Un usano ha subido a IV el texto del enlace que subí ayer sobre las palabras de Glenn acerca de la Operación Warp Speed.
Reports that the final shortlist of coronavirus vaccine candidates in Operation Warp Speed has been decided are premature, says US company Novavax Inc.–with a strong suggestion from the biotech’s R&D chief that his company is still very much in the running.
Operation Warp Speed, President Trump’s special project to accelerate the delivery of a coronavirus vaccine by late 2020, was launched on 15 May, with ex-industry vaccines veteran Moncef Slaoui chosen to spearhead the initiative.
The plan is for the US government to provide extra funding and support (including from agencies such as the Food and Drug Administration) for these chosen candidates so that one or more of them can provide hundreds of millions of vaccine doses to Americans as soon as possible, ideally by the end of 2020.
However, firms details on the project are in short supply, with speculation mounting about who will be on the shortlist of chosen candidates.
On 4 June the New York Times reported that the Warp Speed initiative had already unofficially selected five candidates: Moderna Inc.’s mRNA1273, AstraZeneca and Oxford University’s AZD1222, Pfizer Inc. and BioNTech’s BNT162, plus two candidates still in preclinical development, one from J&J and another from Merck & Co.
Notably absent from that list was Sanofi and GSK’s joint initiative, plus two candidates from US-based companies Inovio and Novavax.
As the New York Times report was neither confirmed nor denied by The White House, many assumed that these five companies did indeed represent the chosen projects.
But Novavax’s president of research and development Gregory Glenn has told Scrip that the matter is still far from decided.
“They have not officially announced anything, so people are writing articles and speculating. I don't think that story is complete, that's all I can say,” he said.
Novavax is a small biotech company specializing in recombinant protein nanoparticle vaccines, but has never brought one to market to date.
It was hit by a late-stage failure for its lead candidate in respiratory syncytial virus in 2019, but the company believes it is now on the cusp of an approvable product in its novel influenza vaccine candidate NanoFlu, as well as its COVID-19 candidate, NVX‑CoV2373.
The company’s technology is an update on the traditional protein-based vaccines technology, marrying this well-established approach with its proprietary nanoparticle platform and Matrix-M adjuvant, which boosts immune responses.
NVX‑CoV2373 entered Phase I/II trials in late May, putting it among the most advanced COVID-19 vaccine candidates.
Like other frontrunners, Novavax has been helped in its efforts to fast-track its vaccine by the international Coalition for Epidemic Preparedness Innovations (CEPI), which has funded it to a total of $388m, the biggest award to a single company so far.
On 4 June, Novavax announced that it had been awarded a $60m contract from the US Department of Defense, to deliver 10 million doses of its vaccine by the end of 2020.
Novavax says these awards were based on data from animal studies of NVX-CoV2373.
Glenn said these show it to be highly immunogenic in producing high titer levels of spike protein-specific antibodies, which block the binding of the spike protein to the receptor, and wild-type virus neutralizing antibodies.
The animal study data, which have yet to be published, show a “very, very strong” immunogenic response to the vaccine candidate, said Glenn.
“CEPI and the US government have seen all the data, and they're very impressed by the potential that our vaccine will work really well, because of the immune response we're eliciting in animals.”
The vote of confidence from the US Department of Defense suggests that Operation Warp Speed will have to seriously consider Novavax.
“They are not going to just bet on adenovectors and mRNA,” he said. “They're going to also, I think, bet on a more tried and true approach, even though [NVX-CoV2373] is new in the sense of a nanoparticle and an adjuvant, it is still close to what has traditionally been licensed.”
Novavax plans to power their Phase II trial to measure the vaccine's efficacy, which could allow its approval to be fast-tracked.
Aquí en castellano lo mas destacado y que esta en negrita en el texto en ingles.
“No han anunciado oficialmente nada, así que la gente está escribiendo artículos y especulando. No creo que la historia esté completa, eso es todo lo que puedo decir "
"CEPI y el gobierno de los Estados Unidos han visto todos los datos, y están muy impresionados por el potencial de que nuestra vacuna funcione realmente bien, debido a la respuesta inmune que provoca en los animales".
El voto de confianza del Departamento de Defensa de EE. UU. Sugiere que la Operación Warp Speed tendrá que considerar seriamente a Novavax. "No solo apostarán por adenovectores y ARNm", dijo. “Creo que también apostarán por un enfoque más probado y verdadero, a pesar de que [NVX-CoV2373] es nuevo en el sentido de una nanopartícula y un adyuvante, todavía está cerca de lo que tradicionalmente ha sido licenciado. "
Me encanta esa expresión de "eso es todo lo que puedo decir " y la enorme confianza que transmite Glenn cada vez que habla de todo lo relacionado con la vacuna del Covid19 de Novavax.
