or what's going on in the fight against Covid, the presentation is very worth seeing.Also, if you are ever going to forward a Novavax newsletter to friends, family or colleagues, today's newsletter is probably the one you should because the information above is seminal for both the company and the fight against Covid. The side effects data in the next story below is also important for the company and the general public, who prefer lower side effects.To receive a daily Novavax news and information newsletter for free that contains updates similar to the one above, sign up here: novavaxinformation.com. This website and newsletter are not owned by or affiliated with Novavax Inc. in any way.
Sobre el tema mRNA, de la presentación de Pfizer, no solo es que los NAbs bajen rápido, es la amplitud de respuesta, su vacuna de la variante BA.1 lo hace peor frente a BA.5 que la original!!!
(estudio en ratones y todo lo favorable que PFE ha podido hacerlo)
La protección con la original frente a Omicron evade muy rápido:
Evidencia de que es una protección muy específica. En ratones, pseudovirus, medida a 1 mes.
La tercera dosis de la original, mucha menos respuesta frente a BA.1 (menos frente a BA.5). La tercera dosis BA.1, mucha menos respuesta frente original, más para BA.1 (pero menos que frente original) y un poco mejor frente a BA.5 que la original pero tampoco por mucho La tercera dosis de la bivalente original/BA.1, mantienen original, mejor respuesta a BA.1 y algo mejor a BA.5 pero lejos de la respuesta de la original frente a original (que eran casi 54000 y la medición para BA.5 con la bivalente es 1500...).
Que enorme trabajo Investing, lastima que no lo aliñes con algo de AT. ;)
Pongo mi parte, en mensual. No los comento, está todo en los gráficos por si queréis mirarlos, tan solo decir que el estocástico se cruzó, y he puesto líneas para que se vea que pasó cada vez que lo ha hecho. Ah, y una cosa más, se avisó en ambas elipses dibujadas.
No puestos niveles fibo para no liarlo más, pero coincide el 23,60 con la zona marcada.
Paciencia.
Es difícil tenerla, pero trae muy buenos resultados.....
Una última observación, ha pasado lo que comenté hace un par de meses que sería lo más postivo:
Creo que como dije lo que más podría ayudar a la acción y la vacuna es una adcom positiva en la que se reflejara la seguridad y eficacia ante variantes. Sería maravilloso que además siguiendo algún comentario reciente contrastaran con la poca duración de la protección actual con las mRNA.
Pues eso está pasando. No sé cuánta gente se habrá enterado, pero bastantes más que antes. Estaba todo el mundo que tiene peso en este tema mirando la VRBPAC. Y es lo que se ha reflejado en el precio y en la decisión de la FDA (de momento) de obligar a usar bivalente con BA.5 a las mRNA. La plataforma que ha prestado la FDA es gracias a que confía en la vacuna, no a que esté en contra de ella (a pesar de los favoritismos).
#26138
Re: Novavax (NVAX): Un Nuevo Comienzo
¿ Qué escenario manejas en cuanto a ingresos, cuota de mercado y valoración de la compañía después de este acontecimiento? ¿Podremos verlo reflejado en nuevos pedidos o ampliación de los mismos como en el caso de la UE?
Te veo optimista y eso me reconforta…
En mi opinión tenemos por delante 4-5 semanas clave para ver de qué forma la cotización finalmente se estabiliza en niveles superiores o bien cae de los actuales. La aprobación de la FDA, un Q2 que sitúe ingresos => 1.1B, recomendación booster en nuevos mercados, la inclusión de COVOVAX en el plan nacional de vacunación y resultados Malaria nos podrían llevar cerca de esas ansiadas 3 cifras y que supondrían capitalizar en menos de 9B, lo que equivaldría a un múltiplo de 2 veces ingresos. Ojalá lleguen nuevos pedidos, es lo que moverá con fuerza la cotización a niveles pasados.
Jon es una posibilidad y una figura tal como un HCH, solo pide que los hombros estén por debajo de la cabeza (por encima sus mínimos en caso de HCHi), dentro de eso, cualquier lugar.
