32 Burst results for "Peter Marks"
"peter marks" Discussed on WTOP
"News. Ten 15, I'm Dmitri soldiers. Thanks for being with us. After saying that we could see them as soon as this year, the Food and Drug Administration's top vaccines official is now changing his timetable for the expected arrival of a combo COVID and flu vaccine. Doctor Peter marks, now believes in September goal for the one shot solution for both viruses is too heavy a lift. Let's talk more about this live with CBS News medical contributor doctor David agus. Doctor Reyes, I know you were traveling a bit and it's so nice of you to take a few minutes to join us here. How unhappy or surprised by the news are you a bit of a setback for us maybe? Yeah, I mean, there are two ways to look at it. One is, you know, getting a bow shots at the same time versus mixing them together. You know, there is certainly more convenience when it's in one syringe rather than two. But we'll see. I mean, I know there is a mad race to try to get them ready for the fall. It's not definitive they won't be there, but it certainly is looking like it may not be this year, it may be next year. That being said, the cadence will still be yearly, you'll get a flu shot and a COVID vaccine in the fall. You know, I just went through when I say went through, I'm not saying it was a huge ordeal, but in September, I got a shingles vaccine in one arm, and then the flu shot, then I came back for the second shingles vaccine and got the COVID booster. I'm not saying I was miserable, but you kind of had to take a little time off for work. So I can just imagine in terms of convincing more and more people to get this thing and stay well. The one shot would really make a difference. No question. One shot would make a difference. But again, we could do both at the same time. I mean, I think that's going to be key. So it just means they won't be together, but they'll be at the same time. So you'll go one visit where you can get your flu shot and your COVID shot. And then there's going to be an RSV vaccine respiratory syncytial virus probably also later in the fall for the elderly in the very young. What about vaccination numbers in general, whether it's the flu or COVID or anything else? Where are we with that? Well, flu are pretty good every year we're about 50%. The problem is the new bivalent Copa booster only about 20% of the country has gotten. So we really fell off. And so the idea was we get on this regular cadence. People know the fall, I got to get both. I got to keep my immunity up and obviously this is a little bit of a hurt to that. Hopefully we can get over this and move forward. Is there a sense of what the hold up is and I know sometimes we expect miracles because the COVID vaccine really did come out so quickly and the research shows it saved many lives. Is it just a question of mechanics here or trying to get the biology right or what's going on? Yeah, I mean remember we're not as of May. We're not going to be under emergency youth authorization ability of the FDA. So it's going to be a full review. So we're not in that expedited panic mode where we have to do things really quickly. And when you do things at regular pace, if you will, it does take longer. Anything else on your mind about vaccines and staying well? No, I think the FDA gave the advisory board gave their approval to two with the RSV vaccines this week. And that's a big positive because we all saw earlier this year in young children and adults that was a big issue. So I think we're in a good spot with the vaccines, making them convenient in a one stop for you to one shot is certainly going to be fantastic. And I hope that happens. But if it doesn't, just getting both shots in the same day is going to be fine. All right. Thank you very much. Good to hear from you as always. Thank you. Doctor David agus, their CBS News medical contributor. And we've learned that it may not be September. It'll be some time after that that they'll perfect that one shot solution so you can get your COVID and flu vaccine at the same time. Stay with us here on WTO. Now bob imler, he's in the WTO traffic
AP News Radio
FDA moves to ease rules for blood donations from gay men
"Federal health regulators are taking steps to allow more people to donate blood by lifting some of the restrictions on gay men and others who are considered at higher risk of having the HIV virus. Current policy is gay bisexual men and others who engage in high risk behavior. Have to show abstinence for three months before donating blood. But doctor Peter marks a hematologist and a director at the Food and Drug Administration says better screening can end that waiting period. The new approach proposes that the current donor history questionnaire be revised to ask all prospective donors regardless of their gender about new or multiple sexual partners in the past three months. If the change is adopted, some will still be turned away. But more people will be allowed to donate. We believe that there will be no change to risk in the blood supply in terms of HIV, hepatitis B or hepatitis C the U.S. began restricting blood donations during the aids crisis in the 80s, but LGBTQ groups and the American medical association say that's no longer needed with better testing technology. I'm Jackie Quinn
ToddCast Podcast with Todd Starnes
Washington Post Applauds Play Promoting Pedophilia
"Post, and we've got this story up at Todd stern's dot com. The Washington Post has published a bizarre review of a play that promotes pedophilia. No, I'm not making this up. It's the most bizarre thing, but again, the story up at Todd starns dot com. And the play is called downstate, and The Washington Post says it's a brilliant production. The reviewer, a guy by the name of Peter marks, I don't know what I did to offend this guy, but I tried to reach out to mister marks to explain I wanted him to explain exactly why he is so enthralled with this play about pedophilia. And instead of returning my calls, he actually blocked me on Twitter. I don't know what that's all about. Anyway, the whole point of the production is that we should feel compassion and sympathy to those who are pedophiles. And The Washington Post calls that brilliant.
AP News Radio
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
WNYC 93.9 FM
"peter marks" Discussed on WNYC 93.9 FM
"Health officials say the new shots will boost people's fading immunity and help protect them against another wave of infections that could sweep the country this fall and winter. Here's doctor Peter marks from the FDA. We are looking at a possible fall wave with a peak around December 1st and by giving the booster now we will hopefully both control the current plateau that we're in as well as address this future potential wave that looms out there. John wary at the University of Pennsylvania thanks to the new boosters will cut the chances of catching and spreading the virus, protecting people against COVID and long COVID. This is great. We have updated boosters that are better tailored to address the viral strains that are present currently. The bottom line is that when you get a boost with these updated boosters, they're going to gain some protection from infection. You're going to protect those around you. And enhance our ability to return to a new normal. But some experts doubt the new shots will be much of an improvement and say there's no way to really know how well they work because they were only tested in mice, not people. John Moore is an immunologist at wild Cornell medicine. The public shouldn't think that it's going to give them some super strong shield against infection. But federal officials are confident that shots are safe and could provide longer lasting protection and even help fight off some new variants that might emerge. The FDA says anyone aged 12 and older can get a booster when they start to become available over the Labor Day weekend as long as it's been at least two months since their last shot, but some experts say people should wait at least four months or the new shots won't work. The CDC advisers meeting today will recommend exactly how to use them, including who should get the shots, should it be anyone aged 12 and older, or maybe at least initially, just people at high risk because they're older or have other health problems. Rob Stein and PR news. We appreciate you tuning in to your local member station, you can also find us on social media, you can visit the morning edition Facebook page or of course we're on Twitter. You can find laila fod at Layla bottle. A Martinez is at a Martinez LA. Stevens gape is at NPR inskeep and you can find me, Rachel Martin, at Rachel NPR. This is NPR news. It's morning edition on WNYC coming up NPR recently reported on people that out of federal prison during the pandemic, only to go back to jail for a minor infractions. That story led to the release of one inmate and a family reunion. I mean, I just went down on my knees and I just cried because it was a long process. More on that story later this hour. WNYC is
WABE 90.1 FM
"peter marks" Discussed on WABE 90.1 FM
