Brazil halts trials of Chinese Covid-19 vaccine https://news.yahoo.com/brazil-halts-trials-chinese-covid-012236748.html Brazil's health regulator said Monday it had suspended clinical trials of a Chinese-developed Covid-19 vaccine after an "adverse incident" involving a volunteer recipient, a blow for one of the most advanced vaccine candidates. The setback for CoronaVac, developed by Chinese pharmaceutical firm Sinovac Biotech, came on the same day US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 percent effectiveness, sending global markets soaring and raising hopes of an end to the pandemic. The Brazilian regulator, Anvisa, said in a statement it had "ruled to interrupt the clinical trial of the CoronaVac vaccine after a serious adverse incident" on October 29. It said it could not give details on what happened because of privacy regulations, but that such incidents included death, potentially fatal side effects, serious disability, hospitalization, birth defects and other "clinically significant events." However, the public health center coordinating the trials of the vaccine in Brazil, the Butantan Institute, said it was "surprised" by the decision. The institute "is investigating in detail what happened," and "is at the Brazilian regulatory agency's disposal to provide any clarification necessary on any adverse incident the clinical trials may have presented," it said. It said it would hold a press conference on Tuesday at 11:00 am (1400 GMT). CoronaVac has been caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a top opponent of far-right President Jair Bolsonaro. - Pandemic politics - Bolsonaro has labeled CoronaVac the vaccine from "that other country," and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca. Last month, Bolsonaro shot down a plan by his own health minister to buy 46 million doses of CoronaVac, saying, "The Brazilian people will not be anyone's guinea pig" and referring to it as "Joao Doria's Chinese vaccine." Doria announced earlier Monday that the first 120,000 doses of CoronaVac would arrive in Sao Paulo on November 20. His state has a deal with Sinovac to buy a total of 46 million doses -- six million produced in China and the remainder produced in Sao Paulo, which broke ground last week on a factory to produce the vaccine domestically. "Officials in the state government fear Bolsonaro will use technical decisions to delay the timeline of the vaccine for political reasons," newspaper Folha de Sao Paulo reported, citing unnamed Doria allies. Anvisa did not immediately respond to a request for comment from AFP. And all are being tested in Brazil, the country with the second-highest death toll in the pandemic, after the United States, with more than 162,000 people killed by the new coronavirus.
Hey Comrade.... our vaccine is also 90% effective. We have no test results to prove this... just trust us. Russia's Sputnik V vaccine also over 90% effective: health ministry https://www.reuters.com/article/idUSKBN27P20T Russia’s Sputnik V vaccine against COVID-19 is more than 90% effective, a representative of the health ministry said on Monday, citing data collated from vaccinations of the public rather than from an ongoing trial. The comments followed a statement earlier on Monday by vaccine developers Pfizer Inc and BioNTech BNTX.O, who said their experimental COVID-19 vaccine was more than 90% effective. “We are responsible for monitoring the effectiveness of the Sputnik V vaccine among citizens who have received it as part of the mass vaccination programme,” Oksana Drapkina, director of a research institute under the health ministry, said in a statement. “Based on our observations, its effectiveness is also more than 90%. The appearance of another effective vaccine - this is good news for everyone,” Drapkina said. Russia is rolling out the vaccine for domestic use despite the fact that late-stage trials have not yet finished. Earlier on Monday, Alexander Gintsburg, director of Moscow’s Gamaleya Institute which developed the Russian vaccine candidate, said he welcomed the Pfizer news. “In the near future we expect to publish interim results of the post-registration trial of the vaccine Sputnik V, the so-called Phase III trials. I am sure that its effectiveness level will also be high,” he said. Russia is gearing up to publish preliminary results of an ongoing large-scale human trial, known as Phase III, this month. It is testing the vaccine on 40,000 people in Moscow.
