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Speaker of the House Nancy Pelosi and Senate Majority Leader Mitch McConnell.Reuters The two most powerful people in Congress — at least for the next two months — renewed their calls for coronavirus stimulus on Friday.A relief deal could prove just as difficult to reach as it did before Election Day.Senate Majority Leader Mitch McConnell, R-Ky., again called for a targeted aid package. In Kentucky, he argued a better than expected October jobs report that saw the U.S. unemployment rate fall to 6.9% reduces the need for a sweeping stimulus bill.- Advertisement – Areas of disagreement between the parties included state and local government aid, enhanced unemployment insurance and liability protections for businesses.Democrats will keep control of the House next Congress, though they will likely lose seats, according to NBC News. Pelosi is expected to serve as speaker for at least one more term.McConnell said earlier this week that he hopes to pass more relief money before the end of the year. How the results of the presidential election will shape President Donald Trump‘s desire to approve a bill during the lame duck session remains to be seen.Though key unresolved states are too close to call in the presidential election, Democrat Joe Biden narrowly leads Trump in Pennsylvania, Georgia, Arizona and Nevada, according to NBC News. Rep. Frank Pallone, D-N.J., appeared with Pelosi on Friday and suggested a Biden presidency would give Democrats more leverage in aid talks.Economists and policymakers, including Federal Reserve Chair Jerome Powell, have warned the economic recovery could lose steam if Congress does not pass more fiscal stimulus. Policies buoying those still unemployed, including supplemental jobless benefits and a federal moratorium on evictions, expired earlier this year.Suspension of federal student loan interest will expire at the end of the year. “I think it reinforces the argument that I’ve been making for the last few months, that something smaller – rather than throwing another $3 trillion at this issue – is more appropriate,” he told reporters, according to Reuters. McConnell noted that he will not necessarily lead the Senate in January: NBC News projects both Republicans and Democrats will hold at least 48 seats, with four races unsettled.Meanwhile, House Speaker Nancy Pelosi called for Republicans to restart aid talks that fell apart before the 2020 election. She told reporters that the “imperative to act could not be greater” after the U.S. posted a record of more than 120,000 new Covid-19 infections on Thursday.Still, she said a narrow bill “doesn’t appeal to me at all.” The chambers of Congress failed to find common ground on relief before the election, as Senate Republicans tried to pass a $500 billion aid bill and House Democrats approved a $2.2 trillion package.- Advertisement – – Advertisement – – Advertisement –
He added: “For all he is eight going on nine, he has not had a hard time of things.“He has run 40 times in his life, which is not a lot for a sprinter of his age, and touch wood he is a very sound horse with no aches and pains. It all contributes to him being in such good form at this stage of his life.” – Advertisement – Judicial returned with a fine effort to finish second in the Palace House Stakes back in June, before adding the Chipchase Stakes at Newcastle on his next start and then also winning the Queensferry Stakes at Chester in August.He has not run since finishing fourth at York in September. But Steve Brown, husband and assistant to Camacho, revealed this weekend’s feature race has been the long-term aim.He said: “Judicial has had a nice preparation for this. The ground at the back-end of the turf season is generally against him, which is why we planned to wait for the Golden Rose.- Advertisement – “I think it looks a stronger race compared to last year, and obviously he will have a penalty to carry for his Group Three win at Newcastle. It will be a tougher test for him, but at the same time we are looking forward to it.“In winning this race last year, he really proved himself over six furlongs, and I think that extra furlong over the last 12 months has really suited him. He has looked a better horse over six furlongs, because he has been able to travel more within himself.”While Judicial is now in his seventh season, Brown feels the fact he has been lightly raced is key to how he is maintaining his form.- Advertisement – Judicial will bid for back-to-back wins in the Betway Golden Rose Stakes at Lingfield.The eight-year-old sprang a 20-1 surprise in the 2019 edition of Saturday’s Listed heat, and trainer Julie Camacho was looking towards All Weather Finals Day with her charge until the April event was cancelled because of the Covid-19 lockdown.- Advertisement –
