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The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256

The European Union has announced it will reopen its borders to travelers from 14 countries, but most Americans have been refused entry for at least another two weeks due to soaring coronavirus infections in the U.S. Travelers from other big countries like Russia, Brazil and India will also miss out. Citizens from the following countries will be allowed into the EU’s 27 members and four other nations in Europe’s visa-free Schengen travel zone: Algeria, Australia, Canada, Georgia, Japan, Montenegro, Morocco, New Zealand, Rwanda, Serbia, South Korea, Thailand, Tunisia and Uruguay. The EU said China is “subject to confirmation of reciprocity,” meaning it must lift all restrictions on European citizens entering China before it will allow Chinese citizens back in.Tuesday’s decree will not apply to travel to Britain, which left the EU in January. Britain now requires all incoming travellers — bar a few exceptions like truck drivers — to go into a self-imposed 14-day quarantine, although the measure is under review and is likely to ease in the coming weeks. The requirement also applies to U.K. citizens.The list of permitted nations is to be updated every 14 days, with new countries being added or even dropping off depending on if they are keeping the disease under control.The daily number of new confirmed cases in the United States has surged over the past week. The U.S. has the world’s worst coronavirus outbreak, with nearly 2.6 million people confirmed infected and over 126,000 dead, according to a tally by Johns Hopkins University that experts say understates the pandemic’s true toll due to limited testing and other reasons.In March, President Donald Trump suspended all people from Europe’s ID check-free travel zone from entering the U.S.The EU imposed restrictions on non-essential travel to its 27 nations, plus Iceland, Liechtenstein, Norway and Switzerland, which are part of the Schengen open-borders area, in March to halt the spread of the virus. Non-EU citizens who are already living in Europe are not included in the ban.More than 15 million Americans are estimated to travel to Europe annually, and any delay would be a further blow to virus-ravaged economies and tourism sectors on both sides of the Atlantic. Around 10 million Europeans are thought to cross the Atlantic for vacations and business each year.___Follow AP coverage of the pandemic at https://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak 2475

The death toll from the 6.9-magnitude earthquake that hit the Indonesian island of Lombok more than a week ago has surged to 436, authorities said Monday.The number is expected to rise further as search and rescue efforts continue in the rubble strewn across the island by the quake and another one that struck on August 9.Indonesia's National Disaster Management Agency (BNPB) has been working with the country's military and police to supply aid and food to the 350,000 people displaced by the quakes.As of Monday, 21 tonnes of aid had been delivered on a cargo plane, according to BNPB spokesperson Sutopo Purwo Nugroho. 631

The Camp Fire is just the latest fire tragedy in California. Residents are still rebuilding in Wine Country more than a year after the destructive wildfires there.In the one year since Kelly Bracewell's Santa Rosa home turned to ash, she's figured out how to be happier. She’s also learned how to live without some of her most cherished possessions.As she rebuilds her own home, she works to help others who lost everything."As an interior designer, it’s been a great distraction,” she says.She says she wants to help put the community back together.Another community member, artist Gregory Roberts, is also using his talents to help people heal.One artist is using the ashes to help the people who lost their homes heal.“I was standing in the studio during the fires, and ash was falling all around,” Roberts describes.Roberts was certain that he, too, would lose his home. Fortunately, his house and pottery studio survived, but the ash raining down over Wine Country gave him an idea.“I wanted to be able to give people back something to let them know that your memories are not actually lost; your memories are all still intact,” he says.Roberts started collecting ash from lost homes. Ashes from 140 homes appeared in a plastic bin on his front porch, some with handwritten notes, of people wanting him to create art from their lost homes."Something from their home, because this idea that everything is lost is a hard one to overcome," Roberts says.Roberts says the ash remnants of homes are different, so the patterns and colors are never the same."I really want each one to be sort of its own unique animal,” Roberts says. “In the same way that each person's home is unique." 1691

The Ebola outbreak in the Democratic Republic of Congo's North Kivu province claimed more lives as the country's Health Ministry announced on Thursday a new death in the city of Mabalako.At least 37 people have died so far in this latest outbreak, the 10th for country.Ebola cases have also been reported in the towns of Beni, Butembo, Oicha, Musienene and Mandima, according to Congo's Health Ministry.A total of 44 cases of hemorrhagic fever have been reported in the region, of which 17 are confirmed and 27 are probable, the ministry said in a statement Thursday. An additional 54 suspected cases are under investigation, the ministry said.On Tuesday, the World Health Organization confirmed that the latest cases in Congo's North Kivu province are part of the Zaire strain of the virus and that there is no link to a separate outbreak, which occurred in the western Equateur province that has since been declared over."It's good news and it's very bad news," WHO Deputy Director-General for Emergency Preparedness and Response Peter Salama told journalists in Geneva, after the new cases were first confirmed."The bad news is that this strain of Ebola carries with it the highest case-fatality-rate of any of the strains of Ebola, anywhere above 50% and higher, according to previous outbreaks," he said. "So, it's the most-deadly variant of the Ebola virus strains that we have, that's the bad news. The good news is that we do have -- although it's still an investigational product -- a safe and effective vaccine, that we were able to deploy last time around."According to WHO, this outbreak, which is in an active conflict zone, will be more complicated to contain than any that came before.Experts believe an experimental vaccine, known as rVSV-ZEBOV, made a difference in containing the earlier outbreak and vaccinations are under way in North Kivu, WHO said. A total of 3,220 doses of the vaccine are currently available in Congo and supplementary doses have been requested, WHO said.First line health workers, who had been in contact with people who were confirmed cases of Ebola, were the first to be vaccinated, WHO said."Vaccines are an important tool in the fight against Ebola," Congo's Health Minister, Oly Ilunga, said on Wednesday. "This is why it has been a priority to move them rapidly into place to begin protecting our health workers and the affected population."North Kivu province is among Congo's most populated provinces, with eight million inhabitants, according to WHO and UN. Its capital is the city of Goma. The region has been experiencing intense insecurity and a worsening humanitarian crisis, with over one million internally displaced people and a continuous outflow of refugees to neighboring countries, including Uganda, Burundi and Tanzania.WHO is working with partners in the local communities to provide information to residents on how to protect themselves from the deadly virus and answer their questions -- steps that are crucial to control an outbreak, said WHO.Congo's Health Ministry announced on August 1 that a cluster of new Ebola cases have been confirmed, just days after it declared an outbreak in Equateur province that claimed 33 lives had ended. That outbreak was the ninth recorded outbreak that Congo has seen since the virus was first discovered in 1976. 3324

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