"Versions of the Moderna and Pfizer BioNTech vaccines that have been reprogrammed to target both the original strain of the virus and and this is the important part, the omicron variant, specifically they're designed to protect against the super contagious omicron sub variants that are infecting most people right now. So federal officials hope the new shots will shore up people's immunity to protect them against omicron better, especially as another surge of infections is expected to hit this fall and winter, and hopefully give people immunity that lasts longer than the original shots, they might even guard against new variants that emerge. Here's the FDA's doctor Peter marks. If I had to say what keeps me up at night most in this pandemic, it's that we have seen lots of twists and turns that were hard to predict. So it's the unknown unknowns that really are concerning by doing this, we've tried to mitigate against that so how are these new boosters likely to work? You know, we're already, that's the big question. And unfortunately, no one really knows for sure. For the first time, the FDA is authorizing these vaccines based on tests and mice instead of people combined with how people's immune systems responded to previous versions of the vaccines, including one targeting the original strain of omicron. The FDA says that leaves no doubt that number one, the vat shots are safe, and number two, the new booths should cut the risk of catching the virus and getting COVID or long COVID. Here's doctor Peter marks again. The public can rest assured that a great deal of care has been taken by the FDA to ensure that these updated boosters meet our rigorous safety effectiveness and manufacturing quality standards while many outside experts that I've been talking to a grace some are more skeptical. Why is that? You know, no one's worried about safety. It's clear the vaccines are very safe for critics say mouse studies just aren't very good at predicting how vaccines work in people. And earlier vaccines, the tests on those earlier vaccines indicate that there are only a bit better than the original shots at best, and so the worry is people will think these new shots protect them more than they really do. Here's John Moore, he's an immunologist at Walcott and medicine. Maybe a modest benefit to protection against infection. But it will be modest, which is why I say don't believe that you're getting super strong shielding against infection. And more and others also worry that the fact that the vaccines were only tested in mice might be getting even harder to convince people to get them. It's been a tough sell already convincing people to get their first or second boosters, and they're still plenty of people out there who haven't gotten any shots. And that's the main reason between four and 500 people are still dying every day from COVID. I'm sure many people are wondering how soon they can get these new boosters. What's the schedule? Yeah, so the CDC will decide by the end of the week exactly who should get these new boosters and how they should be used once they become available next week. The FDA authorized the Moderna booster for anyone 18 and older and the Pfizer BioNTech booster for anyone 12 and older, but some experts think the people who really need them are those at high risk like older people and those with other health problems. Another big question is how long to wait to get the shots. The FDA says two months since the last shot is long enough, but rather say that's too short, people should wait four to 6 months after their last shot or infection, where the new boosters may not just work very well. NPR's rob Stein, thank you. You're welcome, are you any time? A delegation of inspectors from the International Atomic Energy Agency is on its way to the zapper Asia nuclear power plant in southern Ukraine today. It is the largest nuclear power plant in all of Europe, and it's right on the front line, right in the middle of fighting and shelling right now. Some experts fear the plant could melt down in a way similar to what happened in Fukushima Japan over a decade ago. But what would a nuclear crisis like Fukushima look like in a war zone? Well, NPR's cat lawn store has spent time in both Fukushima and Ukraine and joins us now to discuss the risks. I can't. Hey, Elsa. Hey. Okay, so can we just start in Fukushima because you were there right before the pandemic started touring villages that are still mostly empty, ten years out or more than ten years out, what is it like there right now? Yeah, so one thing is that there are all of these bags of radioactive topsoil everywhere, just piles and piles of them, cleanup crews basically have to scrape away all the top soil because that's where the radioactive material settles. Recovery generally in that area has been really, really hard, really expensive. It was a big rice farming area, but that's mostly gone around the plant. So there's not really an economy anymore. And why do experts keep talking about Fukushima as a comparison to the zapper isha plant? As opposed to say like, what happened at Chernobyl? Yeah, so a lot of people think of Chernobyl when they think of nuclear disaster, which is also in Ukraine. But that disaster happened because of design flaws and human errors. Fukushima is a better comparison. It wasn't a war zone, but it was an major disaster zone after a massive tsunami hit it after an earthquake. And workers had a lot of trouble getting into the plan
"peter marks" Discussed on 60-Second Science
"It seems likely the U.S. could face another fall or winter COVID wave. But we could have better booster shots to ward it off. Josh, what are the chances of that? It does look like better boosters are coming, Tonya, the question is whether they'll get here in time to stop that fall wave that you mentioned. And the timing seems to depend on what vaccine makers put in the shots. So what are the choices? Well, both Moderna and Pfizer began developing shots with the ancestral omicron variant months ago, and Moderna has already said those could be ready by August, but the FDA and its vaccine advisory committee just said that the new boosters should be built around the new sub variants, BA four and BA 5, and the vaccine makers say that those shots which they're just starting to test wouldn't be ready until October. But that will be too late to fend off a fall wave. Why pick the slower route? Because it looks like boosters using BA four and 5 will protect people better, since those sub variants are the ones dominating new infections right now, so they'll either be the one circulating in the fall or those fall viruses will be very similar. The FDA wanted boosters that are more likely to produce antibodies that neutralize the sub variants, and lab tests indicate that vaccines built around ancestral omicron don't do that well enough. The sub variants are just different enough from their ancestor to evade an omicron prompted immune response. The idea behind the boosters is to trigger broader based immunity. So the shots contain genetic material from the original SARS CoV-2 virus, the one that hit us in early 2020, as a foundation. And then they add in material from the new sub variants. It's basically teaching your immune system to respond to a wider spectrum of virus versions. So this is kind of a race against time and virologists are hoping the boosters are so effective they can stop or slow down a new wave. Yes, it's a race. I think the FDA was convinced by data showing that people infected by ancestral omicron were getting reinfected by the sub variants, so they were afraid that the same kind of thing would happen if they rolled out old omicron based boosters. Health officials were also worried that people wouldn't get such boosters. That's already a problem. Three quarters of people eligible for boosters have not gotten them, and there seems to be a perception that the shots based on the 2020 virus are outdated. Peter marks, who runs the FDA's vaccine office, says he hopes effective boosters against the latest sub variants will convince a lot more people that the shots are up to date and they should roll up their sleeves. What happens, though, if the fall virus is some new, really different version, new versions seem to keep turning up every couple of months. It is a bit of a gamble, but Trevor Bedford and evolutionary biologist at the Fred Hutchinson cancer center. Thinks it's a good bet the fall virus will be pretty similar. He tracks the way the virus mutates and says all the recent changes keep new versions within the omicron branch of the virus family tree, since those versions have been wildly successful at spreading, he expects that trend to continue. And this summer, vaccine makers and the FDA will be testing those new boosters to make sure they are just as successful at keeping up. Now you're up to speed. Thanks for joining us. Our show is edited by Jeff del vizio and teleka Bose. We're going to take a short summer break for the next two weeks. Even in a pandemic, you need some time off. Especially in a pandemic. But we'll be back the first week of August with a new episode of COVID quickly. And check out Siam dot com for updated and in depth COVID news.
AP News Radio
For now, wary US treads water with transformed COVID-19
"The fast changing coronavirus has kicked off summer in the U.S. with lots of infections but relatively few deaths compared to prior incarnations I'm Ben Thomas with an update on the coronavirus For many people the virus is not nearly as dangerous as it once was but COVID-19 is still killing hundreds of Americans each day The latest count by Johns Hopkins University puts the 7 day moving average at 354 And the Food and Drug Administration this week told vaccine makers to tweak any booster doses intended for fall so they protect against the newest relatives of the omicron variant FDA vaccine chief doctor Peter marks None of us has a crystal ball and we are trying to use every last ounce of what we can from predictive modeling and from the data that we have that's emerging to try to get ahead of a virus that has been very crafty It is a mixed and confusing picture repeat infections are increasingly likely and a sizable share of those infected will face lingering symptoms of long COVID Doctor Arnold monto is the acting chair of the FDA's advisory panel on vaccines Looking in the past doesn't help us a great deal to look in the future for this virus which has baffled a lot of us and made predictions almost irrelevant I'm Ben Thomas
WABE 90.1 FM
"peter marks" Discussed on WABE 90.1 FM
