35 Burst results for "European Medicines Agency"

EU regulator clears Pfizer-BioNTech's tweaked COVID booster

AP News Radio

00:42 sec | 2 weeks ago

EU regulator clears Pfizer-BioNTech's tweaked COVID booster

"European Union health officials have cleared the way for an updated Pfizer BioNTech COVID booster I Norman hall the European medicines agency is recommended the authorization of a tweaked booster dose of Pfizer's BioNTech coronavirus vaccine The updated version will include protection against two of the latest versions of omicron as countries look to bolster their immunization programs ahead of winter the combination booster will target both the original COVID-19 virus as well as the sub variants BA four and BA 5 and should trigger a safe effective immune response According to the World Health Organization the BA 5 version is a responsible for most of the COVID-19 spreading globally I Norman hall

Norman Hall Pfizer European Medicines Agency European Union World Health Organization
Germany: EU could OK combined COVID vaccines next month

AP News Radio

00:48 sec | Last month

Germany: EU could OK combined COVID vaccines next month

"Germany's health minister Karl loiter back says E regulators may authorize the use of vaccines that are each effective against two variants of the coronavirus low to back expects the European medicines agency to meet on September 1 to consider a vaccine that would provide protection against both the original virus and the so called omicron variant also known as BA one the U.S. Food and Drug Administration has said the combination vaccines known as bivalent or multivalent shots will allow boosters to retain the proven benefits of original coronavirus vaccines while providing additional protection such an approach is used with flu shots which are adjusted each year depending on the variants that are circulating I'm Charles De Ledesma

Karl Loiter U.S. Food And Drug Administrat European Medicines Agency Germany FLU Charles De Ledesma
"european medicines agency" Discussed on Bloomberg Radio New York

Bloomberg Radio New York

05:09 min | 9 months ago

"european medicines agency" Discussed on Bloomberg Radio New York

"Thank you for breaking down some of the key themes across these markets Bloomberg's cross asset editor and for real-time commentary and analysis check out markets live That is ML IV On your Bloomberg terminal Okay and the big data point investors are watching today U.S. CPI data inflation data for December And Wall Street is betting on another red hot reading Bloomberg's Vinnie del giudice reports Hang onto your hats again Bloomberg economics as forecasting a 7% inflation rate year over year in November at 6.8% the most since 1982 when Paul Walter was stomping on the brakes at the Federal Reserve COVID-19 is still an issue today as it has been for too long years Bloomberg economics says I'm a crime related bottlenecks could add further upward pressure through the first quarter Yes hang on America If any doubt you guys Bloomberg day break Europe and in China inflation eased in December Bloomberg's Brian Curtis has more on the story The producer price index rose 10.3% from a year earlier slowing from November's 12.9% It was well below forecast The government took measures to boost supplies of commodities and it cracked down on speculation and food prices fell Now the CPI increased one and a half percent that was lower than the projection of 1.7% On the cron is hitting the economy hard and these softer numbers might give the PBOC more scope for easing Brian Curtis Bloomberg daybreak Europe Meanwhile Goldman has trimmed its forecast for China's 2022 GDP growth to 4.3% from the previous estimate of 4.8% citing the increased difficulty of containing a most of the negative effect will be in the first quarter with the rebound to follow depending upon the rollout of booster shots And finally standard chartered may establish a stand-alone wealth management unit in China to sell mutual funds to retail investors sources tell us the bank has already worked on a feasibility study with a consulting firm and the plan is now under management review The move would make stand a chartered the first foreign bank to fully own a wealth manager in China Okay for more on the global news let's cross over to Leigh and guarantee him Tom good morning and thank you European Union regulators are warning that frequent COVID booster vaccines could adversely affect the immune system and may not be feasible Bloomberg's UN pots has this story Repeat booster shots every four months could eventually weaken the immune system and tire people out So that's the warning from the European medicines agency It's recommending countries should leave more time between boosters and tie them to the onset of the cold season in winter Earlier this month Israel became the first country to start giving a fourth jab to those over 60 The UK says that boosters are providing good levels and protection and so far there is no need for a second one In London I'm your impotent Europe Meanwhile over in the U.S. the chief medical adviser Anthony Fauci says he's not on board with the development of an army coron specific vaccine He says time should be spent on developing a vaccine that protects against an umbrella of variants Looking ahead in the context of the inevitable continual emergence of new variants the importance of developing a pan coronavirus vaccine namely one that would be effective against all SARS CoV-2 variants and ultimately against all coronaviruses becomes even more apparent Meanwhile Fauci also said booster vaccines are playing a major role in protecting the population from severe disease Here in Europe France has registered more than 368,000 daily COVID-19 infections in new record as a variant continues to spread across the country Meanwhile the Canadian province of Quebec is reported to be planning a new health tax on those who are not vaccinated Quebec's premier says a 10% of unvaccinated adults represents a 50% of people who are currently in intensive care pads And Novak Djokovic has admitted leaving isolation for immediate interview well knowing he had coronavirus The world tennis number one says the decision to meet a journalist in Belgrade was an era of judgment He's still waiting for a final decision about whether he'll be allowed to stay in Melbourne for the Australian open Global news 24 hours a day on air and on Bloomberg quick take powered by more than 2700 journalists Santa analysts and will then 120 countries This is Bloomberg Tom Leon thank you Okay let's get more of the latest sports news now with Chris cave Southampton boss Ralph haasen hotel has praised his players after their comfortable four one Premier League victory at home to Brentford the result means they've stretched their unbeaten run in the top flight to four matches and move up to 11th Haas and Hutu was particularly pleased after their FA Cup win at the weekend went to extra time Fantastic.

Bloomberg Brian Curtis Vinnie del giudice Paul Walter China Europe U.S. PBOC cron Federal Reserve Goldman European medicines agency
"european medicines agency" Discussed on Bloomberg Radio New York

Bloomberg Radio New York

02:40 min | 10 months ago

"european medicines agency" Discussed on Bloomberg Radio New York

"Reaction perhaps no surprise Deutsche Lufthansa is down 9.8% right now Airbus also something 9.9% And tui is off by 8.7% These are the sort of major airline firms and travel and leisure companies and they have taken perhaps the biggest hit but obviously it's not just them It's others It looks as if investors are kind of selling first thinking later Well there's clearly a huge impact on travel First of all psychological impact but also probably a real impact I think that goes beyond that though if you're looking at we've seen a couple of countries locked down and if there's obviously concern that more countries will have to implement stricter measures that's going to have an effect across the economy across the economies of Europe as everybody sort of retreats back into some amount of the defensive crouch that they spend other parts of the past year and a half Yeah absolutely I mean it looks that way too in bond markets I mean I wonder whether you have a view on the ECB We've had so many ECB speakers this week talking about the pandemic era program would end in March on schedule I mean is there any chance that this might affect pep Well I mean I think everyone's been waiting to see what happens in the next month or two I mean if you look at what's happened in the UK the spike there were spikes that did actually start to tail off Now the question is going to be are we are we seeing the worst of where Europe is right now or is it going to be just continue to get worse And I don't think there's any way to know that yet but in a month or two I think it'll become a lot clearer whether this is something that was a blip It was a temporary thing whether the immunity levels are sort of fast enough I do think it's going to put a lot of pressure on governments to try to roll out boosters much faster to rollout shots to young kids now the European medicines agency has proved it for 5 to 12 year olds But obviously that's where the idea of a new variant has people quite nervous because no one really knows how well vaccines are going to respond to any given new change in this So I think that's sort of where you're seeing the extra level of concern sparked by this by this and it's going to be a little while before we really know Kevin thank you so much for your time Thank you for being with me and giving me that full briefing on what's happening in Europe that is Bloomberg's Brussels bureau chief Kevin white law on Europe's response to this new COVID variant amidst already a pandemic with a big number of cases.

