7 Burst results for "Felipe Ribeiro"

"felipe ribeiro" Discussed on WABE 90.1 FM

WABE 90.1 FM

05:32 min | 4 months ago

"felipe ribeiro" Discussed on WABE 90.1 FM

"And prepare for future pandemics all with a focus on equity That is a long list of aspirations Let's talk about how things actually went up the goals you just mentioned What have the people you've been talking to been marking as the biggest successes so far at least Well first of all Biden's team has done a lot to make vaccines available Here's doctor George's Benjamin ahead of the American public health association I think the fact that they increase vaccinate ours and the places for people to get vaccines was a success Over 500 million shots were given out this year 75% of the public has at least one dose many have three if they've gotten boosters the other relative success expert said is that the administration used the defense production act Now that's a law to get companies to prioritize the government's supply contracts during national emergencies and over the course of the pandemic with both Trump and Biden It's been used more than a hundred times And that's really seemed to help especially with vaccine supply Okay well Selena I want to turn to you because I want to talk about the so so maybe mediocre category Like where has there been some progress but not total success Yeah okay So the first goal with a mixed rating is reopening schools and businesses Many businesses in the majorities of schools are in person although the automotive search has made cases skyrocket across the country and sources told us it's pretty impressive that that's the case but it's not a total success because there's still a lot of controversy especially with schools there has been recent teacher strikes and student walkouts businesses have trouble keeping people there to staff them We also heard mixed reviews on the goal to curb the spread through things like masks and tests Seema locked away at the university of Pittsburgh has been tracking state mitigation measures and she says there were missed opportunities here I do think that there may have been an overemphasis on vaccination as being the easy way to solve this at the cost of testing another mitigation strategies that we could have continued to do The administration is starting to put more muscle into these efforts with the website for free tests and insurance coverage for at home tests but some of our sources say it's just too little too late And another goal in the so so category is equity experts said that the president is committed to helping minority communities low resource communities protect themselves and get healthcare But things were so inequitable to start It's hard to call that a success Last year began with big gaps in vaccination and death rates by race and those gaps of narrative a lot but who's able to test and stay home Who can access early treatment These are still pandemic privileges that are not available to everyone so still lots of work to do there Absolutely Okay well what about the goals that were the biggest misses A lot of our sources talked about restoring trust as a big miss The Biden administration hasn't always delivered on putting career scientists out front for one It's been criticized for that The country is as politically polarized as ever misinformation is rampant and that's a huge problem of trust Another big miss is the global public health effort The U.S. rejoined the World Health Organization after Trump withdrew and the country has started to be out front and in terms of global forums but doctor Celine gounder an epidemiologist at NYU is one of many critics on this who say it's not enough We clearly have not vaccinated the world We have missed multiple deadlines set by the WHO for vaccination targets The Biden administration has pledged over a billion vaccine doses to other countries but it's only delivered about 330 million doses so far and experts say the longer most of the world is unvaccinated the more likely it is that new variants will emerge in the pandemic will drag on Well we are looking back on a whole year Obviously there's still a lot of moving parts But what do you think is the big takeaway here ping Well first of all I should say that oh Macron is also soaring in countries that have managed better than the U.S. so even if the planet gone perfectly the country might still be struggling but sources we talked with say Biden's team made mistakes missed opportunities and faced limitations to their own powers their ability to predict and control a changing virus Some experts said it's time for a formal assessment like the 9 11 commission but for the pandemic that would establish what's been learned what to do differently going forward and it would help the country do better moving through this pandemic and make it a lot more ready for future ones All right Well you can read the full scorecard of Biden's initial pandemic planet NPR dot org That was NPR health reporters ping Huang and Selena Simmons stuff And thanks to both of you Thank you Thanks for having us Let's go now to Afghanistan and the growing number of children there who do not have enough to eat Felipe Ribeiro runs the Afghanistan office of Doctors Without Borders He says he's seeing more and more kids come to their hospitals severely malnourished sometimes there aren't enough beds Time to time we have no other option than to babies in one bed because a lot of patients are coming to us We can not extend the hospital much more And the other hospitals are not able to cope neither These are current situation We've been checking in with Ribeiro since before the country fell to the Taliban 6 months ago he told me stray bullets were flying through a hospital compound in Lashkar gah since southern Afghanistan Staff their retreating wounds from shrapnel and bullets and.

