Latest Vaccine News

Discussion in 'Politics' started by gwb-trading, Apr 24, 2020.

  1. Not "news" for those of us who discussed this in the posts about the problems with current testing.

    Dead cell problem a/k/a "viral shedding."

    Also discussed as part of that is the fact that it is or has been a limitation in determining when a person is actually no long infectious. Viral shedding can go on long after a person is free of live viruses. If the type of test used is just picking fragments of the virus.''

    You are welcome.
    #21     Apr 29, 2020
  2. gwb-trading


    Coronavirus vaccine: where profit and public health collide
    Whoever wins the race to come up with a successful coronavirus vaccine will also win massive profits. But while the industry vows to make a vaccine globally accessible, not all are on board with that idea

    There is a degree of consensus within the medical and scientific community that it will take at least 18 months for a vaccine against COVID-19 to be successfully developed and distributed.

    While some researchers are more optimistic about how soon it is before people can worry a little less about face masks and infection rates, others in the field of drugs science say it could take longer to develop a vaccine against the virus.

    However, a crucial question posing a dilemma for both the pharmaceutical industry and politicians around the globe is already emerging: which countries will be served first with a vaccine?

    German health expert Ilona Kickbusch told DW that health authorities across the world are working to find a viable solution to the distribution issue, but adds: "For the time being, there are no international rules for sharing any possible vaccine in an equitable way."

    Profits reign supreme

    Jürgen Wasem, a professor for healthcare management at the University of Duisburg-Essen in Germany, notes that drugs research and development is usually driven by market forces.

    "This poses the risk that markets in western Europe, Japan and the United States will be supplied first because patients there are able to pay the highest prices," he told DW. "This problem prevails in all pharmaceuticals markets around the world."

    When it comes to developing medicines available for all populations in the world, the image of Big Pharma has long been tarnished. Supply bottlenecks for some specific drugs are often the result of the pricing policies pursued by major drugmakers, says Wasem — a claim, which is nonetheless "difficult to prove in most cases," he says.

    Sometimes, companies strive to keep supply artificially low, he says, to achieve higher market prices. Moreover, certain treatments are often never developed because there isn't a "commercial incentive" to undertake the effort, he adds.

    Private firms lead search for coronavirus cure

    Despite obvious issues with private interests in drugs research and development, Wasem still strongly believes in a market-driven approach, especially in the current search for a coronavirus treatment.

    "What we are seeing is a whole range of competing initiatives out of which some may eventually be successful. Vaccine development is very costly and fraught with risk," he says.

    At the moment, hopes in the global fight against the virus pandemic rest primarily on the shoulders of four major vaccine developers and a large number of smaller biotech companies. Altogether, they've launched almost 80 different vaccine projects, with many of the firms having entered into joint ventures to share the burden. German startup Biontech, for example, has teamed up with US pharmaceutical giant Pfizer.

    More than a dozen different COVID-19 vaccines are scheduled to start clinical trials in the course of this year, with the most promising currently being developed in China, the US and Germany.

    Hopes for a global supply agency

    Amid the pandemic though, governments and international health officials are wary of leaving global distribution of a possible vaccine to market forces, fearing supply bottlenecks and exorbitant prices.

    United Nations Secretary-General António Guterres recently declared a future COVID-19 treatment to be "a public good" that must be made available to everyone. The perception is shared by German Chancellor Angela Merkel, who hopes for multilateral negotiations to reach global agreement on the issue.

    (More at above url)
    #22     May 1, 2020
  3. Wallet


    Hence why low cost treatments will never be allowed.
    #23     May 1, 2020
  4. gwb-trading


    These folks seem optimistic that they will be broadly manufacturing a COVID-19 vaccine soon. I am not so sure.

    Coronavirus vaccine: Moderna signs deal for 1 billion Covid-19 doses a year
    2 min read . Updated: 01 May 2020, 05:59 PM IST Eric Pfanner , James Paton , Bloomberg

    Moderna announced a global agreement under which Lonza Group will ramp up output of the proposed vaccine, which is based on a novel technology that relies on genetic material called mRNA. They expect the first batches to be produced in the US in July

    Moderna Inc., one of the leaders among US companies developing experimental vaccines against the coronavirus, entered a pact with Lonza Group AG aimed at manufacturing 1 billion doses a year.

    The companies announced a global agreement under which the Swiss chemical and pharmaceutical company will ramp up output of the proposed vaccine, which is based on a novel technology that relies on genetic material called mRNA. They expect the first batches to be produced in the US in July.

