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The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274

The stock market is on the comeback trail.After another wobbly session, the Dow soared 287 points, or 1.2%, on Friday. It was the index's best day since August.The Dow had soared 400 points at the open before giving up most of those gains and then resuming its rally. The Dow lost 1,378 points over Wednesday and Thursday.The broader S&P 500 jumped 1.4% on Friday. The Nasdaq, which has taken the brunt of the recent stock market turbulence, spiked 2.3%.Despite Friday's rebound, all three major indexes suffered their worst weeks since March. And the S&P 500 is down three straight weeks. That hasn't happened since the Brexit referendum of June 2016.Investing experts weren't exactly sure what turned stocks negative by midday. The driving forces behind this week's downturn -- trade war and interest rate fears -- were around before this week, and yet market volatility is spiking."The sellers have control right now," said Justin Walters, co-founder of Bespoke Investment Group. "The scariest sell-offs are the ones you can't tie to a specific reason."Stocks had turned sharply south over the past week because investors are concerned about rising interest rates. As the Federal Reserve raises rates to keep the economy from overheating, investors have been getting out of bonds, driving down their price and driving up their yields. Suddenly, the return on bonds has become competitive with some stocks — particularly risky tech stocks.Rising interest rates also increase borrowing costs for households and businesses, eating into corporate profits."What we are seeing now is changing sands. The ground isn't stable and people are figuring out where to go next," said JJ Kinahan, chief market strategist with TD Ameritrade.Tech stocks have come under fire because they are some of the riskiest and most expensive parts of the market. Investors fear that tech companies may not hold up well in a downturn, particularly as interest rates spike. A proxy for the tech sector had its sharpest plunge in seven years on Wednesday.But Big Tech on Friday regained some of its losses. Facebook (FB), Apple (AAPL), Amazon (AMZN), Netflix (NFLX) and Google (GOOGL) were all up.Asian and European markets also came back Friday. The Hang Seng soared 2.2%. Stocks in Shanghai rose 0.9% and the Nikkei rose 0.5%. Stocks in London, Germany and France all rose about a half percentage point.Markets had bounced back Friday morning following news that President Donald Trump plans to meet next month with Chinese leader Xi Jinping at the G-20 summit. That eased some of the investors' fears about another trade war escalation. China also reported its exports rose nearly 15% in September, stronger than expected. That suggests China is weathering the first waves of new tariffs that the Trump administration imposed on billion of Chinese exports this summer.But Kinahan is still worried about US-China trade talks. He thinks that a deal is key in order for the markets to get back on track, adding that a full-blown trade war could undo much of the positives from the Trump administration's pro-business policies."The concern is that if nobody blinks, it could negate all the tax cuts we had," he said.Earnings season also kicked off Friday morning, with JPMorgan (JPM) and Citigroup (C) reporting their quarterly finances before the bell. Wall Street analysts expected the financial sector to post another incredibly profitable quarter — and JPMorgan managed to?beat their already lofty expectations.In times of market turbulence, there's nothing like soaring profits to calm investors' nerves.Rebounds after disastrous market selloffs are common. Investors who think the market may be oversold look to buy stocks they think are suddenly cheap.But markets are fickle. 3804

The Susan B. Anthony Museum has something to say about President Trump’s recent decision to pardon the suffragette.“Objection! Mr. President, Susan B. Anthony must decline your offer of a pardon today,” the museum’s President and CEO Deborah Hughes posted online.President Donald Trump announced Tuesday that he would sign a pardon for Susan B. Anthony on the 100th anniversary of the ratification of the 19th Amendment.Anthony voted in a presidential election in 1872. She was arrested about a week later and eventually convicted of "knowingly, wrongfully, and unlawfully" voting without the right to do so. She was fined 0. 636

The Trump administration supports reopening schools this fall, in addition to sending 125 million reusable masks to school districts they released new guidance this week for districts to reopen safely.The Schools Should Reopen Safely policy is based on three assumed facts by the administration: that prolonged school closures cause harm, children are at low risk for serious illness from Covid-19, and that educating children is a top national priority.President Trump attended a discussion Wednesday about getting children back to school where the policy was discussed with administration leaders, medical experts and educators. Some of the speakers referenced how the coronavirus pandemic has provided an experiment for virtual learning.“But the virtual learning is not like being in a classroom, and we’ve learned that, I think, very strongly — in almost all cases. People thought for a long time that would be the answer but it’s — that’s not the answer. The answer is an old-fashioned one,” President Trump said.The recommendations encourage the use of masks and social distancing, as well as educating students, teachers and staff about Covid-19 symptoms. They follow guidance released earlier this year from the Centers for Disease Control and Prevention.The document lists eight recommendations for schools:Ensure all students, teachers, and staff understand the symptoms of COVID-19 and its risk factors.Require all students, teachers, and staff to self-assess their health every morning before coming to school; if they are symptomatic they should consult their physician.Encourage frequent handwashing or hand sanitizing during the school day, beginning upon entrance to the school, by ensuring that handwashing facilities are widely available throughout the school.Minimize large indoor group gatherings; hold large gatherings outdoors whenever possible.Maintain high standards of hygiene and ventilation within all classrooms, including keeping windows and doors open and running fans and AC units whenever possible.Require students, teachers, and staff to socially distance around high-risk individuals.Encourage the use of masks when social distancing is not possible.Liberally post instructions regarding hygiene and social distancing around the school.There are also recommendations for high-risk teachers and students, including giving these individuals options to stay home.“Provide high-risk students, or students who have high-risk family members, the choice to stay home and engage in distance learning,” the guidance states.The policy is a set of recommendations and not mandatory for schools to reopen. States and districts are able to make their own decisions. 2694

The terms "signing bonus: and "recruiting" are usually reserved fro top-paid professional athletes. Now add nurses to that list.Hospitals across the country are facing a shortage of nurses, and they're stepping up the incentives to fill the jobs.Patients aren't the only ones happy that Christina Predo is working at UCHealth. After all, the hospital gave her a ,000 signing bonus as an incentive to take the job."Other offers before that hadn't even come close," Predo said.Predo needed to find a job where her husband was being relocated. With several offers on the table, in the end it was UCHealth's signing bonus and other perks that sealed the deal."They offered all sorts of help to help move here," Predo said. "They offered someone to actually find me a neighborhood to live in which was awesome. None of the other hospitals actually offered to do that."What's behind the big bonuses? A shortage of nurses. With more than 500,000 seasoned registered nurses expected to retire by 2022, there's a projected need for 1.1 million new nurses to avoid a shortage.Hospitals across the country, including UCHealth, are feeling that crunch already."Well I'll tell you what, we have about 300 positions open," said Kathy Howell, Chief Nursing Executive at UCHealth.Howell says growth has created a greater demand for nurses, and a good economy means more nurses are opting to retire. That's why there's a concerted effort to make the offer to work at UCHealth as attractive as possible, even allowing out-of-state nurses to try out the hospital for a year and covering their housing costs."They go from assignment to assignment within our health system," Howell says. "We also give them a housing stipend, and we usually convert between 35 and 40 percent of them to full-time employees."Most new nurse hires get around ,000 to sign, which Howell doesn't think is out of line."When you look at what turnover of nurses costs and what not having the right nursing complement is to your hospital," Howell says. "That is a very reasonable investment."Ultimately, Howell says it's about delivering the right care to patients, and creating the right environment for the nurses they hire."It's a real comradery. Everyone is super super nice, you really have a say in what you're doing here, your opinion actually matters you don't feel like a number," Predo said.A new way to fill the need for nurses, with a payoff, multifold. 2476

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