Unveiling of “Warp Speed”, America’s First White House Effort for a Coronavirus Vaccine | Science

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AP Photo / Ted S. Warren

By Jon Cohen

Sciences COVID-19 reports are supported by the Pulitzer Center.

Conventional wisdom is that a vaccine for COVID-19 is at least 1 year away, but the organizers of a US government campaign called Operation Warp Speed ​​have little use for conventional wisdom. The project, vaguely described to date but likely to be officially announced by the White House in the coming days, will select a diverse set of candidate vaccines and pour essentially unlimited resources into unprecedented comparative studies on animals, human trials accelerated and manufacturing. Avoiding international cooperation – and any Chinese candidate vaccine – he hopes to have 300 million doses by January 2021 of a proven product, reserved for the Americans.

These details and more, set out for Science by a government official involved in Warp Speed, disrupted some vaccine scientists and public health experts. They are skeptical of the timing and hope that Warp Speed ​​will complement, rather than compete with, the ongoing COVID-19 vaccination efforts, including that announced last month by the National Institutes of Health (NIH). “Duplication only provokes internal struggles and slows people down,” says Nicole Lurie, former United States Assistant Secretary for Preparation and Response, who advises the Coalition for Epidemic Preparedness Innovations (CEPI) a nonprofit that helps coordinate the efforts of the COVID-19 vaccine. “The United States and others around the world should participate in this competition against the virus and not against each other.

Warp Speed, first revealed by Bloomberg News on April 29, has so far only been described. President Donald Trump briefly discussed the initiative the next day, saying, “We will speed up the process like you have never seen before.” According to a CNN May 1 report, that the source who spoke with Science Warp Speed ​​intends to deliver the first 100 million doses of a vaccine in November and another 200 million over the next 2 months.

An extraordinary 110 COVID-19 vaccines are under development, and eight candidates – four from Chinese companies – have participated in small human trials, according to a May 11 update from the World Health Organization ( WHO). But there is less than appears in many efforts, says a veteran of the vaccine who asked not to be named. “Half of them are businesses that have three guys, an administrative assistant and a dog. “

The idea for Warp Speed ​​was born in early April, says the official, a scientist, who was allowed to discuss it with Science if his name has not been used. “By looking around, it became clear that without a truly heroic effort, none of the existing efforts to produce the vaccine was going to lead us to have a vaccine to prevent what is increasingly looking like a second wave that could sweep in October, November, “he said. Warp Speed ​​will have three separate “virtual teams” for development, supply, manufacturing and distribution, led by a “core team” of a few dozen experts from government, industry and academia.

Warp Speed ​​has already reduced its vaccine candidate list to 14 and plans to go ahead with eight candidates, the official said. “The idea for us is to choose a diverse portfolio” of vaccines made with different technologies or platforms. Organizers were concerned that other government investments in vaccines were “heavily weighted” in favor of only two candidates: one made with messenger RNA encoding the surface “spike” protein of the coronavirus and the other using a cold-causing adenovirus to deliver the same protein gene. None of these technologies, according to official notes, have yet resulted in vaccines approved for any disease.

The official declined to identify the Warp Speed ​​vaccine candidates, but highlighted two key criteria: safety and the ability to make hundreds of millions of doses quickly. “We don’t have time to debug manufacturing issues here,” he said. By July, Warp Speed ​​hopes that its eight main candidates will be tested on humans. At the same time, it will fund a large-scale comparison of their safety and effectiveness in hamsters and monkeys to help defeat this group. “If something is really bad, we will get rid of it,” he says.

In addition to the trials, the project will lay the groundwork for “intensive manufacturing” of four different vaccines. More than one may prove worthy and several options protect against incidents of contamination and other supply issues.

