White House announces America’s first “warp speed,” approaches to coronavirus vaccine | Science

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Along John CohenMay. 12, 2020, 17: 05

Science’■ The COVID-19 report is supported by the Pulitzer Center.

The conventional wisdom is that the vaccine for COVID-19 is at least a year ahead, but the organizers of the US Government operation “Operation Warp Speed” use little of their conventional wisdom. Vaguely described to date, but likely to be officially announced by the White House in the near future, the project selects a diverse set of vaccine candidates, unprecedented comparative studies in animals, rapid human trials, And pour essentially unlimited resources into manufacturing. Avoiding international cooperation, and vaccine candidates from China also want to administer 300 million doses of a certified product reserved for Americans by January 2021.

For those and other details, Science Some vaccine scientists and public health professionals are worried, according to government officials involved in warp speed. They are skeptical of the timeline and hoping that Warp Speed ​​will complement, rather than counter, ongoing COVID-19 vaccine efforts, including those announced by the National Institutes of Health last month (NIH). is. “Replication only leads to internal conflict and slowdowns for people,” says Nicole Lurie, a former US Deputy Secretary for Preparation and Response. “The United States and other countries around the world should take part in this race against the virus, not against each other.

Relating

The warp speed first revealed by Bloomberg News on April 29 has been reviewed so far. President Donald Trump the next day briefly described the initiative and said, “We’ll track it quickly, like we’ve never seen it before.” According to a CNN report on May 1, Science Warp Speed ​​confirmed that it will deliver the first 100 million vaccine doses in November, and another 200 million vaccine doses over the next two months.

According to a May 11 update from the World Health Organization (WHO), an amazing 110 COVID-19 vaccines are under development and eight candidates (four Chinese companies) have taken part in a small trial .. But the veteran of the vaccine, who asked not to name it, says that in many efforts, it is nothing short of eye-opening. “Half of them are companies with three men, a management assistant, and a dog.”

The idea of ​​warp speed was born in early April. Science If his name was not used. “In retrospect, without really heroic efforts, none of the existing efforts to produce vaccines look like a second wave that could emerge in October and November. We couldn’t bring a vaccine to prevent this. ” Warp Speed ​​has three independent “virtual teams” for development, supply, manufacturing and distribution, led by a “core team” of dozens of experts in government, industry and academia.

Warp Speed ​​has already narrowed the list of vaccine candidates to 14, and plans to move forward by 8, officials say. “Our idea is to choose a diverse portfolio of vaccines made with different technologies or platforms.” The organizers were concerned that other government vaccine investments were “weighted” to just two candidates. One was made with messenger RNA that encodes a “spike” protein on the surface of the coronavirus, and the other used a cold protein to deliver the gene for the same protein. Neither technology has yet reached an approved vaccine against any disease, according to official memos.

Authorities declined to identify warp speed vaccine candidates, but he emphasized two important criteria: safety and the potential for rapid delivery of hundreds of millions of doses. “We don’t have time to debug manufacturing issues here,” he says. By July, Warpspeed wants eight potential candidates to go to HR trial. At the same time, it will fund a large-scale comparison of their safety and efficacy in hamsters and monkeys, helping them to select their group. “If something really is bad, we get rid of it,” he says.

In parallel with the trial, the project will lay the foundation for a “strong manufacturing” of up to 4 different vaccines. It may turn out to be of multiple value and multiple options prevent pollution incidents and other supply problems.

Warpspeed does not exclude any kind of vaccine, but Chinese ones, such as the inactivated virus vaccine recently shown to protect monkeys from coronaviruses, are rarely considered. “We can’t partner with Chinese companies,” officials say. “It just doesn’t happen.” The decision “was above my salary level,” he added. However, the vaccine of choice may be made by a company that is not headquartered in the United States. (Peter Navarro, White House Trade Advisor, said in a February memo to the Coronavirus Task Force: “The Manhattan Project” for the COVID-19 Vaccine Companies based in the United States are preferred).

Warp Speed’s main goal is to protect the United States. “The attitude here is the oxygen mask approach,” officials say. “Because we want to wear an oxygen mask first, then we help the people around.” Warpspeed plans to “distribute information” to other countries and share manufacturing technology with the rest of the world. He said it could bring additional doses to the.

However, many scientists and organizations argue that the proven COVID-19 vaccine needs to be available and affordable to everyone around the world at the same time. WHO and other groups will accelerate diagnosis, treatment and vaccine development on April 24 to ensure fair and global access to “safe, high quality, effective and affordable” products We established the Access to COVID-19 Tools Accelerator for that purpose. On May 4, the European Commission organized a fundraising activity, the global response of Coronavirus. In the global response of the Coronavirus, leaders in many countries and some philanthropists have pledged $ 8 billion. The United States did not participate. CEPI and another non-profit group, GAVI (Vaccine Alliance), oversees the promotion of vaccines. “It’s a global problem and we need a global solution,” says Seth Berkley, head of GAVI.

While Berkeley supports a plan to select a large number of Warp Speed ​​candidates, “excluding Chinese products is a myopic error, given the fact that they are months away,” he said. say. The Bill & Melinda Gates Foundation will closely follow the “about 15” vaccine candidates, including those from China, and will support the most promising vaccine candidates. “We need a global portfolio so we don’t put all the chips on a part of the roulette table,” he says.

WHO is yet another ambitious COVID-19 vaccine project, Solidarity trial, It plans to compare candidates in human studies. The initiative is led by Andrew Witty, former CEO of GlaxoSmithKline, a major vaccine maker. On Monday, WHO Executive Director Tedros Adhanom Gebreyesus said There are 7 or 8 “top” vaccine candidates The group wants to accelerate. It is unclear what will happen to production and supply if we choose the same vaccine that Warp Speed ​​prioritizes with any of these other groups.

The relationship between warp speed and NIH initiative, COVID-19 therapeutic intervention and accelerated vaccine (ACTIV) remains unclear. The project plans to coordinate clinical trials of several COVID-19 vaccines and use general institutional review boards, safety monitors, and protocols. NIH Director Francisco Linds and co-authors explain in a commentary published online May 11th. Science.. ACTIV is also a controversial human “challenge” study that vaccinates healthy people and expedites vaccine evaluation by intentionally infecting new coronaviruses or attenuated forms of the virus. I am considering.

When asked about NIH’s efforts, a warp speed official said, “We are intelligently cooperating one by one in (ACTIV) and in operation (warp speed), and there is no contradiction at all.” But some scientists on the ACTIV Vaccine Subcommittee say they know little about warp speed. Also, one Peter Hotes member of Baylor College of Medicine is concerned about both the name and the timeline, and the product is often rushed to market without proper testing, the anti-vaccine movement points out. is doing. “Some of the languages ​​that come out of the White House are very harmful,” says Hotez, a member of the team that makes COVID-19 vaccine candidates. For 300 million doses in January, “I don’t know how to collect enough data on efficacy and safety by the end of the year.”

Katherine Edwards, a vaccination expert at Vanderbilt University and a member of ACTIV, says that efficacy tests that ideally track symptomatic disease in highly contagious areas have only mild cases of COVID. Because of that, they also face complex logistic problems-19 I’m not sure they are infected.

Authorities have acknowledged that they are aiming for higher warp speeds. “I know we can reasonably fail,” he says. “And if we fail, we want to make sure we’ve investigated all the different potential ways we could have been doing.”