The Trump administration provided no guidance or financial assistance whatsoever to help states in distributing the vaccine. Due to this lack of planning and financial support --- which the need for should have been obvious for months even to the most dim-witted federal politician -- the states are woefully unprepared. Most States Aren’t Ready to Distribute the Leading COVID-19 Vaccine A review of state distribution plans reveals that officials don’t know how they’ll deal with the difficult storage and transport requirements of Pfizer’s vaccine, especially in the rural areas currently seeing a spike in infections. https://www.propublica.org/article/...dy-to-distribute-the-leading-covid-19-vaccine As the first coronavirus vaccine takes a major stride toward approval, state governments’ distribution plans show many are not ready to deliver the shots. The challenge is especially steep in rural areas, many of which are contending with a surge of infections, meaning that access to the first batch of COVID-19 vaccines may be limited by geography. Pfizer announced Monday that its vaccine demonstrated more than 90% effectiveness and no serious bad reactions in early trial results — an impressive outcome that will pave the way for the company to seek an emergency authorization once it collects more safety data for another week or two. But establishing that the vaccine is safe and effective is just the first step. The Pfizer vaccine is unusually difficult to ship and store: It is administered in two doses given 28 days apart, has to be stored at temperatures of about minus 100 degrees Fahrenheit and will be delivered in dry ice-packed boxes holding 1,000 to 5,000 doses. These cartons can stay cold enough to keep the doses viable for up to 10 days, according to details provided by the company. The ice can be replenished up to three times. Once opened, the packages can keep the vaccine for five days but can’t be opened more than twice a day. The vaccine can also survive in a refrigerator for five days but can’t be refrozen if unused. Health officials haven’t figured out how to get the ultracold doses to critical populations living far from cities, according to a ProPublica review of distribution plans obtained through open records laws in every state. Needing to use 1,000 doses within a few days may be fine for large hospital systems or mass vaccination centers. But it could rule out sending the vaccine to providers who don’t treat that many people, even doctors’ offices in cities. It’s especially challenging in smaller towns, rural areas and Native communities on reservations that are likely to struggle to administer that many doses quickly or to maintain them at ultracold temperatures. The government’s vaccine program, Operation Warp Speed, has projected optimism about its readiness to distribute the vaccine. On Monday, Gen. Gustave Perna told NPR, “I think we’re in a good place,” saying that “with the right planning, we can execute it with zero loss of vaccine.” But the federal program is only going to be responsible for delivering vaccines to the states, which must then figure out on their own how to get the shots to the people who need them most. The Centers for Disease Control and Prevention asked each state to turn in distribution plans on Nov. 2, imagining a scenario in which a vaccine with Pfizer’s specifications came first. ProPublica obtained full preliminary plans for 47 states (Hawaii, Pennsylvania and Minnesota say they’re still working on theirs). Many struggled with how to handle a Pfizer-like vaccine. Washington state’s Health Department does not have its own warehouse that can store the Pfizer vaccine at a cold enough temperature. Arizona expects the Pfizer vaccine cannot be handled by the state’s rural communities and tribal lands. North Dakota and Oregon aren’t sure how to take care of migrant workers. Kansas’ plan appears to mistakenly assume shipments will be far smaller than 1,000 doses. Georgia’s Public Health Department is relying on local districts and counties to work out their own details. “Early, when we don’t have lots of doses, I frankly do not anticipate that vaccine will be widely available in every rural community,” Dr. Amanda Cohn, chief medical officer for the CDC’s Vaccine Task Force, said during a call on vaccine implementation planning with rural stakeholders on Nov. 3. “The first couple months will be not ideal, but we really want to listen to our rural partners and understand what we can do to make it better,” she added. The concern is most pronounced in places like Mt. Vernon Countryside Manor, a nursing home in southern Illinois more than 100 miles from the nearest major city, where the staff is working to contain the facility’s first COVID-19 outbreak. Glenda Lee Young, a nurse at the home, said four residents and an employee tested positive for COVID-19 in recent weeks. The sick have been isolated from the other 70 elderly residents, and are recovering. The surrounding county has a fatality rate of 4.5%, more than double that of Illinois as a whole, according to data from the Johns Hopkins University COVID-19 dashboard. The staff at Mt. Vernon is eager for a vaccine to help them and their residents. Illinois’ distribution plan includes health care workers and people 65 years and older among the first groups to be immunized. “Our people would not travel,” Young said. “If a vaccine becomes available, it would have to come to us.” However, Illinois’ plan does not specify how shots will be provided to rural parts of the state that may not have enough people or ultracold storage. The state’s Department of Public Health didn’t immediately respond to a request for comment. Young said she was not surprised by the