Although Warp Speed ​​does not rule out any type of vaccine, it will not consider those made in China, such as the inactivated virus vaccine recently demonstrated to protect monkeys from coronavirus, a first. “We cannot partner with Chinese companies,” said the official. “It’s just not going to happen. The decision was “above my salary,” he adds. But the vaccines chosen could be made by a company outside of the United States. (White House trade advisor Peter Navarro, in a February memorandum to the Coronavirus Task Force, defended a “Manhattan project” for COVID-19 vaccines that would prioritize companies based in the United States. )

The primary purpose of Warp Speed ​​is to protect the United States. “The attitude here is the approach to the oxygen mask,” said the official. “First we want to put on our oxygen mask, and then we are going to help the people around us.” Warp Speed, he said, plans to “spread information freely” to other countries and share manufacturing technologies, and that could add up to more doses for the world.

Many scientists and organizations have argued, however, that any proven COVID-19 vaccine should be accessible and affordable for everyone around the world at the same time. WHO and other groups formed the COVID-19 tool accelerator on April 24 which aims to accelerate the development of diagnostics, therapies and vaccines, and to guarantee “equitable global access” safe, quality, effective and affordable products. ” The European Commission, in turn, organized a fundraiser on May 4, the Coronavirus Global Response, during which world leaders from many countries and some philanthropists pledged $ 8 billion; the United States did not participate. CEPI and another non-profit group, GAVI, the Vaccine Alliance, will oversee the vaccination campaign. “This is a global problem and it needs a global solution,” said Seth Berkley, who runs GAVI.

Berkley supports Warp Speed’s plan to screen the many candidates, but he calls this a short-sighted mistake to exclude Chinese products, “given that they are two months ahead of schedule.” The Bill & Melinda Gates Foundation is closely monitoring “about fifteen” vaccine candidates, including those from China, and will support the most promising, adds Emilio Emini, a former vaccine developer now with the foundation. “You have to have a global portfolio so you don’t put all of your chips on one part of the roulette table,” he says.

The WHO has yet another ambitious COVID-19 vaccine project, the Solidarity Trial, which plans to compare candidates in human studies. This effort is led by Andrew Witty, former CEO of GlaxoSmithKline, a leading vaccine manufacturer. WHO chief executive Tedros Adhanom Ghebreyesus said on Monday that the group hoped to accelerate seven or eight candidate vaccine candidates. What will happen with production and supply if one of these other groups and Warp Speed ​​selects the same vaccine to prioritize is unknown.

Warp Speed’s relationship to NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative is unclear. Project plans to coordinate clinical trials of multiple COVID-19 vaccines and use institutional review committees, safety monitors and common protocols, say NIH director Francis Collins and co-authors in published comment online on May 11 by Science. ACTIV is also considering controversial human “challenge” studies that would speed up the evaluation of a vaccine by immunizing healthy people and deliberately infecting them with the new coronavirus or a weakened form of it.

Asked about the NIH effort, the Warp Speed ​​official said there was “no conflict at all – they work together – an intellectually (ACTIV) and an operationally (Warp Speed)”. But several scientists on the ACTIV vaccine subcommittee say they know little about the speed of distortion. And a member, Peter Hotez of the Baylor College of Medicine, worries about both his name and his schedule, noting that the anti-vaccine movement maintains that products are often rushed to the market without adequate testing. “Some of the language from the White House is very damaging,” said Hotez, who is part of a team making a candidate for the COVID-19 vaccine. As for the delivery of 300 million doses in January, “I don’t see a way by which you can collect enough efficacy and safety data by the end of the year. “

Kathryn Edwards, a vaccine specialist at Vanderbilt University who also participates in ACTIV, notes that efficacy trials, which will ideally track symptomatic disease in areas of high transmission, also face complex logistical problems given that many people will only have mild cases of COVID. -19 or have no idea they are infected.

The official recognizes that Warp Speed ​​is aiming high. “I know there is a reasonable probability that we will fail,” he said. “And if we fail, I want to make sure that we have studied all of the different possible paths we could have taken. “

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