WASHINGTON — A left-wing group warned Tuesday that the U.S. is fundamentally unprepared to manufacture and distribute hundreds of millions of doses of a Covid-19 vaccine when one becomes available, urging Congress to step up preparedness efforts and spend $40 billion to quickly increase manufacturing and distribution capacity.
In a 20-page report published by the Center for American Progress, two leading Democratic health policy figures called the current vaccine manufacturing setup “haphazard.” Potential shortages of vaccine-brewing equipment, cold storage, and other raw materials, they warned, could pose major bottlenecks to a fast rollout of a Covid-19 vaccine once one is approved.
“Even if we had a vaccine out on Jan. 1 or Feb. 1, that would delay substantially people actually getting it in their arms,” said Zeke Emanuel, a former health policy counselor to the Obama administration and an author of the new report. “Not because it’s not effective, but because we can’t actually put it into vials, we can’t ship it, we don’t have the personnel and the infrastructure to administer it to 300 million people.”
Emanuel and co-author Topher Spiro — a former Capitol Hill aide who played a significant role in crafting the Affordable Care Act in 2009 — say inefficient “fill-finish” capacity, in particular, could present a significant challenge. Companies have to package finished vaccine doses into vials and syringes, then prepare to ship them, all in a sterile environment and often at specific temperatures. But the CAP paper argues that it’s unclear whether companies involved in all aspects of vaccine production are prepared to leap in at anywhere near the scale required for widespread Covid-19 vaccinations.
Currently, leading drug companies have established independent contracts with a number of manufacturers around the world to scale up production of vaccines as they undergo testing and, potentially, gain approval. But the authors warned that many of those contracts rely on untested manufacturers or overlap with one another. The Maryland vaccine developer Novavax and the drug giant Johnson and Johnson, for instance, both hold manufacturing contracts with Emergent BioSolutions, a Maryland company.
The report’s release comes as the Trump administration has increasingly shifted its Covid-19 messaging to focus on the development of a vaccine. In May, the administration launched Operation Warp Speed, a federal initiative to develop, manufacture, and distribute 300 million doses of a Covid-19 vaccine by January 2021.
Even in the hours before the report’s release, Congress moved to meet several of the demands laid out in the CAP paper, at least in part. A bill unveiled last night by Senate Republicans includes $20 billion for vaccine initiatives at BARDA, the pandemic-response agency, as well as $6 billion for vaccine-distribution efforts — a substantial sum that nonetheless falls significantly short of Democrats’ demands.
On Monday, President Trump flew to North Carolina to tour Fujifilm Diosynth Biotechnologies, another manufacturer contracted to produce vaccines under development by Novavax. More broadly, the administration plans to shift its Covid-19 messaging strategy to highlight the potential for a fast vaccine approval, Axios reported Sunday.
Following Trump’s visit, the administration announced a separate effort to bolster vaccine production: a $265 million payment to reserve manufacturing capacity at a Texas facility run by Fujifilm Diosynth, which the CAP report singled out as potentially key to vaccine production efforts.
But the paper’s authors argue that even if drug manufacturers succeed in obtaining approval for a Covid-19 vaccine in record time, the administration, and the pharmaceutical and drug distribution industries more broadly, remain unprepared for what comes next.
“It’s very plausible that we could actually have an effective vaccine, and yet it might take a year and a half or two years for 300 million Americans to get to it because we haven’t planned properly and created the right kinds of infrastructure,” Emanuel said.
Among their most sobering observations: U.S. manufacturers and drug distributors typically produce roughly 663 million injection devices per year. If Americans require two doses of a vaccine to gain some immunity to Covid-19, that means that the industry would need to double its production in short order.
Similarly, they warned that the Centers for Disease Control and Prevention, which currently distributes roughly 75 million vaccine doses per year, will have to multiply that effort eightfold (though in emergencies, the CDC says it can scale up its vaccines-distribution capacity to 900 million doses annually).
Spiro and Emanuel urged the Trump administration to use the Defense Production Act, a wartime law that allows presidents to commandeer private-sector resources, to speed production. The report also stressed that it’s unclear whether drug companies would voluntarily allow competitors that successfully developed vaccines to use their excess manufacturing capacity, which could accelerate the process.
And even when the Food and Drug Administration first authorizes a vaccine, Spiro said, the government should be careful not to immediately devote all available manufacturing capacity to its production, in the event a more effective vaccine receives approval in the ensuing weeks or months.
“It may be the case that the most successful vaccine is not the first one that’s authorized,” Spiro said. “There does need to be an assessment based on science of whether freeing up of capacity should happen with the very first FDA-authorized vaccine or if it’s best to wait for one that might be more successful later.”