35 Burst results for "European Medicines Agency"
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
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
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
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
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.
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.
"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.
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
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
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
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
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
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
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
Spain limits AstraZeneca vaccine to 60 years and up
"Spain who's joined other European nations in limiting the use of the AstraZeneca vaccine due to concerns over links to extremely red blood clotting Spain's health minister has announced after meeting with regional health chiefs that authorities would limit shots to those over sixty years old saying all strategy with AstraZeneca is pivoting the decision came after the European medicines agency said it found a possible link between the shock and the red clocks spring was one of the European countries the briefly halted the use of the A. said vaccine last month when the first blood clot scales were notified until now speaking high reserve the FISA by own tech on the maternal vaccines for those over sixty five I'm Charles the last month
UK advises limiting AstraZeneca in under-30s amid clot worry
"British authorities have recommended the AstraZeneca pave it nineteen vaccine not to be given to adults under thirty where possible because of strengthening evidence that the shot may be linked to red blood clots the recommendation comes as regulators emphasize that the benefits of receiving the vaccine continue to outweigh the risks for most people even though the European medicines agency says it found a possible link between the short and to the red clocks now British authorities have shifted the vaccine position recommending people under thirty he offered alternatives to the aide said with the EMI advisory does not include such age restrictions leading government medic Jonathan van tam says this is of course a correction there's no question about that Charles Taylor this month London
Blood Clots Reportedly 'Very Rare' Side Effect of AstraZeneca Vaccine
"Does believe that there is a possible link between the astra zeneca co covid vaccine and very rare but potentially fatal blood clots. Npr's jason boubyan reports that the european drug regulators says that boycotts must now be listed as a possible side effect. The safety committee of the european medicines agency analyzed eighty six cases of blood clots. That occurred in people up to two weeks after getting the astrazeneca shot and we have concluded that there is indeed a possibility of a very rare event that might occur. That's dr sabine. Strauss the head of the safety committee. She says the unusual immune reaction appear similar to a rare clotting reaction to a blood thinner called heparin. there have been at least eighteen. Potentially vaccine related deaths among the twenty five million people immunized with astra zeneca in europe stresses that with thousands of people dying every day from covid the benefits of the asiatic vaccine far outweigh the potential risk from this rare. Immune reaction jason on. Npr news this
EU regulator finds link between AstraZeneca vaccine and blood clots
"Today said there's a possible link between AstraZeneca's covert vaccine and rare but sometimes fatal blood clots. The AstraZeneca vaccine has already been administered to tens of millions of people. It's on track to be the most widely used vaccine in the world this year. NPR's Jason Beaubien joins us with more. Hi, Jason. Hi, Ari. What exactly did the European Medicines agency say today? So there had been. Some concerns raised that some people appear to be getting hit with a very rare blood clotting condition. In the days following vaccination and initially, the European drug regulators, they said, this rate of a few dozen blood clots was nothing out of the ordinary when you're vaccinating 25 million people. But today, the E M. A safety committee came out and said yes, there does appear to be a link. Dr. Sabin Strauss was the head of that committee, She says they looked at all the available data on 86 events. These clotting cases that occurred in the days after vaccination by AstraZeneca on we have concluded that there is indeed a possibility. Of a very rare event that might occur. They're still saying they don't completely understand what's happening. But this appears to be an immune reaction that they've seen also with a drug called heparin, which is a blood thinner. But the key point here is that they've switched their position now to saying that they think it is plausible that the AstraZeneca vaccine is what's causing these clots. So these clouds are
"european medicines agency" Discussed on WNYC 93.9 FM
