En el otro extremo tenemos a Pfizer y Moderna. Presentaron en junio. Por ejemplo en los resultados de Moderna podemos ver lo siguiente:
COVID-19
The Company presented clinical data at the June VRBPAC meeting demonstrating potent neutralization and cross-reactivity with its monovalent XBB.1.5 vaccine, mRNA-1273.815. Similar neutralization was seen for XBB.1.5, XBB.1.16, and XBB.2.3.2 sub-variants. Following the FDA's recommendation for a monovalent SARS-CoV-2 XBB lineage vaccine, which aligns with other regulators and global public health agencies, Moderna has submitted its updated COVID-19 vaccine to regulators globally for approval or authorization and is ready for fall vaccination season with ample and timely supply.
Moderna ha presentado su vacuna COVID-19 actualizada a los reguladores de todo el mundo para su aprobación o autorización y está lista para la temporada de vacunación de otoño con un suministro amplio y oportuno.
No dicen que tienen la intención ni de presentar ni de vender. Dicen que lo han presentado y que ya están listos para vender.
RSV
Moderna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.
The regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations. No cases of Guillain-Barre Syndrome (GBS) had been reported with mRNA-1345 in the Phase 3 RSV trial as of the April 30 th cutoff date.
Ya tienen la RSV lista esperando autorización de mercado.
Flu
Enrollment has been successfully completed in the Company's Phase 3 immunogenicity trial (P303) for an enhanced formulation of mRNA-1010. This updated formulation is anticipated to generate an improved immune response to influenza B strains and is intended to enable licensure of mRNA-1010 through accelerated approval. The Company expects to share an update on P303 in the third quarter of 2023.
Y con la gripe actualizarán en Q3 como ha ido la fase 3. Y posiblemente tendrán aprobación acelerada.
No veo nada del combo. ¿Se lo dejarán a NVAX?