Deutsche Lufthansa ECB tui Airbus Europe European medicines agency UK Bloomberg's Brussels Kevin Kevin white
"european medicines agency" Discussed on Monocle 24: The Briefing

Monocle 24: The Briefing

05:47 min | 11 months ago

"european medicines agency" Discussed on Monocle 24: The Briefing

"Are back with the briefing on Monaco 24, I'm Tom Edwards now, novavax's COVID-19 jab has received emergency approval in Indonesia with other nations expected to follow suit. It's thought the novavax shot could play a crucial role in helping to inoculate people in developing nations. Let's get more on this now with Monaco's health and science correspondent, doctor Chris Smith. Thanks for joining us as always Chris, great to have you with us this afternoon. Tell us about the significance. I guess not just about this approval in Indonesia, but what more of a rollout like that other approvals could mean across the developing world? Well, another vaccine potentially joining the ranks of those which are being used in the fight against coronavirus. This one are very different technology again. And I believe the first vaccine that novavax is a company has successfully brought to market, assuming they do receive full regulatory approval and not just emergency approval subsequently. It's certainly been good for shareholders. The share price surged by 13% off the back of this news. It's been eagerly awaited, and some commentators myself included are wondering why it's taken so long for them to get to this stage because it did look like a FrontRunner. It's one that the UK government invested in when they were considering placing orders for vaccines last year. How does it work? Well, the new technology here is that they use what's called a baculovirus. This is a virus that infects insect cells, and they've added to that virus, the genetic code for the outer coat and specifically the spike of the coronavirus. And they infect cultured moth cells who couldn't make this up really get you growing in the dish with the insect virus, which carries in the genetic message about the coronavirus and these cells make enormous bucket loads of this particular part of the coronavirus, which then does the magical thing of assembling automatically because of the way the virus proteins tessellate and fit together rather like sort of cubes. And they form what are called virus like particles. So they are basically the empty shell of a coronavirus, which can be harvested purified and then injected into the body, where they produce quite a powerful immune response to the effectiveness data looks like it's more than 90% effective. So it's in line with the other vaccines which are the other frontrunners at the moment. So now this gives us an additional potential weapon. Indonesia as you say are approving this India are expected to follow suit other countries shortly thereafter. We know that the European medicines agency, the EMA are also looking at this as is the UK regulator when they get all the data. And so it will be very, very useful to have an additional weapon to throw at this problem. It could be hugely positive. But I'm interested in that point which you made there about the pace of development and approval progress. We believe that obviously much of the novavax will be distributed through the covax, program, which obviously makes sense on one level, but I don't know a cynic might say the fact that this hasn't been done as swiftly as potentially it might have. Speaks to not complacency, but to a shifting set of priorities in the developing developed world I should say sorry. You know, we've got our House in order. And then we sort of drag our feet when it comes to helping out let's be honest, the majority of the planet is that cynics reading entirely unhelpful or is that on truth to it? Well, I think the board members of the company want to see their product, which actually is going by the name covox. It's great isn't it? You've got novavax, which makes cover vex. They will want to see this out there and being used as fast as possible because this is a way in which companies make money. So I don't think we can entirely blame inertia or on the fact that the UK has its house in order. I think that there are various reasons which haven't been disclosed as to making sure you've got your regulatory House in order. The regulators of various countries are extremely demanding and very, very exacting in what they expect in terms of supporting data to make any kind of appraisal for the licensing of a medicine. Because when you're using things that the scale of millions of people, the opportunity for things to go wrong in a really big way is huge. And for that reason they set very, very high standards because if you think about it, if they get it wrong, you don't just erode public trust in that particular medicine. You erode public trust in all medicines in a territory and possibly beyond across the world. So it's very, very important they get it right. So many, many countries and many, many companies make the decision better to be later to the party, but arrive with everything in order than to rush something out. Get it wrong. And then end up with huge consequences, which I think they probably been cautious and rightly so. Chris, always good to hear from you. Thank you so much. As ever, for being with us, that was our health and science correspondent doctor Chris Smith joining us on the program. Let's change tack slightly though now and get a roundup of the day's main business news next Bloomberg's Ewan Potts is standing by good afternoon to you. You and I want to start with wheat prices, continuing to soar. It brings up to speed. What's behind these gains? Hi, Tom. Yeah, weight trading near a 9 year high. Now the crop, which is going on more land than any other has been hit by a lot of supply problems droughts, frost and heavy rain in many of the key exporting countries. Conditions for newly planted winter wheat are also worsening in areas like the U.S. and Ukraine. Now the world has got plenty of wheat. But a lot of it is held in countries like China, which ship very little abroad. So that means that exporting countries have a disproportionate effect on the price. Russia was last season's top shipper and this year it started taxing exports to safeguard its own supplies and keep domestic costs in check. On the demand side, things are pretty buoyant, Egypt, which is the biggest buyer of wheat in the world temporarily booked at.

novavax Tom Edwards Indonesia Monaco Chris Smith European medicines agency UK Chris India Ewan Potts Bloomberg Tom Ukraine U.S. China Russia Egypt
"european medicines agency" Discussed on Cork's 96fm Opinion Line

Cork's 96fm Opinion Line

08:25 min | 11 months ago

"european medicines agency" Discussed on Cork's 96fm Opinion Line

"What gorgeous morning it is out there. I must say there was light. You notice the the our going back to this morning because there was it was light some as they were sitting into the car just starting to break into a little bit of light and that's been missing for the last few weeks we'll have that though for a few mornings and then speak very jack again. Be happy seventy eight predominates cuban into into introduce lovely louis morning out there and they're telling us i'm seeing in the newspaper this morning that we're in for some cold crisp stuff over the next one which would be very very nice good morning. Eighteen fifty seven five nine six. I trust you survived. The rigors of halloween took the batteries out of the doorbell. I don't mind telling you i did. That's just me not know the dogs. They they lose it absolutely lose when it comes to dorset tennessee. I didn't fancy that good morning and they're all heading back to school today and we don't know what's going on in schools. We know from the covert cases last evening. We know that is. He's no rampant in the five to twelve year olds and let's not put any twist on that. Let us not clear down. Let us not lie to ourselves. It is rampant in the five to twelve year olds. Yes most of them are not getting sick. most of them would have a a bit of a comfort. Most there are those who will get very sick. Unfortunately they're few and far between we'd like to think what it is rampant in the five to twelve year olds. Is it right that they're going back to school this morning. Tony holden says it is the government. Say yeah it's fine. Let's go back to school. It's not a big deal. You wonder though is it. And of course. There's no contact tracing in schools now. So you don't know who's got it and who doesn't have it and all of those complications let me bring back a man who has been on the show little worth professor anthony stains from dc. You anthony good morning good morning. It is precarious. It is rampant in the five to twelve year olds is are we taking risks. At the moment it is high across the whole population is particularly high younger. Children at the molin. But it's pretty high in almost every other age group and it's going is actually going up to bed at the same rate right now and every other age group. She's is disturbing that level. So yeah i think we need to take it more seriously. The government policy has been essentially. Vaccinations will do with us on. Vaccinations are fantastic. And without vaccinations we would have every intensive care about it. Country full and being for waging for ventilation. We don't thought thank god we'd onto the even with vaccinations as the medical officer in south l. Vaccinations will not control this delta variants about seems to be. I think that's true. Unfortunately so the one way to go back to look at other countries such as successfully catch Case numbers down without lengthy lockdowns. I'm i've been look taking a look at what they've done in korea. Where there's there's been very heavy emphasis in south korea vaccinated obviously but also in ventilation unmasking. They have the equivalent of the kobe. Poss for people who want to go to pope restaurants and nightclubs and they've they've nelson any national lofton's they have had regional off towns for short periods of time control major outbreaks. Which is right you know is the right way to. We've talked about before we've been promised that there'd be no more national lockdowns here. We hope against hope that there won't be. Should they be contact tracing in schools. The teachers are saying. Please bring it back. It gives us something to work with. I think it made. I think the government needs to show. They're taking schools seriously on the taking contact tracing seriously and that's been a key part of the successful this phones and many other countries we haven't done of property here. Parents and schools have been recording for months now. Endless major outbreaks in schools schools closed classes. Close children's sent home because about affects covert. Now they're contact. Tracing effectively stopped number reported ipads has gone down but there's no covert is still there and can spread from children to adults and it's so much more worrying because you're right. It's not many children will be seriously with this. Most will have a very minor illness actually hardly noses so we'll have more serious effect that can easily spread the virus fooled people and you know as reinfection becomes more of a problem in older people which is what we're seeing now. Children conspired this fire quite widely through our population. Do you think that nyack which i think is meeting today to discuss a healthcare workers because we're three and a half thousand healthcare workers now absent took over. Do you think nyack is dragging. Its feet a little bit anthony on this. I think that needs to move quickly but those needs to move carefully. I think at this point The healthcare workers is probably a no brainer dire. Will recommend i think at the challenge is going to rise is. When the european medicines agency approves vaccinations for primary school children to the us fda has already done that the ama which is the european is conducting bone independence. Study of the evidence that they don't just copy each other they they worked from ground dope And they will decide. But if i were betting bashing man no but if i work my best be they will decide to go with us and point it lonzo. Nayak's desk i would arch nyack to to preliminary work now. You know to review the materials. The fda materials are all public. Don't know about the materials zona thera available but odd materials. Is there a nyack lucrative at us and begin to form their own view it. What the recommendation be working on it. Now they might does announce a decision for the white by the kuby working on once. They're now are you concerned as we head into winter professor stands goldman. Tell us there will be no more lockdowns. I'm the economy will tell. You can't afford another lockdown. Are you concerned heading into winter. Anthony that we're going to weather this. I really hope there won't be any more reluctance. We've argued you can slap turns as group really since the beginning of oldest no. Who said in a march twenty twenty that locked up were knowledgeable. Good long-term control my last resort rate. It's it's reasonable to use a lot If if things are going is controlled. Use a lifetime decisions at a chance. Look around and see what is going on and being in control measures but we we haven't followed through on that we haven't brought in a full range control measures we're still having discussions about is whether to ventilators in schools we're still having discussions about the primary school children where mouth in many countries those decisions have been made eventually into schools. In some countries. Primary schoolchildren are wearing masks you know if they are not but at least the decision has been made now. Our government has made some very good choices. They've continued with cova. Possible creates chiampou which are linked in the united kingdom of size to abandon. They've also continued with strong vice continuing to wear masks. A fact i see just yesterday. There's been a study published from south korea on the impact of knocking over transport and it suggests the impact. Masking was really quite big. It makes public transport.

