35 Burst results for "FDA"
The NYT Is Eager to Blame the Spread of COVID on YOU
"A meanwhile, The New York Times eager to blame any spread of COVID on you. If you use anything they consider to be a far right platform, that includes gap. Now I don't use gab, but I don't know what's on gab. All I know is that it's a year after omicron surge officials see a reduced COVID threat this winter, who are the officials, Anthony Fauci, does anyone care no? Really? I mean, I've never seen such shattered credibility from the public health agencies ever. A lasting legacy of COVID far right platform spreading health myth. Now, I think that's absurd. Here I am, a conservative talk show host center Wright, perhaps got my two boosters, told this in the beginning, get your two vaccines, got your three boosters. I've got them still haven't had COVID. I fully expect somewhere down the road. I will get it, and I help my immune system has developed the necessary antibodies. No misinformation, there is a tunnel full of people who want to worry about that and that they're fine, but they don't do it on right wing. They find each other everywhere. You don't need to say this is a conspiracy theory. It's not. The CDC dropped the ball the FDA dropped the ball. Parts of the Trump administration originally, while they were doing warp speed, dropped the ball on the communications because they were being driven by Tony Fauci. And now the entire government is wrapped up in trying to prove that they didn't do anything wrong. In fact, public health completely botched the entire pandemic.
CEO Nate Jones Talks About His Company's Xlear Nasal Spray
"Very interesting story here. I want to talk about how the Federal Trade Commission is targeting a company for trying to help people. It's remarkable. Nate Jones joins us, CEO of clear, and that is spelled X clear. Welcome to the Charlie Kirk show. Well, hey, thanks for having me. Tell us your story. No, the story is I'm a founder CEO of a clear spell that are, but it's pronounced clear. And we've been selling nasal hygiene products for over two decades since 2000. And most people are familiar with using a saline spray. Ours actually has xylitol in it. It's a sugar molecule that is actually been shown to block bacterial and viral adhesion of a variety of bacteria and viruses. My father's a physician. He started using it in a nasal spray to wash out the airways of young children. In his practice, that we're having recurrent upper respiratory issues. And so we've been doing this for 20 years. And when this pandemic came along, we had a bunch of doctors that were using it for people with COVID and they called us and said, hey, you guys need to look into this. And so we started doing research and trying to find out what was going on there. And what we found in some of these studies and there was a study that came out of university of Tennessee where they showed that xylitol actually was able to block the SARS CoV-2 virus from adhering to the tissue. And so we started we went to the FDA and said, hey, we would like to do a human trial on this and see if it works. And they said, well, no, you're not a drug. You can't do it. We've tried many times. We tried to go into barda. We've tried getting this information into the CDC. And it's just been ignored.
"fda" Discussed on Bloomberg Radio New York
"There would not be a way for the FDA to know if it was at a level that was dangerous, except years later. It's too late by that. How did it come to be that the agency overseeing the safety of these products relies on the reporting of the manufacturer instead of doing independent testing themselves? The law that created the FDA is about a hundred years old. It's changed a little bit, not that much. You know, the FDA was as small underfunded agency. They didn't have the money to do the studies, so the companies did the studies. And the FDA does vet the studies. They look at the research results, sometimes they disagree completely with what the company says about the implications of the research results, but there is an honor system and the honor system is that the FDA believes that the data that the company is providing the raw data are accurate and they don't check those, and there are certain other things that they don't check. And of course, there's so many products that it would be enormously expensive for the federal government to pay for all of it. Do you think that that is going to change now that we're starting to see an increase in the discovery of harmful substances in products? It sounds like the FDA hasn't been very enthusiastic about the value sure analyses, which I think is disappointing. And I'd like to know why that is. Why do you think that is? As somebody who spends a lot of time looking at the FDA, why do you think that would be? There's always going to be a certain amount
Pfizer study says updated COVID boosters rev up protection
"Pfizer says a study of their updated booster shots shows a significant improvement in antibody levels In newly released findings Pfizer says antibody levels jumped 13 times higher in people 55 and older a month after getting its updated COVID-19 booster And four times the levels generated by an extra dose of the original vaccine Among younger adults antibody levels rose 9 and a half times It's too soon to know how much real world protection that translates into the shots rolled out in September but the CDC says only a little more than 26 million Americans have gotten their updated booster which is tweaked to target the most common strain of omicron variant The FDA's vaccine chief doctor Peter marks says the new data while preliminary should encourage people to get their bivalent booster before the holidays health experts say it's shaping up to be a rough winter with an early flu season children's hospitals already packed with patients battling another respiratory illness called RSV and COVID cases expected to rise I'm Jennifer King
DOJ Raises Threat of ‘Selective Enforcement’ Against Red States
"The administration knows what it is doing I guarantee you it is targeting Republican areas and Republican precincts And this is nothing more than intimidation by the Biden administration during the midterm election I'm telling you this Department of Justice is the most contemptible Political rogue operation We've ever seen Ever seen And it is hiding the ball Hiding the ball people want to know where exactly well they're investigators and prosecutors be looking They won't say So that tells you what the goal is here is to intimidate Republican voters Woodson's group has been trying for months to force DoJ to hand over its strategic plan For implementing Biden's executive order and voting access FGH sued for access to the plane so far justice has only released a heavily redacted copy which and said DoJ's broad explanation of its plan this week still falls short of details FDA's looking for and said the department is still failing to be transparent about its actions less than two weeks before the election Said the limited information the OJ is released amounts to a warning to red states that their processes could be picked apart by the Department of Justice
Does CDC Vote Mean Childhood COVID Vax Will Be Mandatory?
"Are asking Charlie, what does this mean exactly? Does this mean that it's going to be mandated not necessarily but in certain states it's going to be put on the official schedule that then school districts follow to be able to mandate. And also, let's just put it aside for parents that are not as clued into this. Parents that are not as well read, it gets on the official CDC website. That doctors put up on the wall for reference. They say, this is what your children need. This is what your children need to do. This at two months. And if you ask questions, most pediatricians say that have it, you're a bad person. They will scold you. We have a great pediatrician. We don't have that issue. Thankfully, so I want to play a piece of tape here cut one O four, doctor Harvey, kirsch, rich. I'm sorry. Doctor Harvey rich does a great job. Let's play cut one O four. My trust level in those institutions is zero. I have zero trust in the CDC and I have zero trust in the FDA. They have shown their complete corruption with regards to industry sponsors and it's despicable. I believe that the people in charge of those agencies should be prosecuted in court for that degree of corruption. They show that their allegiance has been to their companies and not to the American people. My trust in the CDC is zero.