state’s silence on rural vaccine access. “We get the shaft on a lot of stuff.” Officials Are Trying to Hit “a Moving Target” Health officials stressed that the plans are still evolving as they receive changing information. Even though Pfizer’s vaccine has long been seen as the likely front-runner, details from the trial, including the vaccine’s efficacy in specific populations like the elderly, have yet to be published. Shipping and storage logistics are also expected to continue to be fine-tuned with each passing week. “It’s a moving target,” Dr. Philip Huang, director of the Dallas County Health and Human Services Department, said. “There’s new info every day.” The changing details make it harder to plan, and some officials acknowledged they haven’t gotten very far. “There are too many variables still to be worked out at the federal level,” a spokeswoman for the Georgia Department of Public Health said by way of declining an interview request for this article. “Much of what happens going forward will depend on the vaccine itself, when we receive it and what the protocols will be for prioritizing distribution among various populations.” The problem with waiting for details on the vaccine to be revealed is that mass immunization is a multilayered process, involving public communication campaigns, ordering of equipment, hiring of staff, training of vaccine providers and the added complexity, in this pandemic, of making sure all vaccine sites are safe and won’t contribute to the spread. Operation Warp Speed has said its goal is to begin shipping the day that a vaccine is given the green light by the FDA, so states need to be ready at any moment. For the initial months after the Food and Drug Administration signs off on a vaccine, the CDC advised state and local health authorities to prioritize health care workers, then move on to other essential workers and at-risk populations such as nursing home residents. Access would expand to the general public as manufacturing ramps up to make more doses available. But there are a lot of details left to determine within those broad categories. Some health care workers have more exposure than others; North Dakota wants hospitals to document how they decided whom to vaccinate first. Maryland is prioritizing people in jails and prisons (where sharing close quarters has led to severe outbreaks), but states like Idaho and Mississippi have scheduled them for later. Arkansas, which has a large chicken industry, considers meatpacking workers to be essential. Oklahoma is prioritizing its long-term care population. Some states stressed communities of color, which have been disproportionately sickened and killed by the virus. “We are currently in the midst of a social justice movement across the county,” Kentucky’s plan notes. Rural Communities Are “the Greatest Challenge” Across the country, authorities are grappling with how to accommodate the Pfizer vaccine’s finicky specifications. So far, state plans show few have come up with clear solutions. Oregon, for instance, said it still needs to “develop [a] plan” for how to handle 1,000-dose orders in “remote Oregon locations, while maintaining the ultracold chain and avoiding wastage.” Perna, the general leading logistics for Operation Warp Speed, told NPR that it’s up to states to buy more freezers. That contradicts the CDC’s instruction to not invest in more equipment. But many states said they’re doing so anyway, or at least looking into it. They’re also taking stock of what facilities already exist in their states at hospitals and universities, or where they can get dry ice. North Dakota, where the virus has killed roughly 1 out of every 1,200 people, is considering whether to break down the 1,000-dose packages and, on its own, distribute smaller quantities to individual hospitals and clinics. “The greatest challenge will be to moving small amounts of vaccine to widely scattered locations during Phase 1 since only a small percentage of the small population will be eligible for the vaccine,” the state’s plan said. It describes one health district that has three hospitals, two of which are more than an hour’s drive away from the nearest city via a two-lane road, and eight long-term care facilities that are even more remote. “Reaching small populations without redistribution may not [be] possible.” Even in the case where prioritized health care workers were physically capable of driving themselves to the city to get a vaccine, relying on doctors and nurses to get themselves to a vaccine “doesn’t compute,” said Tim Size, executive director of the Rural Wisconsin Health Cooperative, which represents 43 rural acute hospitals. Wisconsin is battling its worst outbreak of the pandemic, and every hospital is stretched thin on staff, he said. Requiring everyone to take time off, twice, to get the Pfizer vaccine “means two days of lost staff time at a time we’re desperately short of staff.” Size urged Pfizer to figure out a way to package its vaccine in smaller shipments so it could be delivered directly to rural hospitals. A spokeswoman for Pfizer declined