President Trump won a series of key battlegrounds early on Wednesday morning, including Florida, Ohio and Iowa, as Joseph R. Biden Jr. expressed confidence he would ultimately prevail across key Northern states and Arizona as the presidential contest turned into a state-by-state slog that could drag deeper into the week.“We believe we are on track to win this election,” Mr. Biden said in a brief speech after 12:30 a.m. Eastern, saying he was “optimistic” about the outcome once all the votes were counted. – Advertisement – No full states had yet flipped from their 2016 results as of 1 a.m., but several key states had huge portions of ballots still to be counted. Mr. Biden did flip a single Electoral College vote that Mr. Trump had won in 2016, carrying Nebraska’s 2nd Congressional District, which includes Omaha. With millions of legitimate votes still waiting to be counted, Mr. Trump prematurely and recklessly declared that he won the election. Appearing at the White House, he pressed for more vote counting in Arizona, where he is behind, and called to stop the count where he is ahead as he baselessly declared the election “a fraud on the American public.” In an unprecedented move that drew bipartisan condemnation, the president said he intended to go to the Supreme Court to intervene to halt the legitimate counting of the vote.- Advertisement – “We’re going to win this,” Mr. Biden said, urging “patience.”Mr. Biden’s win in Nebraska’s 2nd District was only one of the 270 Electoral College votes that he needs. But it could prove important. It opened a potential pathway to the White House without winning Pennsylvania, if Mr. Biden carried all the states that Mrs. Clinton did and added Michigan, Arizona and Wisconsin, plus Nebraska’s lone vote.In a briefing for donors on Tuesday night, Biden campaign officials acknowledged underperforming among Cuban-Americans in the Miami area, but saw positive signs with their strength in some suburbs in Ohio that they said could be predictive across the Midwest, according to two people familiar with the matter.Campaign officials signaled that Biden’s team was preparing to wait for votes to be counted in three Northern battlegrounds that Mr. Trump carried in 2016 — Pennsylvania, Michigan and Wisconsin — where it still feels bullish.North Carolina and Arizona could still be called relatively quickly. But vote-counting in the so-called former “blue wall” that Mr. Trump flipped in 2016 — Michigan, Wisconsin and Pennsylvania — is not expected to be completed until later in the week. The most encouraging sign on the map for Mr. Biden was in Arizona, where he was leading in a state that Mr. Trump won in 2016. He won New Hampshire and Minnesota, two states that Hillary Clinton had only narrowly carried four years ago and that Mr. Trump had once hoped to flip in 2020. – Advertisement – So far, Mr. Trump was holding off Mr. Biden in two Southern states that the former vice president had hoped to snatch back from the Republican column: Georgia and North Carolina. These were not must-win states for Mr. Biden, but he spent heavily in both states and visited them in the final stretch of the campaign. Mr. Biden lost Texas, a long-shot hope that some Democrats invested in late in hopes of earning a landslide repudiation of Mr. Trump that did not arrive. Georgia has not gone Democratic since 1992. But while Mr. Trump held a narrow lead, much of the remaining vote to be counted appeared to be in the greater Atlanta area, where Mr. Biden performed strongest.Shortly after Mr. Biden spoke, Mr. Trump responded on Twitter, misleadingly saying he was “up big” and claiming without evidence that “they are trying to STEAL the election.” Twitter immediately marked it as content that was “disputed and might be misleading.” – Advertisement –
This is breaking news. Please check back here for updates. First-time claims for unemployment insurance continued a modest trend down last week, though the total remains well above what was considered normal prior to the coronavirus pandemic and was a touch higher than Wall Street estimates.The Labor Department reported Thursday that 751,000 U.S. workers filed for benefits, compared to 758,000 from the week before. Economists surveyed by Dow Jones had been expecting 741,000. This was the third straight week that claims were below 800,000, and the four-week moving average fell to 787,000.- Advertisement – – Advertisement – At the same time, the total for those receiving benefits showed a sharp decline, falling by 1.15 million to 21.5 million. For the same period in 2019, there were 1.44 million people getting benefits, reflecting just how deep the jobless problem remains in the coronavirus pandemic era.The insured unemployment rate, which is a simple computation of those receiving benefits against the total workforce, fell 0.3 percentage points to 5%. The headline unemployment rate, which includes multiple other factors, is expected to edge lower to 7.7% from the 7.9% level in September.Illinois saw the biggest weekly increase in claims, climbing 23,200 to 53,138, according to unadjusted data. Kansas, Kentucky, Ohio and Pennsylvania all reported gains of more than 3,000. Massachusetts reported the biggest decline at 9,055 while Florida, Georgia and Michigan also reported substantial decreases.- Advertisement – The numbers come a day before the government’s official nonfarm payrolls report, which is expected to show a gain of 530,000 in October. However, this week’s report is not part of the survey week the Bureau of Labor Statistics uses to compute the monthly number.Claims have been trending lower since the late-March peak of 6.9 million but remain elevated by historical standards. The pre-pandemic peak was 695,000 in October 1982.Continuing claims fell for the sixth straight week, this time by 538,000 to nearly 7.3 million. However, part of the reason for that was the continued migration from those losing benefits into the Pandemic Emergency Unemployment Assistance program, which saw its rolls increase by 277,564 to 3.96 million. Continuing claims are delayed by a week.- Advertisement –