"Me about today, But they're here and they're doing their best. So in honor of all the lives lost at the hands of white supremacy. I'm asking for everyone to devote their lives to dismantling it. The rally was briefly interrupted by an unidentified white man who angrily called the victims and the A P I. Women at the rally, quote prostitutes for NPR news. I'm Lily Oppenheimer in Atlanta. Biden administration says it's still working to move immigrant Children out of U. S border facilities meant for adults as NPR's Franco or Donets reports. Two more facilities were open this week in Texas, including a convention center in downtown Dallas. Biden administration has been struggling to deal with the growing number of unaccompanied minors at the border. As of Sunday, more than 4200 were being held in jail like border facilities. But this week, the Biden administration opened two additional emergency sites. One is in Midland, Texas. The other is at the Kimberly Hutchinson Convention Center in Dallas. An administration official described them a short term stopgap mechanisms. The official says. Unaccompanied minors spend an average of 34 days in the shelters run by health and human services before being reunited with a family member or vetted sponsor, Franco or Dona as NPR news. Germany is resuming use of AstraZeneca's covert 19 vaccine on the advice of the European Medicines Agency. More than a dozen countries in Europe suspended use of the company's vaccine after reports of blood clots in some recipients. The agency says it can't roll out a link between the vaccine in those clots. But it says the number is small and the benefits of the vaccine outweigh the risks. This is NPR news. White House says it's assessing how the U. S. Could loan stockpile doses of AstraZeneca's cove in 19 vaccine to Mexico and Canada. It hasn't been approved for use in the U. S. Biden administration says the U. S. Has seven million doses of that vaccine. The commissioner of the IRS is offering guidance to taxpayers who have already filed their 2020 federal returns as NPR's Brian Naylor Reports Commissioner Charles Reddick says taxpayers seeking to write off unemployment benefits under the most recent coronavirus relief package passed by Congress should not submit an amended return. The $1.9 trillion relief bill includes a provision that allows many taxpayers who collected unemployment benefits and 2022 right off the 1st $10,200 of those benefits. But millions of Americans have already filed their 2020 tax returns, Iris Commissioner Reddick told a House panel Theeighties NC is working to issue any additional refunds automatically. People who filed should absolutely not file an amended return. So whether they reported it or did not report it do not file an amended return at this time. Reading also said the I R s has staff working weekends and mandatory overtime as they continue to process millions of 2019 returns. Brian Naylor. NPR News in Minnesota 12 jurors have been selected in the trial of the former Minneapolis police officer charged with killing George Floyd last year. Two alternates must still be chosen. I'm Dave Mattingly. NPR News in Washington. Support for NPR comes from NPR stations..
"european medicines agency" Discussed on The World and Everything In It
"Clear eyed about beijing's consistent failure uphold its commitments and we spoke about how beijing's aggressive and authoritarian behavior are challenging the stability security and prosperity of the pacific region. The chinese foreign ministry quickly responded saying quote. There is no room for china to compromise on issues related to sovereign security and core interests. Russian president vladimir putin reacted angrily thursday to recent remarks by president biden calling putin a killer. Putin shot back saying in effect. It takes one to know one he reference to the us history of slavery and injustices against native americans. Jen psaki told reporters. That biden is not afraid to speak his mind. When it comes to the kremlin. We are confident that we can continue to look for ways where there's a mutual interest mutual national interest of but The president is not going to hold back clearly when he has Concerns biden's remarks came during a recent interview with abc's george stephanopoulos. Who asked if he believes. Putin is a killer biden. Responded quote i do. Us intelligence agencies believe the russian government was behind the near fatal poisoning of opposition leader. Alexey novo name biden also hinted at forthcoming penalties against russia that follows declassified intel reports that moscow again tried to interfere with last year's u s election health officials in the european union. Say that after days of scouring all available data on the astra zeneca vaccine that reached a clear scientific conclusion. This is a safe and effective vaccine. Its benefits in protecting people from covid nineteen with the associated risks of death and hospitalization outweigh the possible risks. The head of the european medicines agency ema cook said the ama study data related to a small number of cases in which people develop blood clots after receiving the vaccine. She said they found no evidence. That the astrazeneca's shots increased the risk of clots. But they also can't rule it out without in mind. The amazed dr sabine. Strauss said that the agencies risk assessment committee recommended to add a warning to the s. p. c. and the patient leaflets. So that this information should be provided to healthcare professionals and to the public several eu nations had suspended their use of the vaccine over the past week as health officials investigated reports of clods. But with only a few thousand cases out of millions who received the shot and no confirmed link to the vaccine. Aamer cook said to me. I.