to comment on whether the company is working on that. Later vaccines will likely have less onerous storage requirements, and at least one, made by Johnson & Johnson, only requires one dose instead of two, so many states are hoping to have multiple options to work with that may make it easier to reach remote populations. Some states appeared to be avoiding the issue of Pfizer’s packaging for now. The Kansas Department of Health and Environment’s plan assumes any approved vaccine will be “available in minimal quantities such as 100 doses per order.” Kansas’ department did not respond to requests for comment. “If Pfizer comes out and says they’re going to provide doses of 25 instead of 1,000, that’s a game changer,” said Imelda Garcia, associate commissioner for the Texas Department of State Health Services’ Division for Laboratory and Infectious Disease Services. “The manufacturers were imagining mass vaccination efforts and not really thinking about rural areas. We’ve been pushing pretty hard at the federal level for them to provide smaller packages. We don’t know if that will occur or not.” As Texas and other states consider the need to break down the 1,000-dose packages into smaller shipments, that’s an additional cost that they’d have to shoulder, since the federal government will only pay to move the vaccines once. Several states identified funding as a major problem. Virginia’s plan included a “preparedness gap analysis” that estimates that it will need $71 million to establish and operate mass vaccination clinics, which would include hiring temporary staff and covering facility rental costs, translation services, signage and other operating costs. The plan also calls for a further $2.5 million in equipment such as refrigerators and thermometers and $3 million for public education, including TV, radio and social media ads, as well as “targeted outreach to clinicians, vulnerable populations and other key groups.” CDC Director Robert Redfield has said Congress will need to provide up to $6 billion for vaccine distribution, but funding negotiations stalled ahead of the election. To date, the federal government has allocated 3% of that amount, $200 million, to the states to immunize the nation. Much of the implementation will spill into the next administration. President-elect Joe Biden on Monday named a team of public health experts to advise him on the COVID-19 response. But so far the Trump administration is refusing to cooperate with the transition.
Dear Trump Coronavirus task force -- thanks for nothing and being of no assistance in planning or funding distribution of a vaccine. You had months to sort this out. Pfizer's ultra-cold vaccine, a 'very complex' distribution plan and an exploding head emoji https://www.wral.com/coronavirus/pf...on-plan-and-an-exploding-head-emoji/19379981/ As Molly Howell, a state health official in North Dakota, watched a webinar on how to distribute what's expected to be the first coronavirus vaccine, her head began to spin. "How are we going to do this?" she texted a colleague who was also on the webinar. Her colleague responded with an exploding head emoji. On Monday, Pfizer announced that initial Phase III clinical trial results show its vaccine is more than 90% effective. If approved, Pfizer's vaccine would also be the most fragile vaccine used in the United States, and the state health officials charged with its distribution worry the process will not go smoothly. Pfizer's vaccine needs to be stored at about -75 degrees Celsius, which is about 50 degrees colder than any vaccine currently used in the United States. Doctors' offices, pharmacies and state labs don't have freezers that go nearly that low. The solution is a set of handling and storage requirements that a doctor at the Centers for Disease Control and Prevention described as "very complex." The CDC has asked states to be ready to receive Pfizer's vaccine by Sunday, but state officials say the first time they heard the specific requirements was on Oct. 15, giving them just weeks to prepare. State health officials were "shocked" when they heard the storage requirements for the new vaccine, according to Dr. Kelly Moore, associate director of the Immunization Action Coalition, which is supporting the frontline workers who will administer the coronavirus vaccine. Those requirements include procuring and handling large amounts of dry ice, which is in short supply in many parts of the country. "We all are going into this expecting that there are going to be major glitches," she said. Howell, North Dakota's immunization program manager, calls the prospect of administering Pfizer's vaccine "overwhelming" and "daunting." Claire Hannan, executive director of the Association of Immunization Managers, which also helps states with their vaccine programs, sent Howell the exploding head emoji. "These challenges are so unprecedented. I don't have anything to compare [them] to," Hannan said. Even those on the inside have doubts about how the process is going. "All of the squares of the quilt have not been knit together very squarely at