Biden George's Benjamin Biden administration American public health associa Trump Seema Selena Celine gounder university of Pittsburgh government World Health Organization NYU U.S. ping Huang Selena Simmons Felipe Ribeiro Afghanistan office of Doctors NPR Afghanistan
"felipe ribeiro" Discussed on KQED Radio

KQED Radio

09:13 min | 8 months ago

"felipe ribeiro" Discussed on KQED Radio

"Younger and younger Children and make sure that the vaccine and the doses that were giving are also safe and effective for younger Children. Because Children are not just like little adults, there are real issues to figuring out how to vaccinate Children. Specifically, yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approved for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote. In our view, the rise of the Delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain? What is that risk benefit analysis in general? So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important. To make sure that that we protect against that now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine, um less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children Far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote, you argue that the FDA will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled, and that at least one of the manufacturers expects to have data available to submit to the FDA, Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough. That that they could rely on the very strong safety data at two months and the final approval came at six months, which is which is an important landmark but cautious one and we we really believe that the same situation applies for Children. So we absolutely believe that that we have enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children after two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate Their Children, regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP ignore. Does the FDA or the CDC and the reason for that is that It is important to look at the data from the trials. It is important to make sure that we have approved and authorised the right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for of adults. Lee savvy. Oh beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. First spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay rib, Errol back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again and little good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in in Lashkar gar, but also in the rest of the country. Life is somehow back to some kind of normalcy. If I can put it that way, do you have enough supplies? I'm reading about supply line disruptions, flights not coming in and delivering much needed goods. We have enough supply for now, because basically we are the plane. Um, we arrived in Kabul actually on 13 of August, two days before the fall. And we were able to, uh, supply all of our projects. How long will those supplies last for a couple of weeks, if not months. Want to ask about what your relationship looks like, Um, with the Taliban, which is now running Afghanistan. When when we last spoke, you had been in contact with them. They were not placing restrictions on your women staffers is that still the case is still the case. It's the case of relation. So let's say, uh, I mean, how can I put it professional? We do not have a new restrictions put on our work for time being. But of course, as you can imagine, the we are still in the phase of transition. So basically they're leaving you alone for the most part to do your work. Yeah, we can. We can we can say so. Yes, indeed. They let us work. But the support of the state if I if I can say so is missing because the administration is not functional for time being. And what does that mean? Without the support of the state? What? What have you lost? Well, getting getting visas Been getting the authorizations to import stuff. Um, having a proper banking systems were working and functional having enough cash in the country. Basic stuff? Yeah. So you said, you have enough supplies. Let's talk about money. And these reports that the banking system in Afghanistan is on the verge of collapse. How does that impact you and your operations? It impacts all of us one and and the first ones to be impacted. Actually, the Afghanistan that of facing a lot of difficulties to have access to the savings and the banker comes As you may know, people cannot withdraw more than $200 a week from the from the banks and even thought they have to cure for hours without any guarantee to have access to money because we are all running short of cash. So in Kabul as you move about your daily life, What does it feel like compared to the the spring compared to a few months ago. Um, how can I put it first? It's very quiet and very calm. I have to say, uh, less people in the streets. But it's also linked to is the fact that a lot of people do not have work anymore. Um Less fear before the takeover, as you may know, explosions where we're somehow very common, and nowadays there is not no more of that. Meanwhile, the city's is safer. But he's very, very quiet. Are there certain things you're watching for? Signposts milestone, this markers and all of this that might cause you to think. Okay, This is this is looking more risky. Maybe it is time to go. Well, you know, looking at the economic situation, 11 thing that we might be worried about is what will be the consequences when when it comes to criminality and people trying to basically find find ways to leave. Um, this is one of the main concerns that we are having. The second concern that we're having is, as you have seen, there is no not anymore resistance or fight going on that we might expect some kind of armed opposition to emerge at some stage and how it's going to be to be organized. All. Um I'll was going to work out. And the third point that there is a constant for us. He's the president of the presence of, um Islamic state. Hola. Sun, uh, that that is indeed one of the major concerns. For all of us and starting for the Afghans, Actually, that is Felipe Rivera. He runs MSF Doctors.