"Big surge in the coming winter. Here's how doctor Peter marks at the FDA set the stage for the day long meeting today. That combination of waning immunity combined with the potential emergence of novel variants during a timeless winter when we will move inside a population increases our risk of a major COVID-19 outbreak. So in the end, the committee voted 19 to two that the country should deploy a new generation of vaccines programmed to target omicron for another round of boosters in the fall, but you know, it wasn't an easy call. Well, just what made it so tricky. Well, you know, there are just so many unknowns. This virus involves so fast and it's so unpredictable that it's really tough to pick the best strategy for a booster campaign, a half a year away. Who knows how much immunity people who have left by then and who knows what farron will be spreading by then. Here's how doctor Arnold Vancouver at the University of Michigan put it. He chairs the committee. We're being asked more or less to have a crystal ball today. And to make things even harder, there just isn't a whole lot of data yet about how much better new vaccines targeting overcrowd would really be. You know, studies from Moderna and Pfizer and BioNTech indicate that their new vaccines could provide stronger protection than the original vaccines, but it may not be all that much stronger. And those vaccines, they target the original strain of omicron, which has already been replaced by new sub variants that are even better at sneaking around the immune system. In fact, the CDC released new data today that estimates those new sub variants called BA four and BA 5 are now dominant in the U.S., so Pfizer surprised the committee with new data about another new vaccine tailored to fend off BA four and BA 5 that looks promising, but that was based on experiments involving mice. So it's even more preliminary. So advisers voted to go with some sort of new omicron vaccine. Did they say which one? You know, they didn't specify, but you know, it was clear that most of the advisers felt that the next booster should target these new sub variants be a four and BA 5. Here's how doctor Bruce gellin at the Rockefeller foundation put it. The spirit of the family cup where the puck is going, whereas in advance, I lean to the VA four 5. But many experts endorse targeting both some version of omicron and the original virus to sort of hedge our bets, but it will now be up to the FDA to decide exactly what to do. The agency will probably make its pick by midsummer and the company say they could deliver millions of doses of new omicron vaccines by October or November. All right, NPR health correspondent rob
AP News Radio
FDA authorizes 1st COVID-19 shots for infants, preschoolers
"Federal regulators have paved the way for the nation's youngest kids to start getting COVID-19 vaccine shots next week The FDA has authorized the Moderna and Pfizer vaccines for children 5 and under Vaccinating our youngest children we hope to prevent the most devastating consequences of COVID FDA commissioner Robert caliph says statistics showing the viruses the 5th leading cause of death in kids ages one to four are unnerving and the deaths are preventable CDC advisers are now debating how to use the tot sized vaccines Two shots from Moderna three from Pfizer FDA vaccine chief Peter marks says both will do the job Parents should feel comfortable getting either one of these Sagar Meghani Washington
AP News Radio
FDA advisers weigh COVID-19 shots for babies, young children
"Federal health advisers will decide today whether to endorse COVID-19 vaccine shots for the youngest Americans Kids under 5 are the only ones in the U.S. not yet eligible for the vaccines Food and Drug Administration independent advisers are considering taut sized doses from Pfizer and Moderna and will vote separately on each as their meeting today began FDA vaccine chief doctor Peter marks said more than 440 kids under the age of four had died during the pandemic and while that's far fewer than adult deaths Every life is important And a vaccine preventable deaths are ones that we would like to try to do something about FDA reviewers say both brands appear safe and effective for kids as young as 6 months old If the vaccines clear all regulatory hurdles shots should be available next week Sagar Meghani Washington
The Readout Loud
"peter marks" Discussed on The Readout Loud
"Tough first quarter, right? And with a lot of, you know, a lot of clinical data, readouts that we're just negative. You know, there's just been this preponderance of negative results. And so I think people would like to see over the next three months, clinical trial readouts on a much more positive direction. It's become a regular event in every pandemic reporter's life. Every few months spend 8 straight hours watching the FDA meet with its vaccine advisers over video. This week's meeting was more wide ranging than usual. Instead of discussing a specific vaccine application, the group was trying to hash out how to figure out whether we need to update the COVID vaccines for the fall, when and a number of other tricky questions. Stat reporter drew Joseph covered the whole thing and he's here now to discuss it. Drew, welcome back to the readout loud. Yeah, thanks. It's nice to be here. So the meeting kind of kicked off with one of the trickiest questions of all. Doctor James hildreth, a member of the advisory committee, almost immediately asked why the FDA didn't consult the group on a major decision about boosters just last week, which was of course making fourth shots available to everyone over age 50. How did the FDA respond to that? Yeah, so the timing of this was pretty funny. This meeting had been announced last month at some point, and it was set up as this general discussion as you were talking about Meg. But then last week the FDA made that booster announcement without consulting its verb pack. And so what Peter marks, who's a top vaccine regulator at FDA said in response to doctor Hilda's question was, let's see here. We consider that not as a major expansion or a major change, but something that we looked over the data and felt was reasonable to do at the time. So yeah, so march is basically saying this was sort of, I don't know, just like a tweak almost or something where they didn't need to really convene the whole vrbpac. But if I sort of can read between the lines a little bit, Marx also later referred to this decision as a stop gap measure. I think there's just a little bit of anxiety about what's happening epidemiologically right now, like maybe the U.S. is in the early stages of some size of spike, maybe not a huge one in cases, but and so there's just some anxiety I think about their levels of protection in older populations and for people with immunocompromising conditions just because they're the people who are most vulnerable, even with shots. So I think that was maybe just a way for the FDA to help get people who are who want another shot another shot just to get them a little more protection quite quickly. The meeting really reflected how much uncertainty there is right now, particularly around the future course of the pandemic, as well as the best way to adjust the vaccines to address it. There were some presentations from modelers trying to chart out the future. What did those reveal drew? Yeah, I mean, basically, they reflected the uncertainty as you were saying, but the two seemingly definite things are the virus will keep evolving and that there will be future waves. But it's really hard to predict how big those waves will be when exactly they will be and just how the virus will evolve. There's been a ton of evolution in the virus over the past two and a half years. Kind of way more than experts initially anticipated this thing is just changing really quickly. But then every once in a while, there's sort of like a freak thing like where omicron happens, which is just so wildly different from any other circulating strain. So that there's like all this unpredictability in terms of figuring out what the virus will look like even four months from now. It's basically like a moving target. If you wanted to sign your vaccine to better reflect the circulating strain, like you just don't really know what it's going to look like. And so there's a concern basically if you update your vaccines to better reflect the circulating strain now, what happens if the virus changes the next week or something like that? And it kind of undercuts the power of your updated vaccine. So these are really wrestling with some really tough and by definition unknowable questions. Yeah, and everything you were just saying, it sounds so much like what they do for the flu every year where in February for the northern hemisphere, the decisions are made about which strains to put in the flu vaccine for the fall, is that are we at a point now where the experts think we can think about COVID in the same way. I mean, we're already in April and we're talking about potentially getting ready for a wave in the winter this year, although it sounded like the experts were saying, it's not even determined to be seasonal yet, even though we've seen winter waves before. So they want to prepare for that, but they don't know if we're going to have one, but can we think about this like a flu shot yet? I think people are making the flu comparison perhaps because that's like the best thing we have, the best framework we have if we're trying to build a new system, a new process for updating the COVID vaccines, but yeah, they also talked about that there are some key differences and maybe we're just not quite there with SARS CoV-2, the coronavirus yet. But it does seem like there's a desire at least to have this be like a global decision, something maybe the WHO coordinates and national regulators get involved with as well. So that's.
"peter marks" Discussed on WTOP
"Portnoy has more The president's call with Vladimir Putin lasted roughly an hour an aide says as professional and substantive as it was it resulted in no fundamental change in the dynamic A White House statement says mister Biden warned Putin that an invasion would lead to widespread human suffering and diminish Russia's standing Even a source of say intelligence indicates Putin has told his troops to be ready by Wednesday publicly the U.S. says Russia's intentions still remain unclear One issue that was not brought up Moscow says a U.S. submarine entered Russian waters in the Pacific and a Russian naval vessel chased it off The U.S. denies it entered Russian territory CBS's MTS tayab on Putin's potential next move There has been a lot of talk about what could trigger this war What could trigger this invasion and more importantly what Vladimir Putin is waiting for Some have suggested it's the weather that he wants the ground to freeze before crossing over with his tanks and heavy weaponry I was just up in the north in the northern border area between Belarus and Ukraine It is very mild there It doesn't seem as if that the land is going to freeze or more importantly if that really is even the calculus The FDA is delaying approval of Pfizer's COVID vaccine for young children FDA vaccine chief doctor Peter marks explains why The data that we thought made us realize that we needed to see data from a third dose as in the ongoing trial in order to make it determination that we could proceed with doing an authorization A protest continues for a 6th day at the ambassador bridge linking Windsor Canada and Detroit blocking traffic from flowing That's despite a court order to end the demonstration over COVID-19 restrictions This man is taking part This is an insurrection or terrorism This is grassroots people with their children and they do grandparents and parents coming together and saying hey my rights.