this point," said Dr. William Schaffner, a longtime adviser on vaccines to the CDC. "There are probably more questions than answers." Government assurances and missed deadlines The federal government's vaccine effort is being led by the CDC, the Department of Defense and Operation Warp Speed, a part of the Department of Health and Human Services. In an email to CNN, an HHS spokesperson said the CDC, in coordination with the Department of Defense, is working closely with states and other jurisdictions "to advise and guide every logistical detail in regards to vaccine distribution. Operation Warp Speed is a whole-of-America effort and will be successful because of the partnership and teamwork between the federal and state governments, industry, the healthcare community and academia." Gen. Gustave Perna, formerly the commanding general of the U.S. Army Materiel Command, is chief operating officer of Operation Warp Speed. On "60 Minutes" last Sunday, Perna said he would hold himself personally accountable if the distribution of the vaccine doesn't go smoothly. "Me. Conversation's over. It's pretty easy – me," Perna said when asked where the buck stops if the distribution doesn't go according to plan. "I hold myself 100% personally accountable to that end." "Perna is the best logistician in the U.S. government," said Dr. Nelson Michael, director of the Center for Infectious Disease Research at the Walter Reed Army Institute of Research. "You have the entire weight of a four-star general who knows how to move bullets and beans from Point A to Point B and get them there at the right time." CNN asked Pfizer to address the concerns from state officials about keeping the vaccine at the right temperature, also known as the "cold chain." "Most vaccines need cold chain storage, and we have already initiated development of innovative cold-chain solutions and distribution logistics to facilitate vaccine supply," according to Pfizer spokesman Steven Danehy. "We have also developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place." As states work to implement solutions, deadlines have already been missed. Storing a vaccine at -103 degrees Fahrenheit Four coronavirus vaccines are currently in large-scale Phase III clinical trials, but only Pfizer's has to be kept at around -75 degrees Celsius, or -103 degrees Fahrenheit. The specific requirement is -75 degrees Celsius, +/-15 degrees. The lowest requirement for a current vaccine in the U.S. is about -20 degrees. "These [Pfizer] vaccines will thaw if exposed to open air for five minutes," said Moore, the doctor helping states implement their coronavirus vaccine programs. Moore serves on the external advisory board for Pfizer's coronavirus vaccine. In an Oct. 26 letter, the CDC asked states to be ready to receive Pfizer's vaccine by Nov. 15. State officials interviewed by CNN said it was unlikely they could be. Already, most states have missed Nov. 2 planning deadlines, according to Hannan and a CDC spokesperson. "It would be hard to with a straight face say, 'Oh, we're all set,'" said Christine Finley, Vermont's immunization program manager. "[This] equals a challenge I don't think we've ever seen before." A review by CNN of the 46 state vaccine plans that are online shows only a few states have detailed plans for maintaining the vaccine's cold chain. Most states have just some details in their plans, and a few states don't even mention their cold chain plans. In the past, the CDC has managed relationships with state health agencies, but during the pandemic, the CDC has been sidelined and is now doing the work along with Operation Warp Speed. That has not always gone smoothly, with "an element of having too many bosses," said Laurel Wood, coordinator for public health for the Immunization Action Coalition. "There are many cooks involved." While the CDC historically has enjoyed good relationships with state health departments, she said there's been some tension between Operation Warp Speed and the states. One state program manager was "almost in tears" after receiving a "castigation" by an Operation Warp Speed official who was unhappy with a plan she filed, Wood said. "You've got people coming at you from a thousand different directions." CNN asked the HHS spokesperson for a response to the state officials' concerns. "Only one vaccine candidate requires ultra-cold storage and transport, and they have demonstrated the capability to ship and store directly from manufacturing sites to administration sites to reduce the time in transit, while monitoring temperatures of packaging at all times," according to the statement. The spokesperson did not explain how Pfizer has demonstrated that capability. "[Operation Warp Speed] has been diligently working with vaccine manufacturers to ensure administration sites have the capabilities to receive and maintain a vaccine with cold-storage requirements for up to 10 days. Administration sites can repack opened shipping containers with dry ice multiple times for an additional 15 days. If a shipment of vaccine doses is at risk of expiring, OWS will guide