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  • to end the covert 19 pandemic and to return to some kind of normal, we're gonna need a vaccine.

  • But how long will it take to develop?

  • One 12 to 18 months?

  • Is the timeline that we keep hearing about for a potential cove it 19 vaccine?

  • When do we have a vaccine?

  • 12 to 18 months were 12 18 months away from this going away.

  • But here's a comparison.

  • The fastest vaccine we've previously developed was for months, and that took four years to develop.

  • And typically it takes 10 to 15 years to develop a vaccine, so 12 to 18 months would be a record breaking.

  • So let's look at how vaccines for viruses are typically developed.

  • Stage one.

  • The exploratory stage.

  • The exploratory stages, also known as the research for Discovery Stage for a vaccine here, researchers are trying to come up with the best possible way to immunize us against a virus.

  • This first stage contained between 2 to 4 years.

  • But right now, scientists are speeding through stage one partly because of new technologies and also because this SARS Corona virus has some similarities to the first sauce virus re such as a developing nuclear tied based vaccines that use the viruses genetic code to potentially protects us from infection This is a new way of developing a vaccine where the viruses are in a Ordina prompts our bodies to make a part of the virus, and that's how we develop immunity to it.

  • In January, 2020 Chinese scientists shared the genetic sequence off the new Corona virus.

  • This allowed researchers around the world to understand what the virus looked like and how it worked, and it gave them a head start to developing a vaccine.

  • So if a nucleotide base vaccines work, that could mean that we're done with this first exploratory stage, and that cuts up to four years off our timeline.

  • But and this is a big but nuclear tied based vaccines have never made it through clinical trials on FDA approval, so the exploratory stage can take up to four years.

  • But thanks to existing research on new technologies for vaccine development, some Kobe 19 vaccines may already be through this stage.

  • Stage two pre clinical stage.

  • This is where scientists are testing the vaccine in cell cultures and in animals to see if it triggers an immune response.

  • If there's no immune response or the vaccine is causing harm to cells.

  • Then it's back to square one the exploratory stage.

  • So how quickly can we move through the pre clinical stage for a Kobe 19 vaccine?

  • While the reality is, there's no way to speed up this stage, and it will probably take a least a year.

  • But one way to make this more efficient is to start doing different stages of vaccine development simultaneously.

  • This is exactly what some covert 19 vaccine scientists are doing right now that testing the vaccine and animals at the same time that testing the vaccine in humans doing testing in animals and humans at the same time is unusual.

  • But the FDA does have a fast track process in cases of public health emergencies.

  • Most vaccines don't make it past the pre technical stage, but the American biotech company Moderna is working on a Kogan 19 vaccine I was able to get from the first exploratory stage to human trials in 63 days.

  • Stage three clinical trials.

  • This third stage is clinical trials or testing the vaccine in people.

  • Most vaccines don't ever reach clinical trials, but if they do, then this stage can take 19 months or more, and it consists of three phases.

  • In the first phase, the experimental vaccine is given to a small group of people.

  • This phase can take about three months.

  • If an experimental vaccine is safe, then it moves on to face to face To typically takes at least 6 to 8 months during face to the vaccine is given to several 100 people, including a control group who get a placebo, not the actual vaccine.

  • The control group helps researchers compare how the vaccine works on control for different variables in face.

  • Three.

  • Thousands of people, usually folks in the outbreak area, will receive the experimental vaccine.

  • This phase can also last at least 6 to 8 months, if not longer.

  • And at this point, researchers are looking to make sure the vaccine is effective and to monitor any side effects.

  • These are best case scenarios in terms of the timeline for each phase of human testing.

  • Right now, there are at least three Kobe in 19 vaccines in phase one clinical trials in the U.

  • S.

  • One way to speed up face three clinical trials is to do something called a human challenge trial.

  • That's where people are given the vaccine.

  • But then the scientists intentionally infect them with the virus to see more quickly.

