https://www.kxxv.com/news/national/...-year-but-his-own-experts-temper-expectations
Other
experts interviewed by ABC News have agreed with Bright, saying that developing a vaccine within a 12-month time frame could mean
throwing normal scientific standards out the window, but added that a vaccine could be available by the new year if everything goes perfectly.
https://wtop.com/coronavirus/2020/0...arp-speed-is-missing-tried-and-true-vaccines/
Saad Omer, a Yale University infectious disease
expert, said Operation Warp Speed needs to widen its portfolio to include the older technologies.
Trump’s bet on a vaccine could come at a cost
The danger of going all in on a vaccine may be that President Donald Trump is pinning hopes on a miracle shot while there's considerable reason to believe that the outbreak could stretch on for years.
But outside health
experts say that federal officials need to level with the public, a task complicated by Trump repeatedly vowing that the vaccine is imminent — perhaps arriving before Election Day.
"The perception of the vaccine politics is damaging," said a former Trump HHS administration official. "If they approve one quickly, people are going to be skeptical."
"The White House has consistently looked for magic solutions — hydroxychloroquine, remdesivir, now vaccines — but that's not how it works," added virologist
Peter Hotez, the dean of the National School of Tropical Medicine at Baylor University. "Our first Operation Warp Speed vaccines may only be partially protective and reduce severity of illness, which is important, but may not prevent disease or interrupt transmission."
Experts have called on the administration to focus more on this public-health guidance, especially given that vaccine development efforts could easily fall behind their aggressive timeline. "
If you think the vaccine is not going to be a solution for the U.S. in the next 18 months, there's still time to get this right," said Rajiv Shah, the president of the Rockefeller Foundation and the head of USAID during the Obama administration,
calling for a greater focus on public-health messaging. "There's so much potential to have positive impact right now, but it's not happening."
“Operation Warp Speed had a rocky start,” said one BARDA official, adding that staff inside the HHS biomedical arm have spent weeks confused over who was “calling the shots” for the new vaccine effort and what it meant for their existing work. The effort was further confused by HHS’ decision to bring in consultants from the Boston Consulting Group.
Concerns about political pressure over vaccines have been echoed by Elias Zerhouni, the former head of the National Institutes of Health and a finalist for the Operation Warp Speed role that went to Slaoui.
“It was really obvious to me that
what they wanted was a vaccine. That's it.
Deliver a vaccine by the end of the year,” Zerhouni told NPR on Monday. “There are political overtones to that, and I
said I don't think I'm the right person for that because I don't believe you can do vaccines independent of therapeutics.”
Borio, the former acting chief FDA scientist, said the vaccine sprint should pay off with significant progress toward an effective shot —
if not the full vaccine that Trump has sometimes suggested will be available before the election. "If I had to put money on this, I’d say we have some data and doses at the end of the year for a few of the candidates," she said, singling out a pair of vaccines being developed by Moderna and AstraZeneca.
But both vaccines rely on what's known as a gene-based approach, which Borio said raised a concern: the newer gene-based vaccines
don’t have the same track record of producing potent and durable immune response as traditional protein-based vaccines do.
The ‘hard slog’ of waiting for a coronavirus vaccine
"A vaccine is not a given," said
David Heymann, a professor of infectious disease epidemiology and distinguished fellow at Chatham House.
There are hundreds of vaccine candidates in development, but the vast majority will fail. Assuming one is successful,
it could take years to manufacture billions of doses for the entire globe.
With this in mind, “
waiting for a vaccine is a poor, poor exit strategy," Heymann argued.
Coronavirus: Trump says US reopening, 'vaccine or no vaccine'
Some health
experts have remained sceptical about the rapid timeline for development and distribution proposed by the White House.
"I don't understand how that happens," said
Dr Peter Hotez, co-director of the Medicine Coronavirus Vaccine Team at Baylor College, on CNN after Mr Trump's announcement.
"I don't see a path by which any vaccine is licensed for emergency use or otherwise till the third quarter of 2021," he added.
Dr Rick Bright, an ousted US vaccines director who has accused the White House of exerting political pressure around coronavirus treatments, testified to Congress on Thursday that
such vaccines often take up to a decade to develop.
Getting the facts right on Operation Warp Speed''
It should be emphasized that OWS was launched to almost universal skepticism and even scorn. At the time of OWS’s launch in Spring 2020, a strong consensus prevailed among media, public-health
experts, consultants, and betting markets that regulatory approval by the end of 2020 and the accelerated delivery of 300 million doses were
unrealistic goals. Consider some typical examples:
The June 6, 2020 issue of the medical journal
Lancet opined that “
on average, it takes 10 years to develop a vaccine. With the COVID-19 crisis looming, everyone is hoping that this time will be different. Although many infectious disease experts argue … even 18 months for a first vaccine is an incredibly aggressive schedule.”
The federal government’s top COVID advisor,
Dr. Anthony Fauci, joined the skeptics: In February 2020 and again in April 2020 he predicted that a y
ear to a year and a half would be required for vaccine approval — versus the half year that was actually required.
The media echoed general skepticism about OWS in the Spring of 2020.
Vanity Fair in its May 28, 2020 edition characterized OWS “as dangerous and likely to fail.” CNN complained that OWS neglected “tried and true” procedures for vaccine development in favor of new and untested methods. A
New York Times article dated April 30, 2020 somberly states: “
Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.”