"european medicines agency" Discussed on Bloomberg Radio New York
"Other company involved a Hartford financial services group H IG on the ticker surging now by 14.1%. Chubb shares swinging between gains and losses but shove now up by 3/10 of 1% and the European Union's drug regulator says AstraZeneca's Covad 19 vaccine is safe to use. Giving the block an opportunity to try to turn around its lagging inoculation campaign. After months of disarray, the European Medicines agency says the vaccine is quote safe and effective on the benefits outweigh the risks. American depositary receipts of AstraZeneca. They're down 1.2% financials airlifting US stocks off the lows of the day is banks and lenders have seen benefiting from rising bond yields. In the wake of renewed concern about inflation right now we've got the S and P down 22 points a drop of 6/10 of 1% the Dow up. Wanna wait Hard by 3/10. Well, NASDAQ is dropping 200. And 31 points down another 1.7% as fact by the way, is still positive on the year this year Up by 3.1% 10 Year Yield 1.73%. We've got gold down 8/10 of 1% 17 31 The ounce and West Texas intermediate crude has plunged 6% now at 60 73 a barrel On West Texas Intermediate crude oil is declining as inflation concerns rattle broader sentiment and physical markets in Asia has cooled again. West Texas Intermediate crude here in New York down by 5.9% 102 on Wall Street. Time now for the market drivers report with a focus on American depositary receipts, and here's Dave Wilson. Thanks, Charlie 80 yards or lower, though not as much as US shares, the S and P A. D R Index is down 4/10 of a percent. And the S and P 500 lower by 6/10 of a percent. Germany's Volkswagen has dropped 8.6% in U. S trading the 80 yards it serves in the past three days by about 52, a half percent. As the automaker outlined plans for battery powered vehicles. Now VW wants to overtake Tesla as the world's biggest seller of electric vehicles by 2025..
"european medicines agency" Discussed on WNYC 93.9 FM
"I think it was fully avoidable. And it is getting worse. But Connecticut U. S. Senator Chris Murphy says the recent surge and young migrants at the border started last September and not after the Biden administration took office. Wall Street stocks closed mixed as investors await the outcome of the Federal Reserve Board's latest meeting. The Dow Jones industrials fell 127 points. US. Futures are mixed in after hours trading. This is NPR news. Telecommunications giant Nokia says it plans to eliminate up to 10,000 jobs or 10% of its staff within the next two years. It's part of a restructuring effort designed to help the Finnish company Increase investments and five G technology that as well as cloud and digital infrastructure. Nokia says it will also be able to better compete with the drive ALS, including Sweden's Ericsson and China's while way. More countries around the world are suspending AstraZeneca's vaccine based on fears that they cause blood clots. In Brussels, Teri Schultz reports that the European Medicines Agency says it's ongoing investigation has not found any such connection. After a preliminary review of claims AstraZeneca vaccinations have caused blood clots in some recipients. Head of the European Medicines agency Immer Cook says that's not born out by the evidence at this point, but presence there is no indication that vaccination has caused these conditions. They have not come up in mechanical trials, and they're not listed as known or expected side events with this vaccine, Cook says. Final results of what she describes as a rigorous analysis of the data will be available on Thursday and then the agency will see if it needs to act. But in the meantime, she says, the health risks of not having a Corona virus vaccine are more dangerous than the possibility of developing blood clots. For NPR News. I'm Teri Schultz in Brussels. Former President Trump is encouraging his supporters to get vaccinated against Cove in 19 jumps. First public recommendation for the vaccines comes weeks after reports that he and first lady Melania Trump were vaccinated in January..
"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.
"european medicines agency" Discussed on WSJ What's News
"Is the first nation in the west to grant emergency use authorization for a covid nineteen vaccine ahead of the us and the eu clearing a shot jointly developed by pfizer the us and biontech of germany. It's expected to be distributed in limited numbers within days. The decision is of interest far beyond its borders. Let's bring in london based reporter. Jenny strasbourg jenny. Good morning good morning. Thank you mark jennings. Let's break down the news itself. What does authorization by the uk. Government mean and. How does this compare to. It's currently happening in the united states so the uk and it's pretty brexit transition period has taken the power it has to basically say look. We authorize this for emergency use. There's a pandemic we don't need to wait for the eu medicines regulator. We're going to do this ourselves. And we're not gonna wait for the european regulators to decide so this is not going to be the last authorization we're going to hear about. We're likely there's a lot happening in the in the us. With the fda in europe with the european medicines agency that oversees similar authorizations of medicines across europe. They've got hearings public hearings in the us and in europe coming up in december to discuss this and we could see more of these such decisions before the end of the year with that said distribution will begin immediately correct. The uk government is saying this morning that they expect to start putting shots in arms next week and so the uk has prioritised people. You know this is a bit morbid. But it make sense. According to essentially their vulnerability to dying so they've said look people in care homes the people who care for them who also could carry the virus to the folks in care homes. They'll be first and then you've got frontline. Healthcare workers the nhl of the uk. A the people who are caring for people on hospitals and then people over eighty nine groups that the work through. And you know there's only going to be so much vaccine to go around but they are going to move. You can be sure that the uk will move as quickly as possible. Will this decision influence or even perhaps speed up the process in the united states. You know our headline is uk. I right this is the first time. A western nation has granted emergency use. The uk government is saying eight hundred. Thousand shots will start rolling out next week. There's going to be major coverage of people in uk care homes and you know the