    The agreement is one of several partnerships being struck between drugmakers as they rush to bring protection against Covid-19 to the market. On Thursday, AstraZeneca Plc announced an agreement to make an experimental coronavirus vaccine developed by the University of Oxford, eyeing production capacity for 100 million doses by the end of the year.

    Because prospects for drugs to treat Covid-19 remain uncertain, rolling out vaccines on a widespread scale could be key to reopening economies from lockdowns. Otherwise new waves of infections could emerge, potentially on a seasonal pattern like the flu. If Moderna and Lonza reach their target of 1 billion doses a year, that would be enough for more than one-eighth of the world’s population.

    With dozens of projects under way around the world, the Trump administration wants to make shots available for Americans by the end of 2020. Richard Hatchett, head of the Oslo-based Coalition for Epidemic Preparedness Innovations, has said cooperation between drugmakers could accelerate the process of bringing out a vaccine, which normally would take a year or more.

    New technology

    Moderna’s experimental shot induces the body’s own cells to make virus-like proteins that stimulate an immune response and prepare for an actual infection. It was one of the first proposed coronavirus vaccines to enter human trials. The company said it plans to begin the next phase of studies this quarter.

    Shares of Moderna, which is based in Cambridge, Massachusetts, have more than doubled since the start of the year as its studies of its vaccine candidate have advanced. In premarket trading Friday, they rose 3%.

    The pact with Lonza will enable a tenfold increase in manufacturing, which Moderna has already begun, according to a statement.

    The smaller players in the race won’t be able to produce a vaccine in large quantities on their own. Inovio Pharmaceuticals Inc., another U.S. biotech company in the first stage of testing an experimental vaccine, said Thursday that it agreed to expand a manufacturing collaboration with Germany’s Richter-Helm Biologics.

    A partnership between Sanofi and GlaxoSmithKline Plc announced last month brought together a pair of pharmaceutical giants with manufacturing might. Sanofi will test its experimental coronavirus vaccine with Glaxo supplying so-called adjuvants, additional ingredients that improve efficacy and make it easier to produce shots in larger quantities.
    #24     May 3, 2020
  5. gwb-trading


    Italian scientists claim to have developed world’s first coronavirus vaccine
    ‘Human tests are expected after this summer,’ says chief executive of company developing treatment

    Italian researchers claim to have developed a vaccine that can neutralise the coronavirus in human cells.

    Tests carried out at Rome’s Lazzaro Spallanzani Hospital, which specialises in infectious diseases, generated antibodies in mice that work in human cells.

    “This is the most advanced stage of testing of a candidate vaccine created in Italy,” said Luigi Aurisicchio, chief executive of Takis, the company working on the treatment.

    “According to Spallanzani Hospital, as far as we know we are the first in the world so far to have demonstrated a neutralisation of the coronavirus by a vaccine,” he told the Italian news agency Ansa.

    “We expect this to happen in humans too.”

    “Human tests are expected after this summer,” Mr Aurisicchio said.

    He added: “We are working hard for a vaccine coming from Italian research, with an all-Italian and innovative technology, tested in Italy and made available to everyone.

    “In order to reach this goal, we need the support of national and international institutions and partners who may help us speed up the process.”

    After a single vaccination, the mice developed antibodies capable of blocking the virus from infecting human cells, Mr Aurisicchio claimed.

    He said researchers observed that five candidate vaccines generated a large number of antibodies and they then selected the two with the best results.

    (More at above url)
    #25     May 8, 2020
  6. gwb-trading


    When can a Covid-19 vaccine really be ready?
    Opinion by Kent Sepkowitz

    Control of the Covid-19 pandemic remains elusive. There are now more than 3.4 million cases around the world, with thousands of people dying every day. Given limited treatment options and the difficulties of sustaining social distancing, many people see a vaccine as the only viable path forward.

    But when will a Covid-19 vaccine be available?

    I have no idea. And I promise, neither does anyone else. This is a heated moment with too much hope, too much fear, and too much on the line for anyone to have clear-eyed perspective. That said, for me, fall 2020 seems overly ambitious; even January 2021 is quite early for a safe and effective vaccine to be available for millions of people.

    Vaccines usually take years to develop; CanSinoBIO, a leading company in Beijing, recently received praise for moving an Ebola vaccine from concept to approval in just a little more than three years.

    Why it is so difficult? After all, the basic approach to vaccine development has remained more or less the same for the past 200 years: trick the immune system into developing protection against a specific infection, be it smallpox or rotavirus.

    Sure, the scientific sleight of hand has changed dramatically. We have moved from injecting live pathogens, to killed pathogens, to weakened but still alive pathogens to injecting genetic scraps from the pathogen using the latest techniques. But chicanery has remained the basic MO.

