For doctors who think Trump fumbled the pandemic, the tight election is seen as an insult

first_img– Advertisement – In the spring, U.S. medical workers were heralded as heroes. But by the fall, the rhetoric had started to shift, with the public growing increasingly fatigued by the coronavirus pandemic and President Donald Trump accusing doctors of inflating Covid-19 death counts for money.With the death toll from the coronavirus continuing to tick up, many medical workers say they hoped for a landslide victory for Biden, who has said he’ll follow the advice of scientists if he’s wins the presidency.- Advertisement – Texas and Florida — where there have been more than 960,000 and 827,000 confirmed cases, respectively, so far — solidly went for Trump even though Democrats thought the outbreak gave them a fighting chance in some red states.“Many of us are now questioning whether we’re speaking into an echo chamber,” said Miami-based physician Dr. Krishna Komanduri. Miami-Dade County dealt a big blow to the Biden campaign in Florida and helped seal the state for Trump.The economy, and not the pandemic, was more of a priority for 70% of Trump voters, according to the NBC poll.- Advertisement – “Trump has insulted our integrity and allowed for more than seven months of chaos and excessive deaths to Covid,” said Dr. John Purakal, an emergency medicine physician based in North Carolina. “It’s so surprising to me,” he said. “But here we are.”A variety of polls indicate that the majority of Americans don’t approve of the administration’s management of the coronavirus. In July, just 32% of Americans said they approved of Trump’s pandemic strategy, according to The Associated Press-NORC Center for Public Affairs Research. In August, 7 out of 10 Americans who responded to a CNN poll said the president’s response was embarrassing. NBC exits polls from Election Day and early voting, found that 51% of voters think U.S. efforts to contain the outbreak are going badly.Biden may still eke out a victory. But after the Trump administration undermined or contradicted its own medical experts on everything from wearing masks to reopening schools at the beginning of the outbreak, the tight race feels like a slap in the face for many physicians fighting the pandemic .- Advertisement – For doctors like Komanduri, the economy and the coronavirus are not separate issues. Successfully containing the virus will lead to fewer restrictions, which inevitably opens up the economy, he said.“It’s making me do a serious re-analysis of how I can make a difference,” added Komanduri, who’s the chief of transplantation and cellular therapy at Sylvester Comprehensive Cancer Center. “I went to bed Tuesday night feeling a real sense of helplessness and sadness.”Of course, not all health-care workers lean left and many remain major supporters of the Trump administration. A 2016 study found that 46% of doctors are Republicans. Things appear to have shifted in the past four years, however, with recent analyses indicating that more and more doctors are increasingly aligning themselves with the Democrats.For those who firmly sided with Democrats this year, the race has been too close for comfort. And that feels like a slight.As Purakal points out, hundreds of health-care workers have died from Covid-19, and countless others have been infected.“I really thought that our experiences in the trenches would impact people’s voting decisions,” added Dr. Avital O’Glasser, an associate professor and hospitalist at Oregon Health & Science University.Trump’s response to the virus reflects a disregard for scientific expertise, including his downplaying of the importance of masks. She thought Biden would win in a landslide, so the tight race is a real wake-up call, she said. Even if Biden ultimately wins, she’s been thinking about what she could do to communicate more effectively to people in the future.“Our country doesn’t have the science and math education that a lot of other countries have,” she said.Others say they are feeling exhausted after months fighting the coronavirus, and they were hoping for a clear-cut Biden victory to buoy their spirits.“I can’t help but feeling as a health-care worker that the nation really let us down … even if Biden does win,” added James Kerridge, a director of nursing practice based in Chicago. “All of the clapping doesn’t make up for the feeling of still being canon fodder for an inept administration.”Dr. George Alba, a pulmonologist based in the Boston area, said the election leaves him feeling dismayed. He’s had to live separately from his family for weeks at a time to keep them safe, and he’s been working long hours treating Covid-19 patients.“We felt like we had the nation’s support until the coronavirus became political and the administration started eroding confidence in scientists,” he said. “The sentiment around supporting health-care workers only lasted as long as it was politically convenient.”Others doctors have been doing a lot of soul-searching about what their patients might be going through, and how they can better relate to them.Dr. Laolu Fayanju, a family medicine doctor based in Ohio, treats patients in so-called Rust Belt cities like Youngstown.He’s heard from a lot of his patients that they’ve been having a difficult time during the pandemic and are feeling lonely and isolated. Others are concerned about their job prospects, and felt emboldened by Trump’s promises to bring back manufacturing jobs.He’s recognizing that many of those patients handed Trump a win in Ohio.“I drive through this former General Motors auto plant on my way to work,” he said. “It feels like a mausoleum, a symbolic representation of what the region is going through.”last_img read more

