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The E. coli outbreak linked to romaine lettuce has sickened 43 people in 12 states, the US Food and Drug Administration said Monday.The FDA said that the ongoing outbreak is linked to the "end of season" harvest in some parts of California -- but the agency still says people should not eat any romaine lettuce.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.An additional 22 people in Canada are also ill, so the FDA is coordinating its investigation with the Canadian health and food safety authorities, the agency said.When the outbreak was announced last week, the FDA and the Centers for Disease Control and Prevention warned consumers to stay away from all romaine lettuce, but the FDA said the investigation was focused on California and Mexico."Over the Thanksgiving holiday, the FDA continued to investigate the outbreak," according to a statement from FDA Commissioner Dr. Scott Gottlieb. "Our investigation at this point suggests that romaine lettuce associated with the outbreak comes from areas of California that grow romaine lettuce over the summer months, and that the outbreak appears to be related to 'end of season' romaine lettuce harvested from these areas. The involved areas include the Central Coast growing regions of central and northern California."Lettuce growing and harvesting in the winter months is taking place in California and Arizona's desert regions and Florida, as well as Mexico. Currently, the FDA investigation does not implicate lettuce from any of these areas.While the romaine supply undergoes a "clean break" to ensure all the contaminated lettuce is effectively gone from the market, the FDA has asked producers and distributors to provide clear labeling with the lettuce's date and origin in the future.A task force within the lettuce industry has also been established to determine better solutions for labeling long-term in order to help with tracing."Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date," Gottlieb said. "Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown. If it does not have this information, you should not eat or use it."If consumers, retailers and food service facilities are unable to identify that romaine lettuce products are not affected -- which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation -- we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase."Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the FDA. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill. 3450

The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256

The first experimental COVID-19 vaccine in the U.S. is on track to begin a huge study next month to prove if it really can fend off the coronavirus, while hard-hit Brazil is testing a different shot from China.Where to do crucial, late-stage testing and how many volunteers are needed to roll up their sleeves are big worries for health officials as the virus spread starts tapering off in parts of the world.Moderna Inc. said Thursday the vaccine it is developing with the National Institutes of Health will be tested in 30,000 people in the U.S. Some will get the real shot and some a dummy shot, as scientists carefully compare which group winds up with the most infections.With far fewer COVID-19 cases in China, Sinovac Biotech turned to Brazil, the epicenter of Latin America’s outbreak, for at least part of its final testing. The government of S?o Paulo announced Thursday that Sinovac will ship enough of its experimental vaccine to test in 9,000 Brazilians starting next month.If it works, “with this vaccine we will be able to immunize millions of Brazilians,” said S?o Paulo′s Gov. Joao Doria.Worldwide, about a dozen COVID-19 potential vaccines are in early stages of testing. The NIH expects to help several additional shots move into those final, large-scale studies this summer, including one made by Oxford University that’s also being tested in a few thousand volunteers in Brazil.There’s no guarantee any of the experimental shots will pan out.But if all goes well, “there will be potential to get answers” on which vaccines work by the end of the year, Dr. John Mascola, who directs NIH’s vaccine research center, told a meeting of the National Academy of Medicine on Wednesday.Vaccines train the body to recognize a virus and fight back, and specialists say it’s vital to test shots made in different ways — to increase the odds that at least one kind will work.Sinovac’s vaccine is made by growing the coronavirus in a lab and then killing it. So-called “whole inactivated” vaccines are tried-and-true, used for decades to make shots against polio, flu and other diseases — giving the body a sneak peek at the germ itself — but growing the virus is difficult and requires lab precautions.The vaccine made by the NIH and Moderna contains no actual virus. Those shots contain the genetic code for the aptly named “spike” protein that coats the surface of the coronavirus. The body’s cells use that code to make some harmless spike protein that the immune system reacts to, ready if it later encounters the real thing. The so-called mRNA vaccine is easier to make, but it’s a new and unproven technology.Neither company has yet published results of how their shots fared in smaller, earlier-stage studies, designed to check for serious side effects and how well people’s immune systems respond to different doses.Even before proof that any potential vaccine will work, companies and governments are beginning to stockpile millions of doses so they can be ready to start vaccinating as soon as answers arrive.In the U.S., a program called “Operation Warp Speed” aims to have 300 million doses on hand by January. Under Brazil’s agreement with Sinovac, the Instituto Butantan will learn to produce the Chinese shot.___AP journalist Marcelo Silva de Sousa contributed to this report.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 3499

