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As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first — and how those doses should be distributed.

But already the effort is being complicated by tensions over who gets to make those critical decisions, with some groups feeling sidelined and multiple new actors crowding the stage.

On Tuesday, the National Academy of Medicine, tasked by top U.S. health officials, named an expert panel to develop a framework to determine who should be vaccinated first, when available doses are expected to be scarce. But that panel is ostensibly encroaching on the role of the Advisory Committee on Immunization Practices, a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention for decades, including drawing up the vaccination priority list during the 2009 H1N1 flu pandemic.

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There is also the matter of Operation Warp Speed, the government’s vaccine fast-tracking program that has claimed authority over, among other things, distribution decisions when it comes to Covid-19 vaccines.

Amid so many players, public health experts are expressing concern and confusion.

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“It seems to me like we’ve just assigned four different air traffic control towers to land the same plane,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “Between ACIP, and this new committee, the group working within Operation Warp Speed and just in terms of input from the general community, it’s not clear to me who will make the final decision and how that process will unfold.”

The health of untold numbers could hang in the balance, given that initial batches of vaccine are likely to be available only for a sliver of the population. Additionally, most vaccines will probably be given in two-dose regimens, meaning any figure of available doses would have to be divided in half to see how many people could be vaccinated.

There is no doubt that health care workers will be offered vaccines first. But after that, tough decisions will have to be made about the order in which other frontline workers — which? how many? — are offered priority access to vaccine and who will follow, in what order.

Normally, such decisions would fall to ACIP, which months ago set up a working group to monitor the evolving science on Covid-19 and the vaccines being developed to protect against it. But it’s not clear what task ACIP will be handed here.

“We haven’t been given a firm answer as to what our role will be. We are continuing with our routine planning and discussion, and we will come up with what we think are appropriate guidelines for prioritization. But that we’ve not been given assurances that we will actually be contributing to that,” said José Romero, the panel’s chairman.

Romero told STAT he even had applied to be on the National Academy’s panel after the academy urged people who were interested to nominate themselves. Romero said he never heard back. The agenda for the first public meeting of the panel, scheduled for Friday, states Romero has been invited to speak to the kickoff session. He said late Monday he hadn’t received an invitation.

ACIP member Beth Bell, who chairs its Covid-19 vaccines work group, is also concerned about the National Academy panel working on vaccination priorities before ACIP.

“Hopefully it won’t be a parallel process and it’ll be something which can complement the work of the ACIP,” said Bell, a professor of global health at the University of Washington and a former director of the CDC’s national center for emerging and zoonotic infectious diseases.

She seemed to take some solace from the fact that former CDC director Bill Foege — one of the architects of the smallpox eradication program and a revered figure in public health circles — has been named co-chair of the new panel.

Foege will share chairing duties with Helene Gayle, president and CEO of Chicago Community Trust. Gayle previously worked at the CDC for 20 years on HIV/AIDS and at the Bill and Melinda Gates Foundation. In addition to the co-chairs, the 15 panelists include vaccine experts, ethicists, experts in vaccine hesitancy, global health, health policy, risk communications, and the delivery of health care to low-income populations.

Francis Collins, director of the National Institutes of Health, first asked National Academy of Medicine President Victor Dzau to create the new panel, even though setting vaccination priorities is a public health role — traditionally on the CDC’s turf, not the NIH’s. Later a letter formally requesting that the panel be struck came from Collins and Robert Redfield, the CDC director.

In an interview, Collins seemed puzzled as to why ACIP members might be concerned about the creation of the expert panel. He said the decision-making framework the panel designs “will make their job, I think, a lot more straightforward and less likely to be attacked as being capricious.”

“This is a discussion which is potentially going to be contentious and we want to try to minimize that,” Collins told STAT.

“There are certainly parts of society that are suspicious of what the government is doing, no matter what it is,” he added. “And this takes it out of that framework and provides an opportunity for whose sort of wisest big thinkers to gather and make this kind of a judgment about what those priorities ought to look like,” he said.

“What’s not to love about this?” he said.