– Advertisement – “The resort bubble would let guests leave their rooms and enjoy on-site amenities while completing the mandatory quarantine while wearing GPS-monitored bracelets,” he said, noting that should Hawaii reinstate the mandatory quarantine for all travelers, these bubbles would make it possible for the resort to remain operational for inter-island travel and for locals.The staff at Timbers is made up of locals and their safety is essential, Mr. Moore said.“Our employees go home, many have large families and they are with parents and grandparents and children, and keeping them safe is essential to everyone’s well-being,” he said.- Advertisement – “What the data suggests so far is that here in Hawaii, testing has been the key to safely reopening,” he said. “We now understand the data and the importance of testing. Testing provides a high level of protection for visitors, staff and residents.”The hotel used to have an in-person welcoming process that included staff members putting leis on guests as they arrived and checking them in with a cocktail in hand. Now, a key is waiting for guests when they arrive, and capacity is capped at 60 percent. Each of the hotel’s 72 suites has its own heating, ventilation and air conditioning system.Gary Moore, managing director at Timbers Kauai at Hokuala, said that the reopening has been “anything but clear,” but what is clear is: “We have to find a way to live with the disease.” Mr. Moore said that despite various challenges, the lessons learned at his property about distancing people, mask enforcement, temperature checking and even separating guests and putting them in “bubbles,” could be applied at other resorts.- Advertisement –
Mr. McMillan added that he believes that “in some markets, especially for international travel, until a vaccine is more widely available, testing will become part of the norm.”For Jonathan McManus, the owner of Hotel Wailea Relais & Chateaux in Maui, testing presents a way to reopen safely after months of carrying an empty property. He says it will let him keep employees in jobs.- Advertisement –
Jamie Vardy scored one penalty and missed another as Leicester went top of the Premier League with a 1-0 win over Wolves at the King Power Stadium.Vardy converted from the spot following a contentious call that Max Kilman had handled Dennis Praet’s cross, which referee Anthony Taylor only awarded after checking the VAR review monitor.- Advertisement – How Leicester kept up fine form to go topEyebrows may have been raised when Wolves boss Nuno Espirito Santo claimed Wolves were not in ‘great form’ despite a run of 10 points from four games – but his side did not look like a team with the wind in their sails at the King Power Stadium.They remained resolute defensively up until Kilman was harshly ruled to have handled Praet’s cross when Taylor checked the VAR monitor, allowing Vardy to smash the ball beyond Patricio from 12 yards. But the visitors did struggle to hold onto possession and saw barely five per cent of the ball in the Leicester third before the break. Player ratingsLeicester: Schmeichel (7), Fofana (8), Evans (7), Fuchs (7), Justin (7), Mendy (6), Tielemans (7), Thomas (5), Praet (7), Maddison (7), Vardy (7).- Advertisement – Subs: Albrighton (6), Barnes (6), Morgan (n/a).Wolves: Patricio (7), Kilman (6), Coady (6), Boly (6), Semedo (6), Dendoncker (5), Neves (6), Ait-Nouri (5), Podence (6), Jimenez (6), Neto (6).Subs: Traore (6), Marcal (6), Silva (6).- Advertisement – Man of the match: Wesley Fofana. 3:35 
A more clear-cut decision gave Vardy the chance to double Leicester’s lead before half-time against an out-of-sorts Wolves when Rayan Ait-Nouri wiped out James Justin, but Rui Patricio guessed right to keep out his poor spot kick and keep the visitors in contention before half-time.Their second-half performance showed more attacking threat with Pedro Neto and Ruben Neves testing Kasper Schmeichel, but the Foxes, who could have secured victory late on through Harvey Barnes, saw out the game to go top of the Premier League, at least until Liverpool took on Manchester City on Super Sunday. Leicester City boss Brendan Rodgers says he’s very proud of his team after their 1-0 win over Wolves saw the Foxes reach the top of the Premier League table. The visitors’ habit of second-half revivals was again realised following a Santo team talk, but not before Youri Tielemans had nodded a presentable chance wide within a minute of the restart, and Vardy had seen a dipping effort from wide palmed over.Leicester then needed a superb sliding block from Wesley Fofana to deny Daniel Podence a chance to tap home an equaliser when Nelson Semedo found space on the wing, before Neto powered an effort straight at Kasper Schmeichel, who did well to hold onto it.Wolves still struggled to create clear chances until Leander Dendoncker volleyed just wide from Marcal’s raking pass, before Neves – searching for his first league goal in more than a year – was kept out by a superb Schmeichel stop.Still Leicester carried a threat and nearly sealed three points when substitute Harvey Barnes’ goalbound effort was deflected over by Kilman’s vital block, and despite some late pressure from Wolves, the hosts’ hopes of going top were never seriously threatened.What the managers said… Leicester boss Brendan Rodgers: “I think it’s the best win of the three this week. With so many players