Felipe Rivera Felipe Ribeiro Lashkargah August 19th Afghanistan American Academy of Pediatrics 13 of August Six months FDA today CDC Lashkar gar U. S military two months end of September Kabul southern Afghanistan First One Lee
"felipe ribeiro" Discussed on KCRW

KCRW

06:47 min | 8 months ago

"felipe ribeiro" Discussed on KCRW

"This is all things considered from NPR News. I'm Mary Louise Kelly in Washington and I'm Ailsa Chang in Los Angeles. You have heard a lot about booster shots lately. Are they needed when will they be approved and who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about Children, 11 years old and younger. The vaccine still is not authorized for them, and Dr Francis Collins, the director of the National Institutes of Health, told NPR last month. That he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us now. Welcome. Thank you so much for having me here. Okay. So before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for Children, can you just explain very briefly for us? Why is this taking so long in the first place? So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics actually are available that they're safe and effective And what we know in vaccine development for Children is that we are appropriately more cautious. Typically, vaccine development will start with adults and then we do what's called A gin does de escalation. Where will then work backwards to younger and younger Children? And make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approved for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote in our view, the rise of the delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain what is that risk benefit analysis in general? So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important. To make sure that that we protect against that now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine, um less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children Far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote, you argue that the FDA will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled in that At least one of the manufacturers expects to have data available to submit to the FDA, Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough. That that they could rely on the very strong safety data at two months, and the final approval came at six months, which is which is an important landmark. But but a cautious one and we we really believe that the same situation applies for Children. So we absolutely believe that that we have Enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children after two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate their Children? Regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the C D. C and the reason for that is that it is important to look at the data from the trials. It is important to make sure that we have approved and authorized The right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for of adults. Lee Sabio Beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. First spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again. Hello. Good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in English car guard but also in the rest of the country..

Mary Louise Kelly American Academy of Pediatrics Lee Savio Beers Los Angeles Ailsa Chang Lee Sabio Beers Washington August 19th Food and Drug Administration Felipe Ribeiro Afghanistan 11 years NPR Francis Collins August 6th Lashkargah Six months six months FDA National Institutes of Health
"felipe ribeiro" Discussed on 90.3 KAZU

90.3 KAZU

06:46 min | 8 months ago

"felipe ribeiro" Discussed on 90.3 KAZU

"This is all things considered from NPR news. I'm Mary Louise Kelly in Washington and I'm Ailsa Chang in Los Angeles. You have heard a lot about booster shots lately. Are they needed when will they be approved and who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about Children, 11 years old and younger. The vaccine still is not authorized for them, and Dr Francis Collins, the director of the National Institutes of Health, told NPR last month. That he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us now. Welcome. Thank you so much for having me here. Okay. So before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for Children, can you just explain very briefly for us? Why is this taking so long in the first place? So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics actually are available that they're safe and effective And what we know in vaccine development for Children is that we are appropriately more cautious. Typically, vaccine development will start with adults and then we do what's called A gin does de escalation. Where will then work backwards to younger and younger Children? And make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely that Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approve for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote in our view, the rise of the delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain what is that risk benefit analysis in general? So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important. To make sure that that we protect against that now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine, um less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children Far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote, you argue that the FDA will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled, and that at least one of the manufacturers expects to have data available to submit to the FDA, Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough. That that they could rely on the very strong safety data at two months, and the final approval came at six months, which is which is an important landmark. But but a cautious one and we we really believe that the same situation applies for Children. So we absolutely believe that that we have Enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children after two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate Their Children, regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the CDC, and the reason for that is that it is important to look at the data from the trials. It is important to make sure that we have approved and authorized The right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for other adults. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. I first spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there good to speak with you again and look good to speak you to to Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in English cargo, but also in the rest of the country..

Mary Louise Kelly American Academy of Pediatrics Lee Savio Beers Ailsa Chang Felipe Ribeiro Los Angeles Washington Food and Drug Administration Afghanistan August 19th 11 years August 6th Lashkargah Six months Francis Collins two months six months NPR FDA National Institutes of Health
"felipe ribeiro" Discussed on 90.3 KAZU