U.S. officials warn of challenges administering Eli Lilly’s antibody drug

first_imgIn this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.David Morrison | Eli Lilly via AP States and local health-care systems should expect to face some early challenges administering Eli Lilly‘s coronavirus antibody drug, senior administration officials warned Tuesday, after the FDA authorized the drug to treat patients with Covid-19.Eli Lilly’s drug, similar to the one given to President Donald Trump after he contracted the virus last month, is administered to Covid-19 patients via an IV infusion that takes more than an hour and requires another hour of observation afterward, officials said. That may be difficult in certain health-care settings, and Eli Lilly and the U.S. government are developing “playbooks” to help states navigate the process, said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.“We anticipate that initially there’ll be challenges for the health-care system in administering IV infusions to infected patients,” Woodcock said on a conference call with reporters. “There are probably going to be multiple different solutions depending on the setting, [like] community health centers, home IV, health infusion companies, nursing homes.”- Advertisement – – Advertisement – The Food and Drug Administration on Monday authorized the treatment, called bamlanivimab, for people newly infected with Covid-19 and who are seen as at risk of developing a severe form of the disease. Officials said the treatment shouldn’t be used to treat patients who are hospitalized as there is currently no data to show the drug is helpful at that stage of the disease.The drug will “likely work best early in the disease and the goal during this [emergency use authorization] should be to treat high-risk individuals as soon as possible after they have symptoms and are diagnosed,” Woodcock said. “The data we have suggests that early treatment may help people avoid disease progression and avoid hospitalization.”“We’re all going to need to get the word out that people at high risk have a therapeutic option now .. Because until this point, people have been told to stay at home unless they get very sick,” she added.- Advertisement –center_img Health and Human Services Secretary Alex Azar said the U.S. government, through Operation Warp Speed, will begin distribution of the drug this week. Allocation of the drug will be based on states’ and territories’ share of the country’s total number of confirmed Covid-19 patients and the total number of confirmed hospitalized patients in a given week, he said. The drug will be distributed in two phases, with hospitals and hospital-affiliated locations getting it first, followed by outpatient centers.Health-care facilities must have the appropriate staffing, training and equipment to accommodate an IV infusion, according to Dr. John Redd, chief medical officer for the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.“We have a contract to purchase 300,000 doses of this product through December with the option to purchase another 650,000 doses through next June as well,” Azar said. “There are over 80,000 doses available for allocation and distribution this week, and we’ll be working with state, local and territorial health departments so that patients can receive the infusion in hospitals, outpatient clinics or alternate care settings.”Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can prevent the virus from infecting cells. A recent study in the New England Journal of Medicine found 1.6% of trial participants who received Eli Lilly’s antibody treatment ended up hospitalized or had a coronavirus-related visit to the emergency room, compared with 6.3% of people who received the placebo.Eli Lilly Chairman and CEO Dave Ricks told CNBC earlier in the day that the company’s antibody drug will still be an important treatment for Covid-19, even if a widely available vaccine is brought to market.Even in well-controlled [other] respiratory illness … we still have vaccination and antibody therapy because some patients escape the vaccine and still get the condition, and they need to be managed with a therapy,” he added. “This will be useful in the long term, hopefully at much lower volumes” in fighting Covid-19 as well.–CNBC’s Kevin Stankiewicz contributed to this report. – Advertisement –last_img read more

