AstraZeneca Phase 3 Trials Paused Due To Safety Concerns

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As to Astra, Zeneca trials for the covid nineteen vaccine hit a snag. The debate resumes as to whether the guard rails and safety protocols worked as intended or it's proof that we're moving too fast in a quest to return to normalcy prior to the pandemic Liz Aibo senior correspondent at Kaiser Health News will update us on the status of the trials and what any setback may mean joining us now, with Liz Zibo senior correspondent. At Kaiser Health News. Thank you for coming on today. Liz thanks for having me. The National Institutes of Health has launched an investigation into the case of a patient who suffered spinal cord damage after AstraZeneca's Kovic Nineteen vaccine trial depending on what I read. It's either proof that the testing process is working as designed or that is evidence of moving too fast and the general public at risk start this out for me if you can. I'd say this is the first example I'd say this is the process working there actually several variety of safety valves that are built into the clinical trial process. So this is one in which a potential side effect was picked up, and we don't know yet if this side effect which is supposed to be a spinal problem if that really was related to the vaccine or not that's why the NIH and others are investigating. More is a comparison going back to h one n one and the vaccine which was developed and implemented very early in the Obama Administration politics aside is there any legitimate comparison as to the vaccine trials of? In one back in two thousand and nine and Kobe nineteen today. The process of getting a vaccine will be longer for Kovin because with H one, N one scientists already had a flu shot and other needed to do was to substitute the h one n one flu sequence for other flu sequences that we've used in the past sue scientists were familiar with the Vaccine Day. Knew how that SORTA vaccine worked the big delay was that the flu vaccine is grown in chicken eggs it's a virus so it's going to chicken eggs and not take some time. So there was a little. Bit of a delay some manufacturing delays with the H One n one vaccine this is very different because this corona viruses very new. We've never licensed vaccine against a corona virus before and the technologies that companies are using to create this vaccine are Ulsan new and most of them have never been used to make a vaccine before big picture. Can you describe the process as far as where we are in the progression as far as phase three trials I keep hearing face three what does that mean for the layperson? Any drug that's going to be used in humans goes through a set period of study and set sequence of trials. So I may be tested enough cell in Petri dish ABC dish they might tested on mice for this kind of vaccine. It's being tested in primates than the first type of trial is a phase one trial, and that's just to try to set the correct dose of the of the vaccine or drug, and to find out any early signs about safety. These are small trials just a few dozen people because these are first in human studies they keep them small to. Make sure that no one's hurt. Then we go to face to trial. Their doctors are looking also for safety and some early signs of efficacy and the big really definitive study is the phase three trial and for a vaccine, these are being given in the United States to thirty thousand people for each trial. So there are two trials that are ongoing right now in the united. States one from Pfizer and one from journal they both are going to enroll at least three thousand people in fact, Pfizer? Just announced a couple days ago they're upping that to forty, four, thousand people and. The reason that those trials need to be so big as they wanNA look for rare side effects, they might be able to find out earlier if the vaccine is effective with fewer people but sometimes, they're rare side effects and this spinal problem that patient apparently had with the Astra Zeneca drug called transverse That's really really rare. So you're not gonNA see really rare but serious side effects until you test them in huge numbers of people. So right now we've got two trials that are in face three, their ongoing the Astra Zeneca trial had just started that was also supposed to. Be a thirty thousand person trial that's been paused because of this potential side effect at the end of it. All best case scenario at least in terms of the Astra Zeneca propose vaccine would it be an annual shot like we get the flu shot or is it something which we may take one time and we're done like maybe the chicken pox virus that's a great question, and in some ways this going to resemble the childhood vaccinations. If anyone out there has kids, we know that they don't just get one shot they'll get a series like measles shots you'll get to what the Yeah, that's right. You'll. You'll get one when the child's around maybe a year or eighteen months, and then they get another one before they enter school. So with this one, people don't yet know how many shots were going to need. Now, the first two vaccines that are closest to making it to approval right now in the US, the Pfizer shot, and also the journey shot those right now to dose vaccines. So you get your first dose which primes your immune system, it sort of. The immune system and prepares it, and then with the Maderna's shot, you get your second shot four weeks later, and that really sets off the immune system to be ready to prepare for this virus and ready to respond with the Pfizer. It's slightly different. It's two shots three weeks apart. But one thing people should know is that let's say you get your first shot for weeks. Later, you get a second shot it takes your immune system, a good two weeks to develop those antibodies. So from the day, you get your first inoculation. Until you may be protected would be six weeks. We don't know yet if we're going to need annual boosters like with the flu shot or even a booster sooner than that, we just don't know but that's a really important question. She is Liz Sabo senior correspondent at Kaiser Health News. Thank you so much for coming on today. Thanks for having me.

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