“Apple Silicon is totally in keeping with the strategic goal of Apple to really control an entire stack,” CCS Insight analyst Wayne Lam said. “Now computing, they own everything from silicon to the software to how the user moves the mouse around, so it’s tremendously integrated.”Controlling its own technologies helps Apple integrate its products more deeply. It also means that it controls its own schedule — chips take 3 years to develop, Apple senior vice president Johny Srouji said last year — and has more control over costs.“Apple thinks they can innovate faster than the standard business model of Intel or Qualcomm doing the development on chips and then they build on top of it,” Lam said.Intel is falling behind in manufacturing. Apple proudly said on Tuesday that the M1 chip in the new Macs uses 5-nanometer transistors.“Five-nanometer is the leading edge of process technology right now and there are only a few products out at this point,” Gartner analyst Jon Erensen said. Currently, Intel is shipping chips with 10-nanometer transistors.In general, the more transistors a chipmaker can fit into the same space, the more efficient the chip is. Currently, Intel ships chips only with 10-nanometer transistors.Intel famously controls its own factories, called “fabs,” around the world, compared to Apple, which contracts with companies in Asia to manufacture chips to its own specifications. But Apple’s chip manufacturing partner, TSMC, can make 5-nanometer chips while Intel can’t.“Intel’s had some challenges over the last couple of years on the manufacturing side. And I think those challenges have opened a window or opportunity for ARM-based designs for come in. Apple is one of the the best ARM-based processor designers out there,” Gartner analyst Jon Erensen said.Earlier this year, Intel CEO Bob Swan said that it was considering outsourcing its manufacturing, like what Apple does.“With the challenges that Intel has had moving to 10-nanometer and 7-nanometer while foundries like TSMC and Samsung have pushed more aggressively, it’s taken one of Intel’s key advantages and leveled the playing field a bit,” Erensen said.More battery life, potentially better performance, and laptops that work like phones. Apple says that the M1 Macs are better products than the older models, mainly because Apple claims its chips enbable better performance and longer battery life than it could achieve using Intel’s chips.It’s clear that the new Macs will have improved battery life. Apple’s previous chips have been used in smartphones and tablets, which have significantly smaller batteries.During Apple’s launch event on Tuesday, the company emphasized how it mainly evaluates chips on performance per watt, not raw performance.On the entry-level MacBook Air, Apple says that it can manage 15 hours of web browsing on one charge, nearly 30% more than the advertised 10 to 11 hour battery life of the previous Intel-based model.The new Macs also work more like phones or tablets, Apple said, with features like the ability to wake up from sleep instantly. The new M1 Macs can even run iPhone apps, if the developer takes a few steps to make them available on Apple’s App Store.However, analysts warn that Apple’s performance claims, like that it is faster than comparable PCs, will need to be tested once the computers hit shelves next week.“Performance of the new M1 chip is nearly impossible to gauge as the company didn’t provide any detailed substantiation around any of the performance claims made,” Moor Insights founder Patrick Moorhead said.Apple did not stop selling Intel laptops on Tuesday, and its highest-end laptops are still Intel-based, suggesting that there are still performance advantages to some Intel chips. Apple is the fourth-largest PC maker measured by shipments, according to a Gartner estimate, so its plan to use its own chips in its entire lineup of laptops and desktops, first announced in June, is a blow for Intel.Apple’s chips are based on ARM technology, as opposed to the x86 architecture that Intel’s chips use. ARM was originally designed for mobile devices, and chips built with ARM designs are consistently more efficient, leading to longer battery life. On a laptop, that could mean several extra hours away from the plug.But that’s only one reason why Apple is switching out the brains of its laptops. Here’s a rundown of why Apple made the move:- Advertisement – Apple announced three new Mac computers on Tuesday: a MacBook Air, a 13-inch MacBook Pro, and a Mac Mini. They essentially look the same as their predecessors.What’s new this time is the chip that runs them. Now they’re powered by Apple’s M1 chip instead of Intel processors. Tuesday’s announcement marks the end of a 15-year run where Intel processors powered Apple’s laptops and desktops, and a big shift for the semiconductor industry.- Advertisement – Apple’s strategy of owning core technologies. Apple CEO Tim Cook has frequently said that the company has a “long-term strategy of owning and controlling the primary technologies behind the products we make.”For a computer hardware company, there are few technologies less essential than the silicon processors that the machines run on.Apple has invested heavily in its silicon department, including major purchases, starting with a $278 million purchase of P. A. Semi in 2008, which started the department, and most recently, $1 billion for part of Intel’s modem business in 2019. It’s been building its own A-series chips for iPhones, iPads, and Apple Watches since 2010. Now it’s essentially bringing the same technology to laptops and desktops, meaning that all Apple computers basically run on the same framework.- Advertisement – – Advertisement –