workers caring for people the most vulnerable getting shots. You can imagine that's going to have an impact on a world devastated by this pandemic but you know in fairness like the regulators in the us and in europe have been moving very quickly. Like i don't want to portray this as like a competition among regulators. I think we need to keep in mind that they're all trying to uphold the standards of safety. Make sure this vaccine is effective. Make sure that manufacturing is up to quality standards and keep in mind. There's different manufacturing happening around the world. It's not a simple thing to make. A messenger are a vaccine. It's actually quite difficult task. And finally jenny. You've covered a lot of this from the start. What are the unknowns. What are the questions that you're still asking. You know how long until vaccines will will bring some greater sense of normalcy to our world and you know this is just the start. I think people need to keep in mind that we're not gonna just immediately stop wearing masks and needing to distance needing to take care of each other. This is just the start of a long process. The you know there are a lot of questions about like how long immunity lasts and how long the impact on the human immune system lasts from a vaccine. I think all of us wanna know the whole herd immunity. Will this help us be able to hug each other. What mean that people can see their loved. Ones can get on planes. Feel a little safer. It's gonna take time and also frankly developing nations and poor countries. I mean this. This is a complicated vaccine to store it. Long periods of time the requires very cold temperatures. You know the hope is that there won't be a division between rich and poor countries and that we can take care of the entire world and not just the was countries w reporter. Jenny strasbourg jenny. Many thanks for your clarity.
"european medicines agency" Discussed on WSJ What's News
"As we told you earlier. Britain is the first nation in the west to grant emergency use authorization for a covid nineteen vaccine ahead of the us and the eu clearing a shot jointly developed by pfizer the us and biontech of germany. It's expected to be distributed in limited numbers within days. The decision is of interest far beyond its borders. Let's bring in london based reporter. Jenny strasbourg jenny. Good morning good morning. Thank you mark jennings. Let's break down the news itself. What does authorization by the uk. Government mean and. How does this compare to. It's currently happening in the united states so the uk and it's pretty brexit transition period has taken the power it has to basically say look. We authorize this for emergency use. There's a pandemic we don't need to wait for the eu medicines regulator. We're going to do this ourselves. And we're not gonna wait for the european regulators to decide so this is not going to be the last authorization we're going to hear about. We're likely there's a lot happening in the in the us. With the fda in europe with the european medicines agency that oversees similar authorizations of medicines across europe. They've got hearings public hearings in the us and in europe coming up in december to discuss this and we could see more of these such decisions before the end of the year with that said distribution will begin immediately correct. The uk government is saying this morning that they expect to start putting shots in arms next week and so the uk has prioritised people. You know this is a bit morbid. But it make sense. According to essentially their vulnerability to dying so they've said look people in care homes the people who care for them who also could carry the virus to the folks in care homes. They'll be first and then you've got frontline. Healthcare workers the nhl of the uk. A the people who are caring for people on hospitals and then people over eighty nine groups that the work through. And you know there's only going to be so much vaccine to go around but they are going to move. You can be sure that the uk will move as quickly as possible. Will this decision influence or even perhaps speed up the process in the united states. You know our headline is uk. I right this is the first time. A western nation has granted emergency use. The uk government is saying eight hundred. Thousand shots will start rolling out next week. There's going to be major coverage of people in uk care homes and you know the workers caring for people the most vulnerable getting shots. You can imagine that's going to have an impact on a world devastated by this pandemic but you know in fairness like the regulators in the us and in europe have been moving very quickly. Like i don't want to portray this as like a competition among regulators. I think we need to keep in mind that they're all trying to uphold the standards of safety. Make sure this vaccine is effective. Make sure that manufacturing is up to quality standards and keep in mind. There's different manufacturing happening around the world. It's not a simple thing to make. A messenger are a vaccine. It's actually quite difficult task. And finally jenny. You've covered a lot of this from the start. What are the unknowns. What are the questions that you're still asking. You know how long until vaccines will will bring some greater sense of normalcy to our world and you know this is just the start. I think people need to keep in mind that we're not gonna just immediately stop wearing masks and needing to distance needing to take care of each other. This is just the start of a long process. The you know there are a lot of questions about like how long immunity lasts and how long the impact on the human immune system lasts from a vaccine. I think all of us wanna know the whole herd immunity. Will this help us be able to hug each other. What mean that people can see their loved. Ones can get on planes. Feel a little safer. It's gonna take time and also frankly developing nations and poor countries. I mean this. This is a complicated vaccine to store it. Long periods of time the requires very cold temperatures. You know the hope is that there won't be a division between rich and poor countries and that we can take care of the entire world and not just the was countries
"european medicines agency" Discussed on AP News
"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 in Tech, 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. 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. That's 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 with an AP News Mint 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 in 19 cases a day. Doctor Laura Foreman is the chief of emergency.