Postal worker who recanted his recanting is on tape recanting

first_img– Advertisement – O’Keefe and Project Veritas are an essential part of the Republican Party. Which is again both hilarious and terrifying. Because for the next 60-odd days, they’re in charge of the country. Far from being coercive, the recording shows that the investigators “repeatedly reminded Hopkins that his cooperation was voluntary, and Hopkins agreed to sign a document stating that he was not coerced.” One also asked him if he had a lawyer, and Hopkins said a Project Veritas lawyer was on retention “in case there’s anything that happens.” At which point the agent hinted that maybe he should have a personal lawyer and “I would make whatever efforts possible to have that person here.” That’s about as “coercive” as the interview seems to have been. But Hopkins, clearly in way over his head, later talked to O’Keefe and said he felt like he “got played” by the investigators.The ones playing him are clearly O’Keefe and his team, and who knows what they’re promising Hopkins. Hopkins told inspectors that he’s a libertarian who supported Trump. He didn’t understand Pennsylvania’s rules for the election, i.e., that ballots postmarked Election Day could still be delivered through the following Friday. “It’s so weird that we’re picking up ballots because, at this point [after Election Day], they’re no longer valid,” he told investigators when explaining his concern. He thought it was fraud. “You ever feel like you were doing the right thing but you kind of regret it anyways?” he asked the agent.One gets the sense that Hopkins isn’t the brightest of bulbs, a perfect target for being used by O’Keefe in yet another fraud. It would be sadly hilarious because this guy really is being used, except for the fact that the fraud was used to get Sen. Lindsey Graham to call for a federal investigation, after which Attorney General William Barr authorized federal investigations. It is being used in one of the Trump campaign’s challenges to the Pennsylvania vote.- Advertisement –center_img As one of its key pieces of evidence to challenge the election there, the Trump campaign in Pennsylvania is using the James O’Keefe/Project Veritas-promoted story that a postal worker heard a supervisor tell another worker to backdate ballots. That story was debunked by U.S. Postal Service investigators, who spoke to the worker—Richard Hopkins—who recanted. Then he recanted his recanting again via a video Project Veritas sent out in which they said he had been “interrogated” and “coerced” by agents.Showing just how unsteady the foundation is that Trump has built his legal challenges on, The Washington Post got the recording Project Veritas is using to try to keep this ridiculous claim alive. It was recorded by Hopkins, who told the investigators he was recording, and they let him keep doing it. Which was smart. Because in it, he says he made “assumptions” about the snippets of the conversation he’d overheard that were the basis of his claim and his false affidavit. He said the Erie, Pennsylvania, facility where he heard the conversation was noisy and all he heard for sure were three phrases: “ballots on the 4th,” “all for the 3rd,” and “one postmarked on the 4th.” He said he never heard the word “backdate,” but, “My mind probably added the rest.” Then he talked about the affidavit, saying that it was written by Project Veritas and he wasn’t sure of everything that was in it because he was in “so much shock I wasn’t paying that much attention to what they were telling me.” He told the investigators: “They just wanted me to get the affidavit done so they can utilize it in case they need to subpoena me into the court.”- Advertisement –last_img read more

