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The weather at the beginning of November and the end of October are going to look very different across the country.Temperatures in the eastern half of the country, except the Northeast, took a big drop and even saw some snow. At the same time, the West Coast was dealing with some record-breaking heat. 311
The RV industry has seen a significant increase in rentals and sales over the summer. One company, RVshare, reported more than a 1,000% increase in rentals.Now, the trend seems to be moving beyond just a summer vacation alternative. Some are turning to it as a new way to home-school and work during this pandemic.Some families are turning these RVs into their primary or secondary homes."I think it is difficult for families to be cooped up," said Julie Partridge.Partridge was already considering making the switch to RV life before the pandemic, but after five months of social distancing and quarantining in her home, she decided to finally do it.She sold the family home and hit the road to live, home-school her kids and work from an RV."Obviously our camper is much smaller than our house,” said Partridge. “Substantially smaller, but you have this vast open world available to you. You feel less cooped up in this camper than you do in this 3,000 square foot house."She also feels the move to full-time RV life this fall will also give her kids a unique educational opportunity."We really want to see the national parks,” said Partridge. “I want my kids to do the park ranger program. I want to use that as their science and social studies curriculum from the road. So, we are really excited about those parts."The Partridge family is just one of many either committing to or newly considering RV life in the fall, according to a survey done by the RV rental company RVshare."We have, from our survey, seen that over 30% of people are considering homeschooling from the road and over 40% of people are considering working from the road and that is something that is new to the industry," RVshare Jon Gray."You have school not opening on time, you have a lot of employers turning to work from anywhere models for the extended future and those things have made it to where RVs are appealing deep into the fall," said Gray.The pandemic has changed so much in our lives. Many people are looking to get away from the uncertainty and continued concern with it. This seems to be one way for some to do that."It is saving us money, it is teaching them lessons, it has really been kind of refreshing," said Partridge. 2224
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 US Supreme Court has ruled in favor of Black Lives Matter protest organizer Deray Mckesson.A Louisiana police officer had sued to hold Mckesson accountable for injuries the officer sustained in 2016 when he was hit by a heavy object.Mckesson didn't throw the object.The person who did is still unidentified.A lower court ruling had allowed the suit to move forward.Critics said the decision would dismantle the Civil Rights era precedent safeguarding the first amendment right to protest.The Supreme Court's decision wiped away the earlier ruling, sending the case back to the lower courts to further review Louisiana law.The justices ruled the case needed more guidance from state courts before important constitutional questions are considered. 758
The United Kingdom says it will be the first to conduct COVID-19 vaccine human challenge trials.It's different than other vaccine studies. People will be deliberately infected with the virus, which speeds up the research process.Pending approval, the process will start in January at a London hospital. It will require about 90 healthy young adults between the ages of 18 and 30.The group 1 Day Sooner has recruited from all over the world, including 3,000 Britons.“If the vaccine works, then ideally, people don't get infected and if people do, then they will be closely monitored and treated, but because these are young and healthy people taking part in the trial, I think, researchers feel comfortable doing so because the risks of death are on par with something like kidney donation for people who are young and healthy,” said Abie Rohrig with 1 Day Sooner.Before researchers test the vaccine, they'll do a characterization study. That's where volunteers are infected by getting a vaccine to determine the right amount of virus to give during the trial.Because of the risk, 1 Day Sooner is advocating for the entire process to be made public.Results could come in May. Even though that's likely after other COVID-19 vaccines are licensed, it's still important because we need billions of doses and because of the unique data human challenge trials provide.“Researchers can understand how the virus works in the human body. They can understand the biological markers of immunity. In fact, much of our understanding of other types of coronaviruses come from challenge studies that were conducted in the 1960s in Britain,” said Rohrig.Human challenge volunteers are paid and monitored for at least a year after. 1722