out and such a tough schedule, it was an incredible performance. We had to show a different side to the team today. I thought first half we were very good in our football, some of the quality of combinations, how we got through Wolves and into dangerous areas was very good, and we should have been maybe more than 1-0 up.On going top: “It’s been an incredible start, I’m so happy for the players. It’s important in any season your first steps are positives, and with all players available it would’ve been really good, but for the players we’ve had out for the guys to show that quality and resilience, it’s what you want as a manager.” Wolves’ boss Nuno Espirito Santo wants VAR to be more consistent with decisions after Max Kilman’s handball gave Leicester a penalty that turned out to be the winner. Wolves manager Nuno Espirito Santo: “Leicester started better than us, that led to the situation of the penalties. As the game went by we improved, the second half we were much, much better. We caused situations, produced situations requiring better finishing.“I haven’t seen the images of the penalty. It’s very hard to judge the work of the referees, VAR saw it, Anthony saw it on the screen, but inside it’s difficult to coach a player and tell him he must put his arms away that will create unbalance. It’s very hard, what we want from situations is good and fair decisions.“Week in, week out we see different things. Until they get it right, we’ll be talking about it over and over again, something we don’t want. We have enough problems in football to be suspicious about anything, I don’t want to think about that.”Man of the match – Wesley FofanaBrendan Rodgers made clear he needed defensive reinforcements in the summer and in the shape of Wesley Fofana, it looks like he’s got them.It’s still early days for the 19-year-old, but he looks mature beyond his years at the heart of Leicester’s back three, and with three tackles, two interceptions – a Leicester high – and as many passes in the opposition half as wing-back James Justin across the 90 minutes, showed exactly what Rodgers wants.“Today again he showed he’s strong, aggressive, and has that class on the ball,” he told his post-match press conference. “He made one recovery challenge which was unbelievable. He’s a big talent, we’re delighted with him, he’s loved his start here. He’s been very good.”Opta factsLeicester have won 18 points in their opening eight Premier League games (W6 L2), their best ever start to a top-flight season and best start to a season since winning 19 points in their first eight games in 2008/09 in League One.Wolves have won none of their four away Premier League matches against Leicester (D2 L2), failing to score in every match.Leicester have won their last six matches in all competitions, scoring 15 goals and conceding just twice.Leicester’s Jamie Vardy has scored 23 of the 28 penalties he has taken in the Premier League (82%) and has scored more penalties than any other player since the start of the 2014/15 season.Leicester City have scored seven penalties in the Premier League this season, four more than any other side. The Foxes have been awarded eight so far in 2020/21, the earliest in a campaign a team has ever been awarded as many as eight penalties; the previous earliest was Man Utd last season (16th game).What’s next?Leicester travel to Liverpool after the international break on November 21; Kick-off at 3pm. If they win at Anfield, they will be guaranteed to end the weekend top of the Premier League.Wolves’ next game, at the same time, is at home to Southampton. 2:32 Even so, for all the Foxes’ territory, their only two shots on target before half-time both came from the spot, with Ait-Nouri’s ill-judged lunge on Justin after a poor touch from the Wolves defender giving Vardy the chance to step up from 12 yards again. This time, he went the other way, with Patricio guessing right to keep out a poor spot kick.Wolves were stung into life by that reprieve for the final six minutes of the first period, albeit without testing Kasper Schmeichel, and left Leicester – who looked likely to enjoy a two-goal cushion only minutes earlier – relieved to hear the half-time whistle. 
– Advertisement – Team newsLeicester welcomed back Jonny Evans from injury, with James Maddison also returning.Wolves were unchanged after picking up 10 points from their previous four games. 
Image:Rui Patricio saved Vardy’s second penalty
The TV ad market is on the mend after getting hit by a broader pandemic ad slowdown. But with Covid-19 cases on the rise, some networks are cautious about the coming quarters, even with a big boost from political ads this quarter. In recent days and weeks, media companies including ABC and ESPN parent Disney, Fox, AMC Networks, NBCUniversal parent Comcast, WarnerMedia parent AT&T, ViacomCBS, and Discovery reported earnings that showed the TV ad market warming up after hitting a pandemic-related trough in the second quarter. The record-breaking year for political advertising will give companies a boost in the fourth quarter, some companies warned that macroeconomic factors as the pandemic rages on could impact ad spend again. And it’s all happening as TV is enduring a long-term overall slowdown. – Advertisement – David ZaslavAnjali Sundaram | CNBC “In terms of commercial success, behind the firming advertising marketplace around the globe, we have posted healthy sequential improvement, again, in our advertising revenue growth, which, while still negative year-over-year, is showing demonstrable improvement around the world,” Discovery president and CEO David Zaslav said on its earnings call. “We have seen advertising partners resurface around the globe.”At Comcast, ad revenue increased 12% year-over-year