"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" Discussed on Monocle 24: The Briefing
"Yes, we identified eight areas where we've seen pretty significant costs already from this Brexit process, and the point trying to highlight is that no matter web Brexit goes from here, even if Theresa May's deal passes, whether there's a no deal Brexit where the Brexit is overturned. No matter what the have been cost to the economy. And as I had eight errors identified we found the financial industry's been hit the booder economy, the pharmaceutical sex, that's been labor shortages, the media sector housing credits. Britain's states in the world these are all areas where identity we identified negative impacts from Brexit. So if we look at those different sectors just to specify a bit more, for example, the falling migration. A how much has that been hurting the UK? Yes, so net immigration to the UK since the Brexit vote has fallen to its lowest in six years, and that's caused and exacerbates it labor shortages industries like construction host Potala the national health service, which have been pretty reliance on E workers. So this Cleveland been hit there. But that's the way it ends Fido on the skills front looking at banks than before well straight after the referendum. It seemed that many many bugs would be leaving the country. But actually, maybe not. Quite as many have left yet us we expected what's going on in the city of London. For example. The new ones hair is that's assets have new that's what we've seen to my significant degree. So the moving of balance sheet assets to the lights of Frankfurt's to w we've seen hundreds of billions of euros moved out already. As you said, we haven't seen the excessive moving out of bankers themselves as banks had warned, but the has been nevertheless, a steady trickle of bankers moving on. We expect more of that to happen and already thousands have been announced to move. And the expectation is more of that will we'll we'll continue and also the pound has declined to more than ten percent against the euro seen the referendum in two thousand and sixteen was be the cost of that. Exactly. And the impact of that has been simply higher import costs for for UK companies in turn an increase in inflation as well because those costs of pass throughs prices on on the streets and intern is hurts the consumer spending power that people have you know, the pounds. They have in that pockets. Don't go this far in buying goods. So that's been a hitch consumers, but in related leave for the wider economy that has been hit GDP. So Bloomberg economics calculation was shows that the the growth path of the economy has been less than what it would have been had the UK votes to stay in the so at the macro level that's been that impact as well. How big of a hit does the departure of the European Medicines Agency mean for the UK always more of a symbolic significance..