Phil Kerpen: mRNA Technology Raises Lots of Questions
"Well I think that the main advantage of the mRNA technology had is that it could be scaled up for a hue for the manufacturing could be scaled up to produce an enormous number of doses very quickly which would have been more difficult but the other vaccine platforms And so I think it was selected Principally for practical reasons in terms of manufacturing and delivery more so than it being the best platformer technology to actually make the most effective vaccine And maybe in retrospect that was a mistake Ironically one of the supposed great advantages of it is that they would be able to update it very easily and very quickly and instead of took them forever to update it and the virus has already changing again So that advantage wasn't really borne out But this is a technology that had never been commercialized before There have been a lot of research on it And nobody really knew what the duration of protection would be And because we were doing trying to get this through as quickly as possible get it available to people as quickly as possible We thought this thing would be like one shot or two shots and you'd be protected the rest of your life It seems like it's more like you're protected for a few months And then the question is are people really going to do it two three four times a year and what are the consequences of that going to be Because that had never been tested the repeated application So it raised a lot of questions I think that maybe if we add it all to do over again we would have taken a more traditional approach with a live attenuated or an inactivated vaccine or something like that But remember we've never had a vaccine for any coronavirus before And so the idea that there was some way to do it that would have worked better Who's to say that we would have had anything at all if we had pursued a different path I think the other challenge here Dan is if you're not one of the big guys if you don't have the stroke to get things through at FDA it's almost impossible to navigate that bureaucracy And so what might have otherwise been the best technology which is the novavax protein platform They couldn't get their manufacturing facility approved for like a year and a half while these other ones were moving through because they didn't partner with one of the big guys
Phil Kerpen: COVID Boosters Were Politically Motivated
"Really I mean I generally trusted that the public health infrastructure is probably the least political thing That is now been completely entirely eviscerated You've got guys like me and others who in the past may have inclined to draw their doctors they're not politicians Who are now it's almost to the point now that all the misinformation and the lies in the censorship and the cover ups It gives me no joy in saying this Whenever public health people representing the Biden administration say something my instinct is to believe the opposite is true That's how crazy it is Well look I got the original two doses also I haven't got any boosters or anything like that But I think at the time they rolled it out if you read all the data and you looked at it it made sense to get it for most people And so I don't think you necessarily need to have any regrets people act with the information that's available to them at the time You get more information You change your opinion You integrate that information The problem comes to your point when it becomes political and it starts being dictated on a political basis And what we had with this administration is the extension of the vaccine to younger children and the boosters recommendations were essentially dictated by The White House the top two vaccine officials at the FDA resigned in protest This would have been the biggest scandal in history in a Republican administration and said it was barely covered at all And the only people who were left at FDA are the people who are willing to rubber stamp whatever The White House wants And so we've got a new the new booster that's out there right now was approved on the basis of data from 8 mice for the Pfizer vaccine and ten mice for the Moderna vaccine Now they finally are starting to get some human data now But we've never seen an approval on the basis of something so flimsy before And so it has become completely political And it's very disappointing that that happened
FDA clears updated COVID boosters for kids as young as 5
"The Food and Drug Administration is authorized updated coronavirus boosters for kids as young as 5 tweak boosters rolled out for anyone 12 and older last month Bill Gruber at Pfizer says a high number of kids under 12 have been hospitalized In part because they remain less well protected by vaccine So this is an opportunity with this good news to re energize interest in protecting children for the win The shots available are from Pfizer and Moderna doctor Jason newlin at Washington University in St. Louis says these are bivalent boosters They fight old and new strains Switching the bivalent vaccine targeting what we've currently continue to see circulate which is the BA 5 COVID-19 in our communities makes sense to make sure that our children are better protected against what we're seeing Less than a third of 5 to 11 year olds have had their two primary doses Ed Donahue Washington
Biden's strategy to end hunger in US includes more benefits
"The Biden administration is laying out its strategy for meeting an ambitious goal ending hunger in the U.S. by 2030 The plan includes boosting monthly benefits that help low income Americans buy food and highlights the need for access to healthier food and exercise This week President Biden will host The White House's first hunger nutrition and health conference in more than 50 years The last one under president Nixon aimed to end American hunger for all time and led to a greatly expanded food stamps program and helped for babies But cuts to federal programs and other changes have led to declines in access to food The FDA says about 10% of American households suffered food insecurity last
FDA concedes delays in response to baby formula shortage
"And Drug Administration has conceded that there were delays in its response to the baby formula shortage I Norman hall the FDA says it's sluggish response to the U.S. infant formula shortage resulted from delays in processing a whistleblower complaint and test samples of the nation's largest formula factory The ongoing shortage has forced the U.S. to airlift millions of pounds of powdered formula from overseas Problems highlighted in a ten page report include outdated data sharing systems inadequate staff and training for food regulators and poor visibility into formula supply chains and manufacturing procedures The FDA says it will seek new authority to compel colonies to turn over a key information
FDA Warns Against NyQuil Chicken TikTok Challenge
"From the hill dot com and also from CNN, they're saying now that people are cooking chicken in NyQuil. What in the world? Come on. They're literally stewing the chicken. They're marinating the chicken in NyQuil. What you take for the, you know, if you're not feeling very well. I don't know anybody who likes the taste of medicine by itself, let alone as a marinade for chicken. It's beyond me, but apparently this is something happening on the social media. Nothing good ever happens on TikTok. I'm telling you. Nothing ever. This is just like the tide pod all over again challenge. That's exactly what it is. But I mean, on TikTok, all you have are lesbian and transgender school teachers and people who marinate chicken and NyQuil. And eat tide pods. That's pretty much it. So now the FDA is warning people do not marinate your chicken in NyQuil. And they're saying that people could literally die if they marinate their chicken in liquid NyQuil. The fact that some people think this is okay, shows that our country is doomed currently. I've never seen anything like this. Again, NyQuil, this is the nighttime step police sneezing, aching, stuffy head fever, so you can rest medicine. And for the record, if you want to do anything with chicken, you have to marinate it in a lovely bath of buttermilk and hot sauce. You salt and pepper in the chicken, you dredge it in the Martha white flour, and then you put it in a cast iron skillet filled with peanut oil. That is how you prepare your chicken. That is good. You don't drench it in NyQuil. Yuck. I mean, what's next? Sudafed souffle? Benadryl brownies, grace baker. What about a Tylenol turnover? Ew. You know, you're making me lose my lunchtime appetite.
How Drug Companies Stand to Make Billions by Preying on Children
"Can you talk about how Pfizer and these major companies stand to make billions? Off of children that are being preyed on by weak parents and these predatory doctors and institutions. Talk about lupron. Yeah, so lupron is manufactured by a company called AbbVie. And AbbVie recommends lupron for precocious puberty endometriosis as well as prostate cancer, which is what I believe it was developed to treat. They say that it should only be used for three months. The FDA also doesn't recommend this for gender dysphoria. However, the drug between 2020 and 2021, I believe, increased in sales by some $30 million. And lupron does sell for this purpose. It is the main puberty blocker that I believe is used in the U.S., although there are others. So AbbVie does stand to make a lot of money from this. It was interesting because you were Laura Ingraham Ingram's show the other night, talking about this and I was watching your segment and as I was watching, there was an advertisement for AbbVie, pharmaceuticals, and I thought now isn't that interesting. That they're on TV right now talking about how dangerous this is. And here's this company buying ad time with Fox to talk about how amazing their products are that are actually farming children.
Juul to pay nearly $440M to settle states' teen vaping probe
"Electronic cigarette maker Juul labs has agreed to pay nearly $440 million to settle a two year probe 33 states and Puerto Rico have extracted a $438.5 million agreement from Juul labs after an investigation into its marketing which have been blamed for a surge in underage vaping Connecticut attorney general William Tong made the announcement We think that this will go a long way in stemming the flow of vaping The settlement to be paid out over 6 to ten years amounts to about 25% of the company's U.S. sales last year Juul has agreed to refrain from a host of marketing practices Billboards are gone That's a big deal for us Public transportation advertising Social media advertising And then use some paid influencers They can't do that anymore Federal health regulators are still scrutinizing jewel after a court stayed an attempt by the FDA to ban their E cigarettes from the market I'm Jennifer King
AP EXPLAINER: Should you get a new COVID booster? If so, when?