The excitement of two COVID-19 vaccines with more than 90 percent efficacy is undeniable.In November, both Pfizer and Moderna announced its scientists had developed vaccines with efficacy at or near 95 percent, but scientists are warning these vaccines are not the "silver bullet" to ending the pandemic.“We don’t want to give the public the impression that there’s an emergency use authorization and these vaccines become available in a small amount in December and we can go back to our pre-pandemic behavior,” said William Moss, executive director of the International Vaccine Access Center at Johns Hopkins.In June, the FDA released its vaccine guidelines, saying it would consider emergency use authorization for any vaccine testing with at least 50 percent effectiveness, so there is a reason for celebration, according to Moss, but only after certain questions about the vaccine are answered.Dr. Anthony Fauci has said the initial vaccines will prevent symptoms in those who become infected, rather than kill the virus itself. Moss says that means immunized people might be able to spread COVID-19 to others.He also wonders how long immunization will last. One year? Three years? Will booster doses be needed? They're all careful considerations that will only emerge once one is put into play, according to Moss.“It’s obviously tragic that the [COVID] cases are occurring that quickly, but it does help a vaccine trial because otherwise you just have to wait that much longer for samples to come in,” said Moss.The vaccine process has innovated how scientists and researchers approach these types of situations, however, according to Moss.In traditional vaccines, a small dose of the virus is injected into the body so the immune system can create antibodies. In the COVID-19 vaccine, though, both Moderna and Pfizer have used what is called messenger RNA (mRNA) where the virus’ genetic code is injected into the body so it can instruct cells on what antibodies to produce. Scientists say this way is faster, safer, and can create a stronger immune response as people are not exposed to the virus.“I suspect that if this all goes well and these vaccines are safe and continue to demonstrate 90 to 95 percent efficacy, we’re going to see other vaccines of a similar type,” said Moss. 2298

The exhibition fight between former heavyweight boxing champion Mike Tyson and Roy Jones Jr. has a new date.According to a press release by Triller, the 8-round showdown was slated for Sept. 12 but has been pushed back to Nov. 28."Changing the date to November 28 will give more people the opportunity to see the biggest comeback in boxing history," Tyson said in the news release. "This temporary inconvenience will last longer than Roy Jones Jr. He better be ready, I'm coming full force."New fights on the undercard were also announced. Badou Jack will face off against Blake McKernan and Viddal Riley will take on Rashad Coulter as they join the previously-announced bout between Youtube star Jake Paul vs. former NBA player Nate Robinson."Given the enormous interest, the holiday weekend will make this historic battle an even bigger viewing event, marking the first live Pay-Per-View event brought to the world by Triller as the first of the "Triller Battles" series," Triller said in the release.The full fight card:MAIN CARDMain EventMike Tyson vs. Roy Jones Jr.8 rounds - HeavyweightFeatured Bout 2Jake Paul v. Nate Robinson6 rounds - 188lbsFeatured Bout 3Badou Jake vs. Blake McKernan8 rounds - 192lbsFeatured Bout 4Vidal Riley vs. Randy Coulter6 rounds - 210lbsUNDERCARDBout 5Jamaine Ortiz v. Jesse Garcia8 rounds - 135lbsBout 6Irvin Gonzalez vs. Edward Vasquez8 rounds - 140lbsBout 7Giuseppe Cusumano vs. Nick Jones8 rounds - HeavyweightThe event is to take place at Dignity Health Sports Park in California and the California State Athletic Commission is sanctioning the bout.The "Frontline Battle" will be available to watch on Pay-Per-View and the social media platform Triller. 1701

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