AP News Radio
In reversal, FDA puts brakes on COVID shots for kids under 5
"The food and drug administration is putting the brakes on a speedy review of coronavirus shots for kids under five the FDA is worried about the Makran variant and vaccine G. Peter marks says they urged visor to apply for okay of the extra low dose vaccine before it's clear if kids would need two shots for three this time we believe additional information regarding the ongoing evaluation of a third does it should be considered it was hoped kids under five could get shots within weeks the data they're looking for isn't expected until April well how you align what they've come to do well which is they are using Matthew procedures and they are making sure that they are back Natick eighteen million children under five make up the only age group not eligible for vaccination at Donahue Washington
AP News Radio
US advisers support expanding COVID boosters to all adults
"The government has moved to open cove it nineteen booster shots to all adults as experts worry a steady rise in virus cases could lead to a holiday season search the FDA says anyone eighteen and over can pick either replies or or matured a booster six months after their last dose about a dozen states were already offering the shots on their own amid complaints the federal regulations on who could get them work too confusing we heard loud and clear that people needed something simpler and this I think is simple hours after FDA vaccine chief Peter marks talk to the AP CDC advisers like Dr Camille Nelson cotton agreed all American can understand the track teams that are recommended for them at that time the CDC advisers went even further stressing people fifty and over should get a booster Sager mag ani Washington
The Readout Loud
"peter marks" Discussed on The Readout Loud
"And I think we still have to keep an open mind about where we're going to go with this virus over the years. We had this is not as simple as flu. I wish this were flu. If this weren't influenza pandemic, we would be settling into seasonal influenza already. It would be, you know, it would have delivered its punch. It would have started to become more like a seasonal flu virus and by next year at this time we could feel certain, well, we were back into the flu season. We don't know where this virus is going to go. We just don't yet. When a group of people that doesn't have the option about getting vaccinated yet, and this is a question coming from a place of self interest. Kids under the age of 5, which I have one. What do you think the prospects are of a vaccine for younger kids? We've heard that Pfizer will likely have data by the end of the year. But I asked doctor Peter marks at the FDA, what they were thinking for the timeline and he sort of indicated the risk benefit calculation for even younger children is different than even the 5 to 11 year olds because they're less severely affected by severe disease. But do you expect that we will have a vaccine for younger kids within a sort of near term time frame? You know, I think we will. And I think we will for several reasons is I think doctor Marx's comments are right. But even though it is less likely to cause severe disease in these youngest kids, when you compare that to other vaccine preventable diseases that we actually have routine vaccines for that age of kids, COVID is still a very severe and punishing disease. And that age group. Number two is the fact that they are still serving as major sources of transmission in our community. So when you look at the benefit clearly, we want to make sure there is a real benefit for the child. Not just a community benefit. But if we can show both a health benefit for the child, may not be as significant as for older children, but still there, we can show the benefit to the community and we can show that the risk of the vaccine itself is so very, very low. I think we will see approval of these vaccines. And I do think they will be very important. And like you, I don't have a child under age 5, but I have a grandchild under age 5. So I have a personal interest in this just as you do. So speaking of vaccines and their acceptance, step my colleagues that left faster had a story this week about how the resistance to COVID vaccine mandates is stretching beyond COVID-19 itself with right wing politicians across the country pushing against any vaccine requirement, including for diseases like measles, mumps and rubella, is that on your radar, you worried this kind of backlash can have can pose a threat to public health more broadly even beyond COVID. You know, I think there are a number of threats to public health right now. And I think it goes back to the body politic that we have. One need look only at the vaccine programs you just mentioned and that's a very important point. I also have to say with a very, very heavy heart. I have had a number of what I consider to be absolutely outstanding public health officials, public health scientists who have resigned their jobs because the pressure was so great, not just about COVID, but specifically about the partisan nature of what was happening. And I think you're going to see more and more of those resignations coming. And so I worry about the public health infrastructure. I worry about the funding. I don't think many people realize how we've pretty much kept this country's disease surveillance program operating on bailing wire entwine. It was really a situation where we have counties in this country that are still reporting cases by fax machines. Can you believe that? And so the systems have been antiquated and outdated for so long that we need to basically bring them into the 21st century. What kind of support is going to be available for that, depending on who happens to be in charge of the purse strings at a state or federal government level. And so I think that we have an overall threat to all of public health. The trust of public health. You know, when you look back at many of the public health decisions you get made that are critical and to life threatening conditions. They're not about the ones like vaccines, where typically it takes years and years and many thousands of pages of information and questions asked and answered and asked an answer. Many public health decisions get made just like Jon Snow did back in London. Some over a 140 years ago, when he took the pump handle off that well. And Soho, because he realized that people were likely getting cholera from that at a time 40 years before cholera bacillus was even discovered. And so I think that we make decisions a lot where we have to take action based on the best available information. And if we're blocked from doing that, people will die needlessly for a lot of other reasons. Do you take that food item off the market that you know is contaminated or at least you believe is? And the data supports it, but you have improved it yet. Well, you could wait another three weeks to figure that out. But if you do, more people are going to consume it and die. And so we have a lot of things in public health right now that I think are threatened by the threatening world of governance. And so yes, I worry a lot about vaccines, parents acceptance of vaccines. And what they mean. But I also worry about just the ability of us to actually conduct public health in this country as well as other countries around the world. Well, as you mentioned before, you have your own weekly podcast focus on the COVID pandemic called the osterholm update, which we heartily recommend anyone listening to this to check that out as well. Doctor osam, thanks for joining us. Thank you very much. It's a really great to be with you..
AP News Radio
FDA advisers approve Pfizer’s COVID-19 vaccine for kids
"Government advisers already endorsing the use of Pfizer's coated nineteen vaccine in kids ages five to eleven BAFTA advisers voted after agency vaccine chief Peter marks noted the pandemic has not spared young kids over eighty three hundred Hopwood H. and about a third of which have required intensive care unit stay ended nearly one hundred deaths Fizer reported each study of elementary schoolers found a third of the dose given to teens and adults with nearly ninety one percent effective at preventing symptomatic infection if the FDA itself authorizes the smaller doses the CDC will also have to sign off and say which kids should get them the dirt is also studying its own vaccine in the younger children Sager mag ani Washington
Bloomberg Radio New York
"peter marks" Discussed on Bloomberg Radio New York
"And national news All right thank you Paul the Food and Drug Administration says we can mix and match booster shots They recommend that if you've gotten a COVID vaccine from one drug maker you can get a booster shot from one of the other authorized vaccine manufacturers Doctor Peter marks explained it all in a teleconference A single booster dose of any of the available COVID-19 vaccines may be administered as a booster dose following completion of the primary vaccination series with a different authorized or approved COVID-19 vaccine But doctor Peter marks with the FDA says the agency does not have the last word on this The Centers for Disease Control and Prevention will consult an expert panel later this week before they finalize the official recommendations for boosters We're also waiting to hear from regulators about vaccinations for children as young as 5 years old Surgeon General Vivek Murthy says The White House is already working to make sure those shots will be readily available We've made sure that the vaccines are free Number two we made sure that there's adequate supply that for all the 28 million kids who fall in that range And number three we're making sure that there will be tens of thousands of places where people can receive the vaccine At Surgeon General Vivek Murthy he says once federal regulators give them the green light vaccinations can start taking place in doctors offices children's hospitals pharmacies and in some cases schools British police have charged a man with murder and preparing acts of terrorism in last week's stabbing of a conservative lawmaker Authorities say a 25 year old British man with Somali heritage Ali harby Ali has been charged in the death of David Amos Global news 24 hours a day on air and on Bloomberg quicktake powered by more than 2700 journalists and analysts and more than 120 countries I'm.
Bloomberg Radio New York
"peter marks" Discussed on Bloomberg Radio New York
"Kids 5 to 12 years old Once those children are vaccinated how many more parents that are willing to come back into the labor market I think that path for labor supply in the United States over the next three months 6 months 9 months that's really going to be key to understanding the evolution of the U.S. economy Seth wonderful to catch up as always the chief economist over at Morgan Stanley Seth conference there One of our lead stories right now here at Bloomberg the Central Bank of Erdoğan cuts rates again at the lira's expense His dollar lira right now Dollar try all time highs That's all time weakness for the Turkish lira Tom Dollar lira 9 42 Okay I'm gonna say this John right now I just did the weekly chart for global Wall Street This is real straightforward on a standard deviation basis on a weekly chart Dollar liar is weak lira out to three standard deviations that at the 9 9 46 level as well We just touched that for a cup of coffee a good Turkish cup of coffee John the trendier is incredibly elegant The chart is literally teacher course weak lira I know what you mean by the word elegant though for Tom for many people It's brutal It's brutal right now Mathematically this is incredibly persistent trend John with an inertial force The number one thing I would say John is in all the time in Istanbul it's two fixed income markets How does dollar dominated adapt How does denominated debt What do you think they called the recent increase in inflation Tom over in Turkey Transitory I called it transitory and bringing some of the commentary from that Central Bank a little bit later They cut rates 200 basis points inflation is running at close to 20% in Turkey a very different conversation From New York City on radio on TV this is Bloomberg Now with the latest news from New York City and around the world here's Michael Barr Tom Lisa John the Food and Drug Administration is recommending that people who have received a COVID vaccine be allowed to get a booster shot from one of the other authorized makers Doctor Peter marks spoke in a teleconference A single booster dose of any of the available COVID-19 vaccines may be administered as a booster dose following completion of the primary vaccination series with a different authorized or approved COVID-19 vaccine Doctor Peter marks with the FDA says though the agency does not have the last word the Centers for Disease Control and Prevention will consult an expert panel later this week before finalizing official recommendations for boosters Former president Donald Trump says he's launching a new media company with its own social media platform 9 months after being expelled from social media for his role in inciting the January 6th capitol riot Trump says his goal is launching the Trump media and technology group and its truth social app The full House votes today on whether to hold former Trump adviser Steve Bannon and contempt of Congress for defying a subpoena related to the January 6th capitol riot Former president Bill Clinton has released a video saying he's on the road to recovery after being hospitalized in Southern California for 6 days to treat an infection unrelated to COVID The 75 year old Clinton arrived at his home in New York on Sunday Clinton says in a video released yesterday that he's glad to be back home and touched by the outpouring of support he received a hospitalized.
