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The Don Cesar is a world-famous hotel, where guests expect to have a safe and enjoyable experience, but Stacey Wagers’ birthday dinner there turned into a nightmare. We allege that Don Cesar’s restaurant served her a dangerous chemical that caused extreme pain and injury. As a young woman and mother, she will possibly experience pain and discomfort for the rest of her life. We believe this was entirely preventable had the restaurant not acted recklessly, and we will fight to hold them accountable and make sure it never happens to another guest. 558

The FDA announced on Friday that it has issued an emergency use authorization for a second coronavirus vaccine. Its approval comes just one week after the FDA gave an emergency use authorization for a similar vaccine by Pfizer. That vaccine began distribution earlier this week. Moderna’s vaccine has been hailed as a medical breakthrough. The vaccine has been considered 94.1% effective against the virus. According to Moderna, none of the thousands who were given two shots of the vaccine had severe COVID-19 symptoms. That is compared to 30 patients who were given a placebo who had symptoms.In order to obtain an emergency use authorization, the FDA weighed the vaccine’s benefits against possible side effects. An emergency use authorization is not a full FDA approval, but it allows those outside of a clinical or hospital setting to obtain the vaccine. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn said in a statement. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”According to Moderna, approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.While the vaccine could nearly eliminate the number of hospitalizations and deaths associated with the virus, the shot might result in some symptoms.In an interview with CNN last month, Operation Warp Speed chief scientific adviser Moncef Slaoui said that 10 to 15% of those immunized had noticeable side effects.“Most people will have much less noticeable side effects. That frankly -- in comparison to a 95% protection against an infection that can be deadly or significantly debilitating -- I think is an appropriate balance," he told CNN. 2648

The burned remains of a Michigan woman have been identified by authorities as Susie Zhao, 33. Zhao played poker on the national competitive circuit. Zhao's body was discovered near a park in a Detroit suburb on July 13 around 8 a.m."The female subject was badly burned," according to a press release from White Lake Township Police."Surprised, confused, and saddened," said her former roommate Yuval Bronshtein. "It's hard to picture her having enemies."Bronshtein said Zhao bounced between cities including Los Angeles and Vegas and recently moved back to Michigan to be with family to be with her parents and to confront challenges in her personal life.She was an avid poker player and a national talent on the competitive circuit."She really was a excellent player," said Bart Hanson, a friend and poker rival. "One of the best in L.A. at the level we played at the Commerce Casino and it's the biggest poker room in the world."Authorities said a motive is unclear. The FBI is also assisting in the investigation."I never would have thought anyone would of wanted to do anything to her," Hanson said.This story originally reported by Rudy Harper on wxyz.com. 1170

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 FDA's Vaccines and Related Biological Products Advisory Committee panel has endorsed a second COVID-19 vaccine in the United States.Now the FDA is expected to act quickly to authorize the Moderna vaccine for emergency use and keep it on schedule to be distributed to patients across the country as early next week.The panel voted 20 yeses and one abstain.WATCH RECAP:With the panel recommending EUA, the FDA as a whole would then need to file its own EUA approval. The final step would be a formal recommendation from the Centers for Disease Control and Prevention that Americans should receive the vaccine.Last Thursday, the committee voted in favor of granting EUA to Pfizer's COVID-19 vaccine. By Monday, it was being administered across the country.The panel's meeting comes days after a key FDA report upheld the safety and efficacy results of the Moderna vaccine's Phase III trials. Those statistics showed that the vaccine was 95% effective with no severe side-effects."FDA has determined that the Sponsor has provided adequate information to ensure the vaccine's quality and consistency for authorization of the product under an EUA," the report said.An approval of Moderna's vaccine would immediately boost the supply levels of COVID-19 vaccines in the U.S. Millions of doses are ready to be shipped across the country as soon as approval is granted.The arrival of COVID-19 vaccines comes amid the bleakest stretch to date in the COVID-19 pandemic. The U.S. is currently seeing the highest level of new cases (213.000) and deaths (2,500) each day, according to seven-day rolling averages totaled by the COVID Tracking Project. More Americans than ever are also battling the virus in a hospital (113,000). 1725

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