I have stated regularly that any vaccine should complete the entire trials & safety process before being offered to the general public in the U.S. This needs to be driven by scientists and doctors; politicians should not interfere and attempt to rush deployment of a vaccine and side-step the safety process. As I stated earlier - I will definitely get jabbed as early as possible with any generally available COVID vaccine that has properly completed the appropriate safety trials. However there are many groups before me in line to get the vaccine first.
A national plan is being put in place to allocate the COVID vaccine in four phases... Committee proposes a four-phase plan to allocate a future coronavirus vaccine https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-allocation-nas/index.html Any new coronavirus vaccine, once approved, should be allocated to people in the US in four phases with first responders and high-risk workers in health care facilities at the front of the line, an independent committee recommended Tuesday. People with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings would be a close second, the National Academies of Sciences, Engineering, and Medicine committee said in a draft framework released Tuesday to help policymakers fairly allocate and distribute a coronavirus vaccine. Any vaccine that receives FDA approval is expected to be in limited supply initially, before production ramps up and enough doses become widely available. "While major efforts are being made to have a significant supply of COVID-19 vaccine as soon as possible, the committee has been tasked with considering the tough choices that will need to be made for allocating the tightly constrained initial supplies," committee co-chair Dr. Helene Gayle, president and CEO of the Chicago Community Trust and a former HIV/AIDS expert at the Centers for Disease Control and Prevention, said in a statement. Dr. Eric Toner, a senior scholar at Johns Hopkins Center for Health Security, who was not involved in this report, said the committee was given guidance from the government that they should assume only 10 to 15 million doses of vaccine would be available initially. "So, given that we have a population of 330 million people in the country, that is a very tiny fraction of people who would be able to have access to vaccine right away," Toner told CNN. The 115-page report recommends allocation in four phases. In the first phase, vaccines would go to first responders, high-risk workers in health care facilities as well as people of all ages with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings. In the second phase the vaccine would be distributed to critical risk workers — workers who are both in industries essential to the functioning of society and at substantially high risk of exposure as well as teachers and school staff. The second phase would also include people of all ages with conditions that put them at moderately higher risk; all older adults not included in Phase 1; people in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and staff who work there. Phase one and two combined would cover approximately 45% to 50% of the US population, the report notes. Phase three would include young adults; children; and workers in industries essential to the functioning of society and at increased risk of exposure who were not included in Phases 1 or 2. And phase four would include everyone else. The draft report goes into detail to explain why the vaccine should go first to the people most at risk of catching it, and of spreading it to others -- for example, frontline health workers. The framework document weighs four different criteria. The risk of acquiring and infection: Higher priority is given to individuals who have a greater probability of being in settings where Covid-19 is circulating and exposure to a sufficient dose of the virus. The risk of severe morbidity and mortality: Higher priority is given to individuals who have a greater probability of severe disease or death if they acquire infection. The risk of negative societal impact: Higher priority is given to individuals with societal function and upon whom other people's lives and livelihood depend directly and would be imperiled if they became ill. The risk of transmitting disease to others: Higher priority is given to individuals who have a higher probability of transmitting the disease to others. Minority communities, who are at higher risk than Whites, weren't placed into particular phases based on race/ethnicity, but the underlying circumstances that leave many of them vulnerable were taken into account. "People of color — specifically Black, Hispanic or Latinx, and American Indian and Alaska Native — have been disproportionately impacted by COVID-19 with higher rates of transmission, morbidity, and mortality.," the draft report reads. "Currently there is little evidence that this is biologically mediated, but rather reflects the impact of systemic racism leading to higher rates of co-morbidities that increase the severity of COVID-19 infection and the socioeconomic factors that increase likelihood of acquiring the infection, such as having front line jobs, crowded living conditions, lack of access to personal protective equipment, and inability to work from home," it adds. The report makes recommendations similar to those that have come from other groups. Toner's group at the Johns Hopkins Center for Health Security, released a report last week recommending that frontline health care workers, emergency services personnel and the most vulnerable to the virus should be the first to get any eventual vaccine because "their prioritization would likely avert the greatest overall harm." The Centers for Disease Control and Prevention also suggested healthcare workers should be the first to get vaccinated, followed by non-healthcare essential workers, then adults with medical conditions who are at higher risk for severe Covid-19, and people aged 65 and older. The CDC's Advisory Committee for Immunization Practices is expected to release its own report. Toner said he has "nothing but praise" for this draft framework. "I think they do a very credible job, walking through the ethical principles and the rationale for prioritizing certain groups over others," he said. "They talk about doing the most good-- maximizing the benefits of the vaccine --by giving it to people who are essential to providing care to others during the pandemic, so for health care workers for example. And also prioritizing those people who are at greatest risk -- and that is greatest risk of getting the disease or transmitting the disease or of succumbing to the disease if they get infected." The committee was formed in July at the request of the National Institutes of Health and the CDC to help advise the federal government on how to allocate vaccine. The agencies wanted an outside voice; the National Academies are independent, non-governmental expert organizations that advise the federal government about policies. There will be a public comment period open until 11:59pm on Friday, September 4. The NAS will hold a five-hour-long listening session on Wednesday for the public to ask questions to the study committee directly.