the movement of those doses to sites with larger demand," the statement continued. Getting back to normal depends on this box There are ultra-low-temperature freezers that can keep a vaccine at -75 degrees. Buying them for sites across the country might seem like the obvious solution to keeping a vaccine so cold. But the CDC has told states not to purchase them. "I just want to let all of the listeners know, to not start going online right now in purchasing freezers," CDC's Dr. Amanda Cohn said at a meeting of the agency's Advisory Committee on Immunization Practices. "We are working on solutions through our distribution and administration planning for these very complex storage and handling requirements at this time." That advice was repeated in CDC's vaccine "playbook" sent out to states in September and October. Instead, the CDC wants doctors and nurses to maintain the vaccine with dry ice – something they've never had to do before. The dry ice will go into a box developed by Pfizer, which the company calls a "thermal shipper." Pfizer will use that box to ship the vaccine, opting out of the government's plan to use McKesson, a third-party distributor, which is expected to handle other coronavirus vaccines when they become available. Clinics can then use the shipper to store the vaccine until it's ready to thaw, dilute and inject into arms. Health care workers, essential workers and those at high risk for COVID-19 complications, such as the elderly, are expected to be among the first to get vaccinated. States will administer the vaccination programs. Public health nurses, as well as private doctors, nurses and pharmacists, will give the shots. At Pfizer's webinar with state health officials last month, the company laid out its specific requirements. Once sites receive their thermal shippers filled with vaccine, they're supposed to replenish the dry ice within 24 hours. If they don't use the vaccine within five days, they're supposed to replenish the dry ice again and then again five days later. Clinic staff must act fast when removing vaccine from the shippers. According to Pfizer's instructions, the boxes can be opened only twice a day, each time for no more than a minute. At any point, the vaccine can be removed from the shipper and put in the refrigerator, where it is good for only five days – any longer than that and the vaccines have to be thrown away. When ready to use, nurses dilute the vaccine, making five doses with one vial. Those five shots have to be given within six hours. If more than six hours pass, the vaccines have to be thrown out. This whole process has to happen twice for each patient, since the vaccine is given in two doses spaced three weeks apart. That's why heads began to explode on the Pfizer webinar, according to five people who attended it. Health care workers have never had to procure dry ice before, much less when it's in short supply, as it is in some parts of the country. Handling dry ice can be hazardous – it can burn the skin and, in spaces with poor ventilation, can produce potentially deadly fumes. There's another potential problem. Doctors and nurses overtaxed with coronavirus patients and other responsibilities will be challenged to follow directions perfectly – directions where mere minutes matter. "They're all so insanely busy," said Moore, the doctor who's helping doctors and nurses get ready. "I know they were astonished when they got their first glimpse from Pfizer on all of the steps in this process, on the thermal shipper and how it worked," she said. "You could see all of the brains spinning." "I could start to smell fumes from the gears turning in their minds about, 'Oh my, how are we going to keep up with all of this? This is not what we expected.'" Penny Shelton, executive director of the North Carolina Association of Pharmacists, said she's confident that state and county officials will have a workable distribution plan in place. "It is going to be a challenge, but I think we will figure out a way," Shelton said, adding that, various coronavirus vaccines become more widely available, pharmacies will play a large role in getting people immunized. An unconventional method for keeping vaccine frozen The thermal shippers are essential to the success of the vaccine, but it's not clear that they work. CNN asked Pfizer what tests they've done to show the thermal shippers are capable of keeping the vaccine at -75 degrees. The company didn't respond. A spokesperson for the U.S. Food and Drug Administration said that, before authorizing any vaccine, "the FDA will review vaccine stability information for each particular vaccine candidate. This information reflects anticipated distribution and storage conditions for a specific vaccine candidate, and our review is provided to ensure that the vaccine's quality, safety and efficacy is not compromised prior to its administration." CNN asked the CDC, HHS and Pfizer how they know the thermal shippers work. They did not answer. "When they don't answer questions, that's when I begin to get nervous," said Schaffner, a member of the CDC's Advisory