The incoming Biden administration cannot speak to federal agencies and does not know what issues the current leadership is most concerned with, causing some expert advisors to be open about access and distribution.
“This is an enormously difficult and expensive job, and we are hearing from state and local health officials that they need more help to get through this last mile,” said Jason Schwartz, a public health professor at Yale who is also in the Connecticut Vaccine Advisory Service Committee. “Time is running out to get states and cities what they need. So we don’t have millions of highly effective vaccines, but we don’t have a good way of getting them to the people who need them.”
The US has an average of more than a million new infections per week, and hospitals in the Midwest and Southwest are overcrowded, putting patients in parking lots and calling on FEMA for reinforcement. The news that both Pfizer and Moderna have vaccines that are at least 90 percent effective in studies and could be ready by next month has raised hope that the end is in sight. However, FDA approval is only the first step. The effective distribution of vaccines is a matter of life and death, and any delay in a day could mean thousands more American deaths.
Among the concerns:
– States say they need more than $ 8 billion from the federal government to promote and distribute vaccines.
– The federal government has failed to tell states how many doses they will be given, affecting their ability to plan which of the many priority populations to vaccinate first.
– Almost a dozen The federal states have still not agreed to pass on patient data to the Federal Centers for Disease Control, citing data protection concerns. This means that it will be difficult for the federal government to determine who has been vaccinated and who still needs a second dose.
President Donald Trump took one on Friday Winning lap before the White House announcing the yet-to-be-approved Pfizer vaccine and promising that 20 million doses could be given in December. Moderna announced Monday that it is expected to dispense 20 million doses in December if it receives FDA approval, and Trump administration leaders have promised to do so within 48 hours the FDA, which a Vaccine they will have needles in people’s arms.
However, many state and local health departments say they cannot uphold that promise.
“The federal government has put an incredible amount of money and attention into developing these vaccines and it has taken us very far very quickly,” said Lori Freeman, CEO of the National Association of County and City Health Officials. “We don’t have the investment to get the vaccine from the lab to the people … We don’t have time to bring these things together.”
States, she said, need at least $ 8.4 billion to hire and train people to manage What will likely be multiple vaccines, make sure electronic records can send information across national borders and to the federal government, and run a public health messaging campaign explaining the importance of the vaccine and the place and time of it Procurement will be explained.
Kurt Seetoo, who heads the Maryland Health Department’s immunization center, and Thomas Dobbs, Mississippi’s state health commissioner, told POLITICO they needed more Federal funding to increase staff, especially in the first few weeks.
The staff shortage is compounded by the rise in Covid-19 cases across the country, said Deidre Gifford, the reigning public in Connecticut Health Commissioner. There are 73,000 Americans hospitalized with Covid-19, twice as many as there were a month ago.
“Lots of people who might otherwise work as vaccines could be used to fight the pandemic,” Gifford said.
Congress is unlikely to approve a round of funding prior to the launch of vaccines, and Minister of Health and Human Services Alex Azar has repeatedly denied government requests, insisting that they have the necessary resources and that the federal government should meet any shortfalls will be withheld in the event of an occurrence.
States also need to know how many doses they will receive so they can have an idea of how limited supplies can be rationed in the first few weeks of distribution. While there is general consensus that vaccinating health workers is a top priority, states do not know which health workers to queue up first or how many to vaccinate in the first few weeks. And without knowing how many doses they will receive – or how many retail pharmacies like CVS will be received – states cannot know which vendors to ship vaccines with around the state, which could delay the distribution of vaccines in certain locations.
“It’s not like you can just stand up to vaccination clinics and stick needles in people’s arms,” said Stephen Ostroff, a CDC veteran and former acting general practitioner in Pennsylvania. “My main concern is that states have the infrastructure to easily see who will receive the vaccine and set up clinics to administer it. … It would be nice not to have any open questions when the time comes. ”
Schwartz, the Yale professor who serves on a Connecticut advisory committee, fears the vaccine rollout will be very similar to the botched rollout of HealthCare.gov, which gave the Affordable Care Act an early black eye that it will be difficult to get past could.
“If things go bad in the first few weeks, it could hamper the vaccination program for months to come,” he said.