Cazzie David and Larry David attend the premiere of HBO’s “Curb Your Enthusiasm” at the SVA Theatre in New York on September 27, 2017. Invision/AP/ShutterstockTwo years after Pete Davidson’s whirlwind engagement to Ariana Grande began (and ended), his ex-girlfriend Cazzie David is finally telling her side of the story.The 26-year-old actress and daughter of comedian Larry David was dating Davidson, also 26, for over two years when she hit pause on their relationship in May 2018. According to Cazzie, who detailed their breakup in her book of essays, No One Asked for This, she struggled to convince the Saturday Night Live star that she loved him during their relationship. The author told the Los Angeles Times that she was also scared to give Davidson space because “previously, self-harm and suicide threats had come about from trivial circumstances.”Pete Davidson and Ariana Grande attend the MTV Video Music Awards in New York on August 20, 2018. PA Images/INSTARimages.com- Advertisement – As social media users continued to gush over Davidson and Grande, things got worse for Cazzie, who told the outlet she couldn’t stop picturing her ex and the pop star “immediately falling in love, accompanied by audio of her baby voice whispering sweet nothings in his ear, dubbed over his past declarations of love and trust to me.”Cazzie called the drama a “really pivotal moment” in her life.- Advertisement – – Advertisement – After eventually initiating a “break” with the King of Staten Island star, who has been open about his bipolar diagnosis, past drug use and mental health issues, Cazzie decided she made a mistake. While she called him two days later, he replied that he was “the happiest he had ever been” and ended their romance for good via text. She subsequently learned via Instagram that Davidson was with Grande — and covered up his Cazzie tattoos.According to the L.A. Times, Cazzie “shook uncontrollably” in her dad’s arms “for the entire flight” to her sister’s college graduation at the time. After falling asleep in their hotel room, she woke up “screaming in agony” — and Larry had enough.“CAZZIE, COME ON!” the Curb Your Enthusiasm star told his daughter. “YOUR ANCESTORS SURVIVED THE HOLOCAUST!”- Advertisement – “And writing about it has caused me a ton of anxiety, especially because I talk so much about hating the attention it brought me. Why would I bring more attention to myself by writing about it? But there’s nothing that’s gonna be worse than what I already experienced with that,” she told the L.A. Times.Matt Baron/ShutterstockUs Weekly broke the news in May 2018 that Davidson and Grande were engaged after weeks of dating. They ended their five-month engagement that October. Two years later, Cazzie and Davidson are on good terms. She even thanked him in her book acknowledgments, writing, “Pete. I love you … Your bravery inspires me and your friendship means the world to me.”Listen to Us Weekly’s Hot Hollywood as each week the editors of Us break down the hottest entertainment news stories!
Nintendo Switch sales crossed 735,000 units in the US in the month of October, the company revealed. These numbers shared by NPD include both Nintendo Switch, that launched in 2017, and Nintendo Switch Lite, that launched last year. Nintendo also states that the October 2020 numbers are the second-highest October sales of any video game console in history, following the Wii system that sold 807,000 units in October 2008. These are the strongest sales numbers for Nintendo Switch till date.NPD shared sales numbers for Nintendo Switch and Nintendo Switch Lite for the month of October, revealing that the two consoles combined sold 735,926 units in the US, marking a 136 percent growth when compared to October 2019. Nintendo said that these are the second-highest October sales of any video game console in history with the record currently being held by Wii system that sold 807,000 units in October 2008.- Advertisement – Nintendo Switch has been the best-selling video game console across all consoles for 23 consecutive months – the longest streak since NPD started tracking sales numbers. More than 22.5 million units of Nintendo Switch have been sold in the US alone, according to NPD. Globally, the console has sold 63 million units as per Nintendo’s internal data.Additionally, Nintendo also announced that on Black Friday, customers who purchase Nintendo Switch will get a download code for the digital version of the Mario Kart 8 Deluxe, as well as a three-month individual membership to Nintendo Switch Online. This bundle will be available from November 22 in the US with prices starting at $299.99 (roughly Rs. 22,400).Recently, Nintendo hiked the sales forecast for the Switch to 2.4 crore units by March 2021 as the COVID-19 pandemic boosts consumer spending on home gaming. It reported operating profit between April and September to be JPY 291.4 billion (roughly Rs. 20,800 crores) that was three times last year’s profit in the same period.- Advertisement – Will Xbox Series S, PS5 Digital Edition fail in India? We discussed this on Orbital, our weekly technology podcast, which you can subscribe to via Apple Podcasts, Google Podcasts, or RSS, download the episode, or just hit the play button below. – Advertisement –