because of political ad revenue, which was up 70% over what it generated during the 2016 election. But the company said core advertising, excluding political, was down 6.8% year-over-year. That’s still a “significant improvement” relative to last quarter. Fox Corp also saw advertising momentum, attributed to strong ratings at Fox News and political advertising. The company’s leadership said that in the quarter ended June 30, which is its fiscal fourth quarter, its local stations were experiencing a year-over-year decrease of about 40% in its base ad market (that is, minus political ads and other non-recurring events). CEO Lachlan Murdoch said on Fox’s call that the equivalent drop in the quarter ended Sept. 30 was only 20%. “Including the benefit of political and station acquisitions, we are now pacing ahead of the same time last year. Looking at it slightly differently, at the beginning of Covid our stations were pacing down nearly 50% compared to the prior year. Today, they are pacing ahead.”ViacomCBS said its advertising revenue also improved dramatically, declining only 6% from a year ago, versus the 27% decline it saw in the second quarter.“We’ve also seen certain COVID impacted industries like auto and retail gradually return, which reflects improvement in the economy and the significant value our portfolio brings to advertisers to drive their own business recovery,” ViacomCBS’ president and CEO Bob Bakish said on its earnings call. “Overall, we’re encouraged by what we’re seeing and big picture advertising is certainly moving in the right direction.” Disney said for its broadcasting unit, ad revenue was comparable year-over-year as lower average network viewership was offset by the benefit of an additional week in the current quarter, higher network rates, and an increase in political advertising at its owned TV stations.Uncertain times ahead after political ad boomDiscovery noted visibility is low following the U.S. election, which helped business in the third quarter, and because of rising Covid cases. The company said its U.S. advertising was flat in October year-over-year, while international advertising was down slightly. “This may not be a trend we would necessarily extrapolate, however, for the full quarter, given, number one, some tailwinds from political advertising in the U.S. in October; and number two, risks from rising Covid case numbers globally and beginning government countermeasures, especially in Europe, which pose risks at the back end of the current quarter,” Discovery CFO Gunnar Wiedenfels said on its call. “That said, we are confident to see sequential improvement in the fourth quarter versus Q3 again.” At AT&T, CEO John Stankey said the sports calendar ahead still has a lot of questions. “Clearly, we’ve seen the leagues demonstrate that they can, in fact, put games on, and they can carry them through. The timing of those and how many there are and exactly what transpires in ’21 and where it falls in the calendar is still a little bit uncertain,” he said on the company’s October call. “And until we have a little better visibility on that, it’s hard to, you know, give you exact views of what first, second, third, fourth quarter looks like next year.”ViacomCBS’ leadership said the return of a stable fall schedule at CBS, along with sports, a “successful” upfront and “hot political category” should help in the fourth quarter. AMC Networks said though the ad market is improving sequentially, results in the fourth quarter will be impacted by timing of its shows, including a delay in the airing of “The Walking Dead.” It said its year-over-year decrease in the fourth quarter ad revenue should be in-line with the third quarter.Content production is ramping upMedia companies largely said they had ramped up production again, after pandemic-related restrictions caused severe disruptions earlier this year. Discovery said its content production was nearly back to normal, with only 10% of the company’s production still paused mostly because of travel and local restrictions. Over at AT&T, Stankey said the company had 180 productions underway in February before the pandemic started. As of October, he said the company had about 130 productions up and running. Meanwhile at Viacom, the company said it estimates production levels are at about 95% of last year’s levels at Viacom Media Network, while CBS “essentially has all of the full network series currently in production” and Showtime is producing “almost all” of its series. At AMC Networks, executives said the company is resuming production activity on a number of its shows, including “The Walking Dead” at its studio in Georgia, “Fear the Walking Dead” in Texas, and a new series called “Kevin Can F*** Himself” in Boston. Fox said all of its Fox Entertainment returning shows are back in production, with scheduled return dates in early January.Disney CEO Bob Chapek said although many of its production teams needed to shut down because of Covid in the beginning of March, its animation teams were able to work remotely and continue production “uninterrupted during the pandemic.” He said on the TV side the company has more than 100 live-action scripted and unscripted projects in active production, with dozens more in other stages of pre- or post-production. Disclosure: Comcast owns NBCUniversal, the parent company of CNBC. – Advertisement –
– Advertisement – Here are some of the big-picture trends the networks shared in their earnings: Better than when the pandemic startedTV advertising last quarter showed the market is in a better place than the earlier days of the pandemic.At Discovery, third-quarter ad revenue still declined 7.7% from the previous year, but that was an improvement from the 14% decline in the second quarter.- Advertisement –