NoCo Now ? 1310 KFKA
"peter marks" Discussed on NoCo Now ? 1310 KFKA
"Or the other. Gruber's the comedies aimed to apply to the food and drug administration by the end of the month for emergency use in this age group followed shortly afterward with applications to european and british regulators earlier this month. Fda chief dr peter marks till the ap that was pfizer turns over. Its study results. His agency would evaluate the data hopefully in a matter of weeks to the side of the shots safe and effective enough for younger kids. You heard chris intervene talking about it earlier today on the program. This is a great day for all of these big companies for pfizer. Great it's like. Hey here's what our studies are here. It is but that doesn't always mean that that's what the end results going to be. The car got a little bit ahead of the horse. When it came to boosters everyone is talking about it. Well i'm gonna go get my way well. The fda says maybe not nineteen of fifty. nine year olds. I believe is right right in there. Eighteen fifty nine hundred to sixty four one of those to the fda is now recommending that for you and that was a surprise. I think to a lot of people did they didn't do that. These top line results are very good. News said dr jesse goodman of georgetown university of former fda vaccine chief the level of immune response pfizer reported appears likely to be protective many western countries so far have vaccinated no younger than age. Twelve awaiting evidence of. What's the right dose. And that it works safely. Cuba last week began immunizing children as young as two with its homegrown. Vaccines and chinese regulators have cleared two of its brands down age three. So it's not. It's not out of the question that this is going to be good and it's going to be safe but also i think i'll take a. I'll take our studies on it in our fda a little ahead of you know cuba with their homegrown maxine..
AP News Radio
FDA Official Hopeful Younger Kids Can Get Shots This Year
"The head of the food and drug administration's vaccine program says he's very helpful younger children will be eligible for cobra vaccines before year's end Dr Peter marks of the FDA tells the Associated Press the agency will quickly evaluate Kobe nineteen shots for kids ages five to eleven as soon as it gets the necessary testing data but he says he's very hopeful it could happen in months or even weeks both by Saran materna are testing vaccines on young children even babies with study results expected soon right now only people aged twelve and over can get a vaccine but with the delta variant spreading rapidly among children many parents are getting concerned Jackie Quinn Washington
The Stories Behind Wine
"peter marks" Discussed on The Stories Behind Wine
"Jobs. You can recommend people to pursue. We've talked about being a buyer or some. There's a lot of people We live here. Napa valley being an educator at a winery is a real critical role. You think you'd go to a tasting room and someone just point you know they are educating you. It could also be working for a distributor yourselves. I in you presenting winds but you're educating your buyers about that particular brand or that line there's some people who are independent do tastings for individuals for corporate work. A lot of my friends do corporate tasings quite a bit. That you'd be amazed how much interest there is up at the c. level where in businesses where you've got people who are whining and dining plans. They wanna know about why they don't wanna look foolish when they go out and try to put a deal together and they're ordering something on what it is from the menu. That's another area that i found that people have made a career out of just to corporate and individual training for people who on a no more about line. Even if you're at home and you've got your spouse or your friends that you live with that whole lot about line and you share it with them. You're educating everybody. Does it whether they realize it or not. Yeah and it's a good point. If you wanna get a job as a wine educator but you're having trouble getting higher by somebody just start your own little business doing at go. Do your neighbors your family your friends and let them word of mouth. And there's all kinds of opportunities there to be entrepreneurial and create your own destiny really. I think the instagram. Ah but thanks a lot called you yourself. So i was okay. Napa valley wine gal that too. I see a lot of fun and really great little tick talk videos and other things on instagram or other social media devices. That are just amazing. Younger generation is doing. I mean if. I had the time in the energy to play in that area as well. I would do so but i can't hold a candle to what these kids are doing. These days or amazing how ever sharing the love of wine with others in a fun and engaging and that's what it should be any type your engaging yeah i'm gonna take the kid comment as a compliment because i do host. Instagram lives for the academy. So again another educational near are younger than i am carrying. Yeah by what a year. Not by much The other thing is while you're working toward credentials. Try to job in a wine. School or a winery. Even if it's just as an admin or an assistant are even bolland hearing back gets you the exposure and believe me. I'm trying to remember we. I don't know three or four employees right now at the academy. That started volunteering or as an intern. And the next thing you know they're working fulltime. So that's another good way to enter the field of education so tell us about weight adhesions changing. I love everything. Covert has had a massive impact on us. Talk about some of those changes that you're seeing not just about covert but in general with wine education first of all. I'm truly amazed when i see how much opportunity there is for white education nowadays everywhere. You look somebody's doing blog or somebody's doing videos and certainly cove. It has put a lot of focus on the online department. I think that's only gonna get better one of the things we've been forced to do with kovas to start to go into the virtual world to learn not just about lying but just about everything if your student and that is something that is going to improve with better software better techniques as we all become more familiar learn have utilized the technology better. But one of the things i turn around and somebody else is doing. A new course offered another tasting. Whatever it might be. I think the important thing is to really choose carefully because a lot of folks who are presenting this. I've been say but some of them are not always correct what they're saying or the information that they're providing and i think it's really important that you do refer to somebody perhaps has their credential like wc t. Level three or master saw advanced master song or one of those society when educator title something that gives you the indication that they know what they're talking about and they're not gonna lead you astray. That's a really good point. Mitchell out on wctc level one course level one is pretty basic. And i'm always surprised. Many of her students are already wind. Bloggers or conducting tastings. I'm not saying they don't know what they're doing. But it's always a little bit of a surprise. I guess that they're just getting started. Now i think one of the things that's really changing partly because coburn partly just because technology is that right. Education is just so much more accessible than it used to be. As long as you have an internet connection you anywhere in the world and you can learn about why and acquire some of those much needed credentials. And what we're doing here. Podcasts are numerous podcasts out. There that you can download you're traveling and you don't have access to wifi along. You listen to them at your leisure. Yeah exactly one of the things that i've noticed in my career is i've been in business for thirty some years to admit it but when i was my distributor life distributor network for almost twenty of those years and i remember talking to my boss saying reciting some wine classes because the largest fine wine house east of the mississippi. And he's like no. You're learning every we did learn a lot on job because we would have big importers like cobra. Maternal committed educational seminars for us that he saw no reason for me to take any kind of credential and that is completely different now. I really think that if you to pursue a real career where you're going to make some decent money you're competing against people that have some credentials so it's not a must for it definitely gets especially when you get to the level two or higher. It definitely gets your resume moved up a little bit. Gets you more noticed. It keeps you competitive. So i do think that that's something that i've seen change Sorta like back in my day at college. Degree was more of a nice to have them have to have credentials are the same way. They used to be nice to have now there. You really wanna work seriously wine. I do think credentials become pretty important. I agree with you. And i think it's like you said it certainly can open doors for you. That might normally not be open. Not only are you gaining that knowledge in that confidence. But i think a credential shows an employer that you're taking it seriously that you said the time to work towards that credential make it part of your resume your portfolio to be able to be successful and that's important thing which is a lot of driving initiative which is important. I think so. I know you've heard a lot of wine. Educators or people in the world of wine education beyond having a few credentials or having at least some knowledge of wine and maybe some experience when tasting aside from that one other qualities are what other qualifications were important to you. Can i tell it to story here. Yeah it's kind of a joke. You can't ask people about their marital status or their age. I was asked if there giant. Because i'm a giants fan and there's been a few times when i've hired somebody who's not a giants fan like a dodger fan. It's never worked out. So i think there's something to the fact that if they're giants fan they'll be successful and it's true about me..