"european medicines agency" Discussed on Remainiacs - the Brexit Podcast
"Disinformation in technology and a German born British resident who like Joni Mitchell has looked at Brexit from both sides now. Hello. Welcome back. The last time you were here was at the end of November since then we've had one aborted meaningful vote one historic defeat for the government a plan B, that's really planning and a hat now. This did it make any more sense of a distance that it doesn't think of it. Absolutely not. In fact, I don't think we've moved one step forward at all since where we were from before December before any of this happened, and the only step that we've taken forward is actually a step towards no deal Brexit. So looking good for direction hours towards definitely towards no deal. Brexit vive. I don't know if it is my base case scenario, but I think given what happened yesterday, it's certainly more likely, and I think it's more likely than what business and markets have factored in. I mean, I think they still think the deal will get across the line. But if the choice, ultimately is some kind of reopening of the withdrawal agreement to remove the backstop, the annot deal Brexit, it's going to be a no deal Brexit, even if that means. Turn to a hard border in Orland which I think will happen on inclined to agree with you, unfortunately. And in fact, I was tweeting today about what my top six stockpiling items would which has possibly responsible, but. Anyway, anyway. Tinned tomatoes. Yeah. Yeah. Well, I mean, it's not that I called without weeks. You want to do that. It's the most practical thing that Tricia nonperishable nutritious. Obviously, you know, if fresh food is in short supply, you're going to be after something that is pretending to be fresh. So that was my logic. Also, great grated cheese in the freezer. This point is already elevates its. We'll come to. We'll come to that. That's all even if you so I'll be introducing later. Also with a cease and doen't editor of politics dot co dot UK. And as is crisis gets worse. No longer remain yak, but to remain insomniac. Hello, ian. How are you guessing anymore sleep like a baby? I have sort of the Shimer's of morality going through me. Do you get the sense that we're heading somewhere? Now. Even if it's somewhat yet to to oblivion we're heading to oblivion this this week was the worst for me this week, probably the worst. I think I've had. Yeah. Probably for the whole process because everything is so much of my, you know, how you always like the human, but of us as everything goes badly Roman one time bad, you won't again, and you just need hope somewhere. Right. So you always find is that any avenue where there could be hope and to me it was constantly and has been for the last year has been parliament during these growing signs of being prepared to take things on. So quite apart from the actual propositions yesterday stuff that coop was putting forward agreed or anything the site of parliament, just just not having the spine that when the moment because what if not now, then when may wins it going to be, you know, it's not like you're gonna time in the world. And then not doing it spooked me quite body that had been my hope place for about twelve months now. And then I could feed it sort of chiseling away. So not the best week. I wanted your drink and. I would been drinking. One of the saddest most dismal events last week was the site of the European Medicines Agency saying goodbye to their London office and lowering the EU Twenty-eight flags that was pretty upsetting was no yard. It was. And you know, I mean, we can go over. What did you like what the waste is? When you when you were studying on a single European patents? A while back. David one of the things that David Cameron did very very sensibly was to try and make sure that the court that was handling pharmaceuticals within the UK part of the reason for that was because.
"european medicines agency" Discussed on Today in Focus
"Polk. Would need Dominican. He's lobbied hard for help from scientists in the World Health Organization. Some scientists were looking at the problem. It was hard to get the interest and the money for a new drug to be developed. But what about drugs that existed for another purpose? Repurpose drug is essentially when you have a drug that had been developed for certain disease certain indication when you take that same drug, but then explore whether it might also work against something totally different. In two thousand and five an NGO called the drugs neglected diseases initiative or DND I were on the case. L Torah is one of the founding members of the organization, and she was leading the work on sleeping sickness. We started out there was this one family, which is called nitroimidazol. It's a very broad family of components that we knew had potential as drug candidates. They needed something safe and effective. So they were given access to mine in Acis of developed unused chemical compounds that have been just sitting in the archives of pharmacies. Cook companies some of them for decades. When a drug is not new because it's already been used for another disease. You cannot patterns the chemical substance that underlies the drug, and so companies are not interested in repurposing because they cannot gets the monopolies based on which they have developed their financial model Elson who team hoped that something in all this data currently useless to companies could prove lifesaving for patients in the Diaz e. We set out in a very very systematic. Literature searched and searched and they say, you know, it's examples of where such mostly online, you have a number of searching for a needle in a haystack was difficult names that I cannot even pronounce and eventually they found affairs contender affects Zoll or fancy fish ought. There was this moment with like ES. We have something in your because there is we were always afraid to find out that drug was discontinued. Because it was stuck sick. For instance, while these data show that no there was no reason they just abandoned to compound, and we never knew exactly why. But certainly not because it was not medically promising. It was initially developed four parasitical infections in the nineteen seventies by German company. Hearst who are now part of Snuffy, but it was never used and certainly never identified as a potential cure for one of Diaz as biggest killers, which according to successful trials in the country. It now. The European Medicines Agency have just officially approved this jug for use and synovium helped with the trial. So why didn't they find a use for before? Well, we would never know the exact answer to done. But what we understood is that in the because that compound had been in early preclinical development late seventies early eighties. If I remember well, and that was at the time that many companies kind of dropped their infectious diseases program side, why did they stop what did they close down their infectious disease research? Well, because I mean those moments it was felt that infectious diseases were much less profitable than the newly emerging chronic disease areas where you had blockbuster drugs that were much more profitable than any infectious disease drug. With an infectious disease, you treat it cure it and people don't need the drug anymore chronic diseases, like cancer, or cardiovascular problems or base ity by their nature. You take the drug for a long time perhaps for the rest of your life. So it was a company you can make more money. And in the late seventies. People thought the medical industry was on top of infectious diseases. Antibiotics really put an end to many infectious diseases in the rich countries certainly in the seventies in the eighties. They were saying they were hailing the end of infectious diseases. They really were they were quite triumphalist about it. They were saying infectious diseases are beaten, this is it where is all over that. Was that was before aides, right? They have taken they were quite badly mistaken. And since then we've had antibody resistance, which means that the antibodies don't work as well as they should do..
