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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 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. has now recorded more than 3 million new cases of COVID-19 in the month of November alone, according to a database kept by Johns Hopkins University.According to Johns Hopkins, the U.S. has recorded at least 3.1 million cases of COVID-19 since Nov. 1 — more than 25% of all the cases the country has seen since the pandemic began.The spike in cases has led to a concerning jump in virus-related hospitalizations across the country. According to the COVID Tracking Project, more than 83,000 people across the country are currently battling the coronavirus in a hospital — the most the country has seen since the pandemic began. The COVID Tracking Project reports that while the entire country is seeing a spike in hospitalizations, the Midwest and South have been hit particularly hard — 69% of all COVID-19 hospitalizations across the country have occurred in those two regions.The spike has led to a concerning increase in hospital resources. In some rural hospitals in the Upper Midwest, there aren't beds to spare.The COVID Tracking Project also reports that there has been a significant uptick in deaths since the start of November. Since Oct. 31, the 7-day average of daily deaths has increase from 810 to 1,470. The current rate of deaths per day hasn't been seen in the U.S. since mid-May. The concerning spike occurs as much of the country sees the weather turn colder ahead of winter months, and comes as Americans prepare to celebrate the holiday season — something health officials warn could further facilitate the spread of the virus. The CDC has recommended that Americans not travel to celebrate Thanksgiving with loved ones and recommends against hosting large gatherings this year.It also comes as several drug companies, including AstraZeneca, Moderna and Pfizer have all reported encouraging results from their COVID-19 vaccine trials. While the companies are all pre-producing millions of doses of the drugs prior to authorizaiton, health experts say they likely won't be widely available until spring 2021. 2049
The US Centers for Disease Control and Prevention warned US consumers on Tuesday to not eat romaine lettuce, as it may be contaminated with E. coli.Thirty-two people, including 13 who have been hospitalized, have been infected with the outbreak strain in 11 states, according to the CDC. One of the hospitalized people developed hemolytic uremic syndrome, a potentially life-threatening form of kidney failure. No deaths have been reported.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.The Public Health Agency of Canada has identified an additional 18 people who have become sick with the same strain of of E. coli in Ontario and Quebec.If you have any romaine lettuce at home, you should throw it away, even if you have eaten some and did not get sick, the CDC cautioned."This advice includes all types or uses of romaine lettuce, such as whole heads of romaine, hearts of romaine, and bags and boxes of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad," the CDC said in its announcement.All types and brands of romaine lettuce are suspect because no common grower, supplier, distributor or source company has been identified by the CDC.Retailers and restaurants also should not serve or sell any until more is known about the outbreak.Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the US Food and Drug Administration, which is also investigating the outbreak. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill.Illnesses started in October. This outbreak is not related to a multistate outbreak linked to romaine lettuce this summer.The-CNN-Wire 2311
The US attorney based in Pittsburgh has started the process to seek the death penalty for the man accused of killing 11 worshippers at a synagogue Saturday, an assault during Shabbat services that reverberated across the country and around the world.On Monday, suspected gunman Robert Bowers was brought into federal court in a wheelchair for his first appearance. Wearing a blue shirt and handcuffs -- which US marshals removed so he could sign paperwork -- he spoke only to answer questions from the judge.The shooting struck the heart of historically Jewish Squirrel Hill and spurred sadness and anger as citizens learned the names of those gunned down by the killer."It's hard to understand how significant these losses are to our community unless you understand the significance and intimacy of Squirrel Hill," said Tree of Life congregant Jesse Rabner said."The community is knit so tight that one life affects thousands. It's a norm to be Jewish in Squirrel Hill, and it's a loving and peaceful community."Rabbi Hazzan Jeffrey Myers with Tree of Life said his synagogue will rebuild and "be back stronger and better than ever.""You can cut of some branches from our tree, but Tree of Life has been in Pittsburgh for 154 years. We're not going anywhere," the rabbi told CNN's "New Day" on Monday. "I will not let hate close down my building."Attorney General Jeff Sessions must ultimately give the OK to pursue the death penalty for the alleged gunman, Robert Bowers, the Justice Department said. The attack was the deadliest against Jews in US history."At this point in our investigation, we're treating it as a hate crime," Scott Brady, the US attorney for the Western District of Pennsylvania, said Sunday.When asked if the shooting could be considered an instance of domestic terrorism, Brady said there would need to be evidence the suspect tried to propagate a particular ideology through violence.In an address on Monday in Boston, Sessions labeled the assault a "murderous rampage" and said, "This was not just an attack on the Jewish faith. It was attack on all people of faith, and it was an attack on America's values of protecting those of faith. It cannot, it will not, be tolerated."Sessions said authorities will conduct the case "with vigor and integrity.""He'll be subjected to the death penalty perhaps," the attorney general said of the suspect.Bowers is expected back in court for a preliminary hearing Thursday morning. While two public defenders appeared with him in court Monday, the lawyer or lawyers who will handle his case going forward have yet to be appointed. He is being without bond.Brady will present the case to a federal grand jury within 30 days, he said. 2711