90.3 KAZU

07:06 min | 8 months ago

"felipe ribeiro" Discussed on 90.3 KAZU

"Dot org I'm Lisa Ledeen expect sunshine this afternoon with temperatures mainly in the seventies. And coming up. Some people who have lost loved ones to covid 19 have had their grief compounded by dismissive attitudes about the virus within their communities. That story ahead. This is all things considered from NPR news. I'm Mary Louise Kelly in Washington and I'm Ailsa Chang in Los Angeles. You have heard a lot about booster shots lately. Are they needed when will they be approved and who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about Children, 11 years old and younger. The vaccine still is not authorized for them, and Dr Francis Collins, the director of the National Institutes of Health, told NPR last month. That he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process. Lee savvy. Oh beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us Now. Welcome. Thank you so much for having me here. Okay. So before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for Children, can you just explain very briefly for us? Why is this taking so long in the first place? So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics actually are available that they're safe and effective And what we know in vaccine development for Children is that we are appropriately more cautious. Typically, vaccine development will start with adults and then we do what's called A gin does de escalation. Where will then work backwards to younger and younger Children? And make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approve for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote in our view, the rise of the delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain what is that risk benefit analysis in general? So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important. To make sure that that we protect against that now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children Far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote, you argue that the FDA will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled in that At least one of the manufacturers expects to have data available to submit to the FDA, Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough. That that they could rely on the very strong safety data at two months, and the final approval came at six months, which is which is an important landmark. But but a cautious one and we we really believe that the same situation applies for Children. So we absolutely believe that that we have Enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children after two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate Their Children. Regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the C D. C and the reason for that is that it is important to look at the data from the trials. It is important to make sure that we have approved and authorized The right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for of adults. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. I first spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again and good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in in Lashkar gar, but also in the rest of the country..

Mary Louise Kelly Lisa Ledeen Ailsa Chang American Academy of Pediatrics Lee Savio Beers Los Angeles August 19th Felipe Ribeiro Washington Afghanistan Food and Drug Administration August 6th Six months Ribeiro FDA National Institutes of Health today NPR Francis Collins Lashkar Gar
"felipe ribeiro" Discussed on KCRW

KCRW

06:37 min | 8 months ago

"felipe ribeiro" Discussed on KCRW

"Are they needed when will they be approved and who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about Children, 11 years old and younger. The vaccine still is not authorized for them, and Dr Francis Collins, the director of the National Institutes of Health, told NPR last month. That he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process. Lee savvy. Oh beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us Now. Welcome. Thank you so much for having me here. Okay. So before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for Children, can you just explain very briefly for us? Why is this taking so long in the first place? So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics actually are available that they're safe and effective And what we know in vaccine development for Children is that we are appropriately more cautious. Typically, vaccine development will start with adults and then we do what's called Agen Das de escalation. Where will then work backwards to younger and younger Children and make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approved for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote. In our view, the rise of the Delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain? What is that risk benefit analysis in general. So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk. Outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important to make sure that that we protect against that. Now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote. You argued that the FDA Will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled in that At least one of the manufacturers expects to have data available to submit to the FDA. Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, But the FDA wants six months of data. Why is that? Can you explain that discrepancy And how important is that discrepancy? Yes, absolutely, you know, and this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough. That that they could rely on the very strong safety data at two months, and the final approval came at six months, which is which is an important landmark, but but a cautious one, and we we really believe that the same situation applies for Children. So we absolutely believe that that we have enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children After two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate their Children? Regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the CDC, and the reason for that is that it is important to look at the data from the trial. It is important to make sure that we have approved and authorised the right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for of adults. Lee savvy. Oh beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here to help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. I first spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again. Hello. Good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place in English card capitals in the rest of the country..

Felipe Ribeiro American Academy of Pediatrics August 19th Lashkargah Afghanistan six months Food and Drug Administration 11 years August 6th National Institutes of Health two months Francis Collins NPR last month FDA Lee savvy end of September AP Ribeiro today
"felipe ribeiro" Discussed on WNYC 93.9 FM