Tony holden anthony stains south l national lofton nyack anthony Poss tennessee jack south korea lonzo dc korea nelson fda kuby european medicines agency Nayak ama goldman
"european medicines agency" Discussed on WLS-AM 890

WLS-AM 890

01:41 min | 1 year ago

"european medicines agency" Discussed on WLS-AM 890

"Talk is simply smarter. Wireless WLS AM Chicago 94 7 WLS FM HD to Chicago News is next, but first you're WLS Weather Channel forecast. We'll see you generally clear sky overnight, although dropping down to 63 if he scattered afternoon storms on Tuesday I of 86 sun China on Wednesday cooler, less humid high in the upper seventies from the weather Channel Meteorologist Spark to the O wls Am 8 90 with another update in 30 minutes, 8 90. W. L s The body of a woman who went missing during last week's flooding Inheres in New York was recovered today that brings the death toll from Hurricane Ida or its remnants to at least 69 in eight states. Help is on the way to the region over the weekend and on Labor Day President Biden approving major disaster federal aid for hard hit New Jersey and New York state counties that frees emergency money to restore damaged homes and businesses from hurricane ideas Remnants last week, the president planning to visit both states Tuesday. The storm killed at least 40 people. ABC is Andy Field power has been restored to nearly 70% of greater New Orleans and all about root, but it could take the rest of the month to get service back onto all of Louisiana. Starting tomorrow, masks will be required in all Pennsylvania public and private schools, as well as childcare facilities, the European Medicines Agency and started an expedited evaluation on whether to recommend a booster dose. Fighters. Covid 19 Vaccine Daria Aldinger ABC News Have you gotten vaccinated yet? No, no, no, no, it's time to reconsider. I got the vaccine because I have a pre existing condition because I wanted to get back.

European Medicines Agency New Jersey Daria Aldinger Tuesday ABC Wednesday New Orleans tomorrow New York Louisiana 30 minutes Pennsylvania 63 today last week Ida News ABC News Andy Field President Biden
"european medicines agency" Discussed on The Young Turks

The Young Turks

03:27 min | 1 year ago

"european medicines agency" Discussed on The Young Turks

"On the turks with so many more socialistic to it all right. There's a lot of disinformation out there regarding corona virus. Vaccines and now. We're getting an inside. Look into one now. Defunct marketing firm that was offering money to various online influencers to set. Spread and so disinformation regarding the pfizer. Corona virus vaccine now bbc and the new york times reported on this and the details are definitely interesting but we still don't have a lot of confirmation in regard to who the clients were behind this marketing tactic. Here's what we do know. An influence or marketing agency called phase offered to pay german youtuber mirko droughts men to promote what it said was leaked information that suggested the death rate among people who had the pfizer vaccine was almost three times that of the astra zeneca job. The information provided wasn't true and to murqos credit. He looked into this. He saw some red flags and he's like You guys are trying to get me to conflict things and make it appear as the pfizer vaccine isn't as effective as it really is and so he and another youtuber decided to investigate this a little more. The other youtuber Is a youtuber named leo. Say here received a similar offer. The agency offered him two thousand euros if he would take part face that it was acting for a client who wished to remain anonymous so as i mentioned the two decided to ask some more questions and figure out what's going on who's this weird nefarious client. Who's trying to get us to spread. Disinformation about the vaccine. Face them not to mention the video how to sponsor and instead pretend they were spontaneously giving advice out of concern for their viewers which by the way european countries aren't like the united states in france and germany. That's actually illegal. You have to be up front and honest about sponsored or paid content and then You know phases brief also told these influencers to share a story in french. Newspaper lemond about a data leak from the european medicines agency. The story was genuine but didn't include anything about vaccine deaths. But in this context it would give the false impression that the death rate statistics had come from the leak so basically covering a story in a way that conflates two things to basically misinformed viewers and make them think that more people had died after taking the pfizer vaccine. Now the data that the influencers were asked to share had actually been cobbled together from a bunch of different sources and had been taken out of context. It presented the numbers of people who had died in several countries sometime after receiving different covert vaccines. But just because someone dies after having a vaccine doesn't mean they died because they had the vaccine like they could have died from a car. Accident writes like a database of people who had gotten the vaccine and then for one reason or the other. it doesn't state had died after getting the vaccine. But there's no causation. Right you could draw. You could save if there's a correlation but the correlation means nothing you have to show causation..

pfizer astra zeneca mirko the new york times bbc european medicines agency germany france united states
"european medicines agency" Discussed on NPR News Now

NPR News Now

01:38 min | 1 year ago

"european medicines agency" Discussed on NPR News Now

"European regulators have authorized maderna's covert nineteen vaccine for the immunization of children between twelve and seventeen years old. Npr sydney lufkin has more european teens. Between twelve and seventeen will now be able to get them. Dern cove nineteen shot. Thanks to the decision by the european medicines agency in the united states. The company is waiting for a similar authorization from the food and drug administration in the us. Madonna shot has only been authorized for people eighteen and older but younger teens have been able to get the pfizer vaccine. Since may european regulators say that for twelve to seventeen year olds the madonna vaccine has the same common side effects as it does in people eighteen and up and in a study with adolescents. The vaccine produced a similar antibody response to the one seen in people. Eighteen to twenty five none of the children in the study who received the vaccine developed covert nineteen compared with four who received a placebo sydney lufkin. Npr news thousands of british food workers. Meanwhile will be able to take daily corona virus tests starting today avoiding a requirement to stay indoors after possible exposure to infection as villa marks reports. This comes after grocery stores warned of major staff shortages. The government said that around ten thousand workers in the country's food manufacturing and delivery sector will be able to take daily corona virus tests rather than stay indoors or notify authorities. They may have come in contact with an infected individual grocery store executives one of supply shortages and store closures of almost six hundred and twenty thousand british residents were alerted last week. They should stay away from their place of work. Villa marks reporting in haiti.

maderna Npr sydney lufkin Dern cove european medicines agency food and drug administration Madonna us pfizer Npr government Villa haiti
"european medicines agency" Discussed on Artificial Intelligence (AI Podcast) with Lex Fridman

Artificial Intelligence (AI Podcast) with Lex Fridman

05:16 min | 1 year ago

"european medicines agency" Discussed on Artificial Intelligence (AI Podcast) with Lex Fridman

"He's been there since nineteen seventy two. He was in charge of the offices of science policy and they brought him into the final meeting of this Process where we are trying to design face so once. Fda said yes you can go to phase three. That was november twenty nine th two thousand sixteen. We then negotiated for eight months on the design of phase. Three and all the other information is fascinating is gone this process of design it. Was you know to the extent that i have any artistic creativity it's in protocol design. I really loved that view. Enjoy this. I love it. I love it because it's always trade-offs and it's Yeah it's and knowledge. You know that that we are all biased. And so how do you. There's something beautiful about the scientific process designed to get you to the truth Especially when that scientific process trying to get to the truth of the human organism which is so complicated those very difficult to to dissect to get the the strong effects. And when you're analyzing when you have raiders. They're they're watching a video. There's removing subjectively from that as very very challenging. Yeah they're very much And so we came to this agreement with fda though that we would use this Independent raider pool and And so we learned in face to again. The the double-blind there was no solution to the double-blind problem and both the fda and the european medicines agency in the end agreed that the best design was therapy with inactive placebo versus therapy with full dose. Md may accepting the fact that most people will be able to tell what whether they got nothing or they got full dose md. Most therapists will be able to tell the difference but That makes it harder. Test for us to show a difference between the two groups because we're giving them inactive placebo. Not the anti therapeutic effect of low dose md ama so once we started phase three so then we really start In two thousand eighteen face. Three and the paper in nature madison. That just came out. Was the results of our first phase three study. We came to agreement with fda that we would do to face re studies each would have one hundred persons in them and what the fda said to us is that they thought that we could prove efficacy with smaller numbers than they wanted to see for safety. The reason they said that is it. In phase two. We had a large effect size. So from statistical point of view the bigger of an effect. You're looking for the fewer number of people. You need to get statistical significance when you're trying to find small differences you need large numbers of people to sort of work out the noise So we we were We came to agreement to one hundred person phase. Three studies And the idea is that it's very possible that the first part the first study was show the efficacy because they've had a strong. Yeah yeah and the second but but also safety as well so so you know one of the things we also realized when you work with a highly stigmatized drug in the midst of still you know the drug war and prohibition that we need highly sympathetic subjects and we need to make the best case we can which means we need to work with the hardest cases so that this is really needed and so we end up enrolling people..