"Should you get an updated coronavirus booster Within days Americans will be offered the new bivalent boosters that target both the original coronavirus and today's dominant omicron strains and BA 5 The Pfizer shots are for anyone 12 and older while Moderna's version is for those 18 and up For most people the FDA recommends waiting at least two months after your last booster or COVID-19 infection while CDC experts say it's better to wait three months or as long as 6 months if you're not at high risk CDC adviser doctor Sarah long says that if you wait a little more you get a better immunologic response Another reason to wait a few months is to reduce the risk of heart inflammation a rare vaccine side effect The CDC notes that most Americans eligible for an updated booster have already gone at least 6 months since their last shot I'm Jennifer King
The Story of Eight Lab Mice
"What do you think about the recent news that the vaccine was approved, a vaccine was approved by only testing them on 8 mice. I don't quite understand it. Yeah, I was just kind of reading this story. It's extraordinary. And apparently, one of the vaccines and again, I want to make sure I get this precise because we have a commitment to the truth here on this program. Is one of the vaccines was approved. By only testing the boosters on mice and not on humans. So instead of a set of three blind mice, we have 8 mice that are dictating whether or not we take vaccines or not. Play cut one O three. We're going to do revoke all of their license, revoke the license of 40% of rural pediatricians or myself who wants to see more data about something like the new omicron specific vaccine that yesterday just got magically authorized by the FDA based on 8 mice and no publicly available clinical data in humans. That's how they authorized it. The purpose of science is to challenge orthodoxy and dog money. That's how science advances, and that's exactly what was banned in this bill that governor Newsom may sign at any moment. So apparently we're learning that the vaccine was approved on 8 mice trials. We've been trying to warn people about this and we were laughed at and scoffed at the way they're going to pivot is they're going to blame Donald Trump for this. That article has already been written.
The Audacity of the House Majority Whip
"Sure some of you know about this report that the House Democrats just published a few days ago saying that the Trump administration pushed the vaccine too fast. But I want to talk about it again because it is just so astounding, I mean the audacity. Okay, so this we have here, I'm quoting House majority whip, Jim Clyburn. The select subcommittees findings that the Trump White House officials deliberately and repeatedly sought to bend, the FDA scientific work on coronavirus treatments and vaccines to The White House's political will are yet another example of how the prior administration prioritized politics over public health.
The Current False Scientific Narrative Concerns Dr. Peter McCullough
"So talk to us if you will. What is the state irrespective of that little video cut? What is the state of science today? I'm a political scientist. That's what my doctor do is. I'm not an empirical scientist. But the scientific method is clear whatever the branch of hard science is, you have theories, hypotheses, you test them, and if they fail, then you go back and you look at the hypothesis and you have to start from scratch. What is the status of the scientific method today? How many people have been cowed unlike yourself and now fallen into this idea of there is a politically correct narrative on a given issue, including a pandemic, and I'm just going to follow that narrative. Is that, is that something that concerns you today, doctor McCullough? It concerns me greatly, especially when the narrative is false and misleading. And we see fracturing of the statements all over the place. Let me give you an example for routine testing done on a weekly basis for COVID-19. Every published study done so far shows that has it yield less than 1% and when it's positive, it's more likely to be false positive. The WHO in June of 2021 said stop doing routine testing. Now it takes more than a year later, our CDC comes out in August 11th of 2022, says no more routine testing. How many people at work school and travel were tortured with these nasal PCR tests with or never FDA cleared for that use?
The New York Times Is Lying
"You understand the severity of this? Do you understand how stifling of science this is? You differ with Fauci or the FDA or the CDC or the NIH, you can lose your license to practice medicine. Wow. Do you not understand that the left's use of the term, The New York Times use of the term because The New York Times is left not liberal. The New York Times use of the term false information or a misinformation is a communist tactic to suppress truth. Or more accurately, even, suppress dissent.
"fda" Discussed on The Model Health Show
"The payment like we want company xs product to get approved. Because it's going to help to increase our market share is well and increase our exposure. So this is all happening. This is called post hack contribution so this is after the fact so it's not like they're giving the money right then and there to make the approval. There's like you know what we'll wait a little while you go ahead approve. This will wait a little bit. Nobody would notice. We'll give something later. Let's make this happen. Could be to the tune of tens of thousands hundreds of thousands. They're even some instances where these physicians received over a million dollars. It's available these things song so it sounds like a movie of corruption and deceit. But it's real so think about the drugs that are getting put. Onto the market the drugs that are getting mandated for people to take. Where's the efficacy really at. Are we doing stuff. The right way because in reality. We're seeing that when a drug is approved and it's marketed to the public and used by the public so over four years later when that first safety event is being acknowledged. We don't know what's going to happen. And i encourage you. I implore you to take more precautions and to be more patient with this than ever before regardless of the pressure regardless of what the media or the pharmaceutical companies are well meaning physicians in advocates. Who truly do want to do the right thing. Where do you think. They're getting their information from their getting educated by these same entities that are ripe with corruption and manipulation consistently criminal organizations. This brings us to the point of the fda with these. Well noted well documented again this was published in the journal. Science forty percent physician advised on the fda approval boards receiving payments from pharmaceutical companies. At some point after they approved a drug. This is called bribery. This is.
"fda" Discussed on The Model Health Show
"Obesity. They're just publishing data to affirm what we know already but the question is what are we doing about it. More drugs drugs for the wit gobi drugs for the win. it's not working but again our pharmaceutical interventions have their place but clearly something is wrong here. The system is not just broken. His designed to operate this way and there are people profiting mightily off the farming of sick people off of the farming of our citizens of this brings us back to the fda because another layer of concern here is the revolving door of employees working at the fda and then working at pharmaceutical companies or vice versa. there's a revolving door. They're just sharing people. There's no conflict of interest here not only do pharmaceutical companies provide the fda with massive amounts of funding. That would clearly be a conflict of interest. The fda in pharmaceutical companies also engage in a revolving door of sharing employees for example the former fda commissioner scott gottlieb left the fda and joined pfizer as a member of its board of directors just prior to the beginning of the pandemic in two thousand nineteen. Now listen to this. Even prior to his appointment as the fda commissioner scott gottlieb actually served on the board of directors for multiple pharmaceutical companies also served on the investment board of glaxo smithkline currently the fourth largest vaccine maker in the world. In scott gottlieb has continuously been a strong proponent of mandatory vaccination whatever entities. he's been a part of. this is just one example where someone in a position of power at the fda has also profited mightily from the drugs. The pharmaceutical company sell by literally working at those same pharmaceutical companies. This instance isn't rare. This scenario is not rare in the slightest because nearly thirty percent of fda employees leave the fda get high paying jobs at pharmaceutical companies. This would logically make you question what. Fda employs may be doing to get in the good graces of the pharmaceutical company for their future. Cushy job with them and the reverse happens as well where pharmaceutical company agents employees join. Fda with their insider information one of our us senator stated quote this kind of revolving door influence peddling smacks of corruption.