Some vaccine developers have embraced the idea of the National Academy’s involvement, which the body suggests will set a priorities framework that can be used in the United States and beyond.

“It is the CDC’s responsibility, the ACIP that makes decisions about allocation, but in this very special case, I have personally — and I think many of us have — called for the National Academy of Medicine to create a mechanism to look at health equity and make sure that the allocation is fair,” Julie Gerberding, the chief patient officer at Merck, told a House subcommittee on Tuesday.

Others acknowledge there is confusion about who is doing what — and most importantly, who will make the final decisions.

Osterholm, the University of Minnesota expert, called the composition of the National Academy panel “outstanding. … They couldn’t find two better chairs than Bill and Helene.”

But the excellence of the panel doesn’t negate the fact there isn’t much clarity about roles, he said.

Ultimately the administration in power when vaccine is approved for use will likely dictate who stands where in the vaccine priority line. The current administration’s past decisions about distribution of desperately needed protective equipment for health workers and scarce supplies of the antiviral drug remdesivir don’t instill confidence that the painstakingly crafted recommendations of the National Academy group, or of the ACIP, will be followed to the letter.

“In the end it will be decided by the U.S. government,” Osterholm said. “Look at how the remdesivir situation unfolded nationally. That was a terrible situation.”

The task of setting priority groups won’t be an easy one.

Older adults are most at risk of dying if they become infected. But essential workers in food production and distribution may be at higher risk of contracting the virus. Who should move to the front of the line? Should the vaccination program prioritize people of color, who have contracted and died from Covid-19 in disproportion numbers? At the June meeting of the ACIP, at least one member suggested that should be considered. One of the charges to the National Academy panel is to advise on how communities of color can be assured equitable access to the vaccines.

Other questions asked of the National Academy panel include what criteria should be used to set priorities for equitable allocation of vaccines — for example, how to weigh individual risk, due to age, underlying health conditions, or occupation, versus group risks posed by being in prison, being homeless or being a resident of a long-term care facility. The panel is also being asked to provide input on how to communicate vaccine priority decisions to the wider public, and how to address vaccine hesitancy, especially in high-risk populations.

Collins said the panel has been asked to come up with interim recommendations by Labor Day, which would then be subject to a short period of public comment. Dzau, the academy president, said last week that the final recommendations would probably take about three months to deliver, which would mean early October.

Dzau strenuously refuted the idea that the new panel might be driving in someone else’s lane. The group will create scenarios, he said, of how to deal with the variety of circumstances the country might face, for instance starting to vaccinate with 10 million doses, or 60 million, or 100 million.

“I think our job will be to look at the evidence and the strategy of who should get what and how. … Some kind of priority list and the rationale for that,” Dzau said.

The time frame he and Collins envisage may leave the ACIP with little time to fine-tune the framework the National Academy panel devises. Some of the most aggressive manufacturers have stated they may have enough evidence to support the issuance of an emergency use authorization from the Food and Drug Administration by October.

Beyond questions of priority-setting, there are also concerns about how vaccines will be distributed.

Those concerns were first triggered by the press release announcing the formation of Operation Warp Speed, which claimed distribution as one of the project’s responsibilities.

Four organizations representing professionals who make up the last mile of a vaccine’s journey into arms in the United States wrote to the leaders of Operation Warp Speed on June 23, asking if the project intended to use existing vaccine delivery infrastructure to get Covid-19 vaccines into Americans. They still haven’t received a reply.

“If your job is logistics and you don’t know that there’s a system out there already, it might be easy for you to start planning things down a different path,” said Claire Hannan, executive director of the Association of Immunization Managers, one of the groups. “And we don’t want that to happen.”

Another group that signed the letter, the Association of State and Territorial Health Officials, has since had a discussion with Lt. Gen. Paul Ostrowski, from Operation Warp Speed, said Jim Blumenstock, the organization’s chief program officer for health security. Blumenstock said that after the conversation, he felt more confident that traditional vaccine distribution networks would play a part in the roll out of Covid-19 vaccines.

“The proof is always in the pudding,” he said, recounting that Ostrowski told him that “micro-planning” for vaccine distribution would start in the next two to three weeks.