The Stories Behind Wine
"peter marks" Discussed on The Stories Behind Wine
"All the worthwhile so just stick with stay positive. Yeah and i'll throw my two cents. Don't bite off more than you can chew in the sense that most wind courses that master of wine or mr somebody they have beginner entry level courses and don't be afraid to start at that entry level because those really give you the foundation to continue to build and grow particularly. Wctc we teach a lot of wgn. Kademi i get to teach quite a bit. And that's what i love about. That program is that you can start with level one very basic. But yet you'll learn and then just build on that two levels to three and ultimately diploma which is level for and then go onto your mw go into the big credentials with a good foundation because to try and go right to the top right away. I can't imagine how hard that would be amazing. You're absolutely right and you don't wanna get too discouraged early on and as you said. That's one of the advantage of the. Wc is does have nice progression from level one all the way to diploma which is considered the precursor for anybody who wants to embark on the best program. Exactly one of the reasons i wanted to talk about this particular topic is that when i'm asked what do i do in the white industry and i tell people. I'm a wine educator. They immediately say oh. You mean you're assam. And i kinda laughed because not all psalms educations and not all white educators or songs. And i know you had a variety of different positions as a wine educator. And i went to talk about that because i want her audience to understand that you may get a job. Educating people about wine but it may not have that title for instance. When i was in sales. I used to teach people about wine all the time. But i wasn't an official reinisch. Catering i'm thinking you maybe at drinkers or other positions. That wasn't your title but it was a big part of your job. So can you talk about some of your experiences. Educating people some jobs. I've mentioned earlier when i did it. Triggers but what really started in the education field was while exit. Drivers have really good friend of mine been industry for long times name. Is paul bullard. A he was teaching some wine classes through uc berkeley extension and they needed some additional educators. And when i started in wind the word a lot of people were in the white straight if you had a little bit of knowledge. Hey you're educator. So i started teaching at uc berkeley and with that force me to do. Is that really forced me to know the subject. And that's one of the key things to the good educators. Really need to know your stuff so i work. My what off had started teaching there and then service teaching at drinkers elsewhere. After i left triggers. I went to work for wine. Dot com as buyer and. I had a team that was managing but we took time out to distances together for the people that worked at the company anytime. You're tasting wine. It's a teaching experience in my estimation. That's probably one of the best ways to learn his by tasting because not just describing the wine but understanding the style and how that came about was that the climate was the soil was it the winemaking techniques. Whatever it might be. So it continued to do that as i said at one. Dot com from white dot com went to cope with the american center for wingfield yards. Which was really all about wjr occasion in the accompaniment of great food and great art and i was there for eight years before i was hired brands as their vp of wine education. So as they have been doing education now for about twenty one years last year and a half with the napa valley Academy which is the ultimate dream job. If i can honestly say it's just been working with a great team. It's almost like being back. At the starting point dot com is at the time it really was a startup and now working with wind napa valley wine academy which has grown so quickly in a very short amount of time in bringing in individuals like yourself and others in trying new things at building good curriculum. It's just amazing. Exciting place to be. And that's part of what only about one is. I'm being educated while educating others and that's what makes it a win win. Yeah that's true. While we're teaching. We really never stop learning. We deny that's so important. So i know what i'm teaching and i'm assuming you get this question a lot to people say oh. How do i get to do what you do. You have a cool job. And i'm guessing you've heard that i know a lot of our listeners are wondering how do i you had your path. I've had my bet. What is a typical pat. So can you get some insights. What can our audience. What are some ideas may be self taught or credentials that you'd recommend things that they can start thinking about if this is something. They're interested in pursuing a no. You said that you get satellite karen. I don't get as hell. I can be like me. I'm sure everybody wants to be like you completely on his. I do not get that question but neither afraid of me. I don't know but to answer your question. One of the things to do what we do. Both you and i used term. I think but passion you have to have passion on what we do is we. When we're teaching all we're doing is we're sharing our passion or love for just like let's say went to dinner. Great restaurant you come back and you tell your friends. Oh this was so wonderful. We had great service and you should've seen what they did for the dessert as what we do. We taste the wine. We go visit a region and we share that passion in love with others and it almost comes naturally if you're able to share love of wine if you're making it something that's enjoyable to do. It comes very easily. Just like mr mondavi robert mugabe always said if you enjoy what you do. You'll never work another day in your life and haven't worked for over forty years so there you go. There's so many ways. You can start when i started you started. I think it was really a lot of books or traveling if you had the where for all to do so but nowadays. There's so much more that you can learn with the web with tastings and tastings and thanks so much easier to be able to learn and niemoeller information about wine but it's hard to predict one way that's the best way for individual Pencil what at your disposal. But you don't have the ability to travel than you'll go on the web that look at videos and listen to other people's webinars and do as much tasting locally as you can. You're by yourself. Accordance you can open minds. Keep them preserved for a while and go back to them without spending an arm and a lake is just a matter of making the best opportunity for yourself given the resources that you have available that the good news is there are plenty of resources out there luna. Yeah and one of the things you mentioned books and somebody's interested in crucial i read. There's so many great resources that i'm going to throw out a shameless plug here from the napa valley wine academy if you sign up for our newsletter redo i should say peter does what about once a month now to the academy defend. You're doing live interviews with amazing authors. You can register for most of these owners for free. There's winds to purchase if you wanna participate tasting with actual winick. There's also books to be. Had you have the heavy hitters. You mentioned earlier. Students furrier You johnson and moore's senate others if you wanna know who to learn from honestly sign up for our free webinars. You'll learn a lot in that process that you'll also know who to learn from that always a great experience. There's also tons of credentials out there. And from w which is really the big focus of the napa valley wine academy there's cs w surface officials special so why there's the wind scholar gill ultimately mastered wine master sommelier courses but as we said before just take baby steps of courses are available and now they're online which we'll talk about in a minute but peter earlier we were talking about. What kind of jobs you've had. Are there other jobs. Besides what you have that include wine education maybe not necessarily a wine education job but that has leans in that direction of their other physicians.