"fda" Discussed on The Model Health Show
"Drugs or the third or fourth leading cause of death in our society. It's funny you don't hear more about that. And it has a lot to do again with who's tracking things behind the scenes in propping that up when you go and check out. What are the top ten caused the death. You're not gonna see that unless you know where to look because it's true. It's absolutely true pharmaceutical drugs. He'll hundreds of thousands of americans every year. You have the right to know about it now. You would think that the all powerful fda would crackdown on pharmaceutical companies. Crackdown on all of these deadly incidents to protect us citizens but then you'd be failing to realize that. Today pharmaceutical companies provide the fda with nearly half of their overall budget and upwards of seventy five percent of its scientific review. Budget of the fda itself is coming from those same form sue companies that it's supposed to be regulating. In fact pharmaceutical companies provide billions of dollars in funding to the fda every year. The very organisation responsible for regulating. Drug companies is massively funded by those same drug companies. The question is houses happening. Well it began with the advent of something called user fees under the guise of providing the fda with more resources to approve drugs and get them to the market for patients who may need them. Faster legislation was passed put in place to allow drug companies to begin paying the fda directly hefty user fees with a guarantee date of review to be completed for them. So they're gonna pay these massive fees the fda fast review and a guaranteed date on when they're going to get to their approval again. These user fees are the magnitude of billions of dollars collectively from pharmaceutical companies packets to the. Fda's coffers an analysis that was published in the journal of law medicine ethics titled institutional corruption pharmaceuticals and the myth of safe and effective drugs states quote the authorization of user fees in nineteen ninety-two has turned drug. Companies into the fda's prime clients deepening. The regulatory and cultural capture.
"fda" Discussed on The Model Health Show
"Approved by the fda had some kind of safety event after reaching the market. Nearly one third. Now what's most alarming about. All of this is the timeline of these safety. Events being noticed and being acknowledged the average time from approval of the drug getting to market and the first post market safety event was four point two years later four point two years after the drug is deemed to be safe in allow to be marketed to our citizens now in this analysis again published by the journal of the american medical association. The fda was right about drug safety about sixty nine percent of the time if we were to use the analogy of our education system for example the fda would be a d. student. I now that's okay. If millions of lives weren't routinely destroyed because of the d. student level success rate. That will be okay if they didn't receive billions of dollars in funding each year to ensure that they were above a d. level student to ensure that they are actually doing things with high efficacy but the receiving this funding under the is that having this supreme influence and supreme control is needed in order for them to be the best of the best in the world. But if you actually look at the success rate is far from what people are led to believe again. The median time the average time from the drug being approved as safe then allowed to be marketed and consumed by the public the average time from getting released and being approved to the first acknowledged safety. Event is an average of four point two years later years later now with this being the case unfortunately there have been very well educated and well intentioned people who've naively believed that the recent drugs that have been approved by the fda that if there was a big problem that it would be seen within the first few weeks or the first few months when in reality most of the safety events are seen years later and is just as if this is lost in this conversation and overlooking how biology really works. We don't know all the ramifications of a new drug intervention that quickly. That's just not how biology works now in an attempt to excuse the poor performance seen in this fda analysis david gardner a former fda officials.
"fda" Discussed on The Model Health Show
"Cosmetic act established new drug regulations including pre market approval of all new drugs meaning that drug companies had to prove that their drug was safe before could be sold to the public. Prior to this people's just put stuff out on. The streets would stuff on store shelves without a lot of regulation in so this really brought to bear and again this wasn't that long ago was nineteen thirty eight when this transformation took place of fda grew in power immensely in the preceding years through legislation through government influence in one thousand nine hundred sixty for example drugmakers. Tried to get the sedative. The little approved in the us as it had been approved already in several other countries but the fda blocked it calling for further safety studies to be done on its use and as it turned out the little meyde actually caused thousands of birth defects. The fda's decision to plate safe and to call for further testing saved lives and helped to solidify the fda as a leading regulatory agency. Now all of these things sound pretty great but things have changed dramatically in recent years. The fda was once an organization that was exclusively funded by taxpayers and thus working for our citizens today however the fda is substantially funded by pharmaceutical companies themselves to the tune of billions of dollars each year. Now to find out how he got from there to here and what the results have been because of it. We must take a deep dive into the world of this regulatory agency the fda the food and drug administration. Now you might think that a drug receiving.
"fda" Discussed on 1A
"All three of those really pay play an important role in the absolute number of breakthrough infections. What we're seeing and here's a message. We got from cheryl who says there will be less breakthroughs as more people get into the herd vaccinated people. Andy what's your biggest concern about the relationship between the number of unvaccinated people in the community and the rate of breakthrough cases among vaccinated people. You know the majority of the infections here in the us are being driven by unvaccinated. And what that means is that a vaccinated person ends up being exposed to an awful lot of virus in their community. If they're not taking other measures into account such as wearing a mask or social distancing One of the analogies. Some of my colleagues have used this. A vaccine is like an umbrella. If it's if it's a shower outside the umbrella does a really good job of keeping you dry but if it becomes a thunderstorm thing you're bound to get a little bit wet because of all the water that's coming down and and if you're vaccinated but in an area where there's lots of unvaccinated people lots of virus spread you just going to get exposed to the virus multiple times and because no vaccine is one hundred percent effective. It increases your likelihood of having a breakthrough infection. Well dr lee because breakthrough cases cannon do happen the cdc is recommending that people with compromised immune systems and older adults. Get a booster shot. What is a booster shot. Yeah i think it's it's helpful here to tease out. What the fda has approved emergency us author authorization and what The white house task force has talked about so in immuno-compromised to patients. We have data. That is showing that those who they are likely to get ill. They're likely to have higher risk of pearling shedding and so we really want to protect them. There have been studies that have shown. They are more likely to have breakthrough infections because of their vaccine effectiveness in that population. So what i've been calling. This is actually like a third dose a completion of your vaccine series. And so that's what's been fda approved by the way through e way and so with a third dose in are immuno-compromised patients. It's studies have shown that about thirty. Three to fifty percent will develop an antibody response with that additional dose. I can tell you clinically and what we're seeing here in our hospital at uab of our fully vaccinated people that are admitted with cova symptoms. Thirteen out of twenty sixty five percent are immuno-compromised and so this is very meaningful and it goes back to what their doctor pepper. Gosh is talking about if you have a lot of disease in your community. We want to do everything that we can to protect. Those that may not mountain immune response and just for for people who may be considering. This is this one additional shot. Or is it two shots like the pfizer. Vaccines your first. Go round right so this would be a third shot for the a vaccine. So the visor in the madonna and they're recommending it about twenty eight days after you get that second shot so think of it as a series you know if you have a baby baby gets those three shot series at zero to in six months or two four and six months and very similar. Kind of concept eighty. Can you break down a bit more for us. How boosters actually work in the body will boosters are another way to get your immune response to To not only come back stronger but also to fine-tune the specificity of your immune response so studies have shown that in the case of the amarna vaccines. If you get a booster not only will you get a much higher rise in. Antibodies and particularly the neutralizing antibodies that we think protecting you from infection. But that antibody response also broadens and becomes very good at recognizing the different variants of sars covy to that are circulating. So it's and presumably are the next phase will be to study how well your memory responses because all signed suggests that you're now having even stronger memory response so that if you do see virus in the future your immune system will come back even faster than its it after your regular course of of vaccination so boosters will be working The question really becomes. How do we want. To balance boosters with getting more unvaccinated people vaccinated and do we target specific parts of the population. That need boosters as dr lee was saying and those are questions that that will be answered win the big question and how well we should be hearing something soon. The fda has material for boosters from pfizer they're about to get it from derna and just recently johnson and johnson announced that they have data the efficacy of