The C.D.C. tells health officials to be ready to distribute a vaccine by November, raising concerns over politicized timing. https://www.nytimes.com/2020/09/02/world/covid-19-coronavirus.html#link-b76898b The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November. The new C.D.C. guidance is the latest sign of an accelerating race for a vaccine to greatly ease a pandemic that has killed more than 184,000 Americans. The documents were sent out last week, the same day that President Trump told the nation in his speech to the Republican convention that a vaccine may arrive before the end of the year. Over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said in interviews with news organizations that a vaccine could be available for certain groups before clinical trials have been completed, if the data were overwhelmingly positive. Public health experts agree that agencies at all levels of government should urgently prepare for what will eventually be a vast, complex effort to vaccinate hundreds of millions of Americans. But the possibility of a rollout in late October or early November has also heightened concerns that the Trump administration is seeking to rush the distribution of a vaccine — or simply to suggest that one is possible — before Election Day on Nov. 3.
Inb4 massive healthcare worker walk outs and government threats of license recission unless Trump vaccine is taken.
Fauci says he 'would not hesitate for a moment' to take coronavirus vaccine https://thehill.com/policy/healthca...tate-for-a-moment-to-take-coronavirus-vaccine Anthony Fauci, the nation’s leading infectious diseases expert, said he would feel comfortable taking a coronavirus vaccine if one is approved by the government. “I mean I will look at the data and I would assume and I’m pretty sure it’s going to be the case that a vaccine would not be approved for the American public unless it was indeed both safe and effective. And I keep emphasizing both safe and effective. If that’s the case, Jim, I would not hesitate for a moment to take the vaccine myself and recommend it for my family,” he told CNN anchor Jim Sciutto on Thursday. Fauci, a high-profile member of the White House’s coronavirus task force, said a possible vaccine for the coronavirus could be approved as soon as November or December, but said it is “unlikely, not impossible” that one could come out in October. The remarks come as the government ramps up its efforts to craft a coronavirus vaccine as the pandemic continues to rage across the country. There have been more than 6.1 million confirmed COVID-19 cases in the U.S. and more than 186,000 deaths, both figures that lead every other country in the world. The Centers for Disease Control and Prevention (CDC) asked state governors last week to speed applications for building permits for vaccine distribution sites that would be up and running in early November. “The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” CDC Director Robert Redfield wrote to state governors and health departments. “CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.” The Trump administration has made releasing a vaccine a top priority, particularly as three vaccine makers — Pfizer, Moderna and AstraZeneca — conduct phase three clinical trials, the last step before receiving approval from regulators. However, Democrats and other skeptics of the administration are accusing the White House of rushing to put out a vaccine before Election Day to boost President Trump’s reelection prospects. “Too much of the evidence points to the Trump administration pressuring the FDA [Food and Drug Administration] to approve a vaccine by Election Day to boost the President’s re-election campaign,” Senate Minority Leader Charles Schumer (D-N.Y.) said in a statement, referencing a report from The Washington Post addressing the concerns. “All Americans want a safe and effective vaccine as soon as possible, but if these important life and death decisions appear political, it will only undermine Americans’ confidence in a vaccine and prolong the pandemic.” Fauci dismissed concerns that the FDA was being pressured to roll out a vaccine too quickly, saying trials are being independently conducted and the agency has been clear it will make its determinations solely based on available data. “I mean the FDA has been very explicit that they are going to make a decision based on the data as it comes in. These trials have these independent data and safety monitoring boards that intermittently look at the data,” he said. “So I think that we can have some confidence and have faith in what the FDA is saying. They’re saying very explicitly that they’re going to be making the decision based on the scientific data. And we hope that that’s going to be the case.”
