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  • a co vid 19 vaccine will take at least a year to get approved, which may sound like a long time that it would actually be record breaking.

  • New vaccines usually take between 10 and 15 years to get to market.

  • But a year still won't be fast enough to hold off any upcoming outbreaks.

  • What potentially will our treatments?

  • A treatment helps people who are already sick while the vaccine prevents a disease in healthy people.

  • And that's the main reason of vaccine is going to take so long.

  • As of March 26th, there were over 120 different developers pursuing three different approaches to curing Cove in 19 repurpose drugs, new antibody treatments and vaccines vaccines.

  • Unfortunately, since we know it's given to healthy people, you really have to be very careful what you give because one you want to make sure it's super safe, that you're not going to cause something bad by just giving the vaccine.

  • More importantly is that when you then get infection, that the vaccine is good to tackle the infection.

  • But it's not going to make the reactions so severe.

  • Vaccines air designed to trigger an immune response without actually causing an infection.

  • By taking a weakened inactive or partial virus and introducing it to your system, it can start producing the right antibodies to fight it.

  • Antibodies are created naturally by your body, but it takes time, weeks, sometimes months to produce one just the right shape to fit and therefore fight a virus your body hasn't seen before.

  • For some people facing the co vid 19 pandemic that's too long to wait, the infection could spread rapidly in the lungs, causing lasting damage or even kill a person before the body produces enough antibodies.

  • A vaccine allows your body to go through this process without the risk and sets it up with memory cells that will recognize the pathogen if it ever comes back, getting rid of it before you even know it's there.

  • But vaccines have extra long clinical trial phases because it could take weeks or months for participant to develop immunity.

  • Researchers then have to wait several more months to see if they get sick, since it would be unethical to expose them to the virus intentionally and because vaccines are meant to prevent, it's more difficult to get one approved for compassionate use like when you're already so sick that you are gonna die, you'll try anything and everything, right?

  • And so the FDA gives you permission to sometimes try nontraditional drugs because, you know, you're already pretty much, you know, almost dead, right?

  • Dr.

  • Maria Elena Botas e leads a team at Baylor College of Medicine that's working on a cove in 19 vaccine to, In fact, they're using old research, a vaccine candidate from SARS, one that they developed a decade ago.

  • It's been frozen and constantly monitored ever since interest and funding ran out.

  • The virus that causes SARS and the virus that causes co vid 19 share about 70 to 80% of their genetic makeup, making this vaccine a good jumping off point.

  • As it stands, the original vaccine could offer limited protection against Cove in 19 but it could also accelerate the development of a more effective vaccine.

  • It's a rapid switch strategy where you start doing some studies with the current SARS, you build evidence off safety by bringing that molecule to the clinic fast.

  • You may then stop there and not pursue it, meaning not pursue it for licensure.

  • But by then we will have the other one, and you can rapidly bridge Bridget in and switch it in, and then you continue the studies with the other one that it's more specific.

  • But even with this head start, their vaccine still won't be widely available for at least 12 months after it's developed, the vaccine will move into safety and toxicity testing, followed by a clinical trial, then FDA approval.

  • And this is the case for all 40 plus vaccines currently in development.

  • It's unlikely any of them will be finished and approved in time to affect this pandemic.

  • They could stop future outbreaks.

  • Even the leading frontrunner for a vaccine, a candidate developed by Moderna that's already in human trials after unconventionally bypassing animal testing, is still looking at one year or longer for commercial release.

  • It would be a rare example of a vaccine being approved for compassionate use, but it is worth noting that the company is looking into emergency use of the experimental vaccine specifically for aid workers by fall of this year.

  • Besides taking too long, vaccines don't work well in people who are elderly or immunocompromised, two groups that are at high risk of dying from Cove in 19 antibody treatments get around that these treatments follow a similar path to vaccines toe widespread use.

  • But instead of setting your body up to make antibodies itself, this treatment injects pre made antibodies into your system.

  • They can be administered to people who are infected, and they'll start clearing the virus and they'll clear the infection within a matter of hours.