"european medicines agency" Discussed on AP News
"Correspondent charlesdale desma says this comes despite concerns about the vaccines wide use the European Medicines Agency says it's a positive opinion, a French pharmaceutical company Sanofi's vaccine, the vaccine is the wills first against Dengi which seconds about ninety six million people annually, but experts worry. About its safety records, so far Sanofi previously warned that people who never been sickened by Dan were at risk of serious diseases after receiving the vaccine, and there has been a lawsuit in the Philippines, alleging that it has been linked to three deaths Charleston with London the California based startup rocket lab. Plans to go small as it reaches into space. It said this week it'll build a launch pad in Virginia at NASA Wallops flight facility, it'll use the pad to send satellites about the size of a loaf of bread into orbit. Rocket lab. Recently built its first launch pad in New Zealand, but it's setting up in Virginia at a time of unprecedented growth in the use of smaller and relatively inexpensive. Satellites the devices circle the earth refu- years before they burn up in the atmosphere. The Atlanta-based consulting firm space works predicted in January that up to twenty six hundred of these will be launched into orbit over the next five years rocket labs. Next commercial mission is scheduled to lift off from New Zealand in November and launches from for. Virginia are set to begin as early as summer twenty nineteen. Pope Francis indicated a willingness to visit North Korea during a private visit with South Korean president moon. Jae-in according to Vatican and South Korean officials and South Korean presidential office said in a statement moon conveyed North Korean leader, Kim Jong UN's desire for a papal visit to North Korea a formal invitation directly from North Korea is expected to follow such a trip would be the first by a pope to officially atheist North Korea. And the Vatican secretary of state says it would need serious preparation and consideration. The president says the Saudi explanation of a journalist death is credible. I'm Jacky Quin with an AP news minute Saudi Arabia's confirmed Washington Post columnist Jamal cash. Go gee was killed at the consulate in Turkey saying that he died in a brawl with a group of agents. Several members of congress are casting doubt on that account. But President Trump says it's early will he impose sanctions on the kingdom had been a great ally. In the Middle East. We need them as a counterbalance to Iran. And so it's not specifically solution. The president is threatening to use the US military to close the border with Mexico. If a thorny is there can't hold back a caravan of Honduran migrants, the department of homeland security says a Russian woman's being charged with meddling online to influence, the midterm elections. And a computer system that interacts with the healthcare dot gov website has been hacked users personal information could be compromised. I'm Jackie Quinn. More news right after this. The. Assume to embrace..
"european medicines agency" Discussed on BBC Radio 4
"Water and baptisms ablutions before praise water purifies and symbolizes God's blessings It said that the prophet one so a man performing ablutions near a river who is using copious amounts he rebuked advised that we should never, wastewater even if we're using it near a, flowing river Bank to encourage equitable distribution of. Water to use it well is to respect all who have a right to it not just those, who live, in our. Neighborhoods but people who struggle thousands of miles away That was thought for the day with Mona Siddiqui it's. Nine, minutes to eight I'll biggest scientific collaborators line not across the channel but in the United States said the government's new chief scientific advisor. Yesterday while at the same time emphasizing the. Importance of maintaining scientific links with the European, Union thanks to amendment to the trade Bill which was passed yesterday? The, government will now be required to seek continued UK participation in the EU system for regulating medicines after Brexit. Well Dr Patrick balance has been the chief. Scientific adviser, just since April before that he. Was head of, research and development at the pharmacy. Giant GSK good morning to balance the morning was the result of that. Particular the vote the one relevant to the. European Medicines Agency a relief to you well I think the promise is actually being clear in the past that linking to the is an important thing the regulatory system, for medicines is obviously important keep medicine safe, and effective for the population and in general It's better to seek, harmonisation of, regulation rather than disarming this enshrines that doesn't it well I think the key thing is. That the UK has been a key part of the AMA for many years and that relationship. Is a way of keeping. A harmonization of medicines and the safety and efficacy, right so I think the industry, and many people have argued for on, time that actually trying to, keep this together is the right thing to do when you. Spoke yesterday you you made a point about how close are. Scientific links are across the Atlantic as well that a scientific collaborators are in the United States I wonder what. You, what the implications of that offer example something like Galileo which the EU has said we can't be a part of after Brexit do..