Newsradio 600 KOGO
"peter marks" Discussed on Newsradio 600 KOGO
"Conversations lined up for you. In a moment. I'll check in with Dr Peter marks from the FDA to talk about the Covid 19 vaccines and then the CEO of the wounded Warrior project will join me to talk about the tremendous work they do. And PTSD Awareness month, which is underway right now, in the month of June, 1st to get things started. I'm joined by Dr Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, the center he oversees. Is responsible for assuring the safety and efficacy of biological products, including vaccines. Dr Marx really appreciate you taking the time to come on the show for a few minutes. And the first item I want to ask you about is this Delta variant that everyone has been hearing so much about recently? What do we know about that variant and are the vaccines that Americans have been getting effective at combating it? Yeah, thanks very much for having me and this Delta variant, also known as the 1.617 is a variant that came up in India. And spread very rapidly through certain locations. It's certainly being seen here in the United States to, um what we do know about it. Come not from field trials but comes from laboratory studies. And it looks like the good news is that people who are fully vaccinated who have completed before vaccination series with one of the MRNA vaccines for the Janssen vaccine. They appear to be, uh, protected against that, Um, I Whether the protection is as perfect it is the original variant or Slightly less. You can't say for sure. Because we don't have the results from field trials yet, but, um I we believe that this variant, we have the same protection here with these vaccines. As we do to the variant that came from South Africa. That's B 1.351 variant. So, um, relatively at least reassuring immediately. Um, so far with these variants. Since the last time you and I talked, there's been quite a bit of new research about how safe and and really how effective these vaccines are, especially the Mrna vaccines. Can you break down some of what we've recently learned? Yeah, thanks So much great question, because what we know is anyone of the emergencies authorized vaccines that are available in the United States. They all prevent death and hospitalization from Covid 19. And look the fact that we're now walking around without masks on Outside, uh and, uh, walking into stores that we would not have dreamed of previously says that something has dramatically changed and I would put it to you that it's not just The fact that it's summertime. Um, these vaccines have made a difference. They started to make a difference before the summer time. And they are continuing to make a difference, and they are incredibly important in getting this under control. We have to learn here that we can look at other countries outside of the United States. Where there are variants spreading and we are very lucky to have these highly effective vaccines. We need to use them to prevent further spread of variance within this country because in areas where there are relatively lower vaccination rates He's highly transmissible variants could spread very quickly and create tremendous problems for us, despite the fact that we've made a lot of progress to date, so we don't want to fall back. We want to keep moving forward here. These acting have made a big difference. Um, the side effect profile. These of these vaccines is very, very good. Yes, it's true that people do tend to feel some fatigue. Uh or may feel blue like after getting the Mrna vaccines in particular for a day or two afterwards, but in terms of serious side effects They have been relatively rare. So, uh, really, uh, remarkable a remarkable change due to a vaccine. I'm joined by Dr Peter Marks, director of the Center for Biologics Evaluation of Research at the Food and Drug Administration. I want to turn to the extension of fighters. Emergency use authorization to now include 12 to 15 year olds. Really two questions here one What exactly is an emergency use authorization and then to what went into the decision to make this extension for this age range. Great questions. Both. The important thing to understand is that emergencies authorization was put in place to allow us in public health emergency to make products that might be helpful available when they otherwise we're not. In the case of vaccine. Even before we had an authorized vaccine, we set up front that we were going to hold these vaccines to a standard that was very close to our approval standards. In terms of the ability to show advocacy, and we've done that The emergency is authorized vaccines for studies in very large Randomized trials just like we would use for licensed vaccine. We got at least two months. Median safety follow up on these vaccines. And so we feel that there is clear and compelling efficacy and safety data that these The vaccines work and that they're safe. And so we and we continue to monitor the safety of these vaccines on an ongoing basis in conjunction with our partners at the Center for Disease Control and Prevention, So People can rest assured that these vaccines that have been made available under emergencies authorization are ones that we consider To have met our standards, and they're ones that we had FDA. Any one of us would that week parts about have taken them and we have our families taking them and are anyone we know to take them. So that's that's the emergency use standard. Now what we did in terms of, uh, adding the 12 to 15 year old to the emergency use authorization if we had data in this case submitted by fighter bio impact, which was came from a study conducted in 2200 and 60. Individuals ages 12 through 15. They were randomized about 1 to 1 to receive either the vaccine or a sailing placebo inactive. Uh, comparison vaccine or shot and, uh, comparing those they were able to look at a portion of both individuals to see the immune response and the immune response that was generated in response to the vaccine was excellent. It was very, very similar, in fact, somewhat better. Then the immune response in people who were 16 to 25 years old, And then they looked at whether in 1000 and five uh individuals who got the active vaccine And compare them to, uh 978 individuals who did not get the vaccine and got the sailing placebo. They showed that no one who got the vaccine none of the 12 to 15 worlds. We got the vaccine got Covid 19, whereas 16 of those who got the placebo. Got covid 19 so very, very good act activity and preventing covid 19, and it's really important for people to understand. There's been this kind of urban myth. It has, uh, gone around that that adolescents they don't get severe covid 19. But that's just not true. Yes, they get severe covid 19 less commonly than older adults, but there have been deaths in that age range and just like for other Adolescents, infectious diseases. We feel that vaccination is what can help prevent those deaths and help prevent the morbidity that that the illness They can occur, uh, in some of those individuals as well, I'm joined by Dr Peter Marks, director of the Center for Biologics Evaluation of Research at the Food and Drug Administration. So now that the Pfizer vaccine is authorized for 12 to 15 year olds, I'm sure parents with younger Children are wondering when that authorization might be extended to them. What can you tell us about that? Yeah. So all of the, uh, the authorized vaccines have studies that are in progress. Looking at younger Children at this point, and we would expect sometimes, as we come into the fall to winter time frame will start to see, um the information submitted to FDA that would allow us to.
U.S. Seeks to Pause J&J Shot After Rare Blood-Clot Cases
"Covert vaccine side effects. I'm Dave Anthony Fox news, and it's why Johnson and Johnson shot has been put on hold in the U. S to investigate six rare cases. Fox is Evan Brown has an update live, Yeah. Dave, One of the six people who developed blood clots following injection of Johnson and Johnson vaccine died. Another is in critical condition. Now. The CDC and the FDA insists that condition is caused by a number of factors and is rare. But doctors need to listen to patients who received the Johnson and Johnson vaccine who shows severe headache, abdominal pain, leg pain or shortness of breath, The veer They would want to seek medical attention. And if there are low platelets at that time, one needs to consider this entity the FDA is Dr Peter Marks. Treatment for these clots is difficult because heparin can't be used. However, the regulators say they expect this pause to last days while they review more data. Dave Ivan Johnson and Johnson's also know delaying the vaccine rollout in Europe. President Biden's going to
The World and Everything In It
FDA vaccine advisers recommend Johnson & Johnson's single-dose COVID-19 vaccine
"Truckloads of the johnson and johnson corona virus vaccine will soon roll out across the country that after the fda gave a thumbs up to what will be the third vaccine in emergency use in the united states. The fda is dr. Peter marks made the announcement saturday night guided by careful review of the science and data. We've determined that the vaccines known of potential benefits clearly outweigh its known and potential risks. Johnson and johnson expects to ship twenty million doses in the united states this month and a total of one hundred million by the end of june. The vaccine has two big advantages over the madeira. And pfizer vaccines now in use. It can be shipped and stored at refrigerator temperatures and it only requires one shot rather than to on the other hand studies have shown the other two vaccines to be slightly more effective overall. President biden. stop medical adviser. Dr anthony found she told. Abc's this week. This is a good vaccine. I think we need to pull away from this comparing and parsing numbers until you compare them head to head. Just be really grateful that we have three really efficacious vaccines. And the fda says the johnson and johnson vaccine offers strong protection against what matters. Most serious studies showed one dose was eighty five percent protective against the most severe covid nineteen illness and that protection remained strong. Even in countries like south africa were a worrisome. Variant of the virus is spreading
Weekend Edition Sunday
Vaccinations moving in the right direction despite winter storm, Biden says
"The country is moving in the right direction. He issued a statement after the Food and Drug Administration granted emergency use authorization to Johnson and Johnson's Covad 19 vaccine. The FDA is Dr Peter Mark, says one key advantage of the J and J Vaccine. It could be kept in the refrigerator rather than a deep freezer. The ability for the Yanks and vaccine to be stored in the refrigerator as opposed to a freezer could be beneficial in certain circumstances. J and J Vaccine is also a single dose shot. The FDA clearance means it will be distributed beginning early this week, along with the Fizer and modern a two shot vaccines. And Myanmar
Weekend Edition Sunday
Biden Applauds Approval Of J&J Vaccine
"Says the country is moving in the right direction. He issued a statement after the Food and Drug Administration granted emergency use authorization to Johnson and Johnson's Covad 19 vaccine. The FDA is Dr Peter Mark, says one key advantage of the J and J vaccine. It could be kept in refrigerator rather than a deep freezer. The ability for the Yanks and vaccine to be stored in the refrigerator. A supposed to a freezer could be beneficial In certain circumstances. Change. A vaccine is also a single dose shot. The FDA clearance means it will be distributed beginning early this week. Along with the Fizer and modern a two shot vaccines and
KOA 850 AM
"peter marks" Discussed on KOA 850 AM
