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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.”

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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.

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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.”

  • I agree with those who recognize in the heavily partisan context of this piece, an attempt to discredit the very real, very serious facts the CAP report contains as well as the implications of those facts for public health and our economy. We’re suffering unimpeded spread of this virus and escalating unnecessary fatalities thanks to divisive politics dominating the management of a crisis that demands a united approach, predicated on scoence.

  • The point of this article – that there may be a vaccine but no way to mass produce it in short time – is a very legit concern. But the presentation of this point is offensively tainted, and thus dilutes the severity of the actual issue. If STAT news is supposed to be so deeply politically biased, then it should change its name.

  • It is difficult to imagine the Trump Administration actually doing an adequate level of pre-planning. Trump only responds to direct stimuli – and as he will have his ‘doses’ first, his level of concern for the rest of us will be limited.

  • Why does everyone talk about a vaccine as if it’s just a matter of when, and not if? There are mounting cases of people getting COVID-19 twice in short order. There are cases where the antibodies are gone, not reduced, gone, in a matter of months in people who survive. These do not bode well for vaccine development at all, let alone in a relatively short period of time. What am I missing here?

    • @Slack: It is normal for antibodies to drop after one is over with a virus attack. The current covid-19 antibody tests have their limits, because they can only test the antibody counts, but not the memory cells that produce them. But this doesn’t mean the new vaccines will not be effective. In fact, the memory cells, B cells and T cells (2 types of white blood cells) will continue to be present in the patients or vaccine receivers’ body for years. T-cells fight infected cells and tell other cells to fight. B-cells make antibodies that target specific germs. When one receives a vaccine shot, it induces the immune response and produces the antibodies, which then are recorded into the memory cells. When the real virus attacks, the memory cells will rise to the occasion again. As for the case of reinfection with covid-19, there is no scientific investigation to prove they are real. One plausible explanation is that they are actually one case extending into a long period of time. In the following link, Dr. Francis Collins, the director of NIH, introduced a research about people, who had been exposed to other types of coronavirus in the past, seem to be less susceptible to become severely ill with covid-19, due to the protection of existing memory T cells. https://directorsblog.nih.gov/tag/memory-t-cells/

    • @Lakeside Hermit: Thank you for your reply. As a lay person in this field it’s hard to know what to believe when you are drinking out of a proverbial fire hose. The major case I have read about with double exposure is from 13 sailors aboard the carrier USS Roosevelt. They tested positive, were removed from the ship, recovered, tested negative twice and returned to the ship, only to test positive again. There is also one other case at the Holyoke Soldier’s Home, news of which just broke a few days ago. These are troubling to say the least. Of course, with no national strategy on this matter, and any national action only making it worse, it may not matter very much in the end. These are dad times indeed for our country.

  • Sadly, one can almost guarantee that in addition to any true logistics issues that develop over the manufacture and distribution of any vaccine, the process will surely be politicized. We are no longer a nation of AMERICANS. We are a nation of conservatives and liberals and the latter is more likely to throw wrenches into the gears screaming about the distribution being politically motivated, racist in nature, ignoring the poorer sections of society, etc… I would much prefer if we abolished ALL political parties as that would allow us at least a chance to come back together as Americans. And yes, I view myself as an American not beholden to any political party.

    Until the majority of people take this approach politics will rear its ugly head, just as it did when criticism of the President was immediate when he tried to start closing off borders to keep Covid out of the USA. We have ourselves to blame for anything that goes wrong with this upcoming process because we have allowed the politicians to become the elite and put their tentacles into every aspect of our lives.

    On a positive note…..IF they took their jobs seriously….Most County / local Emergency Management Coordinators already have their people trained in the POD system (Point of Distribution) which will help greatly at the local level….

  • “Left-wing group” in the first four words of the story pretty much tells you everything you need to know about the veracity of the report and its likely bias.

  • We’re not vaccinating 300MM people. Pick your president, it does not matter. Its not happening. Never was. Never will. Aiming for a target of 300MM is a disservice because it isn’t realistic under any set of circumstances. Just like saying we’re vaccinating 7B people. It is simply not happening.

  • in my town one has to have a car to get tested. can’t sit in a waiting room; have to drive our own bubble. partner and i choose not to rape the earth mother for each tank of gas. we walk. I don’t plan to be tested or to be vaccinated because I haven’t been within six feet of anyone other than my partner in three years. The only times I leave the apartment are to go birding before breakfast three mornings a week and to do a curbside pickup of library books once a month.

  • do I really need to know every time a liberal group warns that something good might not happen or something bad might happen? Oh, they do have a suggestion. Good, not just blowing smoke. Use the Defense Production Act. Hmm. Let’s see. I do believe that President Trump and his admin are quite aware of that law and maybe have already mentioned it once or twice. Way to go. Waste of time and space, methinks. Both their warning and this article. So why did I read it? I hoped to learn something from it. Struck out.

  • “Liberal Group” in the headline, and “left-wing” in the text…is that really necessary?

    • Absolutely necessary. Otherwise, how would you know how much salt to add to the depressing news that vaccines are a target moving further and further.

    • I don’t see why this is in the “Politics” section. Drug product delivery is as integral to quality as any upstream process. We shouldn’t allow politics to affect the priority of technical aspects like this one. If there are issues with transport conditions, let’s get it sorted out now and let’s not tolerate partisanship interference from any side.

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