  • If the vaccine really works, it might sound like an extreme way to speed up vaccine development.

  • But it's been done many times before, including with cholera, dengue and Flew.

  • Human Challenge trials raise many ethical red flags.

  • In 2017 there was a proposed Human Challenge trial to speed up a Zika vaccine.

  • And Zika, of course, can cause severe birth defects.

  • And that human challenge Tall was criticized by ethicists as being too risky.

  • So doing the math.

  • The quickest way that a covert 19 vaccine could make its way through human testing without doing human challenge trials is around 15 months.

  • But there could be delays at any point along this timeline stage for regulatory review.

  • At this stage, the vaccine manufacturers submits an application to receive a license so that they can manufacture the vaccine.

  • Typically, it takes the FDA 10 months to conduct a standard review or six months for a priority review.

  • But the FDA can move faster in case of a public health emergency, and some FDA programs allow for a rolling review.

  • That's where the vaccine maker is submitting information as they go along instead of waiting till they finished and then submitting the application.

  • The FDA is responsible for overseeing the safety of any drug or vaccine available in the U.

  • S.

  • So its review of this information is absolutely critical before the vaccine could make its way to a large population.

  • No Kobe 19 vaccines in the U.

  • S.

  • A.

  • Near this stage over in the UK scientists, the University of Oxford are hopeful that emergency approval of their vaccine by UK regulators could mean it's available in September.

  • The best case would be a rolling review of a potential covert 19 vaccine taking less than the usual timeline of 6 to 10 months.

  • Stage five Manufacturing.

  • This is the stage where drug companies start making and distributing their vaccines.

  • It takes an incredible amount of resources on investment in infrastructure, raw materials and scientific expertise.

  • Manufacturing the vaccine can take a long time.

  • According to one estimate, it can take between 7 to 36 months to produce and deliver a vaccine.

  • It can also take a really long time for companies to scale up their manufacturing capabilities.

  • The drug company Pfizer told The New York Times that it took them $600 million on five years just to produce a manufacturing plant for one of their new McCorkell vaccines.

  • And currently we are no at the manufacturing stage for a covert 19 vaccine.

  • But if we were, how quickly would we move?

  • To be honest, this is an unknown and depends very much on the capacity of the drug company involved.

  • Stage six quality control.

  • So we're not done yet.

  • Once the vaccine is distributed to the public, there's the ongoing stage of quality control, and this is done in the U.

  • S.

  • By the CDC, the FDA, on the vaccine maker.

  • So how long will it take for a vaccine is available for the public?

  • Well, we can go through each stage and add up the time taken, but often these air time ranges on.

  • We're seeing right now that sometimes one stage is done at the same time as another stage.

  • When experts optimistically say that they expect to covert 19 vaccine by the end of 2020 they're talking about an emergency use authorized vaccine awfully approved, one on very limited supplies of one.

  • Seeing a vaccine in 12 to 18 months would mean producing millions of doses by January or June of 2021.

  • If things continue to move as quickly as they are now, there's a possibility that there could be a covert 19 vaccine in two years, likely in early 2022.

  • The major delays and potentially seeing a vaccine by the new year would be the time it takes to safely move through clinical trials on the manufacturing stage.

  • Clinical trials usually take a minimum of 15 months, and that's if everything goes perfectly with the vaccine working exactly the way it was designed and not causing major side effects.

  • The manufacturing stage is another unknown, producing a safe and effective vaccine for millions or billions of people could take at minimum seven months.

to end the covert 19 pandemic and to return to some kind of normal, we're gonna need a vaccine.

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新型コロナウイルスのワクチン開発には、なぜ時間がかかるのか? その理由を専門家が解説 | WIRED.jp (新型コロナウイルスのワクチン開発には、なぜ時間がかかるのか? その理由を専門家が解説 | WIRED.jp)

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    林宜悉 に公開 2021 年 01 月 14 日
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