昌吉切包皮术疼不疼(昌吉请问割包茎多少钱) (今日更新中)

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 topic of a condom snorting challenge is going viral on social media, and like the Tide pod challenge, there is a huge safety risk.Who's doing this challenge? It isn't clear ... it's the topic that appears to be viral for now. Still, there are plenty of videos of people taking part on YouTube.It's a trend parents may be adding to the list when watching for their kids taking part in the dangerous challenges often making their ways around social media and sometimes in schools. 495

The White House on Monday blamed Hamas for the deaths of 52 Palestinians who were killed by Israeli security forces during mass protests in Gaza on Monday."The responsibility for these tragic deaths rests squarely with Hamas," White House deputy press secretary Raj Shah said. "Hamas is intentionally and cynically provoking this response and as the secretary of state (Mike Pompeo) said, Israel has a right to defend itself."Pressed repeatedly on whether Israel bears any responsibility and asked whether Israel should show more restraint, Shah again pointed the finger at Hamas -- seemingly absolving Israel of responsibility."We believe that Hamas is responsible for these tragic deaths," Shah said, adding that the terrorist group bears "responsibility for the entire situation right now."The 52 deaths on Monday came on the 70th anniversary of Israel's independence while a delegation of US officials joined Israeli leaders to mark the opening of the new US embassy in Jerusalem. Trump's decision to recognize Jerusalem as Israel's capital and move the US embassy to the city in December has ratcheted up tensions in the region, where Israelis and Palestinians have competing claims to the holy city. The city is home to holy sites from three major religions: Christianity, Judaism and Islam.Israeli forces used lethal and nonlethal means on Monday in an attempt to disperse mass protests that took place at the security fence between Gaza and Israel, which included some Palestinians attempting to cross into Israel.Tuesday marks the "Nabka," or Catastrophe, which remembers the 700,000 Palestinians who were driven from, or left, their homes during the Arab-Israeli war that came with the creation of the Israeli state. 1734

The University of Washington’s Institute for Health Metrics and Evaluation now projects that 67,000 American lives would be saved between now and December 1 by near universal wearing of masks.The IHME released the updated model on Thursday. As part of the update, the IHME said that four states, Arizona, Florida, Mississippi, and South Carolina, have hit an important metric of a daily death rate of eight per one million residents, and that those states should re-impose statewide closures of non-essential businesses.The IHME’s coronavirus projections have been frequently cited in the past by the White House’s coronavirus task force. The group uses state data along with other metrics to create projections on the number of coronavirus-related deaths throughout the US.The model projects with inconsistent use of masks, the US death toll for the coronavirus will be up to 295,000 by December 1, an increase from the current figure of 158,000, per Johns Hopkins University data. The IHME’s projections drops considerably to 228,000 if masks are worn universally outside of the home.IHME director Dr. Christopher Murray said at a news conference on Thursday that mask wearing mandates work, but communities also respond when they see cases are spreading.“People do respond to the circumstances in their community,” Murray said. “Mandates have an important effect.”One thing the model does not take into account is the use of therapeutics of a possible vaccine. Murray said that the IHME is closely monitoring the effectiveness of two potential therapeutics – remdesivir and dexamethasone – and may adjust future models as more is learned about those drugs.The model expects the number of coronavirus-related deaths to ebb and flow into the fall, but begin to increase by November. "November is a month we expect the spread to increase due to seasonality," Murray said. We are expecting considerable daily deaths. That pushes up our projections."“We expect it rise later in the fall,” Murray added.One cause for concern comes at the end of November when families begin to travel for holidays such as Thanksgiving.Murray said that while mask-wearing is not necessary when around family members of the same household, he said mask-wearing may be necessary for holiday gatherings. Murray said his family is taking the recommendation one step further, and is simply not gathering with extended relatives this fall.What’s built into the IHME’s projection is that a number of states will need to implement stricter closures in order to slow the spread. As part of the IHME’s recommendation, states implement closures of non-essential businesses when there is a threshold of eight deaths a day per million. Also part of the modeling is based on 50% of schools being closed in each state for the upcoming year. Murray said with many schools opening or implementing hybrid models, more will be learned in the coming weeks on how easily the virus spreads within schools.Recent measures in Arizona, California, Florida, and Texas has allowed a small decline in cases, but deaths in those states have not dropped off, according to Murray.“We have been seeing cases peaking and hospitalizations peaking and deaths not quite yet peaking, but we expect them to peak in the near future but we don’t expect a sharp decline," Murray said.To see a state-by-state breakdown of the IHME’s projections, click here. 3403

The Trump campaign has dropped a central part of its lawsuit that seeks to delay the certification of election results in Pennsylvania, the state which proved to be the tipping point for Joe Biden in clinching the presidency.On Sunday, the Trump campaign dropped a portion of a lawsuit that alleged that more than 600,000 mail-in and absentee ballots were processed without Republican poll-watchers present. The claim has been a central part of President Donald Trump's argument that the 2020 election has been beset by widespread voter fraud.The Trump campaign's lawsuit now only focuses on claims that Republicans were "illegally disadvantaged" because some voters in Democratic-leaning counties were afforded the ability to fix mistakes on their mail-in ballots, a process called "curing." The Washington Post reports that the issue would likely only affect a small number of votes.Ballot curing is a process that takes place in several states. According to The Associated Press, there is no provision in Pennsylvania state law that prevents counties from affording voters the opportunity to cure ballots.Biden currently holds a lead of about 70,000 votes over Trump, with nearly all of the votes counted.Despite his campaign's altered lawsuit, Trump on Sunday continued to claim on Twitter — without providing evidence — that poll watchers "were thrown out of vote counting rooms in many of our States."Late Sunday evening, Trump tweeted, "I WON THE ELECTION!" a claim that quickly prompted Twitter to add a clarification to his message clarifying that "official sources have called this election differently." 1622

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