  • They will actually help people recover faster as well as reduced the mortality rate.

  • They can be used preventatively, but they don't last long as vaccines dio, so they're primarily used as treatments.

  • But in this outbreak, medical professionals could benefit from a preventative antibody treatment, so antibodies usually take a while to.

  • But we're doing something that is extremely rapid, and that's because we've already let nature do half of the work for us.

  • Sara IVs and other scientists at Distributed Bio are working on a monoclonal antibody based on one that is already able to neutralize a SARS infection.

  • Because these people have already created these antibodies in their bodies and we are just taking those resource is because people have already studied them already, published their sequences, and we're cutting out months.

  • Two years of the drug development process.

  • Once the team identifies the new antibodies that fit the cove in 19 virus, the tightest it still has to go through the same trials of vaccine does, but a shorter version.

  • The team hopes to have a drug available for widespread use by early fall of this year, and they're just one of more than 20 developers hoping to create a successful antibody treatment.

  • Finally, repurposed drugs could be available as early as April.

  • Those air drugs that the FDA or another regulator has already approved to treat other diseases.

  • And that could work for Covad.

  • 19.

  • Repurposed drugs don't need to go through as much testing as experimental ones, which makes a great case for compassionate use and could already exist in large quantities.

  • The World Health Organization has started global trials on the four treatments that look the most promising three repurpose treatments alongside one experimental drug.

  • But there's no guarantee that any will work.

  • One of these treatments, a drug combo used to treat HIV, already failed in a small Chinese study.

  • But the W H O believes a larger trial with potentially thousands of participants in dozens of countries is warranted The study is unusual for going the traditional double blind method, which opens the study up to the possibility of placebo effects.

  • But it also means they could move faster and get answers and hopefully a cure as soon as possible.

  • As of March 24th, the FDA had approved the use of convalescent plasma as an investigational treatment on a limited basis.

  • It involves taking blood plasma from a person who's recovered from Cove in 19 testing it for antibodies and injecting the plasma or a derivative of it, into someone who's sick.

  • It's worked in the past, but not on every disease.

  • So it's not certain if it will be safe or effective for Cove in 19.

  • Which is why, outside of clinical trials, it's on Lee being approved for use in patients with serious or life threatening infections, even if it is proven toe work.

  • Convalescent plasma isn't scalable.

  • The treatment requires large amounts of donated blood from recovered patients, and each donation could be given toe on Lee, a handful of sick patients, so there's no way to manufacturer or distributed as widely as needed for a pandemic.

  • Thes timelines are a best case scenario where nothing goes wrong for both treatments and vaccines.

  • There's the potential.

  • They won't be approved by the FDA for safety or efficacy reasons.

  • And even if they do get through the approval stage, there's still the issue of making sure there's enough to go around.

  • So there's There's three layers of issues, right?

  • So there's the money issues that you don't have enough and be quite on is never enough scalability and suitability, right?

  • You know.

  • So the logistical piece of not only making it but delivering it and this you need it and you know how how often do you make them?

  • Where do you store them?

  • Who's gonna buy them?

  • We're going to need significant financial and government support so that we can scale up these antibodies and manufacture them at a high enough capacity to be delivered to hundreds and hundreds of thousands of people.

  • Both treatments and vaccines are valuable and necessary for fighting cove it 19 but the bottom line is that we likely won't see any way to medically treat or prevent this disease for weeks.

  • All of the developers are working on fairly parallel timelines, simultaneously trying to make long term and short term solutions available to the global public and the rest of us could help by staying home.

  • Social distancing and self quarantine are the only measures that we can take right now.

  • Thio mitigate the spread of this virus.

  • But when we have a medicine, it will allow people to go back to work.

  • And even if the virus does start to come back in ways, it will still reduce the burden on the health care system as well as our economy.

a co vid 19 vaccine will take at least a year to get approved, which may sound like a long time that it would actually be record breaking.

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B1 approved cove antibody infection treatment plasma

What Could Be The Fastest Way To End The Coronavirus Crisis?

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    林宜悉 posted on 2020/10/23
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