boosters in people who got in the. Jj vaccine so all of this is now in the fda or it's on its way to the fda so sometime in the next couple of weeks we should be hearing Some firm guidance from fda cdc about what a booster Schedule we'll we'll we'll be looking like here in the us. Well here's another question. That was left in our voicemail believe vaccinated my husband is fully vaccinated and i was just wondering What is different about the booster that it's necessary now. Why a booster shot. Is that going to help. Ward against the dose of variant. And actually a lot of the questions we get our specifically about the delta variant your response right so i think we measure that vaccine effectiveness in a variety of ways include including prevention of new cases reducing symptomatic illness and then symptomatic disease. We have great data with the vaccine as as what we've already discussed that. It's a fivefold reduction in infection and the twenty-nine nine fold reduction in hospitalization and that's based on data that came out of los angeles a couple of days ago. But what we've seen out of israel. Is that this vaccine effectiveness in the fate in the face of delta has declined from ninety percent to forty percent due to likely the delta varian. But there's a recent paper in the lancet that actually thinks that time may be due to some reasons that we're seeing this reduction in our antibody response so there was a study that showed that the effectiveness of of of the vaccine against infections declined from seventy three percent down to about forty seven percent after five or so months and so that may be due to what we're talking about now that are antibody are neutralizing. Antibodies wayne. But we may still have these memory cells that are prepared in the face of getting exposed again. Okay and when you talk about effectiveness. Is that effectiveness around protecting protecting us from contracting the virus or in our body's ability to fight severe infection. I think it's both and so you're pointing. You're showing something that's really important here. We know a lot about vaccine effectiveness for severe hospitalizations and death. Because that's what was measured with these vaccine studies. What we also want to do is to be able to prevent symptomatic disease as well and what we know with. Delta is that there are higher amounts of virus and we may need higher amounts of those antibodies to control it quickly and actually federal health. Officials will likely recommend this fall. That those who've got the madonna and pfizer vaccines get a booster shot. Eight months after their second dose. But what do we know about. Those who've gotten the johnson and johnson vaccine now. I think what. I've read. Is that johnson and johnson has completed their studies on on whether or not a shot is recommended and so in the coming weeks..
"fda" Discussed on The Last American Vagabond
"As well from you know compromise these are all things that just happened so that emergency uses don't affect again understand unjustified on emergency use in my opinion that shouldn't be allowed as or as well with the approval of my opinion now goes on to say that then says the comedy which is the new name there the official name. That's why they're saying that. Because this is one that's been approved is. Fda approved may by pfizer. It is approved as two dose series prevent cobra nineteen sixteen years of aging older. See i know this is. I think this is meant to be confusing. Now it says they also the fda approved this and the e the emergency was author. That stupid it says the emergency use authorization authorized pfizer vaccine have the same formulation and can be used interchangeably. Now that's the point that they have one that says emergency authorizing label. That can still give that to somebody. Who's there for the approved. a sixteen knows. And that's what they're arguing. None of this. I agree with by the way. But i but this is not. It is approved a sixteen and older according to their data. Which i disagree should be happening. But here's the main point. That i think a lot of people. Independent media are don't understand this says in this at the bottom of that same document. What is emergencies authorization. I've read you this many times. One of the main factors here is about what if once it's approved the emerged. The authorisation just disappears in regard to that specific section of the approval. It's still the emergency authorization in general is still in effect member. That's where we renewed every ninety days by the government by the. Hhs we keep pointing that out. I forget where we are right now and that ninety day process sure will cut back on that a second as it goes closer. That applies anything. They've used that for math. These are all sorts of things. Then you've got these specific emergency use authorization for the injections specifically each one right now. Once they approve any any section of that sixteen and older whatever. That is that improved. And that's no longer the authorized but the emergency authorization is still in effect for twelve and older and for the general country now says this emergency use authorization for pfizer biotech kobe. Nineteen injection or comedy will end when the sector secretary of hhs determines that over which is so arbitrary. Get to pick when they decided to over or when there is a change in the approval status.
"fda" Discussed on The Last American Vagabond
"There was the other one too. That's the other one. I showed you many times which continues to show you. That eleven of thirteen participants showed detectable levels of sarah to protein despite protein in your bloodstream that we're talking about detected in the plasma a people who were injected with madonna as early as one day after the vaccine injection. If you read the study it's longer than that and the point is that it's not just in your site and it's not just go away after a minute it gets into your bloodstream and continue to circulate for a long period of time which continues to hurt you as a lot of peer reviewed studies have shown. But let's keep going on this very informative. Fda document now it says the first anyway issued december eleventh for the pfizer. Kobe scene for individuals. Sixteen or older was based on safety. Ineffectiveness data from a randomized control blinded ongoing clinical trial of thousands of individuals. You see that's just flat out not true. This isn't some old document. They have an update. This is the new document that they damn well know has this study has been on blind. They know that. Peter does she can tell you that he can happily tell has been. It's on blinded. They gave them all the injection but here they are lying to. You blinded ongoing. Well at least they can tell you. It's ongoing even though the twitter sycophants out there keep saying no. It's not your it's over. They finished at your s conspiracy theorists. We'll tell the fda conspiracy theorist then but it is not blinded it has been blinded and they know that to support the fda approval decision today the fda reviewed updated data from the clinical trial which supported the and included a longer duration of follow up in the larger clinical trial population. There lying to you right. I mean how does this right. We literally just talked about the what what just happened. They did not do that right. This data goes up to march thirteen. Twenty twenty one. They lied to you. Here's the fda lying to you again. Updated data from the clinical trial which supported this is including longer duration. No it's not. You just gave the same data period. This it's it's. This is my point. Guys the media. You won't check this. The government doesn't care this is the government. The only thing we have is honest. People peter doshi out there continuing to point out this a flat out lie and no one cares specifically in the fda's review for approval..
"fda" Discussed on The Last American Vagabond
"The fda grant adviser vaccine emergency use authorization enabling access to all americans who wanted one now. Here's peter's one point. He's made a lot. What's actually changing right now. So what's the argument. Why do we need in fda approval. Keep screaming and safe and effective right. So that didn't change. I mean this is playing within their narrative. Right here right. So they're claiming it safe and effective and so they're claiming a safe and effective. So that's why approved okay. So it's the same thing okay so there was no difference than who can access it right because right now you if you. The emergency authorization was being pushed and everybody. And so two is the they're going to mandate so everyone everyone has had access to who's able to so the approval didn't gain access to people. So what are they really concerned about. Oh that's right. They're concerned about having their justification to force it down your throat. So under peter does. She's previous argument. The only thing they're doing this for is to be able to force it on you which is wrong. There's no if it's just about safety then there's no need for the approval because everyone has access to it. They don't like that you get to say no. And they think that removing that stuff at block is going to be able. They're going to allow themselves to force it on you. Further not that it will change. The mind of the hesitant has people who don't want this have already had a thousand opportunities and they've already said no so his main point is this all about creating the illusion that we need to be able to to force it on the people who don't want it and that's justified. Safety doesn't even play into this because it doesn't change the safety of the same scenario as it was before everyone has access. They did before they do now. It says it's sending a clear message that the fda could both address the erroneous demand for vaccines without compromising on the science. A quote again see full approval could mean a high bar it says but here we are the fda reportedly on the verge of granting a licence which they just did you know thirteen months into the still ongoing to your pivotal trial again. He makes this point. We are still in an ongoing trial. It's so infuriating. These things are so very easy to prove but all the sycophants on twitter. We'll keep bleeding at you that you're stupid understand right. Let me ask you twitter expert. Are you better knowledge about this than the senior editor of the british medical journal. I highly doubt they are still ongoing. And your currently in which means you're being experimented on it says with no report that reported data pass march thirteenth unclear unclear efficacy after six months due to the unwinding evidence of waning protection irrespective of the delta variant an limited reporting of safety data..