fda european medicines agency Fda raiders madison
EU Likely to Decide on Moderna COVID Shot for Kids Next Week

AP News Radio

00:50 sec | 1 year ago

EU Likely to Decide on Moderna COVID Shot for Kids Next Week

"European drug regulators are considering Maderas application to authorizes coronavirus vaccine for children twelve and up in the European Union Maderas vaccine was given the green light for anyone eighteen and over in January but so far Pfizer's vaccine is the only one approved for children twelve and up in Europe and North America now Dr Markel capillary a top official at the European medicines agency says a decision on whether to recommend madurez vaccine for children is expected late next week E. U. officials say they've delivered it up back scenes to immunize seventy percent of the adult population there and many countries are looking to expand inoculations to children twelve and up European officials say there's a possible link between the Madera and visor vaccines to very rare cases of chest and heart inflammation mostly in younger adult men but that the benefits still outweigh the risks of covert nineteen I'm Jennifer king

Maderas Dr Markel European Medicines Agency European Union Pfizer North America Europe Heart Inflammation Jennifer King
"european medicines agency" Discussed on The Last American Vagabond

The Last American Vagabond

03:54 min | 1 year ago

"european medicines agency" Discussed on The Last American Vagabond

"Isn't odd that the media report that ninety four percent sixty four percent the company said booster doses of its vaccine developed with bike. Biotech produces levels of neutralizing antibodies. That are five to ten times higher than what's produced after two doses running. Sure you hear that just said and also note that. Remove this from the second article interesting. Now here's what it says again. The company said the booster dose right. So they're making a single shot. Booster after your two doses produces levels of neutralizing antibodies that are five to ten times higher than what's produced after two doses. That you've already gotten craig great so we're jamming thing people's arms twice and yet we just kind of fast tracked into like a month or whatever like it's not very long at all a booster that somehow ten times stronger with just one shot. Why wouldn't if that's why doesn't use use that one. I mean this doesn't make any sense to me. And by the way. I don't trust that at all because remember pfizer's the one that's been caught lying more times than i can count billions and billions of dollars paid out in crimes for lying lying about severe adverse events lying about what they're selling people on and on and on. I have shown you the tracker ten times over. So i don't believe that at all but i find it very telling that one they say that until you that it's the boosters better than everything else and that they delete that in their updated version which says something. But here's what they add. Visor said it would soon publish data about a third dose of vaccine and submitted to the fda the emergence the european medicines agency and other regulators the company's specified it would seek fda emergency authorization for the booster so now we need to authorize a booster of the same thing that we have yet to even approve. I mean historically when people look back on this is gonna it's unless these people take over and readjust history like they always do which is certainly possible if we're able to come clean free of this whole mania and look back it's gonna be so embarrassing because they just. These are the very people that are supposed to be the ones we trust with everything that are out. I mean that's what people like games line. One of the doctors spoken to are pointing at and going. Look these people through everything to win all that conviction about the things about testing all of it just got thrown to the side for the.

craig pfizer fda european medicines agency Visor
EMA Finds Potential Link Between Heart Inflammation and mRNA COVID Shots

AP News Radio

00:50 sec | 1 year ago

EMA Finds Potential Link Between Heart Inflammation and mRNA COVID Shots

"The European medicines agency says his committee has concluded that the coded nineteen vaccines may by fines on Madonna all possibly linked to very rare cases of chest pain on hold information in some people following vaccination the verdict echoes a similar conclusion reached by U. S. officials in June the E. U. drug regulator is recommending that to the two conditions myocarditis and pericarditis included a side effects on the vaccine labels together with a warning to raise awareness among health workers and people receiving the shots also the EMA is recommending people who have a history of a rare condition that causes blood vessels to leak avoided the coronavirus vaccine made by Johnson and Johnson the regulator again once a warning to raise awareness among health workers I'm Charles with as much

European Medicines Agency U. S. E. U. Drug Regulator Madonna Johnson Charles
"european medicines agency" Discussed on Newsradio 600 KOGO

Newsradio 600 KOGO

01:47 min | 1 year ago

"european medicines agency" Discussed on Newsradio 600 KOGO

"For a Corona virus vaccine. The European Medicines Agency has recommended the use of visors. Vaccine for Children ages 12 to 15. The vaccine is already being administered to kids in that same age group in the U. S. And it's been shown to be highly effective against infection in the US fully vaccinated summer. Campers may be able to mostly not wear a mask. The CDC is easing. It's recommended restrictions for summer camp in line with recent changes in general for fully vaccinated people. They consider masks no longer needed for fully vaccinated kids at camp, but they're still recommending them for unvaccinated kids both inside and outside. If it's crowded, or there's sustained contact, though the actual camp rules will remain a local decision, including whether to require any proof of vaccination. Fox is Lisa Brady Disputes about masks and other issues on airplanes, has one carrier, delaying a plan to start selling alcohol again. Southwest Airlines is reversing course in pushing back plans to resume selling alcohol. The move comes after a recent increase in incidents involving unruly passengers. The airline plan to start selling booze on some flights next month. Other airlines have already brought alcohol back to some degree, but not all have. American Airlines is still not serving alcohol in it. Economy. Southwest currently offers soft drinks, which had only recently brought back after serving only water upon request. Southwest has not say when it plans to resume alcohol sales. Hillary Barsky Fox News Hikers in Yellowstone National Park are advised to be on the lookout for bears. Yesterday, a man was attacked by a bear while hiking by himself on a trail near Mammoth Hot Springs. Park. Officials say he suffered significant injuries but was able to hike out.

American Airlines Southwest Airlines Lisa Brady Hillary Barsky Southwest Yellowstone National Park U. S. Mammoth Hot Springs European Medicines Agency US Yesterday next month Fox News CDC Corona 15 Fox both one carrier 12
European Regulators OK Pfizer Vaccine for Children 12-15

AP News Radio

00:38 sec | 1 year ago

European Regulators OK Pfizer Vaccine for Children 12-15

"The European medicines agency has recommended the use of the coronavirus vaccine made by Pfizer and by on tech to be expanded to children age twelve to fifteen the recommendation follows similar decisions by regulators in Canada and the U. S. last month as rich countries move that vaccination targets along the EMA's recommendation is based on the study of more than two thousand adolescents in the US that show the vaccine was safe and effective researchers will continue to monitor the shorts long term protection and safety in the children for another two years I'm Charles de Ledesma

European Medicines Agency Pfizer U. EMA Canada United States Charles De Ledesma
Belgium Suspends J&J Vaccine for Under 41s After Death

AP News Radio

00:46 sec | 1 year ago

Belgium Suspends J&J Vaccine for Under 41s After Death

"Delusion has suspended the use of the Johnson and Johnson could meet nineteen vaccine the people on the forty one following the death of a person who received the shot the government says in a statement it was asking for urgent advice from the European medicines agency the European union's drug regulator before it would consider lifting the suspension officials say the actions being taken off to a single case where there was serious side effects of the administering the Johnson vaccine using the local name for the Johnson and Johnson that day a woman was vaccinated through her foreign employer outside the building system and have died in Belgium last week after developing serious thrombosis and reduce blood platelets I'm Charles that's my

Johnson European Medicines Agency European Union Government Belgium Thrombosis Charles
Denmark Removes J&J From Vaccination Program Over Clot Fears

AP News Radio

00:40 sec | 1 year ago

Denmark Removes J&J From Vaccination Program Over Clot Fears

"Denmark has taken the Johnson and Johnson single guys shot off his back the nation program to investigate reports of bread but potentially dangerous blood clots the Danish health authorities said the benefits of using the Johnson and Johnson shop do not outweigh the risks Denmark has already taken the AstraZeneca shot out of its vaccination program for the same reason both the Jane Jay and AstraZeneca salsa made with similar technology the European medicines agency has concluded that there is a possible link between rabbit severe cases of blood clots and the cabin nineteen vaccine from Johnson and Johnson authorities say the need means that Denmark start finishing college I will be pushed back up to four weeks I'm Karen Thomas