A long and intense face-off ended with KSI shoving Logan Paul The fight was a messy affair and Paul had two points docked for fouling KSI. That was a moment of distress that he needed to overcome.“When I got knocked down? People said: ‘This is it!’“I had five minutes to recover but only took one because I needed to put the pressure on Logan. Even when I was drowsy I knew: ‘I’m not losing this’.“That’s my mind-set with everything – boxing, YouTube, music. If I say that I’m going to win, then I’m going to win.”YouTuber boxing has continued.Jake Paul, Logan’s younger brother, defeated Britain’s AnEsonGib and is scheduled to fight former NBA player Nate Robinson this month. 1:02 A long and intense face-off ended with KSI shoving Logan Paul – Advertisement – 1:14 KSI says beating Logan Paul opened doors to success in other aspects of his career Look back at KSI’s split-decision victory over Logan Paul KSI vs Logan Paul appalled and entertained in equal measure – it was an eccentric, baffling whirlwind of teenagers and online influencers colliding in a spectacle that attracted more eyeballs than they could have ever imagined.The fight itself?In 2018 KSI and Paul brawled to a draw in Manchester in an event dubbed “”the biggest internet event in history” – so on November 9, 2019 they removed their headguards, turned professional, and fought a six-round rematch in Los Angeles which Britain’s KSI won via split decision.“Me and Logan had no right to headline a boxing show like that,” KSI now admits.“A lot of old heads and boxing fanatics were angry, annoyed, confused.“Afterwards people saw what it brought to the scene. It brought a younger audience and got people interested.”That much is true.The stakes for their unique fight a year ago were simple – the loser would become a meme for life, constantly reminded of failure whenever they scrolled through their phone. That was the threat.“If you get knocked out, that’s your career done,” KSI now says.His success in the past 12 months proves there were colossal consequences in that YouTuber boxing match.KSI happily gave Sky Sports his memories on the anniversary but Paul, as you may expect, has not acknowledged it.“Do you see Logan talking about anything? He was a ghost. He saw his socials: ‘You lost, you lost, you lost’.“That sucks.“In the back of your mind it must eat away. No-one wants to lose. Not a lot of people want to be in that situation.”So at what point is it fair to commend these YouTuber boxers for putting on the line the thing that value most? For risking that which they hold dearest? KSI believes that there will be more YouTuber boxing – Advertisement – 0:45 0:33 The trainers clashed at KSI vs Logan Paul press conference! 0:52 Watch KSI’s ring walk ahead of his rematch against Logan Paul Watch KSI’s ring walk ahead of his rematch against Logan Paul – Advertisement – KSI says beating Logan Paul opened doors to success in other aspects of his career The year since has been spent by KSI in a music studio. He has nimbly readjusted to the next phase of a career which started by playing the FIFA video game and streaming it to YouTube, a platform where he currently has 22 million subscribers.“I knew how important it was,” he reflects on the fight.“My legacy was on the line.“If I lost I wouldn’t be able to make a tune with Rick Ross! It wouldn’t have the same feel.“I wouldn’t be as big as I am in music.“Me winning that fight is the reason why so many eyes are now drawn to my music.”KSI has released ‘Really Love’, a song alongside Craig David, and his second album is out next year.“It’s upping my value when it comes to a boxing fight,” he smiles.This was always the plan but would Craig David have looked twice if KSI emerged with a 0-1 boxing record?“I really don’t let things get to me,” KSI said. “Because if I do, I would freak out and panic.“‘I’m fighting in front of millions with everything on the line?’“My head would implode!“I kept everything calm and collected. This was another step in my career that I needed to do to get to the next step.“I knew how big it was. I knew it was humongous. But it never got to me, man.“I never look at social media, newspapers or anything to do with the fight. I focused on training – until the pressure got to me, and I started swinging!” KSI believes that there will be more YouTuber boxing 0:55 KSI on the mooted fight with Jake Paul 1:08 Look back at KSI’s split-decision victory over Logan Paul KSI on the mooted fight with Jake Paul KSI vs Jake Paul is the natural route to go.“We will see more but it’s about finding the right fights,” KSI said. “You need fights where people are invested.“Me and Jake Paul? There is a narrative. I beat his brother, he beat my brother. It is huge. People would love to see it.“It is the finale of fights in terms of YouTuber boxing.”But to entice KSI is now a heftier task than it was a year ago. He added: “Of course I would do it again. I’m waiting for the right contract.