"european medicines agency" Discussed on Novel Targets
"So you might have heard that we received breakthrough designation. From the FDA and the corresponding prime designation from the European Medicines Agency based on the Stater we are discussing the possibility of filing these data with regulatory agencies, and you know, these discussions are always complex syfy when there's a large trials that were not necessarily designed for registration ever study as well designed trial in that sense that it's one randomized into the primary endpoint was independently controlled with this IRC independent response assessment. And therefore, we're quite quits optimistic about the possible chances of registering these data to my knowledge, these are the best data in randomized trial that anyone has so far. So we were really excited when we saw this. And we're happy to show it to the world right now. It's good to hear that may be potential new treatment options in the relapse refractory setting. I wouldn't be surprised if poetry. Pertained celery to approval in two thousand eighteen. That's it for this episode and the end of seasons. Three funny to our friends at genetic for all your support and two particular to holy Cokie who has been instrumental in making the podcast to reality. The past three seasons authentic to forget. But it's we spoken to have been so generous with a time and insights, this is novel targets bring to life the science around innovative new drugs, gene and cell Therapy's. Its production of blue is publishing. These I could produce research. I'm Pete droplet. Thanks for listening.
"european medicines agency" Discussed on FT Brexit Unspun
"Aww would be happy to relocate to the agency itself is still expecting around a quarter of its staff to leave and if those 25 percent of stuff all disproportionately based in the vaults of the agency that look at the approval and authorisation of medicines than one could anticipate some significant delays in reauthorization to allow those medicines to continue to be sold across europe andrew what's the pierre mazeaud view on this very important that we have a a working relationship with them otherwise remark find their way drugs won't be able to easily be approved for the year carry the drug companies that produce those drugs may produce the for europe and may even not consider getting approval for the uk but also even monitoring after a drug is available we work together with europol not it's vital that we continue that process or the patients continue to get high level of drug and drug monitoring that they have now i guess brexit lee has turned the spotlight on just how integrated the european medicines supply chain is and the ema did highlight this issue in no uncertain terms as far back as may when it issued a document making clear that there would have to be separate arrangements on mainland europe to monitor the safety of medicines and the release of batches of met sons in other words a whole infrastructure that would have to be duplicated in order for medicines to continue to be exported from europe into the uk and vice versa mark the uk has its own national regulatory agency the medicines and health care products regulatory agency how well placed as it to fill the gap left by the ema a spurs the first than says the amid charoi does have a good reputation it carries are actually and outsource proportion of the work for the european medicines agency.
"european medicines agency" Discussed on Remainiacs â€“ the Brexit Podcast
"Could make a case for this absolutely no we've already had is of course with this mysterious guarantee given to nisa shocking that we're not she told what are they being guaranteed and if necessary gets it all the other car manufacturers will will say well you know we're entitled to the save saiman presumably they'll have actually some legal falls in saying that certainly deserves a moral force had saying it we've had this week the announcement that the european medicines agency is leaving britain and the european banking authority is leaving britain because of course as nonmembers of eu we won't be able to host those so a lot of the industries particular pharmaceutical industry is based on the fact that the regulator has been here you have all these sorts of organisations that deal with the approval process and the research process for medicines they are here and therefore lots of the kind of manufacturing other jobs are here because the the agency was say so they'll be saying well we're all off to amsterdam and paris the bankers to if if you don't give as some kind of handouts and you know then that the list just that the you're just running through all the lists of britain's main industries will love the rightwing breaks tuesday one a kind of you know sort of neoliberal freetrade paradise in seattle on ten percent on slashing red tape but it it seems that this possibility that you know if there's an if this sort of enough dimond from from ssa vectis workers and businesses the cure epa going in the other direction west you know west sort of the state is constantly expected to intervene to prop up industries like i it's just seems seats behind in any other way i 10 anxious raconte member as she left today at the paul about nationalization and how many people what firmly behind fat concept i think some of this stuff about the you know basically an economic argument and economics remaining quite abstract people.