"With the top official at the Food and Drug Administration about the covert 19 vaccines from their safety and efficacy, the potential side effects and this, of course. Is the topic we've covered extensively. So if you wanna hear past interviews on that subject, and so much more related to cope in 19 make sure to check out the radio communities podcasts, which you can obviously find on IR radio, Also, with February being black History month, I'll be joined by the author of the A. B. C S of black history. Rio Cortez. To talk about her book and some of the major moments and major figures in black history. So all of that, and more is on the way, but first to get things started. I'm joined by Dr Peter Marks, director of the Center for Biologics Evaluation and Research and the Food and Drug Administration. Dr. Marks thank you so much for taking a few minutes to talk to us. And let's start with an overview before we get into the details of the Copan 19 vaccines. Let's start with an overview of what your department within the FDA. Handles. So the senator Biologics evaluation and Research is the part of FDA that's concerned with the review approval on Deacon Tin Ewing safety of Vaccines. Blood products on tell tissue and gene therapies before we get into the cove in 19 vaccines, can you offer up some insight into the history of vaccines in the United States and what we've learned about them over the past couple of decades? So that seems to have been regulated in the United States? Actually, since the beginning of the last century through the Biologic Control Act of 19 0 to the first vaccine to be regulated was the smallpox vaccine. Um and we We have a long history regulating the safety and effectiveness of vaccines over the course of time. Um, we've done this for previous outbreaks, the by the most recent one that people made Remember before this one was the H one n one influenza pandemic, but there have been other things that we participated in. Such is the response to the Ebola outbreak. In Africa, so we we make sure that the vaccines are made with quality. And then we make sure that that data that go into the approval of them show that they are Safe and effective for their intended uses. And then once the vaccines are out there being used. We continue to conduct safety surveillance to make sure that there were no problems that come up using them that we didn't anticipate when we approve them. So how does this process work? Using this coronavirus as an example we have an infectious disease spreading across the planet. Pharmaceutical companies get to work on Reading something to combat it. Where does the FDA come into the picture? And what role does your agency play throughout the development of these vaccines? Yeah, It's a great question because FDA gets involved very early on in this process that makes us unique among global regulators. So even before some of the vaccine manufacturers submitted any type of regulatory document, we already started having discussions about how they would do. Uh, the work that happens before the vaccines going to humans and then, uh, talked about how they would do their early clinical studies and then the later clinical study, So we get involved very early on on discussions. And then as the, uh as the various manufacturers progressed through their development programs, we haven't ongoing dialogue which in these cases for these vaccines culminates And has been culminating in the conduct of these large phase three clinical trials where people by chance either get the active vaccine or a placebo. Something that is unearthed doesn't provide protection and then they compared and we see whether the vaccines work on Ben. We analyze the data that air submitted by the companies to make sure that we agree that everything has been done correctly. And we tried to interpret it in order to be able to put together the instructions for use of the vaccine, which are then given to providers into patients. I'm joined by Dr Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration. So once the vaccine starts getting distributed and given to the public Says the FDA have any role to play after that, Or does the FDA is job? And once the vaccine is approved, no one felt proof. We actually have a very active role, which we participate in In collaboration with the Centers for Disease Control and Prevention and other partners. And that is we maintain safety surveillance over all of the vaccines that are distributed in the country. And obviously for these co 19 vaccines were gonna be paying particular attention because there We're kind of expedited through the development process. So we have less of duration of the safety follow up then we did for some of the other vaccines. The way we make up for that, um is by using large databases in order to see whether there were any untoward side effects that are happening with more frequency in people who are vaccinated then, and people who Um or not. When it comes to these covert 19 vaccines you had mentioned actions were taken to speed up the process of getting them to the public. In the past, it could take years to get a vaccine approved the first to the visor and Madonna vaccines they were done within a year. How is that possible? And how were you able to maintain the safety and efficacy of the vaccines while moving things along that quickly? The first the first thing is to say here is that The great news is that corners were not cut here. All the needed things happened. And the way they happen was by getting rid of essentially dead space, which is that normally when vaccines are developed. They start stop and development. The early phases of development happen, And then they kind of there's a stop and people kind of look at the data and then, okay. Should we go on or should we not go on? Then they moved to the next phase. And then the same thing happens over again and also the manufacturing process for the vaccine doesn't really ramp up until after people know that the vaccines are working. So here what was done Because we knew that this was a terrible pandemic, potentially Even several months ago, Everyone started to eliminate the dead space so that the studies instead of starting and stopping, they went seamlessly from One phase of development into another, and, additionally, manufacturing processes started to get, uh set even at risk early on, so the idea would be that this way. If the vaccines turned out to work, there would be material to be able to be distributed without having to develop that large scale. Um, manufacturing process late in the game, so that all that taken together is what has taken Process..
"peter marks" Discussed on 600 WREC
"Americans listening to Fox sees Ah bill allowing home delivery of beer, wine and liquor is moving forward a state Senate committee approving the measure. The sponsors, Senator Jambo, Wagner, says the bill allows for alcohol delivery, He says there are strict multiple layers of checks and balances, addressing concerns about underage drinking the best Avia Hills Republicans, saying his bill explicitly regulates that alcohol deliveries are made to only adults of legal drinking age. That measure now heading to the full Senate. And Colorado congressman Doug Lamborn, continuing the fight to keep the U. S Space command in Colorado Springs. Instead of putting it hunts film, he's a Republican. He sent a letter to the Government Accountability Office this week asking for an investigation into the way the air Force decided to relocate Space Command to Alabama. I'm Leah Brandon. And this is Alabama's morning news Now back to your host. Here's J T. All right, Leah. Thank you very much. It is 6 35 Alabama's morning as well. This is kind of interesting here. Hopeful news on the vaccine front is word is now coming from the Oxford AstraZeneca covered 19 vaccine that may help keep people from spreading the virus any further. That's according to a study published this week by the vaccines. Developers at Oxford University. Dr Peter Marks the FDA encouraging anyone hesitant to get the code 19 vaccine by the way. To do it says the benefits, the vaccine far outweigh the risks. We would not let these vaccines be given to anyone if we didn't feel comfortable taking them ourselves or giving them to our family. Yeah. He also is adding that the two shot approach actually builds immunity. We see it a second time and that elicits the memory of the first response. And then we make an even stronger response. On this AstraZeneca drug. Yeah, they reviewed the drugs clinical trials and reportedly found it's not only safe and effective, but you know, as we see right there, it helps reduce the transmission of the virus by up to two thirds. Findings are still under review, and experts warn the results are subject to change. But some good news in that front loving that also when we come back home here, we're taking a look at how the distribution is going in the registration. Hooper's mass vaccination site is open. You know, A lot of you continue have some questions about how to register for an appointment. A couple of options, All right. If you have access to a computer in the Internet, you can try to register online. If you're not real tech savvy, or you don't have access. Still, some numbers you can call Jefferson County. Iemma is working with county health officials by the way to get the people registered for the vaccine. And Jim Coker, who was, the director said. We take the information and pass it along to the Jefferson County folks actual schedules and they actually schedule the appointments from there, but Leaders say they're about 10 to 12. People staffed at the me's office daily to get your information the number to call by the way, if you need more information is 205858 22 21 858. 22 21. All right, so there's some help for you in that direction. At the state level, the vaccine hotline is still open to call. That number is 855566. 5333 and we've got these numbers obviously here for you and you can contact us and we'll pass that information along for you. It is 6 38..
WBZ NewsRadio 1030
"peter marks" Discussed on WBZ NewsRadio 1030
"All leased out through behavioral in Methuen had some earlier work crews up there They are now gone. Kevin Brennan, WBC's traffic on the threes and when it comes to the forecast for the rest of the day, it's going to feel a lot like it was yesterday. Looking out the window right now we have some clouds over the city of Boston. We had some snow flurries just a little while ago and we've been seeing this on and off for the past night, say, 36 hours at this point. We have this storm That's been kind of churning right off the coast. And as it does, it's sending these showers, rain and snow little bit of sleet it time's over toward eastern Massachusetts. So keep in mind that right now I'm looking at the radar see a little bit of rain, especially out there on the outer cape and at some snow showers now coming back onto the south shore parts of the North shores. Well, an integrator Boston. This is going to be the case for the rest of the day on and off at a high today about 36 by the coast about 32 north and west. So if you do see any precipitation, icy spots could be a problem. For tonight's and Sprinkles and flurries early. Otherwise we start to clear out alone. You're 32 next couple of days. It starts to warm up ever so slightly with partly sunny skies behind your 40 very brisk in Chile on Friday, but also lots of sun with a high near 36. Right now. It's 32 in North Adams saying 34 in Fall River 33 in Manchester, New Hampshire, and right now in Boston, were up to 32 degrees under overcast skies at 10 05. Top health officials at the FDA say it is very important for anybody who gets the covert vaccine to get the whole dose Commissioner Stephen Han and Dr Peter Marks in a.
Lori and Julia
Peter Mark Jacobson, Fran Drescher and Six Seven Million Dollar discussed on Lori and Julia
"Trust go see it today well always follow the money trail because movie pass has a seven figure stake in the film and line is reporting movie pass accounted for forty percent of the one point six seven million dollar opening of that film which made headlines fords zero percent rotten tomatoes score from twenty three critics san fran drescher excuse me is working on a reboot over ninety sitcom the nanny drescher tells entertainment tonight that she's working on the project with her ex husband and co creator of the show peter mark jacobson saying we're working on a very big project it's going to be very exciting for fans but i'm not at liberty to announce it yet i loved i loved the nanny and i loved the movie she made give your best nanny laugh i can't so annoying but i still loved her.