Committee on Immunization Practices. There are other questions, too. At the August CDC meeting, Pfizer said the shipper could be used for 10 days, and it could be replenished with dry ice for an extended period, but it did not say how long that period was. In September, the group president of Pfizer's Biopharmaceuticals Group, Angela Hwang, said the vaccine can be stored in the shipper for 15 days. In November, a Pfizer spokesperson told CNN that unopened, the shipper can maintain its temperature for 10 days, which allows for extended shipping times, and once opened upon arrival, can be used as temporary storage for up to 15 days, with dry ice being replenished every five days. Such comments have caused confusion among state health officers. In addition, it's unclear where they will get dry ice. HHS has told state governors they will need to obtain the dry ice from local suppliers but has also acknowledged there could be difficulty obtaining dry ice in some parts of the country. The agency says it's exploring options to resolve this, including solutions to provide increased access to dry ice, but it has not yet said what those solutions will ultimately be. Pfizer has told states that, if they can't source dry ice locally, they can use the company's dry ice suppliers. But it has given few details on what that process will look like. That's prompted at least one state, North Dakota, to buy its own dry ice machine – an expensive proposition at $48,000, plus another $40,000 for three months' worth of liquid carbon dioxide, a necessary ingredient to make the ice, according to according to George Gerhardt at the North Dakota Department of Health. Some states are disregarding the CDC's directive not to purchase ultra-low-temperature freezers. North Dakota, for example, has spent $100,000 to purchase 13 such freezers, according to Nicole Peske, a spokeswoman for the state health department. Fears of finger-pointing As state health workers hurry to put their plans in place to distribute the Pfizer vaccine, they know three things are true. One, if there are glitches in getting the vaccine out to the public, the blame will likely fall on them. "I think that there's going to be a level of finger pointing," said Wood, the public health consultant who's helping states with their immunization plans. "People are going to turn around and say, 'Well, public health just wasn't ready. This didn't happen the way that it should have, and these are unprofessional bureaucrats.'" Second, if the distribution of Pfizer's vaccine doesn't go well, an already skeptical public could mistrust distribution of other coronavirus vaccines down the road. "If we lose confidence in the very early, in the first stages, then the downstream ramifications, I think, are pretty profound," Wood said. The third is that, no matter how hard state officials work to plan out the details, no matter how many webinars they attend or CDC playbooks they read, everything right now is theoretical. "There are definitely a lot of opportunities for errors to occur," Moore said. "You don't figure out where the bugs are until you turn the system on. So far, this entire system has just been on paper." State public health officials are resourceful and innovative, Moore said, and right now they're forging ahead. "It's going to be hard. Mistakes will be made, but we will learn from them, and we will get better and better," she said. They try to be optimistic about the prospect of rolling out such an unprecedented immunization plan. "It's a very big deal," said Howell, the North Dakota program manager. "I think we can do it."
Thanks for f@cking all of us Donald... Covid vaccine distribution is undermined by Trump playing politics with transfer of power The Trump administration has stopped all transition activities and funding, and that will slow — if not completely halt — vaccination efforts. https://www.nbcnews.com/think/opini...p-playing-politics-transfer-power-ncna1247305 The safe, timely and equitable distribution of coronavirus vaccines to the American people will be an undertaking akin to landing a spacecraft on an asteroid. For every day — even every hour — of delay, lives will be lost, people will suffer and economic misery will continue. Sulking in electoral defeat, the Trump administration is willfully prolonging the agony. Pfizer announced Monday that its Covid-19 vaccine trials appear to be 90 percent effective in preventing the coronavirus that has infected more than 10 million Americans and killed nearly 250,000. That is indeed great news “for science and humanity,” as Pfizer put it. But creating the vaccine is only the first step — hundreds of millions of doses have to be manufactured and distributed so people can receive them. And the Trump administration is intentionally standing in the way. Emily Murphy, head of the General Services Administration, is refusing to sign the paperwork authorizing funds, office space and access to government records to smooth the transition for the incoming Biden administration. This violates norms established by the George W. Bush and