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<blockquote data-quote="fbirder" data-source="post: 2332916" data-attributes="member: 292398"><p>In the past a new vaccine would have required isolating the virus then finding a way to kill it or weaken it, so that it could still provoke an immune response while not infecting anybody (well, not too many). That could take many years.</p><p></p><p>The RNA sequence of SARS-CoV-2 was emailed around the world by Chinese scientists in January 2020. Three hours later one scientist had already determined a potential vaccine candidate. That cut three years off the development time.</p><p></p><p>In the past vaccine development would have gone along these lines -</p><ol> <li data-xf-list-type="ol">Find a candidate.</li> <li data-xf-list-type="ol">Beg for funding for animal testing.</li> <li data-xf-list-type="ol">Perform the studies.</li> <li data-xf-list-type="ol">Write up and publish results.</li> <li data-xf-list-type="ol">Beg for funding for small scale safety testing in humans.</li> <li data-xf-list-type="ol">Find the volunteers.</li> <li data-xf-list-type="ol">Perform the study.</li> <li data-xf-list-type="ol">Write up and publish the results.</li> <li data-xf-list-type="ol">Repeat steps 5 to 8 for Phase II (safety/efficacy tests in hundreds of humans)</li> <li data-xf-list-type="ol">Repeat steps 5 to 8 for Phase III (safety/efficacy tests in tens of thousands of humans).</li> <li data-xf-list-type="ol">Send all the results to the regulatory agencies</li> <li data-xf-list-type="ol">Wait for approval</li> <li data-xf-list-type="ol">Find somebody to make millions of doses.</li> <li data-xf-list-type="ol">Woo-Hoo. We’ve got a vaccine.</li> </ol><p>Note that all those ‘beg for funding’ steps take a long time - and that time gets longer for each successive phase.</p><p></p><p>But vaccines for covid-19 have thrown that playbook out of the window.</p><p></p><p>The first three steps for animal studies would have been roughly the same. It’s after than things got different. There was no real begging for funding. Money was coming in from governments and big pharma. So they didn’t have to wait to start human trials. And they didn’t have to run them sequentially.</p><p></p><p>Once they they were sure, from Phase I, that it wasn’t going to kill volunteers they could start on Phase II and Phase III. Phase II started first while they tried to get enough volunteers for the efficacy testing. Phase III started before Phase II was complete.</p><p></p><p>And they’re not having to send all the data to the regulatory agencies in one batch. The MHRA have been looking at the data from the AstraZeneca/Oxford as it’s been released. So they should be ready to make a decision within a week or two after the final data.</p><p></p><p>And AZ have already said that they can make 4 million doses for the UK before the end of the year, and a billion doses next year.</p><p></p><p>So that’s how we get a vaccine in less than a year. We don’t cut back on the safety testing, we cut back on the begging for funding and the red tape.</p></blockquote><p></p>
[QUOTE="fbirder, post: 2332916, member: 292398"] In the past a new vaccine would have required isolating the virus then finding a way to kill it or weaken it, so that it could still provoke an immune response while not infecting anybody (well, not too many). That could take many years. The RNA sequence of SARS-CoV-2 was emailed around the world by Chinese scientists in January 2020. Three hours later one scientist had already determined a potential vaccine candidate. That cut three years off the development time. In the past vaccine development would have gone along these lines - [LIST=1] [*]Find a candidate. [*]Beg for funding for animal testing. [*]Perform the studies. [*]Write up and publish results. [*]Beg for funding for small scale safety testing in humans. [*]Find the volunteers. [*]Perform the study. [*]Write up and publish the results. [*]Repeat steps 5 to 8 for Phase II (safety/efficacy tests in hundreds of humans) [*]Repeat steps 5 to 8 for Phase III (safety/efficacy tests in tens of thousands of humans). [*]Send all the results to the regulatory agencies [*]Wait for approval [*]Find somebody to make millions of doses. [*]Woo-Hoo. We’ve got a vaccine. [/LIST] Note that all those ‘beg for funding’ steps take a long time - and that time gets longer for each successive phase. But vaccines for covid-19 have thrown that playbook out of the window. The first three steps for animal studies would have been roughly the same. It’s after than things got different. There was no real begging for funding. Money was coming in from governments and big pharma. So they didn’t have to wait to start human trials. And they didn’t have to run them sequentially. Once they they were sure, from Phase I, that it wasn’t going to kill volunteers they could start on Phase II and Phase III. Phase II started first while they tried to get enough volunteers for the efficacy testing. Phase III started before Phase II was complete. And they’re not having to send all the data to the regulatory agencies in one batch. The MHRA have been looking at the data from the AstraZeneca/Oxford as it’s been released. So they should be ready to make a decision within a week or two after the final data. And AZ have already said that they can make 4 million doses for the UK before the end of the year, and a billion doses next year. So that’s how we get a vaccine in less than a year. We don’t cut back on the safety testing, we cut back on the begging for funding and the red tape. [/QUOTE]
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