Russia’s Covid Vaccine Shows Potential in Peer Review, Lancet Reports https://www.bloomberg.com/news/arti...ne-produces-immune-response-peer-review-shows Shot produces antibody response, no adverse effects: Lancet Publication is first time Russia data has been peer-reviewed Russia’s proposed Covid-19 vaccine induced an antibody response in all participants in early trials and found no serious adverse effects, according to the first vetted data on the controversial project. The vaccine also produced a response in T-cells -- a type of white blood cell that helps the immune system destroy infection -- according to preliminary results from phase 1 and 2 trials that were published Friday in the Lancet medical journal. Russian officials had previously made broadly similar statements about the shot, prior to review by outside experts. Despite limitations in the trials, the peer-reviewed data bolster Russia’s prospects in the race with the U.S., China and Europe to secure a vaccine, following widespread skepticism. Health officials elsewhere criticized the country’s regulatory approval of the shot last month, before it had gone through wider phase 3 trials. Concerns about so-called vaccine nationalism were fueled by allegations that Russian intelligence services orchestrated the hacking of western development programs -- which the Kremlin denied. Friday’s publication marks a “turning point” following “attacks” on the project, said Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund, which is backing the vaccine. “Russia has answered the questions that have been asked about it,” he said on a conference call. “And we are convinced that we have the best vaccine in the world.” No Placebo The trials took place in two Russian hospitals and involved 76 healthy adults aged 18 to 60. The vaccine uses two different human adenoviruses -- relatively harmless germs that normally cause common colds -- that were altered to carry coronavirus proteins that induce an immune response. All participants were given the vaccine and there was no placebo group -- one of several limitations to the trials that were cited in the report. The investigators took convalescent plasma from 4,817 people who had recovered from mild or moderate Covid-19 to compare post-vaccination immunity with natural immunity. Antibody responses were higher in those vaccinated, according to the data. The government has announced plans to begin administering the shot more widely to medical personnel and teachers in the coming weeks, ahead of a broader national campaign slated for late this year. The move has led to concerns that political pressure could prevail over safety considerations and risk public health as the world seeks an end to the pandemic. Two Forms The Russian investigators tested two forms of the vaccine - frozen and freeze-dried. Phase 1 participants were given one of the two-part shots, while phase 2 groups also received a second shot 21 days after the first. All 40 participants in the phase 2 trial produced antibodies, with higher levels found in those who had received the frozen vaccine. Neutralizing antibody responses were found in all phase 2 subjects, while only 61% of phase 1 participants produced them from the single shot. All phase 2 participants showed T-cell responses within 28 days of vaccination, with the frozen shots again proving more effective than the freeze-dried. The investigators said limitations to the study include its size, the short follow-up time of 42 days and the fact that some parts of the phase 1 trial used only male volunteers. The trial also largely focused on people in their 20s and 30s. Russia has also been giving the vaccine to officials and other prominent people outside the trial groups for months without waiting for the full study results. On Friday, Moscow Mayor Sergei Sobyanin, 62, told Russian President Vladimir Putin in a televised video conference that he’d had the shot and felt only minor discomfort at the time. Putin said last month that one of his daughters also had the inoculation and was feeling fine. The Kremlin hasn’t disclosed whether Putin has been vaccinated. Phase 3 Trial A phase 3 trial was approved on Aug. 26 for 40,000 volunteers from different age and risk groups. “The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any Covid-19 vaccine has not yet been shown,” said Naor Bar-Zeev, an associate professor at the Johns Hopkins Bloomberg School of Public Health, in a linked commentary in The Lancet. “Showing safety will be crucial with Covid-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly.”
Trump claims coronavirus vaccine could be delivered next month https://www.foxbusiness.com/politics/trump-coronavirus-vaccine-delivered-october President Trump indicated a coronavirus vaccine could be available next month during a rally in Pennsylvania on Thursday. The president noted that three vaccines are in the final stages of clinical trials. “Under Operation Warp Speed we remain on track to produce a safe and effective vaccine in that record time that we talked about,” Trump said in Latrobe, Pennsylvania. “It will be delivered before, in my opinion, before the end of the year – but it really might even be delivered before the end of October.” The president denied the timing had anything to do with the election, but that it would be nice because “we want to save people.” Trump specifically mentioned Pfizer, which he said is expecting results from ongoing trials within the coming weeks. The company did not immediately return FOX Business’ request for comment on whether it was on track to potentially meet that timeline. Pfizer’s CEO said this week that it should know whether its vaccine works in October, at which time it would immediately seek approval, as reported by Reuters. Other companies that are conducting large clinical trials include Moderna and AstraZeneca. Top U.S. infectious diseases expert Anthony Fauci, however, has cautioned against rushing the widespread distribution of a potential vaccine that has not proven safe and effective in large trials. In terms of the virus itself, Trump called it a “disgrace” and indicated that China could have stopped it from spreading to the rest of the U.S.