May 5, 2006 (CIDRAP News) – The latest human infected with H5N1 avian influenza died of the infection yesterday in Egypt, while a leading influenza expert called H5N1 the worst flu virus he has seen.The Egyptian victim was a 27-year-old woman from Cairo whose H5N1 case was announced yesterday, according to the World Health Organization (WHO). She had been hospitalized with bilateral pneumonia May 1, and a WHO statement yesterday had described her condition as stable.She was the 13th Egyptian confirmed to have an H5N1 infection and the fifth to die of it. Her case was the first reported in Egypt since early April. The WHO’s global case count now stands at 206 cases with 114 deaths.Meanwhile, virologist and influenza expert Robert G. Webster, attending an avian flu conference in Singapore, told the Associated Press (AP), “I’ve worked with flu all my life, and this [H5N1] is the worst influenza virus that I have ever seen.”Webster, who works at St. Jude Children’s Research Hospital in Memphis, said that in poultry, the virus invades the brain and destroys the respiratory tract, the AP reported. Concerning the threat of a human pandemic triggered by H5N1, he said, “If that happens, God help us.”According to the story, he predicted it would take at least 10 more mutations to give the virus the ability to spread from person to person. He added there was no way to know when or if that will happen.”All of those mutations are out there . . . but the virus hasn’t succeeded in bringing it together,” Webster was quoted as saying.He also said far more needs to be done to prepare for a pandemic and to understand the virus’s behavior. Calling for stockpiling of more H5N1 vaccine, he labeled current efforts “miserable,” according to the story.Webster said research has been hampered by cultural attitudes preventing autopsies of victims, with autopsies conducted on only six people since the virus began spreading in late 2003.In other developments, the 21 countries in the group Asia Pacific Economic Cooperation (APEC), meeting in Vietnam, agreed today on a plan for joint efforts to respond to the avian flu situation. The organization consists mostly of Asian and Western Pacific countries, but also includes the United States, Canada, Russia, Mexico, Peru, and Chile.The 5-page plan calls for various kinds of cooperation. For example, the members agreed to:Increase the prompt reporting of avian and human cases and sharing of biological specimensEncourage the business sector to get involved in the prevention and control of avian fluEstablish “best practices and common approaches to risk communications”Work to improve biosecurity on commercial and “transition” poultry farmsDevelop ways to exchange information on “management of travelers” to minimize damage to trade and travelEncourage steps, such as use of pre-authorized visas and customs, to ease the entry of WHO rapid response teams into countries that have invited themSee also:WHO statement on death of Egyptian womanhttp://www.who.int/csr/don/2006_05_05/en/index.html
Nov 28, 2006 (CIDRAP News) – H5N1 avian influenza has been confirmed at a second poultry farm near the site of a recent outbreak, South Korea’s agriculture ministry told news services today.The farm is about 2 miles (3 kilometers) from the first reported outbreak in Iksan in North Jeolla province, about 141 miles (230 kilometers) south of Seoul, according to an Agence France-Presse (AFP) report. The owner of the second farm requested that his chickens be tested for H5N1 avian flu yesterday after 206 of 12,000 chickens died, the Korea Times reported.The National Veterinary Research and Quarantine Service confirmed that the chickens were infected with the H5N1 virus, the Times report said.The outbreaks on the two farms are South Korea’s first in almost 3 years. No human cases of H5N1 illness have ever been reported in South Korea.An agriculture official told Reuters today that there have been no reports of infections associated with the current outbreak in local residents or quarantine workers. AFP reported that health authorities have vaccinated 151 people living with 500 meters of the second outbreak; the report didn’t specify what kind of vaccine was used.The second outbreak has raised concern that the virus has spread outside the high-risk zone around the first affected farm, the Times report said. Expanding the quarantine zone beyond the site of the first outbreak could greatly increase the number of chickens, dogs, cats, and other animals that officials would kill.The AFP report said more than 170,000 chickens at farms within 500 meters of the first outbreak have been killed in the past 2 days, along with a number of pigs and dogs.The agriculture ministry confirmed three other avian flu outbreaks in other districts but said they involved a mild strain, according to AFP.In other avian flu developments, China is considering phasing out live-poultry markets in an effort to prevent the spread of avian flu, according to another AFP report today. A document released by China’s State Council suggests a ban on any new live-poultry markets and recommends that existing markets be moved out of densely populated urban areas.Poultry markets present an avian flu exposure risk because chickens are often slaughtered there in unsanitary conditions. The markets also serve as hubs for viral spread as birds are moved to farms or other markets.About 46,000 poultry have died in 10 outbreaks in seven Chinese provinces this year, Xinhua, China’s state news agency, reported on Nov 10. Jia Youling, chief veterinary officer and director of the Veterinary Bureau in the Ministry of Agriculture, said at a press conference that another 2.94 million fowl were culled, Xinhua reported.