Obama administrations, as well as the law: The Presidential Transition Act requires that the outgoing administration provide resources to the incoming administration. The intention of the law was to prevent a handover of executive power from weakening the country in the face of an ongoing challenge like, say, a global pandemic. The Trump administration, through Murphy, is saying to America: “You didn’t vote for us, so why should we do anything for you? You should have known that the basic functioning of the government would grind to a halt if the president didn’t get his way.” I’m not surprised. I was the homeland security adviser to Vice President Mike Pence and his lead adviser and staffer on the White House coronavirus task force. I was involved in the White House’s internal discussions on the pandemic and efforts to mount a massive vaccination effort. While there, I organized and participated in every meeting of the coronavirus task force until I left the administration in August. I saw firsthand how politics dominated the task force’s work, how the president’s overriding concern for the economy and his re-election rather than the welfare of the American people cost lives. When we briefed the president and vice president on the coronavirus’s ravaging effects on Hispanic and Black communities, their response was only to position minority staffers on the task force more prominently for photo ops. Public health experts have a saying: Vaccines don’t matter; vaccinations do. Having a viable vaccine in a vial somewhere is nice, but it doesn’t do any good unless it’s reproduced in enough doses for every American (and eventually every human) and distributed in a way that it can be administered everywhere — every apartment building in New York City and every small town in the Rockies. It’s a logistical effort big enough to make even Amazon blush. While doctors, nurses and state and local public health officials are likely to be the ones administering most of the vaccines, it’s going to take a massive effort by the federal and state government working with the pharmaceutical companies to manufacture and distribute the vaccine. And that doesn’t even consider the nuances, like paying for it all. Whatever plans the Trump administration might have to execute this Herculean challenge, its official policy is not to share them with the Biden team until they absolutely have to. In a normal transition, the outgoing policymakers, staffers and experts would already be filling in their successors on what projects are underway, what stages they’re at, what the next steps are, and other information the next administration needs to successfully confront the most urgent threats facing the country. But the Trump administration has stopped all transition efforts, activities and funding, and that will slow, if not completely halt, efforts to get vaccines to the American people. Since the transition hasn’t been formally approved, the vital information the next administration needs is either being shared in limited ways through unofficial channels, or not at all. The inevitable result if this continues is that the Biden Covid-19 response team will have to waste valuable time getting up to speed and retracing the few steps this administration has already taken. On top of that, the federal government is scheduled to run out of money on Dec. 11, almost six weeks before the Biden administration takes over. Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi seem to have, in principle, decided to pass new spending bills for 2021 and avert a government shutdown. But if President Donald Trump decides to oppose the legislation, he could force a government shutdown (as he’s done before). The shutdown could last until after the new Congress takes office, on Jan. 3, and Biden is inaugurated, on Jan. 20. The debate over the details is far from clear, and the budget measures are getting tangled up in a coronavirus relief bill — another urgently needed measure to help Americans struggling from coronavirus and facilitate treatment of the disease. With the parties in Congress unable to come to an agreement on issues such as testing or state and local relief, delaying one until Biden is installed would only extend the timeline of the ongoing hardship. Americans should breathe a sigh of relief that Trump was defeated at the ballot box last week, and give themselves a pat on the back for participating in an orderly, fair and free election with historic turnout amid a pandemic. But they should not slip into complacency, because Trump will still be in office for more than two months. For his entire presidency, he has made an enemy out of anyone who dared to tell him what he didn’t want to hear. Now that includes the American people.
How are things going with the vaccine Comrade.... Russia says vaccine 92% effective as 4 doctors who got it catch COVID https://www.cbsnews.com/news/russia-covid-vaccine-infected-doctors-effectiveness/
Are you really going to be first in line for a vaccine that injects messenger RNA in your cells? No... I did not think so, you fear monger.