SARS virus spreads to many organs

first_img The findings partially parallel an earlier study in which Chinese researchers found the SARS-CoV in the intestinal tract, sweat glands, and kidneys of SARS victims, in addition to the lungs. That study, however, found no virus in the lymph nodes or muscles. See also: Their study was published electronically in advance of the Jan 15, 2005, issue of the Journal of Infectious Diseases. The authors note that watery diarrhea has often been reported as a SARS symptom. That observation and their own findings indicate that gastrointestinal involvement is common in SARS, which has “implications for infection-control measures and the potential for fecal-oral transmission in community outbreaks,” the report says. The study focused on victims of the SARS outbreak in the Toronto area from March to September of 2003. Autopsies were performed on 21 of 44 patients whose deaths were attributed to SARS. Fifty-one patients who died of other causes during the outbreak and underwent autopsies were used as controls. The researchers found SARS-CoV in 19 of 19 patients who died within 51 days after the onset of infection. All 206 postmortem samples from the 51 non-SARS patients were negative for the virus. Besides the lungs, the SARS virus was found in the small and large bowel, lymph nodes, spleen, liver, heart, kidney, and skeletal muscle of at least some patients. The virus was found in the small and large bowel in 73% (11 of 15) of patients, in the heart in 40% (7 of 18), and in skeletal muscle in 12% (2 of 17).center_img May 10, 2004, CIDRAP News story, “Study suggests food, sweat, waste could spread SARS virus” Reverse-transcriptase polymerase chain reaction (RT-PCR) tests were used to detect SARS-CoV in organ samples. Dec 23, 2004 (CIDRAP News) – Although primarily associated with lung infection, the coronavirus that causes SARS (severe acute respiratory syndrome) spreads throughout the human body, Canadian researchers have found. “We observed extrapulmonary dissemination of the virus into all major organs, especially the bowel and lymph nodes. These data have implications for the clinical manifestation, disease course and outcome, and transmission of SARS-CoV [SARS coronavirus],” says the report by Gabriella A. Farcas and colleagues of the University of Toronto and three other Toronto institutions. Farcas GA, Poutanen SM, Mazzulli T, et al. Fatal severe acute respiratory syndrome is associated with multiorgan involvement by coronavirus. J Infect Dis 2005 Jan 15:191(2):193-7 [Abstract]last_img read more