May 11, 2007 (CIDRAP News) – The city of Edmonton, Alta., recently announced that it was stockpiling an herbal supplement in the hope of boosting the immunity of police, firefighters, and other essential workers during an influenza pandemic.By buying a ginseng product from CV Technologies, Inc., a company based in Edmonton, the city has become the first in North America to add an herbal supplement to its pandemic stockpile, according to media reports.The supplement, COLD-fX, is a proprietary extract of North American ginseng that contains what the company calls unique polysaccharide components. It is Canada’s top-selling over-the-counter cold and flu remedy, according to an Apr 23 company press release. Warren Michaels, CV Technologies’ vice president of media relations, told CIDRAP News the company launched COLD-fX in the United States in October 2006 and that sales have been modest.City says decision took timeBob Black, Edmonton’s director of emergency preparedness, said in the CV Technologies press release that COLD-fX is another tool the city can use for pandemic preparedness. “There are so many unknowns in planning for a possible pandemic that anything we can do to be prepared makes sense,” he said. “We need to take every reasonable precaution to help our emergency personnel stay on the job, so they can help others.”The stockpile will be used to treat 5,000 key city employees, such as police, firefighters, paramedics, and waste disposal workers. It consists of 600,000 pills, an 8-week supply, according to an Apr 25 report by the Toronto Globe and Mail.CV Technologies, which pitched the stockpiling idea to Edmonton’s pandemic planners, said it would split the $250,000 cost of the program with the city as part of the company’s social responsibility program. Black told CIDRAP News that the agreement stipulates that Edmonton will pay $30,000 up front to secure access to a stockpile of COLD-fX and will be required to pay its remaining share only if and when the city needs the remedy in a pandemic setting.The product has a 5-year shelf life, but the company said it would make sure the city has access to a fresh supply regardless of when it uses the stockpile.Jacqueline Shan, PhD, DSc, CV Technologies’ chief executive officer and chief scientific officer, said that in a pandemic, “COLD-fX may help provide additional protection to front line workers by enhancing their immune systems” until an effective vaccine becomes available.Black said the city spent more than a year considering if it should stockpile COLD-fX. Senior officials and an epidemiologist from the city’s occupational health and safety office were involved in the discussions. “It wasn’t a spur-of-the-moment decision. On the balance, it seemed like a prudent thing to do” he said.Emergency preparedness officials are faced with tough questions about whether workers, particularly those in health and public safety jobs, like paramedics, firefighters, and police, will come to work during a pandemic, Black said. Having an herbal remedy on hand that might boost immunity could potentially make employees feel more confident about showing up for work, he said.Canadian health officials may have a heightened sensitivity about protecting workers during a public health emergency because of their experience with SARS (severe acute respiratory syndrome) in 2003, Black said. A final report on the outbreak that was issued in January faulted hospital officials for not doing more to protect their workers; nine hospital workers in Toronto contracted SARS while caring for critically ill patients.Studies suggest possible benefitsSome randomized, double-blind, placebo-controlled studies have suggested that COLD-fX can help people reduce their number of colds and the duration and severity of symptoms.Two controlled trials were described in one report in the January 2004 issue of the Journal of the American Geriatrics Society. The researchers evaluated the effect of COLD-fX on the number of laboratory-confirmed acute respiratory illnesses in 198 nursing home and assisted-living residents (average ages, 83.5 and 81) in the 2000 and 2000-01 flu seasons.Ninety percent of the subjects had received the influenza vaccine. Half received a 200-mg COLD-fX tablet twice a day, while the others received placebo tablets.Investigators found that more people in the placebo group (9 of 101 subjects) than in the treatment group (1 of 97 subjects) were diagnosed with flu or respiratory syncytial virus. They calculated that the overall risk was reduced by 89% in the treatment group and concluded that COLD-fX was a safe, well-tolerated, and potentially effective treatment for preventing acute respiratory illnesses.During the 2003-04 cold and flu season, another research group, headed by Gerald N. Predy of the regional public health agency based in Edmonton, studied whether the ginseng supplement could prevent colds in a group of 323 Edmonton adults aged 18 to 85 who had not received seasonal flu vaccination. Their findings appeared in the October 2005 issue of the Canadian Medical Association Journal (CMAJ).The volunteers, who had a history of at least two colds the previous season, randomly received two COLD-fX capsules or a placebo daily for 4 months. Colds were verified by a symptom scoring system and graded on a 4-point severity scale.Researchers found that those who took COLD-fX had fewer colds and the colds they did have were milder and less persistent. The authors concluded that the treatment appeared to reduce the number of recurrent colds by almost 13%, the severity of colds by 15.4%, and the average duration of colds by 2.4 days.In a commentary published in the same issue of CMAJ, Ronald B. Turner, MD, professor of pediatrics at the University of Virginia School of Medicine in Charlottesville, wrote that problems with natural remedy studies typically include a lack of information about the active ingredients they contain, lack of a clear understanding of the mechanism of action, and lot-to-lot variability in the products. However, he said the COLD-fX was standardized to reduce such variability.Turner wrote that it was not clear how the effects of North American ginseng relate to viral respiratory infections. “Enhancement of interferon-gamma activity might be expected to reduce the severity of symptoms, but enhancement of the elaboration of inflammatory cytokines might be expected to increase the severity,” he wrote.Few rigorous, reproducible studies have shown either conventional or alternative cold treatments to be beneficial, Turner wrote. Further studies involving well-characterized and standardized ginseng preparations were needed to confirm the results of the CMAJ study, he stated.Public health experts weigh inPaula Steib, communications director for the Association of State and Territorial Health Officials (ASTHO) in Washington, DC, told CIDRAP News in an e-mail that it’s not surprising to see a metropolitan area like Edmonton stockpile a natural remedy. Canada, along with Australia, Britain, and other European countries, has a long tradition of using homeopathic and herbal remedies, which are available in pharmacies and often prescribed by physicians, she said.”The situation is very different in the US where most homeopathic and herbal remedies are scoffed at by the medical establishment,” Steib said. “ASTHO is unaware of any state that is