STAT asked Operation Warp Speed for interviews about these issues. The requests were neither turned down nor granted — they were merely acknowledged.

Hannan, who hadn’t heard anything from Operation Warp Speed as of Monday, remains unsettled.

“I am still very concerned about how distribution will be carried out and about the lack of planning with state and local public health agencies,” she told STAT.  “We have received no assurance that existing vaccine allocation, distribution, and tracking systems will be used.”

Damian Garde contributed reporting

  • Does anyone here know about the hydrogel biometric nano-particles they will be putting into the vaccine as well? Connected to an AI platform. They are about to enslave you. And yo are lining up for it. Over a 99.8% survival rate virus. “A Military-Funded Biosensor Could Be the Future of Pandemic Detection” https://www.defenseone.com/technology/2020/03/military-funded-biosensor-could-be-future-pandemic-detection/163497/

    “Why are pandemics so hard to stop? Often it’s because the disease moves faster than people can be tested for it. The Defense Department is helping to fund a new study to determine whether an under-the-skin biosensor can help trackers keep up — by detecting flu-like infections even before their symptoms begin to show. Its maker, Profusa, says the sensor is on track to try for FDA approval by early next year….”

    “Dr. Carrie Madej, DO is a Internal Medicine Specialist in McDonough, GA and has over 19 years of experience in the medical field. She graduated from Kansas City Univ Of Medicine Bioscience College Of Osteopathic Medicine medical school in 2001. She is affiliated with medical facilities Piedmont Fayette Hospital and Southern Regional Medical Center. ” https://www.healthgrades.com/physician/dr-carrie-madej-y7thx

    Dr. Madej warns of permanent biometric particles which become part of your body: https://youtu.be/mx6Qu-xQE1Y

  • Medical personnel and their families should be first. Then first responders and teachers – along with their families. And trash collection workers should be on this list.

    The reason you want to vaccinate the families also is so you do lot lose the services of – for example – a vaccinated nurse because she has to care for her sick husband.

    Next is members of the military assigned to ‘expeditionary’ units (the first units to be deployed if a war starts).

    Next is key infrastructure workers.

    Next is everybody involved in food production and distribution.

    The idea here is to protect society first.

    I’m a disabled veteran and as a result my ability to contribute to society is limited. My medical issues would likely put me high on the priority list. But a quote from Star Trek sums up the issue: ‘The needs of the many outweigh the needs of the few – or the one.’

  • Personally, I like the way they distributed the vaccine in the movie “Contagion” (which deals with a different and more deadly virus). Ping-pong balls numbered 1 to 366 were drawn randomly in a televised drawing and those whose birthdays were drawn got the vaccine and a wristband showing they’d been vaccinated.

    This is similar to the way the US ran the draft lotteries during the Vietnam War. Obviously, since this method is completely fair and no one is privileged, that is not the way it will be done for this pandemic.

  • Elderly, the vaccine has said to be less than effective. I’m elderly and i won’t lining up for as vaccine they have tested properly. Side effects aren’t just sore arm or chills or headache. Guillain-Barre syndrome,febrile seizures, encepalopathy,petit mal seizures,paralysis,
    spectrum disorders,allergic reactions, meningitis, pneumonia, sepsis epiglottitis, intractable
    fever, blisters,eye disorders, loss of vision, body rash, encephalitis, death, intestinal problems,neurological,syncope, blood clots,etc. Silly to say only minor side effects
    when life goes on for years as these issues surface. One or 2 weeks is no test for vaccine side effects. The public isn’t stupid.
    Doesn’t work well in elderly, so why burden them with so many other diseases for a vaccine that doesn’t work and isn’t tested against placebo. PHARMA doesn’t want to see placebo testing.
    Please don’t bring up the ethical issues. I’d volunteer and i am well
    educated as are many of my friends who feel the same. We are not against vaccines. We are against truly untested by time and application this vaccine and new RNA miracles
    proposed to provide fast track solutions. Physicians aren’t early adapters, especially for a vaccine not really needed except by those who are elderly or with organ impairment and compromised immune systems. Under 50 yrs of age or so the immune system takes care of the virus 99.9% of the time. This issue is about money for a floundering,too large
    PHARMA line-up who need new Billion(s) of
    dollar prescription drugs to keep their shareholders happy and bonuses coming.
    Truly this isn’t going to work out well. What, next year new novel virus with new vaccine needed that never is placebo tested or followed for side effects. Too busy to do that. On to the next virus pandemic. Flu, T.B.,CANCER…kill many, many more. No
    marshalling of the world’s best minds and
    seemingly endless resources while destroying people’s lives and businesses.
    Next the housing bust and the banks take homes for pennies on the dollar. Right now
    1/3 of homeowners are
    behind in their monthly
    payments with so many jobs lost and futures destroyed. This isn’t over by bringing out the Covid 19 savior vaccine. Amazing psychological warfare going on worldwide. People are very scared
    and those working with the public have frayed
    nerves and the face masks make it more stressful whether it is of value or not. It’s not only the shoppers that
    have short fuses, the workers are acting out.
    Very sad. Very wrong.
    Be well.