Chiron wins H5N1 vaccine contract; WHO says virus is changing

first_imgOct 28, 2005 (CIDRAP News) – The US government has awarded Chiron Corp. a $62.5 million contract to make a vaccine for H5N1 avian influenza as part of efforts to prepare for a possible human flu pandemic.Meanwhile, the World Health Organization (WHO) said today that recent isolates of the H5N1 virus from birds and humans in Asia show slight genetic changes from the isolate on which current experimental H5N1 vaccines are based. However, the WHO is not recommending changing the prototype strain used for vaccines at this point.Chiron, based in Emeryville, Calif., said it would supply the vaccine to the government in 2006. It is not yet known how many people the vaccine would protect, because the dose size has yet to be determined in clinical trials, officials said.The Department of Health and Human Services (HHS) has a stated goal of stockpiling enough H5N1 vaccine to vaccinate 20 million people. In September the agency awarded Sanofi Pasteur a $100 million contract to supply an H5N1 vaccine. The dose size for that vaccine also remains to be determined.”An influenza vaccine effective against the H5N1 virus is our best hope of protecting the American people from a virus for which they have no immunity,” HHS Secretary Mike Leavitt said in announcing the contract yesterday.Chiron said it would make the vaccine at its plant in Liverpool, England, where the company’s seasonal flu vaccine is made, but production of the H5N1 vaccine will not affect production of the seasonal vaccine.Chiron won a contract from the National Institute of Allergy and Infectious Diseases (NIAID) in May 2004 to produce small amounts of an H5N1 vaccine for use in clinical trials. In yesterday’s announcement, the company said it would provide the vaccine for NIAID studies “later this year.”The vaccine to be tested by NIAID and the one to be produced under the HHS contract are the same, Chiron spokeswoman Alison Marquiss told CIDRAP News. However, the vaccine for HHS will be in bulk form, whereas the vaccine for the NIAID will be in “filled and finished form.” The NIAID will test various doses and formulations of the vaccine, she said.Marquiss said plans call for making the HHS vaccine after production of this year’s seasonal flu vaccine is finished, which should permit delivery of the experimental vaccine in the first half of 2006.WHO cites changes in H5N1The WHO said its monitoring of H5N1 viruses has revealed recent changes in the hemagglutinin (HA) genes of viruses from birds in several countries and from humans in Indonesia. HA is a surface protein on flu viruses that enables them to attach to and enter host cells; it also serves to identify the viruses to the human immune system. (In virus names like H5N1, “H5″ signifies the hemagglutinin type.)”Recent investigations have indicated that H5 haemagglutinins (HA) genes of viruses from birds in China, Indonesia, Japan, Mongolia, Russia, South Korea and Turkey, and 3 viruses from humans in Indonesia are genetically distinguishable from the prototype strains selected last year for influenza pandemic vaccine development,” the WHO said. “There is also evidence of antigenic variation among the HA of recent viruses. However, their geographical spread and pathogenicity in human populations remain unclear.”The WHO said it does not recommend changing the H5N1 prototype strains chosen previously for vaccine development. But the agency said its “H5 Reference Laboratory Network” has begun developing H5N1 vaccine prototype strains from the recent viruses.There is no guarantee that the experimental H5N1 vaccines now under development would work in the event of a pandemic, since the virus is likely to evolve further before that happens. But experts hope that the vaccines would be close enough to the pandemic strain to provide at least some cross-protection. The viral changes reported by the WHO seem to suggest that the vaccines now in development would be less likely to work well, though the WHO didn’t say that.The agency said it urgently needs analyses of more recent H5N1 viruses from both animals and humans “in order to obtain a better understanding of the evolution of the viruses and their antigenic relationships.” The statement called on countries to quickly share viral isolates and specimens with the WHO lab network.Progress on other avian flu vaccinesIn other news, Chiron today announced promising preliminary results in a clinical trial of a vaccine for another avian flu virus that has been known to infect humans, known as H9N2. The virus caused serious illness in three people in Hong Kong in 1999 and 2003 and is viewed as capable of evolving into a pandemic strain.Four different doses of Chiron’s experimental H9N2 vaccine were tested in 96 people. Some of the doses contained an adjuvant (a substance that stimulates the immune system) called MF59. All the formulations containing MF59 generated antibody levels believed high enough to protect a person from the virus, the company said. The lowest dose used was 3.75 micrograms, only a quarter of the amount used in seasonal flu vaccines.Vaccine formulations without MF59 generated significantly lower levels of antibodies, the company said. The trial was supported by the NIAID, which awarded Chiron a contract in August 2004 to make up to 40,000 doses.Progress on still another avian flu vaccine was reported by the European Union (EU) Commission yesterday. Researchers from several countries have developed an experimental vaccine for the H7N1 virus, which is viewed as another potential pandemic strain, the EU statement said.H7N1 caused deadly outbreaks in Italian poultry in 1999 and was related to the H7N7 virus, which devastated Dutch poultry flocks in 2003, the EU said. European researchers reported recently that antibodies to H7 viruses were found in Italian poultry workers in 2003.The H7N1 vaccine was developed by the “FLUPAN” consortium, including flu experts from the United Kingdom, Italy, Norway, and Sanofi Pasteur in France, the EU statement said. They used reverse genetics to create the vaccine, called RD-3.”The risk of H7 emerging as a pandemic influenza strain is considered to be lower than H5N1,” the EU statement said. “Nonetheless, it is expected that the H7 FLUPAN research will be a valuable resource for pandemic vaccine development in the future.”See also:Oct 27 HHS news releasehttp://archive.hhs.gov/news/press/2005pres/20051027.htmlOct 15 Journal of Infectious Diseases article on H7 viruseshttp://www.journals.uchicago.edu/doi/full/10.1086/444390last_img read more