    Given all this know-how and our powerful computers, brilliant vaccine experts, lab space and plenty of money, many still wonder why we can't just muscle our way forward.

    Alas, it turns out that the modern age, though surely higher tech than the eras that came before, is still not up to the task of medical miracles on demand. Human biology remains far too complex for our minds (and our computers) to comprehend.

    That said, this is an exciting moment. On April 30, the World Health Organization posted an up-to-date inventory of Covid-19 vaccine initiatives. The list included eight trials -- half of which are in China -- currently enrolling human volunteers, and 94 trials still in pre-clinical development.

    In addition, health agencies, pharmaceutical and biotech companies, and researchers have pledged to collaborate closely across countries and scientific communities.

    Before digging into the vaccine list, a quick terminology review: The starting place for a clinical trial is "Phase 1," which is designed only to assess product safety. If there is no evidence of danger, the product progresses to "Phase 2" to determine whether the disease responds to the new product. If things look good, the last is "Phase 3," usually a large randomized trial involving thousands of people to determine safety and efficacy at long last.

    Of the eight trials currently enrolling volunteers, only three are in Phase 2. Of these, only the "Oxford Trial" (a Phase 1/Phase 2 hybrid) from the United Kingdom has prevention of Covid-19 infection, rather than a laboratory result, as the primary desired outcome.

    Why? The Oxford team has the odd advantage of conducting the trial in Britain, where rates of infection are still high. Germany and China, however, lack sufficient cases to accurately test vaccine efficacy. And since ethical constraints prevent scientists from infecting participants with a serious disease, a consortium of German, Chinese and American companies are developing a product currently being tested only in Germany, that instead uses surrogate markers -- antibody measurements -- against the virus. Teams will examine both the amount and duration of antibodies against the disease created in response to the vaccine.

    These groups have benefited from extensive experience in the field of vaccine development. They already have worked out certain techniques and theories, giving them a substantial head start -- a screaming endorsement for the long-term value of research that may not seem immediately pressing. As we now see, what may seem like an interesting but obscure pathogen today may be the cause of a pandemic tomorrow.

    Though many teams are working toward a vaccine, many roadblocks have been developed to intentionally slow the process in the name of safety. The history of vaccination has cast a long, dark shadow of side effects, both real and imagined. Injecting foreign material into people hoping that it will trigger a specific reaction without stirring up anything else is a medical high-wire act that has come to seem routine. It is anything but, as the history of vaccines -- and vaccine discontinuation -- attests.

    There is another potential pitfall as well: a worry that the vaccine might make the infection more severe.
    This is more than just theory. For decades, dengue fever, a viral infection common in tropical climates, has been known to cause a much more severe infection the second time certain people develop the disease.

    Many clinicians believe this phenomenon may occur after other respiratory infections -- including coronavirus -- though thorough investigation similar to the dengue work has not been done. Indeed, the increased severity of the "second wave" of the 1918 Spanish Flu, with the predominance of fatalities in younger people, may have been due to hyper-inflammation, perhaps due to previous influenza exposure.

    Thus some experts fear that if a Covid-19 vaccine does its job provoking the immune system, the body could go into a destructive overdrive when exposed to the actual virus.

    This is a doomsday scenario to be sure, but one that is giving the scientific community substantial pause as the world rushes headlong toward a vaccine. Veteran vaccinologists remain haunted by past missteps and are speaking up; indeed, placing the focus on caution, not speed, is the plea of many who have been through this before.

    The appropriate balance of urgent need against patient safety, they all agree, can be accomplished with thorough screening of volunteers and monitoring not only symptoms but markers of immune activity and over-activity. Regulatory involvement to aggregate any adverse events across a large study population also will be necessary to detect any early clusters of unexpected symptoms.

    In many ways the new "hurry versus slow down" tension over vaccine development exactly recapitulates the "anti-lockdown versus shelter-in-place" conflict: one side desperate to return to life before the pandemic at any cost and the other arguing that safety must always come first.

    And curiously, President Donald Trump's bromide that the cure must not be worse than the disease, while completely misguided for the issue of shelter-at-home, is on target for vaccine development. Because the only thing worse than no vaccine during a pandemic is a vaccine that makes matters worse.
    #26     May 11, 2020
  7. gwb-trading


    Let’s Say There’s a Covid-19 Vaccine—Who Gets It First?
    An immunization shot is still in development, but debate over who gets priority has already begun.

    The race to find a vaccine against Covid-19 is well underway. It has to be—without one, the Before Time is never coming back. More than a hundred candidates are cooking, most still preliminary. A handful are in early human studies, three in Phase II clinical trials designed to see if they actually confer immunity to the disease.

