White House names finalists for Operation Warp Speed — with 5 expected names and one notable omission
A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.
Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.
Paul HudsonNotably absent from that list is Sanofi. The French vaccine giant has worked with BARDA since the agency’s early days and received $30 million in funding earlier this year for its recombinant DNA Covid-19 vaccine effort. The omission comes after CEO Paul Hudson caused an intercontinental stir last month when he said that the US would get the “right to the largest pre-order” of their vaccine because the federal government had backed the project at-risk, although the company later walked back some of those comments.
A couple other much-hyped vaccine efforts were left out, including those from NovaVax and Inovio. Investors, who had sent their stocks cloud-bound during the pandemic, quickly took note of their exclusion, sinking shares 12% and 11%, respectively.
It’s possible, though, that other names may arise. Bloomberg reported late yesterday that the White House had selected 7 different candidates, although they were able to give only the names of the five that the Times reported.
A formal announcement is expected to be made later this month, the New York Times reported. A spokesperson for HHS, which oversees the vast bulk of the government’s vaccine and drug response, declined to comment.
The new winnowing appears to be part of the third phase of the project, which was formally announced in a press release on May 15. HHS said at the time that 14 different vaccine candidates had been selected out of the 100-plus in development but, with the exception of billionaire physician Patrick Soon-Shiong, none of the makers of those candidates said whether they were part of the project and neither did the government.
According to HHS, those 14 candidates would then be cut down to 8 different candidates and, finally, to 3-5 candidates that will proceed to “large-scale randomized trials.” These candidates are also those that, in partnership with the government, will go into large-scale manufacturing before they’ve been fully tested or authorized — a crucial step for assuring that when a vaccine is proven, it can also be rapidly deployed.
The companies will also likely get additional funding, the New York Times reported, on top of the roughly $2.2 billion already allocated between Moderna, J&J, and AstraZeneca. BARDA received $6.5 billion under the CARES Act, although that fund is not exclusively for vaccines.
The administration has not publicly set goalposts for the operation, but in late April Bloomberg quoted an official at 300 million doses by January and most statements have given a similar range. NIAID chief Anthony Fauci said on Tuesday “by the beginning of 2021 we hope to have a couple of hundred million doses.”
Ken Frazier Merck That timeline would be orders of magnitude faster than the ordinary pace of vaccine development, which can often take at least a decade, and some virologist and vaccine developers have questioned how attainable it is. That group includes Merck CEO Ken Frazier, who told FT that a 12-18 month timeline for a vaccine was “very aggressive” and “not something I would put out there that I would want to hold Merck to.”
Much of the work to reach that goal is already underway. AstraZeneca’s agreement with BARDA called for the company to provide 300 million doses to the US, starting in October, and Moderna signed an agreement with Swiss CMO Lonza to produce a billion doses per year, with the first batches coming in July.
The selected candidates cover at least three different technologies, including mRNA from Moderna and BioNTech and adenoviral vectors from J&J and AstraZeneca. Merck has two candidates, one that uses a vector called VSV and another that uses a measles virus vector. It was not clear which candidate was selected by the government, although the VSV one has already been backed by $38 million from BARDA and the agency put several hundred million dollars behind an Ebola vaccine from Merck that used the same platform.
The furthest along of the efforts are AstraZeneca and Moderna, both of which are now in Phase II. Fauci said in an interview with JAMA on Tuesday that Moderna could move into a global, 30,000-person Phase III trial next month.
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