Two-thirds of Americans say they won't get COVID-19 vaccine when it's first available, USA TODAY/ Suffolk Poll shows https://www.usatoday.com/story/news...ake-vaccine-right-away-poll-shows/5696982002/ Two-thirds of U.S. voters say they won't try to get a coronavirus vaccine as soon as it becomes available and one in four say they don't want to get it ever, according to a new USA TODAY/Suffolk poll released the same week that the number of COVID-19 cases surpassed 6 million. “I don’t plan on being anyone’s guinea pig,” Ebony Dew, an independent from Capitol Heights, Maryland, said. “I don’t plan on getting it at all.” More:As Americans await a COVID-19 vaccine, health officials worry the US isn't ready for one The 40-year-old access control specialist questions the safety of a potential vaccine, echoing concerns shared by millions of Americans. “I feel like their testing is a trial and error," Dew said. "And I also feel that they don’t really know all that much about this virus, so how can they create a cure for it just yet?” The poll of 1,000 voters follows similar surveys conducted in the past month that indicate as many as one third of Americans would decline a vaccine, fueled by mistrust of the Trump administration's push to speed up its development as well as a sizable slice of the country that generally oppose immunizations of any kind. President Donald Trump has been promoting Operation Warp Speed, a multi-agency initiative to expedite rapid production of COVID-19 tests, treatments and vaccines. Its goal is to produce and deliver 300 million doses of vaccine by January. Three vaccine candidates are in Phase 3 trials in the United States, and more are expected to enter Phase 3 trials by the end of September, according to Alex Azar, secretary of Health and Human Services. Experts say the level of public resistance to an immunization against a virus that has already killed more than 185,000 Americans is concerning because it undermines the utility of the vaccine. “If you have 330 million doses of vaccine and nobody wants it, it accomplishes nothing. You've got to use the vaccine. It’s just as important as how effective the vaccine is,” said Dr. David Salmon, a professor at the Bloomberg School of Public Health at Johns Hopkins University and an expert in global disease epidemiology and control. “You probably need between 70 and 80% of the population to get immune in order to really control COVID," he said. "And when I say immune, I mean both get the vaccine and the vaccine worked for them." The USA TODAY/Suffolk poll found that about two-thirds of the 1,000 voters surveyed – 67% – would either not take the vaccine until others have tried it (44%) or not take it at all (23%) The other third of respondents were split between those who said they would take the vaccine as soon as it's available (27%) or those who were undecided (6%). Those 75 and older were by far the likeliest to say they will get the vaccine right away. The poll, taken Aug. 28-31, surveyed registered voters by cell phone and landline and has a margin of error of plus or minus 3.1 percentage points. Democrats (86%) are more likely than Republicans (61%) to get the vaccine at some point. Men and women were evenly split but the youngest respondents (those under 24) and the oldest (those 75 and older) were the likeliest to get the vaccine either right away or after seeing how the initial immunizations went. Hispanic voters (17%) and Black voters (15%) are less willing than white voters (31%) to take the vaccine as soon as it became available, according to the poll. The survey found that both groups also were likelier not to take the vaccine at all, compared to whites. Some experts say that voters of color will need to be reassured about the vaccine due to often being treated poorly by those in the medical field. Antonio Gonzalez, a Democrat from Portland, Oregon, is among those polled who would wait before getting the vaccine. More:Why volunteer for a vaccine clinical trial? Duty, love and a willingness to experiment, participants say “I think I would do a little bit of reading just to just to understand the process of this vaccine’s creation and how it aligns up to what could be considered best practices for general vaccine creation,” he said. Eileen Burnatt-Hall, a Democrat from Palmdale, California, and Debra Hall, a Republican from Farmington, New Mexico, would immediately get the vaccine once it's available. Both likened it to the flu shot. “I get the flu shot right away so I don’t know what would persuade me to wait," Burnatt-Hall, 64, said. "All these people complain about getting the flu, but they don’t (get) the shot so, I would just go ahead and do it,” she said. Forty-one percent of those surveyed would not get the coronavirus vaccine if the federal government mandated it versus 50% of those who said they would. Dozens of doctors, nurses and health officials interviewed by Kaiser Health News and The Associated Press expressed concern about the country’s readiness to conduct mass vaccinations, as well as frustration with months of inconsistent information from the federal government. The gaps include figuring out how officials will keep track of who has gotten which doses and how they’ll keep the workers who give the shots safe with enough protective gear and syringes to do their jobs. David Brockman, an independent voter from Columbus, Indiana, would “consider” getting the vaccine, but would be further put off if he was mandated by the government to get it. “If they’re forcing me to get something like that, it makes me think more that there’s something behind it," he said. As for the vaccine itself, Brockman is still unsure if he can trust it. “I just don’t know if that would be something that right away I would just like stick my arm out and say ‘hey, oh yeah. Give it to me.” Scientists have also voiced concern over the readiness of the vaccine, worried that pressure from Trump ahead of the Nov. 3 election might lead the FDA to approve the vaccine before it is fully tested. Concern over political pressure comes after the Food and Drug Administration claimed blood plasma reduced deaths in coronavirus patients by 35% as justification for issuing an Emergency Use Authorization for plasma – another treatment the president has said is promising. However, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he’s confident that the experts in charge of the vaccine will not be swayed by politics.