Johnson Denmark Astrazeneca Jane Jay European Medicines Agency Karen Thomas
EU Agency Says People Should Get 2nd Dose of AstraZeneca Too

AP News Radio

00:47 sec | 1 year ago

EU Agency Says People Should Get 2nd Dose of AstraZeneca Too

"And he you agency says people should get that second shot of the AstraZeneca rather than some of the vaccine the FIA's the European medicines agency says citizens who received the first those of AstraZeneca's could be nineteen vaccine should get that second one two despite the rare risk of blood clots that would be linked to the shot in guidance the E. U. drug regulator says people should continue to get a second ashes I think it does four to twelve weeks off for the first one the Amsterdam based drug regulator said earlier this month there was a possible link between the AstraZeneca vaccine and let blood clotting disorders but he said the benefits of getting shots outweighed the risks I'm Charles collect as much

Astrazeneca European Medicines Agency FIA Amsterdam Charles
J&J to Restart Vaccine Shipments to Europe

Heartland Newsfeed Radio Network

00:16 sec | 1 year ago

J&J to Restart Vaccine Shipments to Europe

"And johnson will resume its covid nineteen vaccine rollout in europe. The company announced tuesday with adding packaging labels warning of a rare risk of blood clots europe's health regulators the european medicines agency said the vaccine's benefits outweigh the risk of the rare side effects.

Europe Johnson European Medicines Agency
European Regulator Finds Possible Link Between J and J Vaccine and Blood Clots

Breakfast with Sammy J

00:46 sec | 1 year ago

European Regulator Finds Possible Link Between J and J Vaccine and Blood Clots

"They use medicines regulator has warned. There's a possible link between the Johnson and Johnson covert 19 vaccine and rare blood clots. Your correspondent Samantha Holy The European Medicines Agency pulls the rollout of the Johnson and Johnson vaccine after US officials detected eight rare blood clock cases. Including one death among the nearly seven million people who've been vaccinated, European officials have now concluded unusual clots with low blood platelets should be listed as a rare side effect. What it sees. As with the estrogenic, a vaccine over all the benefits outweigh the risks. The UK is yet to approve the Johnson and Johnson vaccine.

Johnson Rare Blood Clots Samantha Holy European Medicines Agency United States UK
Johnson

Mark and Melynda

00:36 sec | 1 year ago

Johnson

"And Johnson covert shot remains on hold in the U. S. When European regulators have decided to go ahead with that vaccine, adding a new label boxes. Simon Ellen European Union's drugs regulator, says it's found a possible link between Johnson and Johnson's Corona virus vaccine on blood clots in very rare cases, but the European medicines agencies Sabine Strauss Says the shots benefits outweigh any risks. The product information will be updated to reflect this information on will include a warning on an update off the side effects of the CDC holds its latest meeting on the issue later this week.

Johnson Simon Ellen European Union Sabine Strauss U. CDC
EMA discusses Johnson and Johnson possible link to blood clots

AP News Radio

00:38 sec | 1 year ago

EMA discusses Johnson and Johnson possible link to blood clots

"Experts at the agency that regulates drugs for the European union says a warning about very unusual blood clots should be added to labels for Johnson and Johnson's coded nineteen vaccine the European medicines agency says these rare blood disorders should be considered as very rare side effects of the vaccine European officials say they consider the old current available evidence from the U. S. including eight reports of serious cases over red blood clots associated with low blood counts including one death I'm Charles de Ledesma

Johnson European Medicines Agency European Union U. Charles De Ledesma
European Regulator Finds Possible Link Between Vaccine and Blood Clots

Mark and Melynda

00:40 sec | 1 year ago

European Regulator Finds Possible Link Between Vaccine and Blood Clots

"Regulators in Europe announced their findings on a covert shot still on hold in the U. S. Fox is Simon Owen Live in London, at least of the European Union's drugs regulator says it's found a possible link between Johnson and Johnson's Corona virus vaccine. And blood clots in very rare cases, But the European medicines agencies, Sabine Strauss says that shots benefits outweigh any risks. Product information will be updated to reflect this information on will include a warning on a date off the side effects, she said. The agency is aware off eight reports from the U. S of blood clotting disorders. Among seven million people who received the

S. Fox Simon Owen European Medicines Agencies Sabine Strauss Johnson European Union Europe London U.
EU Agency Calls For Blood-Clot Warning on J and J Vaccine

WTOP 24 Hour News

00:33 sec | 1 year ago

EU Agency Calls For Blood-Clot Warning on J and J Vaccine

"The Johnson and Johnson covert vaccine should come with a warning about blood clots. Last week, J and J stopped its European rollout after US officials recommended a pause in the vaccine when they detected six very rare blood clot cases. Among nearly seven million people who had been vaccinated. The European Medicines Agency says the rare blood disorder should be considered as a very rare side effect. The U. S could be getting use of the vaccine again later this week. It's not clear yet when it will be distributed again in Europe. Traveling outside the U. S. The spring or

Johnson European Medicines Agency United States Europe U.
EU Drug Regulator Prepares to Issue Advice on J

AP News Radio

00:46 sec | 1 year ago

EU Drug Regulator Prepares to Issue Advice on J

"These drug regulator who issue advice on the Johnson and Johnson coronavirus vaccine experts at the European medicines agency are preparing to present their conclusions into possible links between the J. and J. shot on very rare cases von usual closing disorders detected in the U. S. last week J. and J. halted its European road out of this one does vaccine often the food and drug administration recommended officials pulls its use while the court cases were examined J. and J. has advised European governments to store that does his until the regulator issues guidance on their use widespread use of the shop in Europe has not yet started Charles Taylor this month London

Johnson European Medicines Agency Food And Drug Administration J. Europe Charles Taylor London
COVID-19 vaccine reaches world's far corners

UN News

01:17 min | 1 year ago

COVID-19 vaccine reaches world's far corners

"More than one. Hundred countries and economies have now received cave nineteen vaccines through the un partnered equitable corona virus. Busting scheme kovacs. The first delivery of life saving jobs arrived in ghana on the twenty fourth of february announcing the news on thursday the world health organization. Who said that more than thirty. Eight million doses of astrazeneca fire and serum institute of india have being transported globally. So far the aim is to deliver at least two billion doses of vaccines in two thousand and twenty one. In particular to developing countries. The development comes as who and other health regulators reaffirmed the overwhelming value of the astra zeneca or a covid nineteen vaccine amid ongoing concerns about clotting events among a very small number. You've had the job in statements on wednesday evening. Who's global advisory committee on vaccine safety. The european medicines agency and the uk's regulator or concluded that the benefits of taking the vaccine outweigh the very rare potential risks more than one hundred ninety million doses of the astros. Zenica vaccine have been administered today but only one hundred eighty. Two cases of clotting have been reported. Who said as it advised countries to continue to vaccinate with the as at vaccine not that it had saved millions of lives and prevented serious illness

Astrazeneca Fire And Serum Ins Kovacs Astra Zeneca World Health Organization Ghana UN Jobs European Medicines Agency Zenica Astros UK
Australia halts AstraZeneca vaccine for most people under 50

Fresh Air

00:22 sec | 1 year ago

Australia halts AstraZeneca vaccine for most people under 50

"Australia is the latest country to restrict use of the covert vaccine developed by AstraZeneca. It's recommending that the shots not be given to people under the age of 50. Australia's announcement follows the latest statement from the European Medicines Agency that it had found a possible link between the AstraZeneca vaccine and

Australia Astrazeneca European Medicines Agency
COVAX Reaches Over 100 Economies, 42 Days After First International Delivery

UN News

01:17 min | 1 year ago

COVAX Reaches Over 100 Economies, 42 Days After First International Delivery

"Than one hundred countries and economies have now received covid nineteen vaccines through the un partnered equitable corona virus. Busting scheme kovacs. The first delivery of life saving jobs arrived in ghana on the twenty four of february announcing the news on thursday the un world health organization. Who said the more than thirty eight million doses of astrazeneca pfizer biotech and serum institute of india had been transported globally so far kovacs aims to supply vaccines to all those requested them. In the first half of this year the development comes as who and other health regulators reaffirmed the overwhelming value of the astra zeneca or as ed covid nineteen vaccine amid ongoing concerns about clotting events among a very small number had the job in statements on wednesday evening the. Who's global advisory committee on vaccine safety. The european medicines agency and the uk's regulator all concluded that the benefits of taking the vaccine outweigh the very rare potential risks. More than one hundred and nine hundred million doses of the astra zeneca vaccine have been administered. Todate but only one hundred eighty two cases of clotting have been reported. Who said its advice to countries to continue to vaccinate with the as at vaccine noting that it has saved millions of lives and prevented serious illness