WNYC 93.9 FM

06:47 min | 8 months ago

"felipe ribeiro" Discussed on WNYC 93.9 FM

"This is all things considered from NPR news. I'm Mary Louise Kelly in Washington and I'm Ailsa Chang in Los Angeles. You have heard a lot about booster shots lately. Are they needed when will they be approved and who will actually get them? But there are still tens of millions of people in this country who aren't even eligible for a first vaccine shot. We're talking about Children, 11 years old and younger, The vaccine still is not authorized for them. And Dr Francis Collins, the director of the National Institutes of Health, told NPR last month that he doesn't see a vaccine for kids coming before the end of this year. That timeline has prompted organizations like the American Academy of Pediatrics to urge the Food and Drug Administration to accelerate its authorization process. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. She joins us now. Welcome. Thank you so much for having me here. Okay. So before we get to this letter that you wrote, which urged the FDA to speed up approval of the vaccine for Children, can you just explain very briefly for us? Why is this taking so long in the first place? So I think one of the most important things to emphasize here is that the FDA authorization and approval process really is in place to make sure that when vaccines or any therapeutics actually are available that they're safe and effective And what we know in vaccine development for Children is that we are appropriately more cautious. Typically, vaccine development will start with adults and then we do what's called A gin does de escalation. Where will then work backwards to younger and younger Children? And make sure that the vaccine and the doses that were giving are also safe and effective for younger Children? Because Children are not just like little adults? They there are real issues to figuring out how to vaccinate Children specifically. Yes, absolutely. Children are smaller. They have different physiology there at a different stage of their development, and we want to make sure that anything that we approved for them that's authorized for them is safe and effective. Well, then let's turn to the letter that you wrote. To the FDA in this letter, you say that quote in our view, the rise of the delta variant changes the risk benefit analysis for authorizing vaccines in Children. Can you explain what is that risk benefit analysis in general? So one of the things that we think about every vaccine. Every medication has a potential side effect. And so does the risk outweigh the important benefit that this particular therapeutic can bring. So, for example, we know that covid 19 can be an incredibly serious illness, so it's important. To make sure that that we protect against that now we also know that for younger Children, the risk of severe covid infection is less. And so what we have to do is way is the risk of the vaccine, um less than or greater than the risk of Covid infection. Two Children, and I think it's very clear to us that the risk of covid in Children Far outweighs any potential risk of the vaccine. And just to be clear in this letter that you wrote, you argue that the FDA will have very soon the data it will need to authorize the vaccine for Children, right? Can you just explain what is that data that the FDA will have quite soon? Our understanding from what we're hearing from the clinical trial sites and from the manufacturers is that their trials are are fully enrolled in that At least one of the manufacturers expects to have data available to submit to the FDA, Hopefully, by the end of September, perhaps early in October, and so what That means is that once that data is submitted, the FDA will have a chance to look at it to determine, um the safety and effectiveness of the vaccine and consider the risk benefit for Children. Okay, but the FDA wants Six months of data. Why is that? Can you explain that discrepancy? And how important is that discrepancy? Yes, absolutely, You know, And this is actually something that we've seen with the emergency use authorization of the vaccine and adults. The emergency use authorization came after two months because the FDA really felt and believed that the benefit of approving the vaccine because of the public health emergency was great enough that that they could rely on the very strong safety data at Few months, and the final approval came at six months, which is which is an important landmark, but a cautious one. Um and we really believe that the same situation applies for Children. So we absolutely believe that that we have enough data to determine the safety and efficacy of the vaccine for emergency use authorization in Children After two months. I'm curious because you're a pediatrician. Are you seeing parents coming into your office and asking you to go ahead and just vaccinate their Children? Regardless of what the FDA eventually decides. We are hearing from pediatricians across the country that parents are interested in receiving the FDA vaccine. What we can call off label for their younger Children. We don't recommend that at the AP, and nor does the FDA or the CDC. And the reason for that is that it is important to look at the data from the trials that you Is important to make sure that we have approved and authorised the right safe and effective dose for Children. And what we know of the trials is that the dose for younger Children is likely to be less than that for of adults. Lee Savio Beers is a pediatrician and the president of the American Academy of Pediatrics. Thank you very much for joining us today. Well, thank you so much for having me here. To help grasp day to day life in Afghanistan and how it's changing. One of the people we've been checking in with is Felipe Ribeiro. He runs the Afghanistan office of Doctors without Borders. First spoke with him on August 6th nine days before Kabul fell to the Taliban. And then he was describing the situation in Lashkargah, one of the cities where his medical teams operate as horrific daily bombings burn and shrapnel wounds, stray bullets flying around the hospital compound. When we checked back August 19th. It was a different scene. Much calmer. The Lashkar Gah hospital was full, but not all war injuries. They were delivering healthy babies again. Well, we have asked fully pay Ribeiro back to hear how it's going. Now that the U. S military is gone, and the Taliban have announced an interim government Hi there Good to speak with you again and look good to speak. You too. Tell me about Lashkar Gar and how it's going now. This is southern Afghanistan. What does your team say? How are they describing the situation today? The situation is very common in the south. I mean, it's basically very calm all over the place. In English car guard but also in the rest of the country..

Mary Louise Kelly Lee Savio Beers American Academy of Pediatrics Ailsa Chang Los Angeles Washington Felipe Ribeiro Food and Drug Administration August 19th 11 years Afghanistan Francis Collins Six months August 6th six months NPR last month National Institutes of Health today FDA