"fda" Discussed on Ron Paul Liberty Report
"But there it's going to be sold as this is the final stamp of approval. The fda is god. god almighty has spoken. And if you don't get a job then you're against god and the science but we know that the fda's record of approving drugs. It's not all that great. You know anyone who's had some problems solidified problems. You can go down the list of drugs that have been approved of actually had to be rescinded So it's not as set in stone as one might think or certainly as mainstream media might want to portray but the thing that we do know. Is that everyone who every american who wants to have a shot has either got it or can easily get it without a problem. So what does it mean to have the fool. Fda approval before for twelve and above actually twelve and under that. Still under emergency use at this point but what does it mean. It means i think the doors open now for vaccine mandates. He's going to be get the shot or get out of work was interesting that we see. Dr paul is that's running up against something else which is fundamental labor shortage. And i know this is anecdotal. But i've seen several things where a company a small company would say. Listen guys you need to get your shot or you're going to get fired and they all got together and said okay. We're leaving and they changed the rules. I've seen that several times on twitter over the weekend and again that's anecdotal but it's going to be interesting. How those two are going to square and example of what you just described Is what happened in houston methodist hospital There were people should take no how what's going on. If the people who were involved in participating you know to to an extreme in helping people who had covert nurses and the aides who were exposed and they come up with a conclusion. I don't want to shot you. Think you'd think they would at least be recognized. Why are you doing this. They must have a perception so They they were fired as laid off temporarily. But they were out of there. Now you hear the the The advertisements going all across the country To find nursing shortage so we all this thing about a lot of jobs available and no Nobody available nobody wants to work. It is so different than if you're in a depression and People there are jobs no jobs available now the head jobs available you find people. Only government could create a situation like bank to on this fda and the approval of this drug on what will happen if you make the point that You know the ball you know. The final opinion is is not yet. It's going to be determined..
"fda" Discussed on Slate's If Then
"Who are still holding out on vaccines as we're taping this episode. The fda is expected to give emergency authorization for booster shots for immuno-compromised people at any moment. But sarah has reported that some folks in the biden administration. Worry that the need for boosters might feed fears of the vaccines are ineffective and slow down vaccination rates the administration has left walking a tight rope eagerly awaiting approval being very careful not to appear to be pressuring the fda and right now the agency doesn't even have a permanent boss someone to fight it's public battles in washington one thing that definitely people inside the fda and former fda officials want to see is a permanent commissioner. So right now there's an acting. Commissioner president biden has not named a permanent person to the post and while the acting. Commissioner janet woodcock has been there for decades on his very experienced. I think that there is this general desire that someone on top of the agency can really B- it's be as mascot beat the person on the on the airwaves on television. Who can say. Here's what to expect about an fda vaccine approval. Here's how we did it To have that public face that right now is basically falling on on fouts. She who people bradley trust. But he's not the head of the fda no and indeed fouts has been out there saying gee. I hope they do this soon. I hope i don't predict that. I hope that it will be within the next few weeks. I hope it's within the month of august. If that's the case. Yeah i guess. I wonder how the lack of a permanent head kind of plays into all of this. Like is it as you're saying that there's no one out there to be a cheerleader and explain what the agency does or does that have organizational ramifications internally. Fda is a massive place never really sort of well oiled machine so the vaccine department is headed up by a man called. Peter marks who has while trusted well respected Even among or i should say regardless of political party. He worked closely with the trump administration and now with the biden administration so in terms of the vaccine decisions. It doesn't actually matter who's on top of the agency. And i know that sounds weird but i think it's more about these lingering confidence questions and kind of the public facing aspects of this in the story that you wrote. You had sources telling you that you know people in the administration were frustrated by how slow this process was but of course if you as an administration as the biden administration has done come out and say we believe in science. We want science to lead the way you have to let the science have the time to to breathe. How how do the various players involved strike a balance here. it's hard i mean You talk to foul. she will. He'll talk on on television but he also he'll tell reporters individually that he's not saying he wants them to approve it soon. He's saying he hopes they'll prove it soon. But he's still saying it and you know it is very delicate. Play that they have here. The events of last year is still hang heavy over. Fda the idea that president trump was openly pressuring the agency and that the biden administration feels in the way that it's been described to me that they want to make sure that they are showing people that are leading with science and not trying to leave the scientists in so while they want this they are also conditioning. It on when fda's ready there's a sentence From the new york times columnist. Michelle goldberg that. That really stuck with me. She wrote about kids and and getting emergency use authorization for kids. And she's writing about the fda and she wrote at some point too much institutional risk aversion is a risk itself. And it it like it somehow nailed. How complicated all of this is because yes it science but that sentences like oh wait. Maybe this is politics. I see exactly where she is coming from there. I think the opposite is equally damaging though that if you move too quickly on something You could be paying for that for years in. So what is so interesting though about that. Sentiment is kind of already in motion. The fda has learned a.
