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The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The group, in a 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days. The vaccine had already been authorization by officials in Canada and the UK.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Millions of shots would then ship to begin vaccinating health care workers and nursing home residents, but the Centers for Disease Control and Prevention will need to formally recommend the vaccine before health care officials can begin distributing the shots.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing the efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant to take the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush, and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.Widespread access to the general public is not expected until the spring. 4342
The concerns of COVID-19 are on the minds of many Americans.In the Latino community, the concern is heightened. Latinos are three times more likely to get the virus, according to a Johns Hopkins study. Latino voters recently named the novel coronavirus as a top concern during a Pew Research study.A California doctor has taken a proactive approach to help his community in the state’s Central Valley stop the spread of the disease and help prevent the economic distress the virus can bring.California’s Central Valley, also known as the “Bread Basket of America,” is where most of the food in the United States comes from. It is here where thousands of Latinos work under extreme conditions like triple degree heat, poor air quality, and long hours to put food on your table. The California Department of Public Health shows that nearly half of the deaths in the Central Valley area from the Latino community. They also account for more than 60 percent of the cases.“If there is no one to pick in the fields, if there is not one to pack the meat, which feeds a majority of the country, then the whole country would definitely feel it,” said Dr. Juan Bautista, the medical director at Bautista Medical Center.Dr. Bautista is part of the 60 percent of Latinos that got the virus. Although being relatively healthy, his underlying asthma condition made fighting the virus tough. He was hospitalized for six days.Dr. Bautista says Latinos are high-risk because of the prevalence of diabetes and asthma in the community.“Diabetes places a major factor, not just in your immune system, but also your response to the medications we give with COVID,” he explained.Medications like Dexamethasone can cause patients’ blood sugar to rise. For a diabetic patient, this medication can have bad side effects or even be taken off the table as a form of treatment due to the risks.Reina Gonzalez spent an entire month over the summer on a ventilator. She is a breast cancer survivor, and now, a survivor of this deadly virus. On Tuesday, she was celebrating her granddaughter’s first birth. Months after her initial diagnosis and release from the hospital, she is still unable to work due to her physical condition.“When I start moving or walking or any minimum exercise, my pulse races up a lot and my heart,” described Gonzalez.She feels fortunate to be able to apply for workers' compensation to help pay for her medical bills, but most of Dr. Bautista’s patients aren’t as fortunate.Dr. Bautista says the average cost of a test in the Central Valley is between 0 to 0. In an effort to increase testing, Dr. Bautista is now offering free, rapid testing at his practice. He and his staff are available every weekday from 5:30 to 8:30 p.m., an optimal time for working families. The testing is free and turns out results in 30 minutes or less.Fast test results are critical in this underserved community. It slows down the spread of the disease because people are not returning to work as they wait for test results.“They are not willing to miss work,” said Dr. Bautista, regarding the financial need of his patients.During this time, Dr. Bautista says he has learned medicine isn’t the only thing he needs in order to help his patients. He now finds himself educating them on social services available to them.During the rapids test sessions, programs offering financial aid to those who test positive are offered. The next issue to tackle when it comes to the impact of the virus is the long-term health complications many are left with.“We are starting to learn now that this, although it may have a low death rate the disability it brings, is definitely significant,” he said.With a high survival rate, many will need long-term care, leaving a community that has been disproportionately attacked by this virus with possibly decades of chronic health care issues. 3866
The creators of "Glee" are creating a college fund for Naya Rivera's son after her untimely death.In a statement, producers of the hit show, Ryan Murphy, Brad Falchuk, and Ian Brennan, paid tribute to Rivera and praised her as "a joy to be around.""It didn't take more than an episode or two for us to realize that we have lucked into finding one of the most talented, special stars we would ever have the pleasure of working with," the three said in the release. "Naya could act, she could dance, and she could sing (could she ever sing!) She could nail a joke as well as she could crush you with an emotional scene. She could move between being scary tough and deeply vulnerable with ease. She was a joy to write for, a joy to direct, and a joy to be around." 769
The election may be over but the term of President Donald Trump is not. So what can President Trump do between now and January 20, 2021?FIVE BIG AREASPresident Trump will likely be exploring options without Congress. The most obvious actions include the power to pardon, appoint top officials, fire top officials, approve military action and issue executive orders. President Trump could very well pardon anyone he wants, including former advisers Michael Flynn or Paul Manafort. President Trump may also explore the possibility of preemptively pardoning members of his own family as various investigations continue. HIRING AND FIRING President Trump has already begun the process of firing some top officials, including Secretary of Defense Mark Esper. President Trump may exercise that authority with other officials, such as the FBI Director who he has publicly criticized. The commander-in-chief may also continue to appoint top posts. He appears poised to confirm Judy Sheldon to the Federal Reserve before the end of his term, a position which has the power to influence interest rates and monetary policy for decades to come. EXECUTIVE ACTIONSPresident Trump will also continue to have authority to conduct military strikes since he is Commander-in-Chief. He will also have the ability to issue executive orders, although any order he issues could be immediately reversed when President-elect Biden takes office. 1428
The FBI has located human remains in the wreckage of the Horizon Air plane that crashed Friday after it was stolen and flown by an airport worker."While the focus of our investigation thus far has centered on Richard Russell, 29, of Sumner, Washington, the FBI is awaiting the results of a review by the Pierce County Medical Examiner's Office," FBI Seattle said in a statement.Authorities said Russell took off in the stolen plane at Seattle-Tacoma International Airport on Friday night, flew for about an hour with military jets chasing him and crashed the 76-seater on a heavily wooded island.The flight data recorder and components of the cockpit voice recorder have been recovered and are with the National Transportation Safety Board, according to the FBI. 770