    But nobody thinks finding a winner will be easy; vaccine development typically takes years. That’s time researchers and governments don’t feel like they have. Globally, more than 4 million people have gotten sick, and 280,000 have died. People sheltering in place and the closure of businesses has cost 30 million jobs in the United States alone. As the famed virologist Peter Piot wrote in an account of his own experience after getting sick with Covid-19, “the only real exit strategy from this crisis is a vaccine that can be rolled out worldwide.”

    Even if scientists do develop a safe, broadly effective vaccine, nobody knows how to give it to billions of people. It’ll be scarce at first and—depending on how it works and how it’s made—potentially difficult to transport. They have to figure out how to deploy it now, so that a planet’s worth of people in desperate need will be able to get it.

    One approach might be to initially give the vaccine only to members of specific groups. Of course, then someone will have to decide which groups get priority. That order will be hard to figure out. Even if the answer is “whoever is most at risk of dying,” the epidemiological data still isn’t clear on which group meets that criterion. Older people are more likely to get severely ill and die, but researchers are still trying to work out the role that children play as carriers, for example. “The more fine-grained that is, the more we can define the risk groups, both with respect to how much risk they have of getting infected and the risk of severe outcomes,” says Andreas Handel, an infectious disease modeler at the University of Georgia.

    And “most at risk” isn’t necessarily the right answer. Maybe people at high risk of catching the disease but with a lower risk of bad outcomes should be first in line. That could mean prioritizing people with high-exposure jobs that involve a lot of public contact, or that could mean addressing the systemic problems that have led to poorer, African American, and Latinx people facing more illness and death from Covid-19. That’s not easy. “It could be groups with underlying health conditions, or people who, because of the kind of work they’re doing, can’t avoid contact—like health care workers, police officers, grocery store workers,” Handel says.

    Alternatively, maybe the vaccine should go to the groups for whom it’d do the most good, immunologically speaking. The vaccine against seasonal influenza, for example, isn’t as effective in older people. If a Covid-19 vaccine has the same limitation, that’s a big problem.

    It could also be a solution. Maybe the best bet is giving the vaccine to people who mount the biggest immune response to it—young, healthy people, perhaps—to start building a roundabout sort of herd immunity. “It could be conceptually possible that it’s better to give it to age groups that don’t need it as much, but indirectly protect the other age groups,” Handel says. “The question then is, should you focus on giving the vaccine to those who don’t directly benefit the most because their risk is lower, but if they’re vaccinated, they can’t get it and pass it on to their parents?”

    By the time a vaccine is available, the pandemic may have entirely new geopolitical characteristics. Researchers don’t expect that the disease itself will have changed in important ways, but if hotspots arise in countries with bad health infrastructure or a damaged civil society, that’ll make it difficult for those nations to afford a vaccine, and hard for them to deploy it. “How do we make public health and ethical decisions, both within countries and globally, to ensure there’s equitable and affordable access to scarce lifesaving resources?” asks Lawrence Gostin, a health policy researcher at Georgetown University and co-author of a recent article on vaccine distribution equity in the Journal of the American Medical Association. “Countries are likely to compete with one another for scarce vaccines and hoard them for their own citizens. How do you create and advance planning and protocol to ensure that all countries cooperate and share scarce lifesaving resources?” This isn’t just academic; during the H1N1 influenza pandemic in 2009, countries hoarded vaccines even though the disease killed 18,000 people worldwide—a horrifying number that today nevertheless manages to seem small.

    Getting vaccines to poorer and socially unsettled parts of the world can be dangerous for health care workers. And parts of the world with less energy infrastructure challenge the so-called cold chain if a vaccine requires refrigeration. (An Ebola vaccine gets to people who need it in the Democratic Republic of Congo in an entirely new kind of portable cooler.)

    Countries with more fragile societies also present a communications challenge. If people don’t know what’s going on, or don’t know how a vaccine works, they might refuse it. Imagine if the first time you heard about a vaccine was when people rolled into your town wearing full hazmat gear, wanting to give you a shot. “We need to be careful, even in the more advanced parts of the world, with the best and most sophisticated health care systems, about how we communicate, how we get communities to understand what’s going on,” says Chimeremma Nnadi, Global Medical Director for Vaccines at Merck and a former medical officer at the Centers for Disease Control and Prevention. “If you look at the global south, for instance, where you see systems and structures that are not as advanced, for most of those places the same suspicion around the origins of the vaccine is very free-flowing.”