H5N1 spreads to more Indian districts

first_imgJan 5, 2009 (CIDRAP News) – Animal health officials in India’s West Bengal state recently reported new H5N1 avian influenza outbreaks in two more districts, according to media reports.Officials from the affected districts said the virus was found in two villages in Darjeeling and adjacent sites in Jalpaiguri, according to a Jan 3 report from Reuters. The outbreaks involved chickens, the Times of India reported yesterday. The two districts are neighbors in the northern part of West Bengal state.Surendra Gupta, an official with Darjeeling district, said 30 culling teams were slated to start destroying birds yesterday, and Bandana Yadav, an official from Jalpaiguri, said 10 teams from the district also set out yesterday to cull birds within the outbreak radius.In late November the virus cropped up in India again after a 5-month lull, striking birds in Assam state, according to previous reports. In mid December, neighboring West Bengal state started reporting fresh outbreaks. An area of Bangladesh that borders both states has also reported recent H5N1 outbreaks.Elsewhere, veterinary officials in Vietnam recently confirmed in a statement released to the Vietnam Agriculture newspaper an H5N1 outbreak in Thai Nguyen province in the northern part of the country, according to a Dec 29 report from Xinhua, China’s state news service.The outbreak struck 100 45-day-old poultry and was the province’s second outbreak in 2008, the report said.In other developments, livestock officials in South Korea reported that they detected the low-pathogenic H5N2 virus at a duck farm in North Chungchong province, in the central part of the country, according to a Jan 2 report from the World Organization for Animal Health (OIE).No bird illnesses or deaths were reported, but officials found the virus during ongoing surveillance of all duck farms that began in September, the report said. Authorities culled 6,837 birds to control the spread of the virus.Investigators haven’t determined the source of the virus. South Korea’s last H5N2 outbreak occurred in October 2008 when the virus was detected at a duck farm in the city of Yesan, in South Chungchong province.See also:Jan 2 OIE report on South Korea’s H5N2 outbreakDec 1, 2008, CIDRAP News story “India reports new H5N1 outbreak”last_img read more