Kovacs Un World Health Organization Astrazeneca Pfizer Biotech Serum Institute Ed Covid Ghana Astra UN European Medicines Agency India UK
"european medicines agency" Discussed on KCRW

KCRW

01:56 min | 1 year ago

"european medicines agency" Discussed on KCRW

"Suppressed, and anyone who has A new opinion, different from a very narrow point of view. When we came here to show that we're not alone that there are many of us. Before today's rally, authorities rounded up Alexei Navalny's AIDS. Warned protesters they could be prosecuted on mass riding charges which carry up to 15 years. Lucy and Kim NPR NEWS. Moscow This is NPR. In Chicago, the school district and teachers. Unions say they've agreed on four coronavirus safety issues, but they remain at odds over whether in person classes should resume tomorrow or be phased in as staff gets vaccinated. German Chancellor Angela Merkel is summoning state governors to meet tomorrow morning to address the country. Slow vaccine rollout as my Nicholson report's just over 2% of the population has received an initial dose so far, according to Michael's office, representatives from major vaccine manufacturers and from the EU Commission a due to join her on Germany's 16 state governors. To find solutions to the major shortfall in vaccines. Speaking to the Frankfurter Allgemeine, a newspaper on Sunday, Federal Health Minister Jens Spahn said there's no reason why the corona virus vaccines from China and Russia couldn't be used in Europe, providing they're approved by the European Medicines Agency. While the E m a granted full approval of the Oxford AstraZeneca vaccine on Friday, Germany's health authorities recommended has given only to those under the age of 65. Citing a lack of trial data about efficacy in the elderly. For NPR news. I'm Esme you Nicholson in Berlin. Britain's 100 Year old captain Tom Moore, who walked laps around his garden to raise money for the National Health Service has been hospitalized. His daughter posted on his Twitter.

Nicholson Lucy NPR Germany Alexei Navalny Kim NPR Angela Merkel Frankfurter Allgemeine Jens Spahn Twitter Oxford AstraZeneca European Medicines Agency Chancellor National Health Service Chicago Berlin Moscow Tom Moore EU Commission
"european medicines agency" Discussed on WBZ NewsRadio 1030

WBZ NewsRadio 1030

04:35 min | 1 year ago

"european medicines agency" Discussed on WBZ NewsRadio 1030

"The Oval Office last night. It was quite loud, and it pitted members of the White House counsel against Chief of staff Mark Meadows. Here's what we know the conflict was over former campaign attorneys Sidney Powell. Former because she was fired a little while ago and she was invited back into the White House over the weekend, and Michael Flynn and this was over a couple of plans one for President Trump. His plan to impose martial law to overturn the election results. Allegedly. That was earlier and he also wanted to pitch an executive order last night to seize voting machines in key swing states to examine a B. C's Johnson. Tucci says Powell's presence that's the attorney was shocking to those inside the White House. She was disavowed by everybody. Broody Giuliani came out in, issued a statement terminating her from the group. I'm told by my sources that the Rudy was not Present in the Oval Office Friday night he actually was on the phone and told the president the plan that the two were pitching was a bad idea. It's 11 47 police arrest a man in Manchester for allegedly threatening someone with a gun for blocking the road. Say they got a call for a car stuck in the snow on Eastern AB on Sunday, Another car stopped to help. That's when harness Kulik allegedly drove up the street. He couldn't pass the two cars. So what did he do? He said he took out a gun. From his car and then pointed the gun at the two of them, the person in distress and the Good Samaritan. The Fizer vaccine has been given the green light for use in the U by scientist All right. This is a panel they still need to get the official government rubber stamp, but it looks like a go And it comes weeks after Britain and the U. S. Gave it. Emergency use authorization. This is Margie Agnes Hein with the European Medicines Agency today, our human medicines Committee, the CH empty Recommended the conditional marketing authorization for the first Corbett 19 vaccine for the EU market. This is a significant milestone in the fight against the pandemic. Trucks are waiting to get out of England and they're backing up for miles. People are stranded at airports. Many nations have imposed travel restrictions on the UK, and it comes over concerns about that new strain of the virus that apparently spreads more easily than others. It doesn't mean it's more gelateria. Harmful. It just means it spreads pretty easily. Ah growing number of countries air halting air travel now from the UK, while France has banned trucks from the country for 48 hours minimum while they look at this new variant this new mutation of the virus and keep in mind viruses mutate all the time. British health officials say the strain is out of control around London and southeastern England. It's not clear again yet if it's more dangerous, it just is able to spread over in Texas. The distribution of vaccine brings new hope to the region Hard hit, but it's also bringing controversy first in line for vaccination in the Rio Grande Valley, where doctors in frontline nurses Then says Dr John Krauss came paramedics are E M. T s are in the midst of this. They're taking care of patients not knowing what they're getting into. But in one border city ideas were not being checked. Photojournalist with the Texas Tribune captured images of a state senator at a man identifying himself as a sheriff's deputy waiting their turn. The problem is that neither job category is supposed to receive the vaccine yet. Jim really? An ABC News Dallas Summer, an island businesses are reopening today, somewhere just increasing capacity. This is the end of Rhode Island's three week pause period. The measure, of course from Governor Ray Mondo was health control of Covad surge in the ocean state. And million's air flying over the holidays. Despite all the warnings to stay at home, don't travel Now. The CDC is working to track down passengers on a united flight last we could try to help save a dying man. Mid flight, the man aboard United Flight 5 91 from Orlando to Los Angeles. Died from a heart attack. But this passenger says she heard his wife say he recently had covert like symptoms when it was just it. Female nurse. She was the first one to get over there, Talk to them. That's when I had heard in other people had heard he was having symptoms like trouble breathing in loss of taste and smell. We do not know if the man actually had the virus. That was ABC. Geo Benitez. It's 11 51.

Kulik White House President Trump Oval Office Sidney Powell ABC Broody Giuliani Rudy Tucci Good Samaritan Manchester Texas Tribune Mark Meadows Michael Flynn UK England Chief of staff Margie Agnes Hein
"european medicines agency" Discussed on KQED Radio

KQED Radio

05:59 min | 1 year ago

"european medicines agency" Discussed on KQED Radio

"We have more than 30,000 square meters off temperature controlled rooms at the airport, the U. K's decision to approve five this vaccine has put pressure on other countries. Health agencies to follow suit. Decision is expected from the European Medicines Agency on the FDA within days. It was in Christ will be great. When you say, Shall we consider her almost immediately. Shin is changing. Also fascists pending authorization. The U. S and Europe share a hope to begin administering the first vaccines by the end of this year. Prioritizing frontline health workers on the most vulnerable. The U. S. Expects to receive a total of 40 million doses from Fiza and competitive Madonna by the end of this year. That's enough to vaccinate 20 million people. Vaccines, one of four that could be rolled out globally by spring, 2021 offering hope for an end to the pandemic that has already claimed 1.5 million lives for the PBS news Hour on Lucy half in purse. While a new class of congressional representatives joined the halls of the Capitol in the New year, we chat with departing members who lost tough reelection races. Earlier this week. I spoke with outgoing Democratic congresswoman Donna Shalala. Lisa days Your dad continues our coverage. Well. House Democrats lost some races in Republican leaning districts. One Republican, was ousted by a challenger from the right. We've followed Republican Denver, Riggleman of Virginia throughout his freshman term in Congress, and he joins us now, Congressman. Thank you. No, the charge and the headlines in your race. Where that you weren't conservative enough, But I want to ask you. Why do you think you lost And what does it mean to be in the Republican Party right now? I think one of the reasons I lost Lisa and by the way, thanks for having me, I think is one of the reasons that I lost was really might have been in minded way of doing things. And, you know, once I officiate that same sex wedding back in summer of 2019 I mean, some of the things that I stood for as far as health care on real broadband in a district bigger than New Jersey. I think some of those things actually sort of conspired against me, right And also, you know, I was new to politics, and I thought an independent minded persons what people want and I think that's why I won. I think it's also why I lost. What do you think it means to be a Republican? Are? Are you still a Republican? Very difficult right now. You know, I feel like that. I'm willingly tribe Elice, right? And I think a lot of it has to do what what I'm saying with some of the bizarre conspiracy theories, I'm saying Obligated by just certain people on the right. I really think the Republicans should stay out of people's pocketbooks. But I think they should stay out of people's bedrooms. Two and I'm seeing a party that's just small enough to fit in the bedroom. And that's not really the way that I'm wired. And so it's interesting thing. I thought it was a constitutional Republican in the mold of the Teddy Roosevelt and Abraham Lincoln's But as far as thespian some of the specific portions of the Virginia Republican Party I don't think I'm a great fit. You know, there's also the Trump Republican Party. You are one of the few House Republicans to have said openly that Joe Biden won the election. You're in the Freedom Caucus. You know the Republicans who are saying the election is rigged without giving any proof. I wonder. Why do you think they're saying that? Are they talking themselves into believing it is this politics? Why is that? I don't know what's in their heart, Lisa, But I tell you, you know, my background is an intelligence officer. It is this information. It's radicalization, its counterterrorism, and I'm not sure they're afraid of voters. If they're worried about being tossed out of the tribe of there's something in them that actually believe some of this because I will tell you I've seen sort of odd things in my life. Some of these conspiracy theories that are coming out the dark corners of the Internet and now now are getting life. The real world. I'm enough. You know what's next? You know, aliens are beaming information, the voting machines. I mean, this is crazy, and I think we need to be very cognizant about information that could radicalize others that's really based on nothing but myth and conspiracy theories. Charlottesville is in your district, a place that has dealt with rhetoric turning into violence as we saw in 2017 when a protester was killed, and now we see Trump allies still saying things like this week that his opponent should be shot. How dangerous do you think that rhetoric is, or are we paying too much attention to these sort of lone extreme voices. May. I think you drag everything into the light and let the sunlight disinfected. But I think what's also scary is you have to retired generals they're talking about, you know, martial law, and I think it's very odd that that's not a bigger story because what they're basing it on his ridiculous whether it's essay trying to, you know, crack into computers. Whether it's you know, Dominion having code that's been manipulated, whether it's the army storming some barracks and Germany all these things were just poppycock on. I think we gotta be worried about the radicalization of those based on again based on information that's just not true. This is dangerous on this can convert into dangerous behavior. I've been warning about this for months, and I think we're seeing some of that. Sort of that bizzare manifestation of conspiracy theories that are being made real by people that don't have proper information. And I think this is a massive Griff. I think when you talk about the cracking I think the only thing they're cracking into our people's pocketbooks on this, Griff. I don't hear you mentioning President Trump and any responsibility he has for this. He does have responsibility. I think that's where I got in trouble. I think when you re tweet, something other says that Joe Biden killed Seal Team six. I think when you re tweet something where says it? Almost Sala bin Laden.

