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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 Wounded Warrior Project has released its 2017 survey results. The organization says the survey was completed by 34,000 veterans this year. The results showed that more injured veterans are trusting the Department of Veterans Affairs for health care concerns.The results also showed that more warriors are gainfully employed than in past years.Below are some of the challenges faced by veterans who were surveyed.  445

The way lawyers for Kyle Rittenhouse tell it, he wasn’t just a scared teenager acting in self-defense when he shot to death two Kenosha, Wisconsin, protesters. He was a courageous defender of liberty, a patriot exercising his right to bear arms amid rioting in the streets.The dramatic rhetoric has helped raise nearly million to pay for the 17-year-old’s defense against homicide charges in the killing of two protesters, and wounding of a third. The shootings happened on the third night of demonstrations following the police shooting of Jacob Blake. “A 17-year-old citizen is being sacrificed by politicians, but it’s not Kyle Rittenhouse they are after. Their end game is to strip away the constitutional right of all citizens to defend our communities,” says the voice-over at the end of a video released this week by a group tied to Rittenhouse’s legal team.But some legal experts say there are risks in turning a fairly straightforward self-defense case into a sweeping political argument that could play into a stereotype that he is a gun-crazed militia member out to start a revolution.“They’re playing to his most negative characteristics and stereotypes, what his critics want to perceive him as — a crazy militia member out to cause harm and start a revolution,” said Robert Barnes, a prominent Los Angeles defense attorney.Rittenhouse’s high-profile defense and fund-raising teams, led by Los Angeles-based Pierce and Atlanta attorney Lin Wood, respectively, refused to speak to The Associated Press about their strategy ahead of the teen’s next court appearance Friday, a hearing in Illinois on whether to return him to Wisconsin.Earlier this week, a new lawsuit claims Facebook promoted conspiracy theories among the members of militia groups and is responsible for a series of shootings in Kenosha that left protesters dead in the days following the shooting of Jacob Blake. 1902

The U.S. Department of Agriculture (USDA) says it has identified some of the seeds that were mysteriously mailed to Americans from China.Osama El-Lissy, with the Plant Protection program of USDA's Animal and Plant Health Inspection Service, says 14 different species of seeds have been identified.The identified seeds include mustard, cabbage, morning glory, mint, sage, rosemary, lavender, hibiscus and roses, according to El-Lissy.Over the past few months, people across the country have received the seeds in unsolicited packages that appear to be coming from China.Officials are concerned that some of the seeds received in the U.S. could be invasive plant species, but the seeds identified so far appear to be harmless.Still, if you get unsolicited seeds in the mail, the USDA says you should not open the packets or plant the seeds. You’re asked to save the seeds and the package they came in, place everything in a mailing envelope, and contact your state plant regulatory official or APHIS State plant health director for instructions on where to send the package.The USDA says it’s important to evaluate the seed packages because they could carry seed born viruses or other diseases, posing a significant risk for U.S. agriculture and natural resources.“Imported vegetable or agricultural seed must meet labeling and phytosanitary requirements and be inspected by APHIS and CBP at the port of entry,” wrote the USDA in a release. “Some seeds, including citrus, corn, cotton, okra, tomato, and pepper seed, are restricted and may require an import permit, phytosanitary certificate, inspection at a USDA Plant Inspection Station, or testing to ensure any potential risks are mitigated.”While the USDA is still investigating why the seeds are being sent, officials say they don’t have any evidence that it’s anything other than an internet “brushing scam,” where sellers send unsolicited items to unsuspecting consumers and the post false reviews to boost sales.“Brushing scams involving seed packets in international mail shipments are not uncommon,” wrote the USDA in a release. “U.S. Customs and Border Protection (CBP) has intercepted similar seed shipments in recent years.” 2194

The second night of the Republican National Convention was one that featured three Trumps not named Donald, and also had its share of controversy.Before Tuesday’s festivities commenced, the Republican Party booted Mary Ann Mendoza from its slate of speakers following an anti-Semitic remark on Twitter. The evening also included an address from current Secretary of State Mike Pompeo, who became the first active secretary of state in recent times to speak at a major political convention, prompting questions from Democrats whether the speech was a violation of government ethic rules.President’s family takes center stage at RNCTwo of President Donald Trump children, along with his wife Melania, were featured during Tuesday’s portion of the convention. Their speeches followed one given by Trump’s son Donald Trump Jr. on Monday.While generally the family of candidates avoid partisan attacks, Eric Trump went after after Joe Biden and the Democrats.“He is a career politician who has never signed the front of a check and does not know the slightest thing about the American worker or the American business,” Eric Trump said.Tiffany Trump, who graduated from law school earlier this year, related to those struggling to find work amid the coronavirus pandemic."Like so many students across the world, I graduated from law school during the pandemic,” Tiffany Trump said. “As a recent graduate, I can relate to so many of you who might be looking for a job. My father built a thriving economy once, and believe me... he will do it again."The evening concluded with remarks from First Lady Melania Trump, who spoke from the newly-remodeled White House Rose Garden.Melania Trump also acknowledged the impact the coronavirus has had on the US, which has claimed nearly 180,000 American lives, and the jobs of millions of Americans.“I want to acknowledge the fact that since March, our lives have changed drastically,” the first lady said. “The invisible enemy, COVID-19, swept across our beautiful country. And impacted all of us. My deepest sympathy goes out to everyone who has lost a loved one and my prayers are with those who are ill or suffering. I know many people are anxious and some feel helpless. I want you to know you are not alone."Unlike her stepson Eric, Melania said she would not attack Joe Biden.“I don't want to use this precious time attacking the other side, because, as we saw last week, that kind of talk only serves to divide the country further,” she said.Trump hosts citizenship ceremony at the White HouseIn an unusual sight that mixed politics and official business, the president hosted a citizenship ceremony for five permanent residents turned citizens.“Today America rejoices as we welcome five absolutely incredible new members into our great American family. You are now fellow citizens of the greatest nation on the face of God’s earth. Congratulations," Trump told the new US citizens.To Trump, the moment reflected an opportunity to promote legal immigration over those who come to the US illegally.“You followed the rules, you obeyed the laws, you learned your history, embraced our values, and proved yourselves to be men and women of the highest integrity,” Trump said. “It’s not so easy. You went through a lot, and we appreciate you being here with us today.”Anti-abortion speaker in Twitter spat during RNCAbby Johnson, a former employee of Planned Parenthood who spoke out against the organization, was in the midst of a Twitter war moments before she spoke during the RNC.Johnson said that she stood by comments she previously made that voting should only be open to the head of the household.In May, Johnson tweeted, "Then they would have to decide on one vote. In a Godly household, the husband would get the final say."“Yes. So shocking! A husband and wife who are in agreement and a wife who honors her husband as the head of the home. Gasp!! What a weird, biblical concept,” Johnson tweeted on Tuesday in response to the May tweets.Johnson later added, “I would never try to prevent women from voting.” 4062