stockpiling remedies that are not part of the CDC’s strategic national stockpile program.”Jeffrey Duchin, MD, chief of communicable disease control for Seattle King County Public Health in Washington, said Edmonton’s plan to stockpile COLD-fX for its essential employees sounded interesting, but he said it was unclear from the studies whether the remedy would be of value.”It appears safe and inexpensive, but it shows how little else people feel they have to turn to,” he said.Communities that consider adding an alternative remedy to their stockpiles should weigh the costs and benefits, Duchin said. If they have met other stockpiling needs, such as having adequate supplies of oseltamivir (Tamiflu) and personal protective equipment, and still have money left in their pandemic preparedness budgets, then it might be reasonable to consider adding something extra, he said.Black said the city has increased its supplies of personal protective equipment and other items its employees would need and noted that other public health functions, including stockpiling vaccines and antivirals, are handled by the province and its health authorities.NIH says ginseng may have potentialThe CMAJ study caught the attention of the US National Institutes of Health (NIH), which in September 2006 included it in its annual bibliography of significant advances in dietary supplement research. “These findings suggest that North American ginseng may be an attractive natural prophylactic for upper respiratory tract infections,” the NIH said. “Additional studies are needed to confirm these findings.”In January, the Nutrition Action Health Letter, a publication of the Center for Science in the Public Interest, a health advocacy group, included COLD-fX in a review of eight popular over-the-counter cold remedies. The publication said that more studies are needed to confirm that COLD-fX can shorten or prevent colds or flu. “Even so, COLD-fX is the only remedy we found with any evidence that it might improve your chances of getting through the cold and flu season without coming down with something,” the article said.Michaels said CV Technologies doesn’t want to overstate COLD-fX’s potential in a pandemic situation, but he said the company believes the product has merit and is a legitimate candidate for incorporation into pandemic plans.The company is exploring the possibility of applying for US Food and Drug Administration approval to market COLD-fX specifically as a preventive for colds and is conducting a phase 3 clinical trial for that purpose. The company also recently launched a trial to see if COLD-fX improves the immunity of healthcare workers and is investigating the precise biochemical pathways by which the product affects the immune system, according to information on the company’s Web site.See also:McElhaney JE, Gravenstein S, Cole SK, et al. A placebo controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. J Am Geriatr Soc 2004 Jan;52(1):13-9 [Abstract]Predy GN, Goel V, Lovlin R, et al. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ 2005 Oct;173(9):1043-8 [Full text]Turner B. Studies of “natural” remedies for the common cold: pitfalls and pratfalls. (Commentary) CMAJ 2005 Oct 25;173(9):1051-2 [Full text]CV Technologies news releaseSARS Commission final reporthttp://www.ontla.on.ca/library/repository/mon/16000/268478.pdfNIH press releasehttp://www.nih.gov/news/pr/sep2006/od-21.htmNIH bibliographies of dietary supplement research advanceshttp://ods.od.nih.gov/Research/Annual_Bibliographies.aspxSchardt D. Un-catching colds: do popular remedies work? Nutrition Action Healthletter 2007 Jan/Feb;8-11 [Full text]
In 2004 Acambis temporarily halted one of its phase 3 trials comparing ACAM2000 with Dryvax, the currently licensed smallpox vaccine that is no longer produced, after myopericarditis developed in at least three of the research subjects. The HHS, in an Apr 20 release of its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, said it was planning to stockpile a weaker version of the smallpox vaccinemodified vaccinia Ankara (MVA)for certain groups, such as pregnant women and immuncompromised people, who can’t receive the conventional smallpox vaccine. The agency “is well advanced in the pre-award stage” of a program to buy an MVA vaccine. Two companies have developed MVA vaccines: Acambis and Copenhagen-based Bavarian Nordic. Acambis has a contract with the US Department of Health and Human Services (HHS) to make 209 million doses of smallpox vaccine for the Strategic National Stockpile (SNS) to use in the event of a terrorist release of smallpox virus. Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness in Washington, told CIDRAP News in an e-mail that the company has delivered 192.5 million doses of ACAM2000 so far and has been paid $573,650,000. May 18, 2007 (CIDRAP News) A US Food and Drug Administration (FDA) panel yesterday recommended that the agency approve a smallpox vaccine made by British biotechnology company Acambis plc that is currently being stockpiled for the US government. “This vaccine should not be used lightly,” said Pamela McInnes, a panelist who directs the Center for Integrative Biology and Infectious Diseases at the National Institutes of Health. See also: Panel members said if the FDA approves the vaccine it should require the company to continue clinical trials and other measures, Reuters reported. The US Centers for Disease Control and Prevention (CDC) and Acambis are discussing an arrangement for Acambis to provide long-term production of the vaccine using a US-based supply chain and production (ie, warm-base manufacturing), Acambis said in its press release. Having an FDA-licensed product is a prerequisite to finalizing a warm-base manufacturing contract with the CDC, Garland said. HHS countermeasures implementation planhttp://www.hhs.gov/aspr/ophemc/enterprise/strategy/strategy.html Panelists said they had to weigh the risks of heart inflammation, which would be unacceptable for routine vaccination, against the threat that US military personnel and others in high-risk settings face regarding smallpox exposure, Reuters reported. Ian Garland, Acambis’ chief executive officer, said in a company press release that the FDA panel’s recommendation reinforces the company’s confidence that ACAM2000 will be licensed. The FDA told Acambis its target date for an approval decision is Aug 31, 2007. The panel unanimously voted 11 to 0 that ACAM2000 is both safe and effective, Karen Reilly, an FDA spokesperson, told CIDRAP News in an e-mail after the meeting. The FDA is not bound by the advisory panel recommendations but usually follows them. The positive recommendation came despite some concerns panel members raised about the side effects of the vaccine. Some outside experts who spoke at the meeting said the risk of heart inflammation in people who had been vaccinated warranted further review, according to a Reuters report yesterday. May 17 Acambis news releasehttp://www.acambis.com/default.asp?id=1893 ACAM2000 uses vaccinia virus, a close relative of smallpox, and is grown in cell culture. It is derived from Dryvax, a first-generation vaccine that was used in global smallpox eradication programs. The newer vaccine is grown in cell culture rather than on the skin of calves, which is thought to produce a purer and safer vaccine that has less risk of rare but serious complications.