Path to swine flu vaccine has major hurdles

first_imgMay 1, 2009 (CIDRAP News) – National and international health authorities said today that they have begun the first steps in manufacturing a vaccine against the novel H1N1 swine influenza, though they appeared to disagree over whether full-scale manufacturing will move forward.But flu-vaccine experts in several countries warned that major manufacturing and regulatory hurdles lie in the path toward achieving a pandemic vaccine, hurdles that have been recognized by governments for years but never successfully dealt with.There is agreement on one point: The current seasonal flu vaccine will not protect against the novel virus. If authorities decide that a swine-flu vaccine is necessary, a new one will have to be formulated.”There is very little chance that the seasonal vaccine as used in the vast majority of countries in the world would be effective against this particular virus,” Dr. Marie-Paule Kieny, director of the World Health Organization’s Initiative for Vaccine Research, said in a briefing today in Geneva.This year’s seasonal vaccine formula will be administered soon in the southern hemisphere and currently is being manufactured for the northern hemisphere. Some manufacturers have grown all the vaccine virus needed for their production run, have moved the result to bulk storage for later packaging, and therefore could be ready to start a limited-production test of the new virus if necessary. But others are not done: According to the Centers for Disease Control and Prevention, some manufacturers have had difficulty growing one of the three major seasonal vaccine components, a strain that induces immunity to the family of viruses known as influenza B.That lag raises the possibility that manufacturers could be asked to short-circuit work on the seasonal vaccine in order to begin handling the seed strain of the novel virus, a move that would reduce the amount of vaccine available in the northern hemisphere next winter.”Some of the manufacturers may be 60% through, some of the manufacturers may be a little bit less, and not the same level either for the three components,” Kieny said. “We are in discussion with them to try to see at what moment it might be the best solution to stop the seasonal and to start the pandemic” formula.An immutable timelineWHO and CDC representatives said today that the timeline for producing even test lots of a swine-flu vaccine is immutable.It begins with the CDC’s Atlanta labs—the lead institution of the four international influenza collaborating centers—developing a “seed strain” of vaccine virus out of one of the isolates taken from the swine flu victims. That process, which takes 2 to 3 weeks, aims to develop a hybrid virus that retains the immune profile of the original virus but grows well in embryonated chicken eggs, which are the main growth medium used in flu-virus manufacturing. The result is then given to manufacturers to develop small pilot lots of vaccine for animal and human trials, a process that can take up to 11 weeks of production before any trials begin.Rumors are circulating among some flu scientists that the strain being used at the CDC for the vaccine seed strain is not growing well in eggs. The WHO and CDC appeared to acknowledge this Friday, disclosing that they are preparing two seed strains for manufacturers: one that was naturally reassorted by allowing viruses to mix in eggs, and another tuned via a patented process called reverse genetics that cuts and pastes genes from the swine virus with a non-pathogenic virus in order to achieve the highest possible growth rate. Manufacturers will be allowed to choose, the agencies said.At the moment, the naturally reassorted strains are being grown at the CDC and at New York Medical College, and the reverse-engineered strains are being worked on at the CDC and the other WHO collaborating centers along with the Food and Drug Administration. WHO convened an international meeting of manufacturers 2 days ago, and “several dozen” are prepared to receive strains, Kieny said.Vaccine yield is unpredictableThat production will go smoothly is not guaranteed: Since 2000, seasonal flu-vaccine delivery has been delayed several times because strains did not grow as well as predicted or eggs proved vulnerable to contamination. But if the swine-flu seed strains grow as well as hoped, by early autumn manufacturers and regulatory authorities will have to consider how to begin testing the pilot lots.That is a key issue for safety: In the abortive 1976 swine-flu outbreak, the vaccine caused a paralysis (Guillain-Barre syndrome) that occurred approximately once in every 1 million doses given, a proportion that was not reflected in the trials conducted then. But it will also determine in what size doses the vaccine will be given, if it moves to full manufacture—and that is a critical issue because international capacity for making vaccine is limited.The “standard dose” of antigen for flu vaccine is 15 micrograms (mcg) of flu-virus proteins. (Seasonal vaccines comprise three doses of 15 mcg—two from the influenza A family and one representing influenza B—in a single shot.) The larger the dose needed to produce immunity, the smaller the number of people who can be vaccinated if the formula moves to full production. Testing would also determine whether immunity could be achieved with one dose or would require two, a need that would effectively halve the number of shots available.Current estimates of global capacity vary wildly. Rear Admiral Anne Schuchat, MD, interim deputy director of the CDC’s Science and Public Health Program, told Congress Thursday that US manufacturing capacity would allow for the production of 600 million doses, or two shots for every US resident. Kieny said Friday the current global capacity is approximately 700 million doses. A report released in March by the International federation of Pharmaceutical Manufacturers and Associations puts current global capacity at 917 million doses—but it relies on assumptions that include an average dose of 9 micrograms, not 15.Still dependent on eggsBoth the limitation on manufacturing capacity and the time it takes to produce doses are dictated by the dependence on chicken eggs, a technology that has been essentially unchanged for 50 years. Since concerns over avian flu H5N1 first sparked in 1997, numerous experts have warned that egg-based vaccines would leave the world exposed to vaccine shortfalls at a critical moment. Nevertheless, plants with faster, cleaner next generation-technology, cell culture, are not scheduled to come online in the United States for 2 more years.”That is the real frustration, that we have been talking about this for 12, 13 years and have not yet found the will to do this better and faster,” said Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group. “And here we are in a global emergency, at phase 5 of 6. What does it take?”The WHO and CDC seemed to disagree Friday over whether manufacture of a vaccine would move ahead, with the CDC’s Dr. Nancy Cox, director of the influenza division, saying that discussions are under way, and Kieny saying, “It seems most likely we will proceed.”If pilot lots pass clinical trials and move to full manufacture—a process that would take several more months—another significant hurdle remains: how to get the vaccine past government regulators.A monovalent vaccine (one containing only one strain) could be presented to the FDA under existing licenses, said Dr. David Fedson, a former vaccine-industry researcher and longtime critic of pandemic preparations—but authorities would then have to rely on citizens to return for one or two shots in addition to the standard seasonal vaccine. Combining the new vaccine with the existing vaccine into a quadrivalent (four-strain) product, while potentially more acceptable to consumers, would face far more regulatory hurdles because it would represent a new formulation—and, if it were contaminated or held up by manufacturing problems, could imperil potentially the entire seasonal vaccine supply.The issue of manufacturing capacity, and possibly also of immunogenicity, could be solved at a stroke if a new vaccine were to include an adjuvant, effectively an immune-system activator that allows doses to be diluted and thus makes many more shots available. Pandemic planners have pushed for adjuvant licensure in the United States for years; they were first called for after the 1957 pandemic. But so far, only one adjuvant has been licensed in the United States, and regulators have said that in order to be approved, any adjuvanted vaccine must be tested using the exact adjuvant-antigen dosage that will be marketed—thus requiring an additional layer of testing that is unlikely to fit the need for speed in achieving a pandemic vaccine.See also: CDC press briefing transcripthttp://www.cdc.gov/media/transcripts/2009/t090501.htmWHO press briefing audio filelast_img read more