"fda" Discussed on Slate's If Then
"How can you help. Ensure our future is filled with trees by choosing paper and paper packaging because when you buy products made from this natural renewable resource you encourage forest owners to plant and grow trees for generations to come in the united states family and privately owned forest lands provide most of the wood and fiber used to make all kinds of essential items like the paper paper packaging. You come on every day. These forest owners care for their land and the trees on it with sustainability in mind working to keep both healthy and thriving over the decades. Sustainable forestry has continued to evolve encompassing all of the ways the paper industry helps forests stay vital and productive from preserving wildlife habitats to protecting water sources to preventing soil erosion learn more about the benefits that paper and packaging create for our forests at paper for nature dot com choose paper and paper packaging and be a force four nature. This podcast is supported by. At and t. active armor right now. Our lives are on our phones. I use mine to schedule. Podcast guests read the news and video. Call my family. There's no room for fraud calls thankfully. At and t. Makes customer security a priority helping block those pesky calls. It's not complicated. At and t. Active armor twenty four seven proactive network security and fraud call blocking to help stop threats at no extra charge. Compatible device or service required visit att dot com slash active armor for details. This is what next tvd. i'm lizzie. O'leary and i'm talking with political reporter sara over m- all right now. The fda feels a little bit like a watched pot public. Health officials are anxiously hoping for full approval of the three cova vaccines and at the same time. They and a lot of parents are waiting on what the agency has to say about vaccines for kids. And what the clinical trials for those pediatric vaccines show. What do we know about the the trials for kids. I mean i'm the mother of a one year old. I want him vaccinated yesterday. But you know like any person who i think. Trust and independent agency or believes in the independence of agencies. I want them to have looked at all of of the data. And i do feel like that kind of encapsulates where they are. Where a lot of a lot of people are so. Where are we in those trials. What we know about them is that there are a lot smaller than the adult trials. Where the adults for each manufacturer. They had to enroll at least thirty thousand adults. These trials actually are only a few thousand kids and the reason for that is. It's it's hard to enroll kids in special very very young children. I mean they are going down to as young as six months old. We know that did are expected. In the fall. probably visor madonna. I because they started trials earliest in that also. The trials are ongoing in in several countries does approving the vaccines for adult use full approval delay at all emergencies authorization for kids or are they totally separate tracks. It does not delay at all but the tracks could merge there are real questions right now within fda and even within the the vaccine manufacturers about whether they would apply for emergency use in children reason for that being emergency use has to be something done because the benefits far outweigh any sort of risk in not that they think that it's risky to children but severe cove. Nineteen is less risky to children than it is to adults in so it is possible especially if they've already got the foundation of adults and teenagers being approved for this that they might wait out. Emergency use authorization for children. It's a really hard sell to tell parents of a six-year-old. Hey this is emergency use authorized. Your child needs to get it. There's this policy discussion about whether it's better to just go to approve with those and that is not a definitive. That is ongoing. They are still talking about what what that will look like. So we don't know yet whether someone like my child who's the youngest batch out there would maybe get an emergency use authorization or whether we'll skip straight to full approval for him. Yeah we don't know there's also the idea that you have some large employers mandating vaccines the military doing it. You know how how much does full approval matter in making employers comfortable with mandates and maybe making employees comfortable with those mandates. I think it's sad. And that's one of the reasons why biden officials have been so keen for fda to approve as fast as possible. President biden did say that he wants every federal worker to be vaccinated or to undergo routine testing. But that doesn't apply to the department of defense they have to have it actually be approved or else they're definitely gonna face legal battles from from armed service members who say why am i required to get something that's not approved and be there has to be a safety argument for it that we need you to have this for your own safety that that one's an easier argument to make then there are the other people who aren't vaccinated yet those who twelve and older who just chosen not to get their shots and there's some evidence that full. Fda approval might nudge some of them toward the shot in opole from the kaiser family foundation roughly thirty percent of unvaccinated. People said they'd be more likely to get a fully approved vaccine rather than one with an emergency use authorization. I wonder if you think. Full approval might really sway people or if it's a sort of a proxy for discomfort with the whole process. Kaiser actually touched on this in that poll because they said that while thirty percent of people said that when they asked respondents is it approved authorized. Two-thirds thought it already was approved. And so there's a general public lack of understanding about this process. I don't blame people. It's it's a regulatory process that few people have had to understand before this pandemic. But i think you're totally right that this could be kind of a proxy for general safety concerns or general hesitations in that. There's going to have to be much more dialogue to get people on board with. Yeah i i you know i hear you describe this regulatory process that does sound quite thorough because the fda was specific and making it through. And yet i think the word emergency still trips people. Yeah it's it's not a sound particularly nice phrase emergency authorization in it. It does imply the urgency that we have had around this and now. We've all been living with these vaccinations and we know that largely You know about things have not happened or when they have the blood clots. You know the other reactions. We now have a better understanding of them. I think another part of the challenge there though is is not just that all of us who got vaccinated are fine but this idea of whether these vaccines are gonna be around for years and years the specter of of boosters And how that could also play into confidence questions for people.
"fda" Discussed on Slate's If Then
"Are inspectors looking at facilities that is vital because The consistency of vaccines is is crucial. Obviously thinking you don't want your vaccine to be slightly different than the one that you're you know brother sister friend guy in so just as they are asking all the companies about you know. The data in different populations who was enrolled in clinical trials. They are doing on site visits to factories. Batch testing different batches that come off the production line to make sure they're exactly like each other and you know looking at at the hygiene safety etc. That's one of the reasons. Actually one of the major reasons. That's another vaccine. Astrazeneca hasn't even bothered filing for authorisation yet in in might not even file for approval. They haven't gotten those production questions sorted out and so that is just as important to the fda as analyzing the clinical trial data. I feel like in the past few weeks. The demands for the fda to grant full approval to these kobe. Vaccines have gotten a lot louder. I guess it kind of want to explore the reasons why with you and why it matters you wrote a story saying the fda is expected to approve the pfizer vaccine by early september and that people within the fda were working around the clock. And i have to admit. I read it and thought wait a minute. We're they already working around the clock fair. Hey i even thought that i mean it is. It is typical that it takes this amount of time for a vaccine or new medicine to be approved. Fda actually bylaws is required to review new drugs and vaccines in a certain amount of time and they have not reached that time limit with these vaccines. But you're right in in questioning why there wouldn't be twenty.
"fda" Discussed on Slate's If Then
"How can you help ensure our futures filled with trees by choosing paper and paper packaging because when you buy products made from this natural renewable resource you encourage forest owners to plant and grow trees for generations to come in the united states family and privately owned forest lands provide most of the wood and fiber used to make all kinds of essential items like with paper and paper packaging. You count on every day. These forest owners care for their land and the trees on it with sustainability in mind working to keep both healthy and thriving over the decades. Sustainable forestry has continued to evolve encompassing all of the ways the paper industry helps forestay vital and productive from preserving wildlife habitats to protecting water sources to preventing soil erosion learn more about the benefits that paper and packaging create for our forests at paper for nature dot com choose paper and paper packaging and be a force for nature toward the end of last year. An important group of doctors started meeting online the vaccines and related biological products advisory committee into mouthful. The group evaluates vaccines and advises the fda. The agency doesn't have to do what these doctors recommend. But it often does are like you add my welcome to this one hundred sixty second meeting vaccine related biological advisory committee of the fda last year. The committee started looking at the cova. Vaccines beginning with pfizer. We have one cat at of us today and that is to discuss and vote on the emergency use authorization of the pfizer buying check ovid nineteen vaccine for the prevent the whole thing and the public record. If you listen to their meetings you can hear the doctors ask the company representatives all sorts of questions about the vaccines mechanisms reactions. Who was included in clinical trials. Thank you dr manteo. My question is provider and it relates to the recruitment of minorities into the study. My understanding is that the minorities were recruited fairly late in the process. Do we have an adequate Follow up to the to that group compared to the majority of participants at the end of the big