Republican Party Lisa Joe Biden Virginia Republican Party Trump European Medicines Agency Europe Sala bin Laden Donna Shalala U. K U. S Fiza New Jersey FDA Virginia Germany Congress Teddy Roosevelt Freedom Caucus
"european medicines agency" Discussed on Newsradio 700 WLW

Newsradio 700 WLW

08:00 min | 1 year ago

"european medicines agency" Discussed on Newsradio 700 WLW

"Don't want to be in a man Can it It's going to be on solid ground again. Stone here on 700 wlw. About seven o'clock this morning. You get to the building. Going up to the sixth floor. Press the button elevator comes down. I'm the only one here. All of a sudden by the fourth florists. This uncomfortable elevator stops like this is not the sixth floor. I'm not. I'm bad at math. I'm not that bad. And I realize, like the elevator stopped for some reason, so I hit the button. None of the buttons are working. Zero. This is not situation. So I kind of pride the door up a little bit. And Pete Pete to where I am. And you could see a crack of light of Mike. Okay? At least I'm near a floor. How'd I get myself into this situation? So I opened the call box door that very few people know you know how many times have I had to do this? Like this could be interesting. I wonder if it's hooked up. So have the four elevators. They shot one off in midstream, and that was our heart was making cuts or something. And it's all anybody with seven budget cut in an elevator. Anyway, I was stuck in the elevator 40 minutes before they guess the elevator text family were dispatched to come out and rescue me. I felt like baby Jessica and well, so run of the late this morning. I apologize if I'm or scatterbrain than usual, which if you listen to the show You know, that is entirely the plan. It's the A T h D working, so we'll begin with us will be a little more elevator talk later in the hour, by the way, but I can't tell you this. That We are on the cost by guest of getting this vaccine for the visor and soon Moderno will start turning this thing out. But what's interesting about it is the UK just announced they have approved emergency authorization of at least a fighter vaccine right now, which is 95% effective. No serious side effects. Although you've got to keep it at 94 degrees below zero, which is very close to the temperature. The elevator I stuck in this morning. Pete Seeger is with PCs Advisors That's a healthcare consultancy for businesses. And a P Good morning. Welcome to show. Good morning, Scott. It's Paul. I'm sorry. When I think of this peace, Paul. Oh, well, there was a folk singer named Pete Seeger back in the pizza. Eat your Siegert, not Seeger. I think that's maybe where the confusion is. So my apologies. I just got out of an elevator. So forgive me. Understand? Yeah. S O s o. The White house called the head of the FDA into explain why our approval is being delayed. You look at it you go. The British Health Ministry is pretty good at what they do. Um, We're not talking about some third world country. I don't think I trust the Chinese the Russians on this, but You okay? There are allies. There are closest friends for a long time and you look at what they've done in their They prove this. So why can't we do the same thing? Well, we will. They think there's been some some difference and It's kind of an opportunity to talk a little bit about Brexit. In a way the medic, Medicines and healthcare products Regulatory Agency, the N H R A is the agency in the UK that makes these approvals and they and then you have Brexit happening. 12 31. And their messaging to the world really, that we'll do things quickly, and I think there's an intense there that will come to them in the future. And so they're trying to look like the faster Organization, and it's not that they're rushing it necessarily. They've been doing rolling reviews with visor and buying tech and other drug manufacturers. In fact, I heard that they even have their response rate to the drug companies. When they submitted data with his quickest 10 minutes asking questions, so they've been Doing these rolling reviews with the intent of getting this thing out quickly as possible. So it's not the FDA dragon. I mean, I guess, you know, knowing Trump on the waning days of his administration obviously is going. Hey, listen, We want America to be first. We want to be first in everything. America first, right and Is this kind of what did you feel like? This is like a space race. Basically, we lost the Russians. Only this case was the British. It seems that way. Yes, but we think the messaging here While the image IRA is messing the drug companies for the future likely the FDA is in in the E M. A. The European Medicines agency did 12 10 on the 10th. We'll have a public hearing on our meetings, emergency youth with the intent of Really convincing people that it hasn't been rushed in because we have to get People to take the vaccine to get to herd immunity at some point in the same thing. I think the same theory is in place and the rest of the European Union so but the thing is, we have the vaccine. We haven't in Ohio right now. It's being distributed to 10 locations, including You See health here in Cincinnati is one of the 10 spot, so it's not like I guess it's ready to go. We just have to get the green light from the FDA before they could start inoculating people. Exactly. Yeah, they've already been getting it ready and staged in different geography. There's 64 jurisdictional immunizations centers that air getting their orders in this they have to have their orders in by this week. Yeah, but all those shipping already begun. Yeah, And I think the big thing here too, because people are wondering, Paul, Uh, how am I going to get the vaccine? How am I going to get the you know, for the for the average person? We're talking probably spring summer, right before perfectly healthy person. You're not in line yet. It's there were gonna be 20 million enough. What we expect is that we'll have enough to immunize 20 million people by the end of this year and based on the A sip, which is the organization that Recommend to the CDC who should get the vaccine first. Basically, they voted 13 to 1 on Tuesday that it would go to healthcare workers in the U. S, followed by those in nursing facilities still nursing facilities. That's 24 million people in those two groups, and we're gonna have enough for 20 Million. So yeah, There's something like 18 8 just 18 minute million health care workers alone, So there's enough to cover them eventually, not immediately, but eventually, But, you know, you talk about cops and firefighters, nursing homes. We're not even close to it. That number yet. Right. That's right, however. What happens Paulo happens when modern rules there's out, then I mean, how many company doses do they have? Because it's It's a similar, obviously similar vax right? It is and that the halving the amount for 20 million assumes that they get approval as well this month, alerting, see distribution, actually. Okay, so it's lumping. It's it's counting on Madonna and Fizer vaccine and And whatever else comes down the pike. Maybe. And here's the thing. Are we going to decide on one vaccine? Paul Seeger that sometime and it's because it's you know, you get the flu shot. Now it was the flu shot or you get your immunization schedule. When your child right goes to the doctor before they go to school. You get immunizing all that we don't really have different Do we have different brands or different manufacturers of that, or Are we? Just gonna at some point is just gonna whittle its way down a one manufacturer. I think we'll end up having many. We're gonna have five actually, by February. That we anticipate will likely be approved for emergencies by the FDA and then production adviser in the journal. We talked a lot about AstraZeneca has worked with Oxford University. They'll have one that they have one. That's Close behind and then Johnson, Johnson and Novavax and there's many others and productions kind of the arms race of pharmacy right now that we haven't really seen at this level and not only that, but the Russia and China have clear their vaccines. They're not waiting for clinical. So you know, white schools got results, which is in Russia in China. That makes sense, right? Eh? So I'm not sure about the safety and efficacy there. If we're just going, Hey, we're running this thing out there and you know they don't care. There's no lawsuits there if you kill a whole bunch of people. Yeah, I wouldn't line up for either of those, but the other five that I've mentioned in front of the others that are in production and certainly gonna be if I would line right up for those AstraZeneca's and some of the others. The first two. We've talked about facts. They require extreme cold storage. And there's Had essentially build a whole new way of transporting and storing these vaccines and some of the others..