“When I was in the Mayweather camp I spoke to people there. I understand how valuable I am, how in demand I am.“Fight Jake Paul for less money than I got for fighting Logan? Why would I do that?”Interestingly Viddal Riley, the 4-0 cruiserweight prospect who acted as KSI’s trainer for the Paul fight, has distanced himself from returning to the YouTuber boxing scene.Riley told Sky Sports: “It needs to stop. It’s gone too far now.“The only fight that makes sense is Jake and KSI. Once that happens, end it on a high note before YouTuber boxing gets a bad name.”KSI’s response?“Once the right money is made, I’ll talk to Viddal and he will come around,” he smiled.So will the rest of us.Watch an exclusive interview with KSI on the Sky Sports Boxing YouTube page. – Advertisement – The enormity of what was on the line between KSI and Logan Paul in YouTuber boxing’s most outrageous moment may only be truly clear a year later.The winner KSI (Knowledge, Strength, Integrity) had his net worth valued at £12 million on The Sunday Times’ Rich List in May 2020 but, since then, has released his debut studio album and, more recently still, a single with Craig David. Yes, really.“I knew that if I won it would open a lot of doors. And it did,” KSI frankly tells Sky Sports one year after beating Paul – but the lure of the boxing ring is proving addictive to him. The trainers clashed at KSI vs Logan Paul press conference!
– Advertisement – Highlights of the Nations League Group A3 match between Switzerland and Spain Sergio Ramos had two penalties saved in his 177th game for Spain – the record for most international caps by a European player – before a late goal by Gerard Moreno earned a 1-1 draw with Switzerland in the Nations League on Saturday.Ramos had scored all of his previous 25 penalties but was thwarted when Yann Sommer guessed the right way and repelled his spot kick in the 58th minute to preserve his side’s lead.- Advertisement – The Spain captain, who overtook Italy goalkeeper Gianluigi Buffon’s record for the most international caps by a European player (176), won the first penalty when his header hit Ricardo Rodriguez on the back of the arm, but he failed to capitalise on the advantage.Switzerland had gone ahead in the 23rd minute through Remo Freuler and could have doubled their lead in the second half but Ramos came to his side’s rescue with a goal-line clearance.Spain then earned a second penalty in the 79th minute which led to Swiss defender Nico Elvedi being sent off. However, Ramos was again outwitted by Sommer, who could not be fooled by the defender’s poorly-taken Panenka penalty and easily caught the ball. 3:24 Highlights of the Nations League Group A4 match between Germany and Ukraine 1:35 Highlights of the Nations League Group A3 match between Portugal and France 2:41 Watch Sergio Ramos miss two penalties as Spain dropped points against Switzerland in their Nations League group A4 game France should have been ahead by half-time but Anthony Martial missed three chances, two saved by Rui Patricio and one hitting the crossbar. Jose Fonte hit the post as Portugal pressed for an equaliser in the second half.Timo Werner scored each side of the break to aid Germany’s comeback with a 3-1 win over Ukraine as they topped the Group A4 with a game left to play.The Germans got off to a strong start but had to come from behind after Roman Yaremchuk scored against the run of play to give Ukraine a surprise 12th minute lead.Leon Goretzka set up the next two goals, first launching a quick break and sending Leroy Sane through for the equaliser in the 23rd minute and then controlling a Robin Koch cross and lofting the ball for Werner to head the hosts in front 10 minutes later. 4:34 The decision paid off quickly as the Juventus player had a stinging shot saved and created another chance for winger Emil Forsberg. He gave his side the lead when he held off Mateo Kovacic to side-foot home his first goal for his country in the 36th minute.Danielson made it two in first-half stoppage time, swooping in at the near post to send Sebastian Larsson’s corner flying into the net with a glancing header to cap Sweden’s best 45 minutes of the competition so far.They continued to dominate in the second half but Croatia muscled their way back into the game and pulled a goal back when an Ivan Perisic header deflected off Danielson and into the net.In Nations League C1, Cyprus recorded a first win of the campaign after coming from behind to pull off a shock 2-1 victory over Luxembourg, who finished with 10 men in Nicosia. Montenegro’s goalless draw in Azerbaijan, where they also had a player sent off, was enough to edge them top of the table.Nations League D1 leaders Faroe Islands extended their unbeaten run with a 1-1 draw against Latvia in Riga. Malta came from behind to beat Andorra 3-1 and sit second on eight points, with a game against the leaders next on November 17.Saturday’s only D2 fixture saw leaders Gibraltar held to a goalless draw in San Marino, who played most of the second half with 10 men. Substitute Moreno saved Ramos’ blushes in the 89th minute, finally beating Sommer by lashing home a cross from Sergio