Each state submitted a vaccine distribution plan to the CDC, but POLITICO’s review of these documents revealed many placeholders that states lacked basic information, such as: B. when vaccines arrive or how many doses they might receive.
“There are still many details to be worked out and the federal government’s position, such as tests, like PPE, like masks, refer to the states, and although it’s up to the states, they don’t provide of resources for states to do what they need to do, ”New York governor Andrew Cuomo who heads the National Governors Association told MSNBC’s Katy Tur on Friday.
The White House has said that Cuomo’s criticism is politically motivated and that he regularly fails to attend the governor’s briefings on vaccine distribution.
Meanwhile, around a dozen states, including some headed by Republicans, have opposed the Trump administration’s request to share patient information when Covid-19 vaccines become available and cited numerous privacy restrictions, some of which are a matter of state law. The dispute could make it harder for the CDC to track who received a vaccine, adding to the difficulty of delivering, tracking and monitoring vaccines that require a second dose.
“We need to know where each vial is, whether it was in the factory, on a truck, or given out to a vaccination site,” said Matthew Hepburn, director of vaccine development at Operation Warp Speed, the intergovernmental effort to distribute a vaccine during the month a press conference.
However, several state officials fear that sharing personal information could deter people from receiving the vaccine.
Meanwhile, some states are still learning about the Trump administration’s unproven Vaccine Administration Management System, a new center for scheduling admissions and managing vaccine supplies, and another new system developed by technology firm Palantir, led by Trump- Ally Peter Thiel was developed to oversee the manufacture, government planning, and delivery of the vaccine.
“When new systems are introduced, there is disruption,” said Hemi Tewarson, a senior policy fellow at the Duke-Margolis Center for Health Policy. “It’s in the nature of the systems. It’s nobody’s fault. That’s just the way it is.”
An HHS spokesman said it was important for states to share data, but IT infrastructure was not affected by delays in signing data usage agreements. The vaccine management system is up and running and more tests are planned for next week, according to HHS.
Of course, many state officials and local health officials believe they can handle the challenges. Cindy Findley, director of the vaccination division at the Pennsylvania Department of Health, said her state had the money she needed and praised the CDC for making necessary changes to the state’s data usage agreement. Others have praised Operation Warp Speed for being at the height of proliferation in less than a year, an accomplishment that many considered out of reach. And the Trump administration paid drug companies to hold millions of doses before FDA approval, a move largely approved by public health experts.
However, time is running out and many challenges remain to be addressed. A consistent fear shared by public health experts, state officials, and members of the Trump administration is that people don’t want the vaccine, either because they fear science has been politicized or because they believe the coronavirus has been overhyped.
A recent poll found that no more than 70 percent of respondents said they were likely to receive a vaccine even if it was 90 percent effective. However, there was no national campaign to promote a vaccine. While Trump has hyped the vaccine as a miracle cure, he has also claimed that the virus is no big deal and that the vast majority of people will recover in just a few days.
“Even in a good year, our influenza vaccination rate is pretty bad and we’ve been campaigning for it for decades,” said Peter Hotez, virologist and dean of the National School of Tropical Medicine at Baylor College of Medicine. “That tells us it will be a challenge for Covid-19.”
An HHS spokesman said the agency intends to provide regular safety and effectiveness updates to reduce anxiety, and work with health care providers to increase their confidence in approved vaccines.
Howard Sklamberg, an attorney for Arnold & Porter and a former FDA official, said the Biden administration may have been on hiatus because the vaccine was announced after the election but before the inauguration so Trump can praise its effectiveness without that To raise fears that it was rushed for political reasons.
“The distribution starts in the Trump administration and they say it’s great, and then Biden comes in and also says it’s great,” he said.
Despite all of these challenges, the Biden team was not briefed by Trump officials as the President refused to allow the election and begin the formal transition. The president-elect said Monday the cover-up could lead to unnecessary deaths, and his new chief of staff, Ron Klain, said the new administration does not know where the Trump team is on vaccine distribution or what problems they are working or struggling with.
“The bigger problem will be the mechanics of manufacturing and distribution that will bring this vaccine out,” Klain said on NBC’s Meet the Press on Sunday. “There are people at HHS who are making plans to implement this vaccine. Our experts have to speak to these people as soon as possible so that nothing subsides in this change in power that we will have on January 20th. “