meetings. There were three one for each vaccine. The panel voted in favor of emergency. Use authorizations they said the benefits of these vaccines outweigh the risks shortly thereafter. The fda granted the eu. As sarah over mall. Watch this all. Play out could you lay out kind of the relationship between that. Advisory committee the fda and the various authorizations. How does that picture fit together. The advisory committees have played an important role for the fda for years. They're a group of outside experts in the case of this vaccine committee. A lot of virologist vaccine experts and pediatricians in also people from different agencies. they'll have representatives from fda from cdc from the nih what they didn't kind of lay out the concerns that can be had about vaccines in a way where they ask questions about you know. Have you had enough data from pregnant women. Have you had enough data from ultra elderly people people who are above the age of eighty or ninety. Why are there not enough non white people in this trial when this panel is asking questions. Do you ever get hints about things. They or the agency might wanna see as a vaccine moves toward full approval after that. Emergency use authorization totally. Yeah yeah that's one really valuable thing about these panels outside experts don't have to Be as diplomatic may be government officials. Dues they will variously say you know you are missing information about this and i wanna see this so in the months between those committee meetings out of the authorization and the approvals that we could have within the next few weeks or months. Those companies have been working on answers for those questions in a more complete picture of what their vaccine does. And who doesn't foreign. How well it does it for different populations nine months after those i e you as the data overwhelmingly suggests the vaccines are safe. And effective and recent data published in the new england journal of medicine says full amarna vaccination is about eighty eight percent effective at preventing symptomatic kovin with the delta variant. But those questions that the advisory committee asked about pregnant women minority populations and various rare side effects. The answers to those questions will dictate how soon the vaccine's clear the next big regulatory hurdle full approval. The whole idea here is that when fda approved something. They're putting their stamp on it saying this is safe and effective its benefits absolutely do way its risks and also we know what those risks are. So if you're a call this feels like a century ago but when the pfizer vaccine rolled out there were reports of serious allergic reactions that we're not seeing in the early data that was submitted for the authorisation. Once you roll something out to the broader population you are going to get a bigger picture of how a vaccine works or doesn't work or what risks happen. The ideas that with approval. They know what those lists are for a wide range of people per exactly they have more data. They have tens of thousands of people that they've been tracking for months and months and so they're heading higher bar than they did for the authorisation. And ideally all those questions answered you know. I think a lot of people are maybe bluntly wondering what's taking the fda so long is is not a fair question to ask. It is especially when you know. People have only just recently gotten familiar. With how the vaccine development process works like. Yeah what what is taking up the ace along and the answer said it generally does take them months to approve something. Of course you would expect that with covet vaccine. It'd be a lot of urgency. And i think that there is but what they're doing in those months between authorization and eventual approval is going through all these raw data for tens of thousands of people. So where the emergency use authorization depended on fifteen thousand people. Overall trials had to be thirty thousand people in you'll get people enrolled with any range of medical issues people across the board on age People with any other. You know socioeconomic factors that can play into this People with different jobs where they could be highly exposed. It's about enrolling all those people than handing on that information to fema and they have to go through all of that all those thousands of pages about those thousands of people and so that's ultimately why it's taking this long. What else goes into the process that we might not think about. I didn't know for example that you know there.
"fda" Discussed on Slate's If Then
"Toward the end of last year. An important group of doctors started meeting online the vaccines and related biological products advisory committee into mouthful. The group evaluates vaccines and advises the fda. The agency doesn't have to do what these doctors recommend. But it often does are like you add my welcome to this one hundred sixty second meeting vaccine related biological advisory committee of the fda last year. The committee started looking at the cova. Vaccines beginning with pfizer. We have one cat at of us today and that is to discuss and vote on the emergency use authorization of the pfizer buying check ovid nineteen vaccine for the prevent the whole thing and the public record. If you listen to their meetings you can hear the doctors ask the company representatives all sorts of questions about the vaccines mechanisms reactions. Who was included in clinical trials. Thank you dr manteo. My question is provider and it relates to the recruitment of minorities into the study. My understanding is that the minorities were recruited fairly late in the process. Do we have an adequate Follow up to the to that group compared to the majority of participants at the end of the big meetings. There were three one for each vaccine. The panel voted in favor of emergency. Use authorizations they said the benefits of these vaccines outweigh the risks shortly thereafter. The fda granted the eu.
"fda" Discussed on KOA 850 AM
"FDA now says the Fizer Cove in 19 vaccine is okay for kids ages, 12 and up. The Madonna and Johnson and Johnson vaccines there right now on Lee approved for ages 18 and over. Yeah, that Fizer vaccine eligibility expansion could be a major step towards getting kids back in school. This phone right now we're looking at the implications of the expansion with Dr Dean Fanelli, Dean. Thanks for coming on with us. My pleasure. Thank you for having me. I'm assuming the data shows that the FDA thinks that the Fizer vaccine is safe and effective, and that's why they've they've gone through with this is that is that the only reason just purely on the date of its safety? Yeah, The extent extended this out. As you mentioned they tested this in about 2200 Children, ages 12 to 15. And it was shown to be 100% effective in preventing the symptoms of the virus. No kids that received the vaccine in that age group contracted the virus is certainly good news and you're absolutely right. It does expand this out. Extended the authorization out to Children is youngest wealth when could shot start going into arms? Also, the CDC is now reviewing the FBI's organization, and we could see Children as young as 12 receiving this, maybe by the end of this week, probably more likely next week. Are we seeing anything more with vaccine hesitancy, and I wonder for her? I guess adults, her parents of kids of this age. If they don't feel safe getting it, they're less likely to have their kids get it is does that make sense? Yeah, I think you hit it on the head. And I think that's probably what will see parents that were hesitant or skeptical about getting this probably are likely to see that extend to their Children as well. You know, we we do know that over 150 million people have gotten this On. Do you know these are very safe and I'll certainly with the J and J pause. You know, that's kind of that definitive point where we saw hesitation and the drop off in the average daily vaccinations go from over three million. To about two million. So there is that skepticism and it's likely to parallel between adults and Children. See, I would think it would even add another layer of hesitancy that people who are vaccinated, maybe more shy about getting young kids, especially if they weigh less than £100. You know, Littler kids, they might be more worried about getting them vaccinated. What do you say to those parents? Yeah, That's a great point. And what I'd say is similar to the flu. You know the the benefits off getting the vaccine clearly outweigh the risks. You know, over 3.5 million Children have gotten the virus. Several 100 have died so You know, Although we keep hearing that the highest risk people are over 65 this It's not a 0%. When it comes to Children. Children are at risk. And as we start seeing Children participating, more sports and summer camps and back to school, you know, we will start seeing the number of cases go up so clearly, you know, I agree with you 100% that the you know parents are very concerned about the safety of their kids. But when you look at the two getting the virus or getting the vaccine, the vaccine is clearly the better. Way to go, Doctor. Do you think these people that have vaccine hesitancy with covert? Are they also skeptical of whether it's the flu shot? Whether it's the MMR the HPV or they just in general vaccines overall? Or is it just specific to the covert vaccine that they're a little more cautious? I think there is a group of people that are just you know, anti vaxxers across the board, but I think we do see when it comes to the Corona virus vaccine. There's a higher degree of that so people that are typically get the flu. I think there's more skepticism when it comes to the drivers. Just people believe it was done very quickly, which itwas but nonetheless, the trials were done. And as I've mentioned, you know, we've had over 250 million doses and about 150 million Americans that have gotten us so it's out there and, you know That pause was related to the J and J vaccine and let the blood clots with regard to the M R in a vaccines. We haven't really seen any severe issues. Aside from that 24 hour period that certain people have of flu like symptoms. When have you heard that the emergency use authorization on these vaccines will be made permanent. And do you think that'll help with Maybe legitimizing the vaccines even more. I do think that will help. We're a little off on that. So the visor has will submit its application for approval on that should take about six months. They submitted it on a expedited Uh, application. So typically, that would take around 10 months in the expediter wave. Probably take about six months. So definitely sometime later this year, we'll see Fizer approved and likely shortly thereafter, we'll see modern as well. Doctor Dean Fanelli. Thank you So much for your insight. We appreciate it. Thank you. My pleasure. Thank you. It's a 29. We've got the news ahead in just a moment. The drive.