El epidemiólogo de la Casa Blanca dijo que la pausa en los ensayos de la vacuna de Oxford “es desafortunada y deben investigarla”

Anthony Fauci también explicó que no es un evento inusual en un ensayo clínico y consideró que con suerte podrá resolverse para seguir adelante

El experto en enfermedades infecciosas Anthony Fauci dijo este miércoles que la decisión de AstraZeneca de hacer una pausa en los ensayos mundiales de su vacuna experimental contra el coronavirus fue desafortunada, pero no es una precaución de seguridad inusual en el proceso de desarrollo de una vacuna.

Fauci, director del Instituto Nacional de Alergia y Enfermedades Infecciosas de los Estados Unidos, añadió que esperaba que la compañía pudiera proceder con su ensayo.

“Este candidato en particular de la compañía AstraZeneca tuvo un evento adverso grave, lo que significa que se puso el resto de la inscripción de voluntarios individuales en espera hasta que se pueda averiguar con precisión lo que pasó”, explicó Fauci en una entrevista con el programa “This Morning”, de CBS.

El laboratorio anunció en la víspera que pausó voluntariamente los ensayos, incluidos los de la fase 3, después de registrar una enfermedad inexplicable en un participante. La detención permitirá que un comité independiente revise los datos de seguridad, un trabajo que se realizará con la agilidad posible para minimizar cualquier impacto potencial en la línea de tiempo del ensayo.

“Es realmente una de las válvulas de seguridad que se tienen en ensayos clínicos como este, así que es desafortunado que haya sucedido”, dijo Fauci. “Con suerte, lo resolverán y podrán proceder con el resto del ensayo, pero no lo sabes. Necesitan investigarlo más a fondo”.

La Organización Mundial de la Salud ha descrito la vacuna, que AstraZeneca está desarrollando con la Universidad de Oxford, como probablemente la principal candidata del mundo y la más avanzada en términos de desarrollo. El movimiento del martes fue visto como una disminución de las perspectivas de un pronto despliegue.

Por su parte, el ministro británico de Sanidad, Matt Hancock, admitió que esta interrupción es “obviamente un desafío para esta particular vacuna”, pero matizó: “En realidad no es la primera vez que esto le ha pasado a la vacuna de Oxford y es un proceso normal en los ensayos clínicos”.

AstraZeneca no ha facilitado información sobre el estado de salud del voluntario que ha enfermado, pero los medios destacaron este miércoles que se espera su recuperación.

La potencial vacuna, que dio resultados prometedores en los primeros ensayos, estaba siendo sometida a pruebas clínicas en el Reino Unido, Estados Unidos, Brasil y Sudáfrica. El mes pasado, los Gobiernos de Argentina y México, así como la fundación mexicana Slim, llegaron a un acuerdo con AstraZeneca y la Universidad de Oxford para fabricar la vacuna para sus países y distribuirla después al resto de América Latina, excepto Brasil.
(Con información de Reuters y EFE)

US infectious disease chief Dr Anthony Fauci

Anthony Fauci calls pausing of Oxford coronavirus vaccine trial ‘unfortunate’

White House adviser: ‘Hopefully, they’ll work it out’
Drug maker AstraZeneca reviewing safety data after illness

The White House coronavirus adviser Anthony Fauci said on Wednesday that AstraZeneca’s decision to pause global trials of its experimental coronavirus vaccine was “unfortunate” – but not an uncommon safety precaution in a vaccine development process.

The UK drugmaker AstraZeneca said on Tuesday it had voluntarily paused trials, including late-stage ones, after an unexplained illness in a participant.

The company said it was working to expedite a review of safety data by an independent committee to minimize any potential impact on the trial timeline.

“This particular candidate from the AstraZeneca company had a serious adverse event, which means you put the rest of the enrollment of individual volunteers on hold until you can work out precisely what went on,” Fauci, the director of the National Institute of Allergy and Infectious Diseases and the top public health expert on the coronavirus, said in an interview with CBS News on Wednesday morning.

“It’s really one of the safety valves that you have on clinical trials such as this, so it’s unfortunate that it happened,” Fauci added. “Hopefully, they’ll work it out and be able to proceed along with the remainder of the trial but you don’t know. They need to investigate it further.”

The vaccine, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization as probably the world’s leading candidate and the most advanced in terms of development.

Ashish Jha, dean of the Brown University school of public health said via Twitter that the significance of the interruption was unclear.

“We have no idea whether this is a big deal or not. Science is hard. This is why we have to let the trials play out. I remain optimistic we will have a vaccine found to be safe and effective in upcoming months,” he said, but cautioned: “Optimism isn’t evidence. Let’s let science drive this process.”

AstraZeneca’s announcement was seen as dimming prospects for an early rollout, which has become a political flashpoint in the presidential election.

On Monday, Donald Trump accused Democrats of “disparaging” for political gain a vaccine he repeatedly has said could be available before the 3 November election. “It’s so dangerous for our country, what they say, but the vaccine will be very safe and very effective,” he said.

Trump’s comments came after Kamala Harris, the Democrats’ vice-presidential candidate, said she “would not trust his word” on getting the vaccine. “I would trust the word of public health experts and scientists, but not Donald Trump,” Harris said.

The Democratic presidential candidate, Joe Biden, amplified Harris’s comments. Biden said Trump had said “so many things that aren’t true, I’m worried if we do have a really good vaccine, people are going to be reluctant to take it. So he’s undermining public confidence.”

On Tuesday, nine pharmaceutical companies issued a joint pledge that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted.

They vowed that any potential vaccine would be decided based on “large, high-quality clinical trials”. The companies said they would follow guidance from US regulatory agencies but did not rule out seeking emergency authorization.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.

The statements are broadly in line with Fauci’s position that a vaccine is unlikely to be ready by the presidential election, and put into further perspective action by the Centers for Disease Control and Prevention (CDC) last week in asking states to ready distribution facilities by 1 November.

At a health conference on Tuesday, Fauci said it was more likely that a vaccine would be ready by “the end of the year” as drug companies race to complete patient enrollment for late-stage trials. “It’s unlikely we’ll have a definitive answer” by 3 November, Fauci said.

Last week, Stephen Hahn, commissioner of the Food and Drug Administration, said the agency would not cut corners as it evaluates vaccines. But Hahn also told the Financial Times that it might be “appropriate” to approve a vaccine before clinical trials were complete if the benefits outweighed the risks. But the suspension of AstraZeneca’s trials places that position in greater doubt.

A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian on Tuesday the trial has been stopped to review the “potentially unexplained illness” in one of the participants.

The spokesman stressed that the adverse reaction was recorded in only a single participant and said pausing trials was common during vaccine development.

“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” the spokesman said.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.

“We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.” BY Edward Helmore and agencies