    One way to address a few of these problems all at once might be not to think of the solution as being only one vaccine. That’s one of the centerpieces of a new framework in an article in the journal Science this week, co-written by Larry Corey of the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Center, John Mascola and Anthony Fauci of the National Institute of Allergy and Infectious Diseases, and Francis Collins, head of the National Institutes of Health. (That’s a heavy-hitting shared byline.) “What we outline is an approach that we feel will do what is best for the world, which is to identify as many effective vaccines as we can, to characterize their effectiveness as transparently and with as great veracity as we can, and to set up a system that allows the immediate translation of effectiveness into licensure and manufacturing and distribution into people’s arms as quickly as possible,” Corey told WIRED. “That has been a major issue for vaccines since eternity.”

    Putting multiple vaccines into action could help serve many populations in lots of locations living under different conditions. “The diversity of the vaccination, the logistic aspect of things—cold chain, one dose or two doses, side effect profiles—all these things are why we want to have more than one platform and why we’re thinking about how to advance as many platforms as we can,” Corey says.

    Having a bunch of approved vaccines might also help accelerate the typical curve of improvement. “History tells us that the first vaccines that get licensed generally are not the ones that are widely used. They usually get replaced after a couple years,” says Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “We improve on them.” And the goal of multiple vaccines might also help deal with some of the competitive aspects of the race, if the various companies and labs working on the problem know that they still stand a chance of being successful even if they aren’t the first to market.

    It’s not a perfect solution, for sure. In the fight against Ebola in the DRC, Gostin says, “there were two effective vaccines, but there were huge implementation problems. One: There was enormous controversy about whether it’s too confusing to deploy two vaccines that needed different doses. But even more important, you had community distrust and political violence.” That has been true for the last-mile efforts to eradicate polio, too. “In both of them, the bottom line was a lot of anti-vaccine attitudes, public distrust, and violence against health workers and vaccine workers,” Gostin says.

    The question of who will get a Covid-19 vaccine first, and how to get it to them, is central to the planning of international non-governmental organizations like the Coalition for Epidemic Preparedness Innovation and Gavi, the Vaccine Alliance, and to national CDCs and the World Health Organization. “Covid-19 has demonstrated over and over that for public health, for government, for economists, and for any elemental human endeavor, that we’re learning a lot,” Nnadi says. “We’re essentially building the plane as we fly it.” And so far, that plane is jetting through heavy fog, with only the ghost of a flight plan.
    #27     May 12, 2020
    Bugenhagen likes this.

  8. Some of these writers like to plunge right into the navel-gazing right off and then go in circles.

    In, the U.S. if you have lots of access to testing at some point and then access to a vaccine at some point, then just apply both testing and vaccines full-bore at all nursing homes first. Test them every day if needed before you start testing people in some county that has 2-3 cases just for fun. Probably that is not the right strategy for Africa, but hey, I don't live in Africa and am not defining what their strategy should be. But in the U.S. we need to dial back all this talk about how "we don't know anything about this pandemic." Actually we have learned about has hard and concretely as possibly that nursing homes are the epi-center for outbreaks, and deaths. Take care of bidness. Start going with what you do know and go from there.

    Possibly I am just on the rag too. but sheesh. A little bit of pareto goes a long ways sometimes.
    #28     May 12, 2020
  9. gwb-trading


    I expect medical staff and first responders will be first on the broader list in the U.S.

    The reality is that it is likely to go more like this...

    U.S. COVID-19 Vaccine Priority List

    1. Politicians and their families.
    2. The Super Rich.
    3. Lobbyists and Major Political Donors.
    4. Staffs of top politicians
    5. Corporate Executives.
    6. Foreigners who pay big money.
    7. Medical staff at hospitals which donate money to politicians.
    8. One or two random minorities for government publicity.
    9. Cronies of politicians.
    10. Military on active deployment status and in ships.
    11. Anyone in a patronage position given to them by a politician.
    12. First Responders and medical staff in top 20% wealth zipcodes.
    13. Those who suddenly donated to politicians
    14. The rest of the military.
    15. First Responders and medical staff in poorer zip codes.
    16. The upper middle class.
    17. People working in meat packing plants and grocery stores for publicity.
    18. A few random middle class neighborhoods for publicity.
    19. YOU
    20. The poor and everyone else
    #29     May 12, 2020
    CaptainObvious and Bugenhagen like this.
  10. I treat it like the flu shots when they were in short supply.

    medical workers, elderly, children and those who work with those groups first..

    after that voluntary since many of us don't get flu shots and don't get the flu. granted I could get COVID and not get symptoms but still spread it so we have to had more precautions for those that don't get it.
    #30     May 12, 2020