Voy a hacer un ejercicio de especulación y te pongo un ejemplo, ni tiene que llegar o incluso ni quedarse ahí.
Pero si soy fiel a como los dibujo, ahora trazando líneas, ayer rompió resistencia, y bien pudiera entenderse como la rotura de la neckline, tal cual las trazo, y no habría lugar a bajada más que a una vuelta a esa línea, lo pongo:
Apuesto por esta segunda opción, ya ves lo que varía de trazar una línea de una manera a otra, y esa es precisamente la diferencia, no es el AT, es quien intenta manejarlo, como la interpretación personal de cualquier dato.
Paciencia.
Es difícil tenerla, pero trae muy buenos resultados.....
Complicado decir. Pero si las agencias y gobiernos se basan en estos datos deberían ayudar a que se use, que llegue a la gente de a pie es más complicado, hace falta mucha difusión de la información y el público está muy cansado del tema. Pero como sabemos muy bien por aquí, el bicho tenía poca pinta de desaparecer y por mucho que se trate de ignorarlo, aunque parezca un método infalible, pues no sirve de nada.
Mucha gente pasará de vacunarse, especialmente menores de 60 o así. Porque pensarán que para qué me voy a poner un booster de BA.5 (o lo que toque) 3 meses después de pillarlo. Porque las vacunas actuales no te protegen de infección más que una ventana pequeña tras la dosis, así que para cuando salgan la mayoría se habrá contagiado ya. Es aquí donde debería entrar NVAX y explicar esto hasta la saciedad con sus gráficas y las de mRNA para que la gente se diera cuenta que es la mejor solución (obviamente por confirmar muchos de estos datos cómo se traducen en un entorno real, pero tienen muy buena pinta).
Pero es lo de siempre, un mínimo hay garantizado mientras el bicho siga y no haya complicaciones mayores, por eso en los $40 era un precio con bastante buena rentabilidad/riesgo como comenté. El rango por arriba dependerá de los pedidos futuros, que son muy complicados de predecir. Más cuando PFE tiene tantas dosis comprometidas este año y el que viene en USA y EU.
Yo voy tradeando y gestionando el riesgo conforme salen noticias. Añadí algo más ayer en $54 y puede que aumente a principio de semana si se deja. Los gráficos pintan muy bien y el EUA en USA parece que no está lejos. Si no pasa nada imagino que habrá cierta subida hasta la ER, que es donde tenía planeado llevar de nuevo una posición más grande porque las cifras eran cuando mejor iban a ser. Como siempre, mi posición es la mayor de mi cartera pero es bastante pequeña comparado con la mayoría por aquí y con lo que llevaba el año pasado (4-8 veces menos dependiendo de los trades), así que cada uno evalúe su riesgo dependiendo de su situación...
#26142
Re: Novavax (NVAX): Un Nuevo Comienzo
Muchas gracias!entendido. Veremos que entrada conseguimos. La posicion gorda la mantengo intacta y ahi seguira. Con esta entrada la idea seria intentar subirme a la posible ola para mantenerne en ella un tiempo finito goloso.
Ojo que este invierno va a ser jodido. Es evidente que hace falta NVAX. Debería, en este punto, ser la vacuna de referencia. Haría falta que Stan se reuniera con la EMA y les pasase la presentación de la FDA. Y una reunión con alguna autoridad China no estaría mal
#26144
Re: Novavax (NVAX): Un Nuevo Comienzo
Llegados a este punto, estaría muy incómodo yendo a corto. Desde el punto de vista bursátil en general queda un evento que nos podría hacer retroceder como al resto del mercado y es una subida de tipos del 0'75 en julio frente al 0'5 esperado. Pero salvando eso, creo y digo bien alto creo (porque esto es NVAX y siempre hay un cisne negro) que pocos sustos nos quedan
#26145
Re: Novavax (NVAX): Un Nuevo Comienzo
Por otra parte, a nivel de mercado, es necesario que NVAX no descuide oriente y Europa que son sus grandes clientes. Deberían empezar a hacer marketing potente. Ojo que en octubre los tenemos en Barcelona
