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The U.S. will pay drug company Pfizer .95 billion to produce and deliver 100 million doses of the company's COVID-19 vaccine candidate should the drug prove effective in human trials the company said in a press release on Wednesday.Pfizer will deliver the vaccine if and when the drug receives Emergency Use Authorization from the FDA after a large-scale Phase 3 trial.According to the reports, the deal includes an option for the government to purchase an additional 500 million doses of the vaccine.“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” Health and Human Services Sec. Alex Azar said in a statement. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”Pfizer and German firm BioNTech are working together to develop the vaccine.On Monday, Pfizer said in a press release that results from Phases 1 and 2 of a German trial indicated that the drug "could potentially be administered safely, with a manageable tolerability profile," according to data from the tests.Biotech company Moderna is also working to develop a coronavirus vaccine. That candidate will move into Phase 3 testing by the end of the month, and the government has also agreed to purchase and distribute the drug should the large-scale test prove effective. 1497

The Trump administration on Thursday imposed penalties on 17 individuals over their alleged roles in the killing of dissident journalist Jamal Khashoggi.The fresh sanctions from the Treasury Department come hours after Saudi prosecutors said they would seek the death penalty for five people charged in the death of Khashoggi, who was a contributor to The Washington Post."The Saudi officials we are sanctioning were involved in the abhorrent killing of Jamal Khashoggi," said Treasury Secretary Steven Mnuchin in a statement. "These individuals who targeted and brutally killed a journalist who resided and worked in the United States must face consequences for their actions."The secretary said the US government would work "diligently" to obtain all the facts on the death of Khashoggi and hold "accountable" any individual found responsible."The Government of Saudi Arabia must take appropriate steps to end any targeting of political dissidents or journalists," he said.Mnuchin had previously told reporters it would be "premature" to discuss whether the US would impose sanctions on the Saudi government.Earlier on Thursday, the Saudi Public Prosecutor's office said a total of 11 people were charged, adding that the five people facing capital punishment were directly involved in "ordering and executing the crime."The prosecution also shared details of the journalist's murder, saying Khashoggi was killed on October 2 following "a fight and a quarrel" at the Saudi consulate in Istanbul. Prosecutors say Khashoggi was tied up and injected with an overdose of a sedative that killed him, then his body was chopped up and given to a local collaborator. 1668

The US officially relocated its embassy to Jerusalem on Monday, formally upending decades of American foreign policy in a move that was met with clashes and protests along the Gaza-Israeli border.Here is what we know: 225

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 U.S. Surgeon General is talking about structural racism, saying it's partly why the coronavirus has disproportionately affected Black and Latino Americans.Surgeon General Jerome Adams plans to focus on two initiatives soon, high blood pressure and maternal mortality, which is women dying from pregnancy or childbirth issues.The office plans to put out science-based summaries designed to create urgent action on both issues that disproportionately affect communities of color.Earlier this month, the Institute for Health Metrics and Evaluation declared racism a public health crisis.“Racism is a public health issue,” said Dr. Ali Mokdad with the Institute for Health Metrics and Evaluation. “I’ve been on record saying it’s more dangerous than COVID-19, simply because we're going to find a vaccine for COVID-19.”They are currently working with the National Institutes of Health on providing data down to the county level of the burden of disease by race.Mokdad used life expectancy as an example. He says within a county there are high disparities, sometimes 15 years less based on where minorities or lower income people live.“Provide data in order to tell people this is what we see. These are the problems, keeping in mind you cannot change what you cannot measure,” said Mokdad.The CDC is also now requiring states to collect data about race, ethnicity, gender, and zip code for coronavirus cases.Racism in healthcare affects everyone, socially and economically.“What people don’t realize is we are paying for it one way or another and right now when you look at the United States, we spend more money on health than every other country,” said Mokdad.Mokdad and other health professionals we talked to all pointed to universal health care as another obvious solution to addressing structural racism. 1818