FDA Paul Seeger Pete Seeger UK AstraZeneca Pete Pete flu America Stone Ohio European Union Cincinnati Mike Moderno White house Jessica Russia Brexit British Health Ministry Scott
"european medicines agency" Discussed on AP News

AP News

03:34 min | 1 year ago

"european medicines agency" Discussed on AP News

"Becomes available, But a panel of experts has recommended starting with health care workers and nurse Going home residents. The current estimate is that about 20 million vaccine doses will be provided once approval is granted. So it was the job of 14 members of the advisory committee on Immunization practices to decide who should receive their protection. First, it has been a Solomon's choice, Dr Peter Salah. Gee, we all feel that all U. S. Residents should eventually have safe. Have access to safe and effective vaccine. They all agree. Healthcare workers 21 million people should be first in line and most voted for nursing home. Patients to vaccines could be approved soon, but widespread distribution isn't expected until the spring. Jackie Quinn Washington The two top contenders at the moment are the vaccines developed by Fizer. And the German company Bio N. Tek and then the other one developed by Madonna with the National Institutes of Health in the U. S. And they both had very good efficacy data suggesting that they're effective and they're safe. Those air under consideration by both the European Medicines Agency and the U S. I. Mike Rossi, a reporting president. Trump teases at a 2024 White House run. With hopes of overturning the 2020 election fading, President Donald Trump hinted Tuesday night at making a 2024 presidential run and White House holiday reception, Trump told the crowd. It's been an amazing four years. We're trying to do another four years. Otherwise I'll see you in four years. Video of Trump's remarks was live streamed on Facebook by attendee Pam Pollard, who was national committeewoman for the Oklahoma GOP. Trump's began hosting holiday parties this week. Mike Rossia Washington I might Grassi a reporting president. Trump teases at a 2024 election run. At the White House holiday reception Tuesday night, President Donald Trump repeated his unproven allegations of election fraud, while also hinting at a return to the campaign trail in 2024. From told attendees were trying to do another four years. Otherwise I'll see you in four years. Video of the remarks was streamed Live on Facebook by Pam Pollard, who was national committeewoman for the Oklahoma GOP. The video showed dozens of people many without masks crammed into the cross Hall of the White House state floor. Mike Grassi, a Washington at the White House holiday reception Tuesday night, President Donald Trump repeated his unproven allegations of election fraud while also hinting at a return to the campaign trail in 2024. Trump told attendees were trying to do another four years. Otherwise, I'll see you in four years. Video of the remarks was streamed Live on Facebook, by Pam Pollard was national committeewoman for the Oklahoma GOP. The video showed dozens of people many without masks crammed into the cross hall of the White House. State floor. Mike Grassi, a Washington with hopes of overturning the 2020 election fading, President Donald Trump hinted Tuesday night at making a 2024 presidential run. And White House holiday reception, Trump told the crowd. It's been an amazing four years. We're trying to do another four years. Otherwise, I'll see you in four years. Video of Trump's remarks was live streamed on Facebook by attendee Pam Pollard, who was national committeewoman for the Oklahoma GOP. The Trumps began hosting holiday parties this week. Mike Rossia Washington. It Has to stop. Gabriel Sterling says he had to say something after learning a twentysomething elections contractor and Gwinnett County has endured death threats just because he's taking part in the recount. I've got police protection outside my house. Fine..

President Donald Trump White House Oklahoma GOP Pam Pollard Facebook Mike Grassi Mike Rossia Washington president Jackie Quinn Washington fraud National Institutes of Health Solomon Mike Rossi European Medicines Agency U. S. Dr Peter Salah Washington Bio N. Tek
"european medicines agency" Discussed on AP News

AP News

02:45 min | 1 year ago

"european medicines agency" Discussed on AP News

"I definitely think there's a lot of optimism because the beginning of the year none of the research had really begun on any of these vaccines. And here we are about 10 months later, with three potentially effective vaccines that look like they will likely be approved. How quickly people get them will depend on each country's ability to roll out the logistics of a mass vaccination program. But it does seem very optimistic that we will have something In the next few months. Hopefully, that will help us slow down this pandemic. The two top contenders at the moment are the vaccines developed by Fizer. And the German company Bio N Tek and then the other one developed by Madonna with the National Institutes of Health in the U. S. And they both had very good efficacy data suggesting that they're effective and they're safe. Those air under consideration by both the European Medicines Agency and the U. S. The Oxford vaccine that is being developed with AstraZeneca. We're still waiting for fuller data on it. So the data that came out last week were a bit confusing, and researchers did not release the full study that everyone needs to see. So it's just a little bit further behind than the other two. That doesn't mean that it won't prove ultimately to be safe and effective. But we just don't have the data right now to know that for sure, as far as the European Medicines agency is concerned, they're not approving vaccines based on emergency use. So what they are doing is looking at the data. In an expedited way, so they are looking at everything that they would need to make an informed decision. It's just done a bit faster than regular times because the data has been submitted. To the regulator. As it becomes available that will be guidance that we'll go to states and it will ultimately be a responsibility of state governors and state governments to translate those priority recommendations into the actionable plans for where vaccine doses are given, as they become available, as they become distributed to state's gonna take AH, lot of people a lot of support. Us on the health of health community, from medical community from governments and ultimately, to build the kind of buying from the public that we need to get this vaccine and as many people as quickly as possible, state health officials are telling us that they have desperately Limited resources to support the kind of work that they're expected to do in the in the in the weeks and months ahead. We need a very high up take in order to really put out this this wildfire of canned Emmick. We're living through right now. At least 70 80% the estimate Mary, but we need a large percentage of the population to be vaccinated. I'm Rita Foley within a P newsman at health officials are getting ready for the Corona virus outbreak to get much worse because of Thanksgiving holiday gatherings, they warn, will spread the virus. Us now. Averages 170,000 U Cove. It 19 cases a day. Doctor Laura Foreman is the chief of emergency medicine. A.

European Medicines Agency Doctor Laura Foreman National Institutes of Health Bio N Tek Rita Foley Madonna Mary
"european medicines agency" Discussed on AP News

AP News

02:02 min | 1 year ago

"european medicines agency" Discussed on AP News

"Role in astronomical discoveries for more than half a century completely collapsed. A 900 ton receiver platform fell onto the reflector dish. Ed Donahue. AP News I'm Ed Donahue with an AP News Minute European regulators may approve a Corona virus vaccine developed by Fizer and buy on tech within four weeks. It could mean the shot is rolled out first in the U. S and Britain. Rebecca Coil with the American Immunization Registry Association, says this has to be done right after the best independent distributed and the doses have been administered. There's a there's a need to really demonstrate. Where the vaccines air going on go into account. For all of that one important factor is tracking vaccinations have multiple products out there. Different types of vaccines are not interchangeable. And it's going to be on us to make sure that a person on Lee receives the type of product that they need to receive. The European Medicines Agency plans to convene a meeting by the end of the month to decide if there was enough safety and efficacy data about the vaccine for it to be approved. I'm a Donahue AP News. I'm Ed Donahue with Hope's growing that a Corona virus vaccine maybe on the way soon. Jason Schwartz at the Yale University School of Public Health, says preparation is important. State health officials are telling us that they have desperately limited resources to support the kind of work that they're expected to do in the in the in the weeks and months ahead. Health officials worry the pandemic is going to get worse. Following Thanksgiving. The AP s Rita Foley has the story. The US now averages more than 170,000, U Cove in 19 cases a day. And Dr Anthony Fauci warns. We're not even seeing the effects of the Thanksgiving holiday gatherings immediately. You see the difference to what? Three weeks from now, which would put it right at the time that people would be traveling for Christmas Doctor Lower Foreman is the chief of emergency.

Ed Donahue AP European Medicines Agency Dr Anthony Fauci Fizer American Immunization Registry Rebecca Coil Doctor Lower Foreman Yale University School of Publ US Rita Foley Jason Schwartz Britain Lee