Aug 16, 2007 (CIDRAP News) – The British pharmaceutical company GlaxoSmithKline (GSK) recently announced another major order of prepandemic H5N1 influenza vaccine from the US Department of Health and Human Services (HHS), along with plans to launch a North American clinical trial of the vaccine.HHS ordered enough vaccine in bulk form to provide 22.5 million 15-microgram (mcg) doses, the company announced on Aug 3. The order is in addition to the bulk equivalent of 5 million 15-mcg doses that HHS ordered in November 2006, officials said.The cost of the new vaccine order is $97 million, according to Marc Wolfson, a spokesman for the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, DC.The new order includes 9 million doses produced in the 2006 “manufacturing campaign” and 13.5 million doses to be produced in the 2007 campaign, GSK reported. The vaccine is based on clade 2 strain of the H5N1 virus.GSK will make the bulk vaccine at its facility in Ste. Foy, Quebec, and store it in Marietta, Pa.When HHS announced the plan to buy H5N1 vaccine from GSK in November 2006, the agency said it was ordering 800,000 doses, not the 5 million doses cited in the company’s Aug 3 announcement. Wolfson of HHS and Ken Inchausti, a GSK spokesman in Philadelphia, explained that the two announcements involve the same amount of bulk vaccine, but the HHS statement was based on a dose of 90 mcg, whereas the company announcement assumed a dose of 15 mcg.”The confusion between the 5 million doses that GSK talks about and what we have is that we’re still ordering it at the bulk rate of 90 [mcg] per dose,” Wolfson told CIDRAP News. “They’re doing tests that could possibly take it down to 15 [mcg] per dose, and if you do the math, that’s where the difference comes.”Based on 90 mcg per dose, HHS currently has 2.3 million doses of GSK vaccine in its H5N1 vaccine stockpile, Wolfson reported.The vaccine contract provides that HHS may direct the company to formulate the bulk vaccine into doses in the future, GSK said. In addition, HHS has an option to buy the vaccine in combination with one of the company’s proprietary adjuvants, or immune-boosting chemicals, which could reduce the amount of vaccine antigen needed to induce a protective immune response, the company reported.Funds for the vaccine contract will come through the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response, according to GSK.Clinical trial startingGSK also announced the start of the first North American clinical trial of its prepandemic H5N1 vaccine. The trial is described as a phase1/2 study that will compare the safety and immunogenicity of the H5N1 antigen alone and in combination with one of GSK’s adjuvant systems in 675 adult volunteers. Inchausti said the trial will be conducted at sites in Montana, California, Florida, Georgia, Alabama, Kansas, and Nevada and in Halifax and Quebec, Canada.The company said it plans to follow up later this year with a phase 3 trial that will involve about 4,400 volunteers. Results of the phase 1/2 trial are expected in early 2008.Last March, GSK reported that in a clinical trial, one of its adjuvanted H5N1 vaccines triggered a strong immune response with two 3.8-mcg doses, or about half of the 15-mcg dose typically used for each viral strain in seasonal flu vaccines. The company also said tests showed that the vaccine, based on a Vietnam strain of H5N1, generated cross-reactive immunity against an Indonesian strain.GSK, Baxter sign vaccine deals with UKIn other developments, both GSK and US-based Baxter International today announced agreements to sell vaccine to the United Kingdom in the event of a flu pandemic.Under the GSK agreement, the company will make preparations to provide a “tailored” vaccine as soon as possible after a pandemic is declared by the World Health Organization, according to a company news release. GSK said it also has agreements to sell pandemic vaccines to Switzerland, Denmark, and Iceland.Baxter, based in Deerfield, Ill., said its European subsidiary in the UK signed an agreement giving the UK an option to buy Baxter’s vaccine in the event of a pandemic. The company’s candidate pandemic vaccine is produced in vero cell culture rather than in eggs, the conventional medium for flu vaccine production. Baxter said it recently enrolled volunteers for a phase 3 clinical study of its cell-based H5N1 vaccine in Europe.See also: Mar 6 CIDRAP News story “Glaxo H5N1 vaccine may work against multiple strains”Nov 20, 2006, CIDRAP News story “HHS awards 3 contracts for more H5N1 vaccine”