Reguilon.Germany lead Group A4 with nine points, while Spain are second with eight and must win Tuesday’s showdown at home to Joachim Loew’s side in order to progress to the final four. Switzerland stay in last place and can avoid relegation to the Nations League League B by beating Ukraine on Tuesday.France handed defending Nations League champions Portugal a rare defeat, winning 1-0 in Lisbon with N’Golo Kante’s second-half strike enough to reach the competition’s final four at the expense of the holders.Kante scored only his second France goal in the 54th minute to leave them top of League A Group 3 with 13 points from five games, three ahead of Portugal and with the better head-to-head record to give themselves an unassailable lead. – Advertisement – Ukraine almost equalised in the 53rd when Oleksandr Zinchenko’s deflected shot beat goalkeeper Manuel Neuer but bounced off the post.Werner fired in his second goal of the evening in the 64th before Ukraine hit the woodwork twice more in a strong finish.Goals from Dejan Kulusevski and Marcus Danielson snapped Sweden’s four-game losing streak in the Nations League as they beat Croatia 2-1 in Stockholm.Needing a win to avoid relegation from Group A3, the victory keeps Sweden’s survival hopes alive as they head into their final group game against France in Paris on Wednesday, despite still being bottom of the group.Sweden boss Janne Andersson had to watch the game from home following a positive test for COVID-19 and 20-year-old forward Kulusevski was chosen to start up front with Marcus Berg. – Advertisement –
Within weeks, the Food and Drug Administration is expected to review safety and efficacy data for what may be the first Covid-19 vaccine in the United States, with hopes of immunizing some Americans soon after.But about a half-dozen states and the District of Columbia have planned an extra layer of scrutiny: committees that would vet any vaccine reviewed by the F.D.A., a step many public health experts and officials deem unnecessary given a federal review process they describe as meticulous.- Advertisement – Throughout the pandemic, Mr. Trump and his administration have been criticized for putting pressure on federal health agencies — including the F.D.A. and the C.D.C. — to ease restrictions and speed approvals for vaccines and unproven treatments, such as hydroxychloroquine.The White House initially opposed F.D.A. guidelines that called for gathering comprehensive safety data before the agency would issue an emergency authorization for a vaccine. (The guidelines would have made it nearly impossible to have one approved before the election.) Then, in early October, the administration relented.Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the F.D.A.’s transparency and guidelines helped assuage the fears of many public health experts who felt “the White House was putting their thumb on the scale in a very big way.”Now, he said, he was “absolutely confident in the F.D.A. process” and thought the state review committees were “absolutely unnecessary.” This past week, he was named to Mr. Biden’s coronavirus task force. The committees — most of them in states led by Democratic governors — are in part a response to the Trump administration’s handling of the pandemic and concerns that political considerations would influence vaccine approvals.“The people of this country don’t trust this federal government with this vaccine process,” Gov. Andrew Cuomo of New York said in September when announcing his state’s vaccine committee, led by a Nobel-winning virologist. State officials said they did not believe they would slow any vaccinations. They hoped to examine clinical trial data once it became available, conducting their reviews alongside the federal government.It may not even be possible for states to hold up a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former F.D.A. lawyers said that states would not be able to thwart distribution during a pandemic.Besides New York, officials in California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines offered for F.D.A. approval. Governors in Nevada, Oregon and Washington have joined California’s effort, with each state adding a representative to the panel.Safety and efficacy data will also be examined by two independent federal advisory committees of medical experts. One panel counsels the F.D.A.; the other offers recommendations to the Centers for Disease Control and Prevention, which sets guidelines and priorities on who should get a vaccine.“It’s an incredibly rigorous and intense process that is evidence- and science-based,” said Dr. Julie Morita, who has served on the C.D.C.’s advisory committee and is an executive vice president at the Robert Wood Johnson Foundation, a public health philanthropy.Dr. Morita said she thought the state committees would ultimately come to the same conclusions as the federal government, but worried about a lack of consistent messaging.