Preservation of Dubrovnik tradition: New uniforms of Dubrovnik trombonists presented

first_img Photo: Anna Serrano Photographer According to tradition, the date of the founding of this historical-military unit dates back to 1417, when they were mentioned as “bombers” or artillerymen as part of the military forces of the Republic of Dubrovnik. At that time, the people of Dubrovnik were known for making “bombard” cannons, while nowadays the Dubrovnik trombonists are named after the trombone, a weapon from which they fire platoons that are associated with firing from cannons. Trombonists participate in all important events in Dubrovnik, but also throughout Lijepa naša. Their most important role is to lead the procession on the feast of the patron saint of the city, St. Blaise, on the third of February, when the day of the city of Dubrovnik is also celebrated.Let us respect ourselves, so that others may respect us. The Society of Dubrovnik Trombonists gathers members from 18 to 80 years of age and all of them pass on the values ​​of the Dubrovnik tradition from generation to generation.As part of the ValamArt program, one of the nine umbrella programs for Valamar’s socially responsible business, the Dubrovnik Trombonists Association received financial support from Valamar, and in 2018 the trombonists will receive new uniforms. We continuously support numerous cultural initiatives and projects, and the main performance of the Dubrovnik trombonists at the Feast of St. Blaise, which is on the UNESCO list of intangible heritage, is certainly one of them, said Valamar.Due to their practicality, trombonists wore uniforms similar to the uniforms of soldiers and hunters for many years, and in 1997 the artist Marin Gozze designed a new uniform solution in accordance with the historical colors and characteristics of the Republic of Dubrovnik. “Today, twenty years later, the time has come to renew our uniforms and with the support of Mr. Gozza we expect an even more beautiful and solemn uniform. The importance of the renewal of uniforms was also recognized by Valamar Riviera, which pays great attention to projects with important cultural significance, and I believe that in 2018 we will perform together in new uniforms.Said Tomislav Macan, president of the Dubrovnik Trombonists.Thus, the celebration of the day of the Dubrovnik trombonists on the day of the patron saint of artillery, St. Barbara, on December 4 was an ideal occasion to complete sketches their new uniforms. Photo: Valamar Riviera Photo: Valamar Rivieralast_img read more

The story of the ban on tyramol in Croatia among the top 5 untruths about the European Union

first_imgYou can read the statement of the European Commission in the attachment. Under the prism of the EU asking us to comply with the laws of the European Union, some cities such as the islands of Mljet and Šolta, Rijeka, Kaštela… have made a ridiculous and insane decision to ban the washing of clothes at home. This year, a lot of media dust has been raised by the insane decision to ban the hanging of laundry on the facades of buildings and houses in some of our cities and municipalities on the coast. Photo: EK Side dish: European Commission / Fact or fiction? The most far-fetched Euromyths of 2019 And this is exactly where the story of the ban on tyramol in Croatia lies, as a deliberate misinterpretation of EU regulations or as untruth. Instead of preserving and nurturing our authentic way and culture of living, we forbid it. Totally against the very essence of tourism and the main motive for travel, where authenticity plays a major role. Photo: European commission However, as it was immediately clear that this is not about harmonization with EU laws, but about a decision based on the law on communal economy means a decision on communal order, it was this decision that the European Commission “laughed” at in its statement. listed the top 5 biggest untruths about the EU this year. last_img read more

Housebuilders face upheaval with new planning guidance

first_imgTo access this article REGISTER NOWWould you like print copies, app and digital replica access too? SUBSCRIBE for as little as £5 per week. Would you like to read more?Register for free to finish this article.Sign up now for the following benefits:Four FREE articles of your choice per monthBreaking news, comment and analysis from industry experts as it happensChoose from our portfolio of email newsletterslast_img