1. No entiendo por qué tanto escándalo por el booster de USA.
Ya dijo la propia NOVAVAX en la earning call que no iban a usarse en USA este año, ese mercado olvidado completamente. Lo dijeron ellos bien claro. Parece que se le ha olvidado a todo el mundo en todos los foros. Ni mercado en USA ni mercado COVAX en 2022. Fueron palabras textuales.
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
2. Estos son 3 puntos muy claros. No leais lo que no está escrito ni lo que queráis leer:
to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine
Lo dice bien claro el primer booster para aquellos que tengan 2 dosis (que es primary vaccination).
for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate
Para aquellos que la bivalente de Pfizer o Moderna no sea accesible o no apropiada por temas clínicos. Es decir, para aquellos que les haya sentado mal las mRNAs = casi nadie
and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
Para aquellos que la elijan = casi nadie porque todo el mundo hace lo que le dicen.
Ya se encargó hace poco la administración Biden de hacer una compra de millones de dosis de Pfizer y Moderna antes de finalizar la emergencia por covid. Por tanto no hay intención ninguna de usar Novavax en USA en el corto/medio plazo.
Cuando se termine la emergencia será otra cosa.
3. Y el último punto del que nadie habla y yo lo considero el más importante y NO PARAN DE INCLUIRLO EN CASI TODAS LAS PRs:
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA
La vacuna de Novavax no está aprobada sino solamente para emergencia. A ver si tenemos esto CLARO porque cuando acabe la emergencia veremos a ver que pasa con Novavax si no la tiene aprobada y no la dejan vender. Esto haría fácilmente un -50% en la cotización simplemente para robar más a los inversores. Y Novavax no para de anunciarlo en las PRs.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Más de lo mismo, a menos que la aprueben para cuando termine la emergencia obviamente.
Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA)
Y la tercera vez que lo dicen en la misma PR.