“The last thing we need right now is any kind of miscommunication about what the recommendations are,” she said. “The more aligned everybody is, the better for the public.” Dr. Morita is now serving on President-elect Joseph R. Biden Jr.’s Covid-19 task force. The reviews are intended to help persuade a hesitant public to get shots once they are approved, several state officials said in interviews. Recent polls show that between a third and half of Americans would be reluctant to get a coronavirus vaccine.- Advertisement – State officials have said Mr. Trump’s loss in the election will not alter their plans for reviews. Indeed, the first F.D.A. authorizations may fall under Mr. Trump’s watch. Pfizer announced last week that its vaccine, developed with the German company BioNTech, appeared more than 90 percent effective in early data from clinical trials, and Moderna’s vaccine is close behind in the development process.Trust IssuesThe tension between states and the federal government illustrates a heightened politicalization of vaccines and their approvals, a process that is routinely accepted by physicians and public health departments across the country.“This has become a somewhat political conversation,” Dr. Mark Ghaly, California’s health secretary, acknowledged in an interview. He said the state’s review was intended “to give Californians additional confidence and trust in the system.”The state committee, named in October, is still deciding on a process, but it plans to assess some of the same data used by the federal advisory committees, according to Dr. Arthur Reingold, the group’s chairman.Dr. Reingold, head of epidemiology at the University of California, Berkeley School of Public Health, served on the C.D.C.’s advisory committee less than two years ago and said he had the “greatest respect” for it.“We have an unusual set of circumstances, and we are trying to respond to those circumstances,” Dr. Reingold said. “At the end of the day, these vaccines will not help us if people do not accept them.” Dr. Reingold said he thought the group would complete its review swiftly, given the experience of its members, some of whom also serve on the C.D.C.’s advisory committee. Pfizer has said it plans to ask the F.D.A. for emergency authorization this month. The application would include two months of follow-up safety data from “Phase 3” trials. Phase 3 marks one of the last steps in the development process, when tens of thousands of volunteers get a vaccine and wait to see if they become infected, compared with others who received a placebo.Those trials are large enough to reveal some rarer side effects or more severe problems that may not have surfaced earlier. By September, Pfizer’s trial had 44,000 participants, and no serious safety concerns have been reported.Once the F.D.A. receives an application for emergency use, it begins a review of the data and sends a summary of the information to its advisory committee, which eventually makes a recommendation to the agency.If the F.D.A. authorizes the vaccine, the C.D.C. advisory group meets to decide how the vaccines should be used and allocated.In interviews, members of several states acknowledged the committees’ expertise, insisting that their own assessments would not be duplicative.Officials in West Virginia and the District of Columbia said their aim was to communicate the safety and effectiveness of a vaccine to the public, not necessarily to approve or deny its use.“We recognize that those institutions have expertise and assets that we don’t have. It’s not to replicate that process,” said Dr. Deidre Gifford, Connecticut’s top public health official and co-chair of its vaccine committee. Dr. Gifford said her group — made up of a dozen doctors and health experts appointed by the governor — would examine the approval process to confirm that it has been typical, or as typical as it could be during a pandemic. “We want shots in arms within 24 hours,” Mr. Mango said at a news briefing last month for Operation Warp Speed, the federal effort to secure a vaccine. “Any delay that the state wants to impose will be a delay in getting its citizens — its most vulnerable citizens — vaccines. We think it is actually counterproductive for them to talk about this.” – Advertisement – But some health officials and experts worry that the state reviews could instead create inconsistency and sow doubt about a crucial tool in stopping the global contagion.Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services, said state leaders were undermining the expertise of the F.D.A., which he called the “most rigorous organization in the world.” In an effort to address state officials’ concerns, the F.D.A. said last week that it would offer briefings on its vetting process and the basis for any decision to authorize a vaccine.Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, which reviews vaccines, said he wanted the process to be transparent and welcomed questions from state officials. He also said he had felt “buffered” by the F.D.A. commissioner, Dr. Stephen Hahn, from any White House interference. He added that F.D.A. physicians and researchers who assessed vaccines were “civil servants” and “not political appointees.” Similarly, in New York, the state committee would work as quickly as possible, said Gareth Rhodes, a member of Mr. Cuomo’s coronavirus task force and special counsel at the Department of Financial Services.The group will gather “whatever information they need to confidently make a recommendation to the Department of Health,” Mr. Rhodes said. That would include reviewing data made public through the C.D.C. and F.D.A. advisory groups, as well as getting information directly from vaccine makers.Mr. Cuomo, speaking with CNN on Friday, said the goal was “to give people confidence,” adding, “As soon as the F.D.A. approves it, we will have our panel approve it.”In an interview with The New York Times, Mr. Cuomo said if his state panel expressed confidence in the vaccine, he would be the first New York resident to receive it and his adult children would be vaccinated on television to reassure the public it was safe.Earlier that day, Mr. Trump attacked New York’s planned review, claiming that the state would not receive vaccines when they are first rolled out across the country.A Rigorous ProcessHealth experts who had been involved in recommending other vaccines said there was little reason for the public to doubt the approval process, which takes into account comprehensive clinical trials conducted by universities and other independent bodies. One of the main goals is to “reassure the public and the governor that it was free of political interference,” she said.Dr. Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr. Biden’s coronavirus team, described the state reviews as “a symbol of the utter breakdown in trust in the process,” and said he did not think they would reveal anything the federal reviews did not.“From a practical standpoint, it’s probably not going to be that important,” he said. “From a trust standpoint, it may be helpful.”Sheila Kaplan contributed reporting. – Advertisement –
Mar 18, 2008 (CIDRAP News) – The United Nations Food and Agriculture Organization (FAO) today warned that H5N1 avian influenza levels in Indonesia’s poultry are so high that conditions may be ripe for the type of viral mutation that could spark an influenza pandemic.”I am deeply concerned that the high level of virus circulation in birds in the country could create conditions for the virus to mutate and to finally cause a human influenza pandemic,” said Joseph Domenech, the FAO’s chief veterinary officer, in a press release today.Also, new H5N1 virus strains have recently emerged in Indonesia that might limit the effectiveness of the poultry vaccines used there, Domenech said.He said that Indonesia has the world’s highest H5N1 mortality rate and that human cases will keep rising unless the country and its international partners do more to stamp out the virus in birds.The FAO said the disease has hit 31 of 33 provinces in Indonesia and is endemic in Java, Sumatra, Bali, and southern Sulawesi islands. About 20% of the country’s 1.4 billion chickens are spread among 30 million backyard flocks, putting them in close contact with people.Despite “major control efforts,” Indonesia has failed to contain the spread of the virus in poultry, Domenech said. “Indonesia is facing an uphill battle against a virus that is difficult to contain,” he said. “Major human and financial resources, stronger political commitment and strengthened coordination between central, province, and district authorities are required to improve surveillance and control measures.”Problems controlling the virus in Indonesia stem from a highly decentralized administration, poorly resourced national veterinary services, little collaboration with commercial poultry producers, and insufficient national and international financial and human resources, the FAO said. International donors have contributed $25 million to the effort so far, the agency reported.The emergence of the new H5N1 virus strains and the possible lapse in vaccine protection are under investigation by Indonesia’s agriculture ministry, with technical assistance from the FAO and World Organization for Animal Health (OIE) and financial assistance from the United States and Australia, the FAO said.”Also required are more investigations and the development of better poultry vaccines,” Domenech said.The FAO said it has helped train 1,350 “participatory disease surveillance and response teams” that are working to control avian flu in 193 of Indonesia’s 448 districts. By June, more than 2,000 response teams will be working in over 300 districts, the agency said.In other developments, agriculture officials in China recently informed Hong Kong’s Food and Health Bureau that the H5N1 virus struck birds in a poultry market in the city of Guangzhou, in southern China’s Guangdong province, according to an Associated Press (AP) report yesterday. Hong Kong officials said the outbreak is China’s fifth of the year, the report said.The outbreak at the Guangzhou market killed 114 birds, and 518 others were culled to control the disease, the AP reported.Elsewhere, veterinary officials in Vietnam announced on Mar 16 an outbreak in ducks in yet another province, Quang Nam in the central part of the country, according to a Mar 17 report by Thanh Nien News, a Vietnamese news service. The H5N1 virus struck 300 birds, and the remaining ducks, along with poultry on nearby farms, were culled.See also:Mar 18 FAO statement