    • I hope people don’t just accept the doomsday predictions of this comment as is. The vaccines being developed have not shown to the as dangerous or as ineffective as your negative comments suggest. I suppose you would rather we simply not try. Then you could complain about that.

  • I was ten years old in Cincinnati when local heroes Sabin and Salk developed and gave away the polio vaccine to the world. How things have changed. I still have my MD signed permission slip to return to school.

    • Your memory is slightly misleading. In my opinion, there was only one true hero — Jonas Salk. Albert Sabin (who had far more influence in the NIH and other bodies), despised Salk and did everything possible to slow the progress of Salk’s vaccine. Salk cared only about humanity and getting a vaccine as soon as possible (and was a loner and was difficult to work with for that reason). His vaccine came out first, and it was proved effective in a 1954 national trial. Salk refused to patent it, and it revolutionized the world.

      Sabin’s vaccine (which had some advantages because it was oral rather than by injection and didn’t need booster shots), came later, and it was tested in the Soviet Union in 1959. That was the only place they could test it, because it was the only large country that hadn’t already inoculated its children with the Salk vaccine. Because it was easier to use, it eventually took over, but if the world had waited for it rather than using the Salk vaccine, millions more would have gotten polio.

      This is all explained in the book “Polio, An American Story” by historian David Oshinsky.

  • Here’s a possible scenario, based on past behavior: the administration will put the vaccines on the ‘open market’, where the various states, as well as other countries, can bid against each other for them. This is pure capitalism at work! Then the governors in each state, at least the ones that got any, will hand them out as they see fit: some states following wise guidelines based on science, others, not so much.

  • Too many cooks, spoil the broth, sounds familiar? Anyway, taking into consideration how the Trump administration does things, I would not be surprised if Operation Warp Speed will take the lead in the distribution, priority selection of target population, of available vaccines.

  • is it reasonable to consider antibody testing before vaccination? (this may go for trials too). if doses are really scarce and the priority populations are those that have been heavily infected already, it may be wise to test for antibodies and only vaccinate those whose antibody titre is less than a specified level. the wisdom of this may also depend on the type/mechanism of vaccine functionality.

    • I think this is a great idea – especially if there are reliable instant tests that can be administered by the time the vaccines become available.

  • This highlights the general dysfunctionality of the US government, exacerbated by the COVID-19 crisis.
    My favorite example is “food” — where FDA (CFSAN) and Dept of Ag have overlapping but conflicting responsibilities, the former to the consumer (mainly) and the latter to the farmer.

    • True, but this will go far beyond just how competent or not the government is. I could see legal action be taking by groups who feel THEY should be in line to be vaccinated first. Then you have the massive number of people who, even if given a priority position, will not accept the vaccine because they think this is all either hogwash or a giant government / multi government conspiracy of some kind.

      Personally, even though I might be prioritized due to age and my association with emergency services…The way this thing is being rushed I will likely wait a good while and see how the wide effect and unexpected side effects play out….

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