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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 CDC appears to be making slight changes to who should be tested for coronavirus for a second time this week, after their changes on Monday sparked confusion and reaction from the scientific community.On Monday, the CDC updated their website to read that testing is no longer recommended for symptom-less people who were within 6 feet of an infected person for more than 15 minutes.This set off a wave of confusion about who should be tested and the reason for the change. All questions were directed to the CDC’s parent organization, the Department of Health and Human Services.In a statement distributed to media Thursday, CDC Director Robert Redfield said those who come in contact with a confirmed or probable COVID-19 patient(s) could be tested, even if they don’t show symptoms, according to TheHill.com.“Testing is meant to drive actions and achieve specific public health objectives. Everyone who needs a COVID-19 test, can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action,” Redfield said in the statement.The New York Times reports the guidelines are not changed on the Centers for Disease Control and Prevention’s website, and appears unlikely the agency will change them. 1326
The family whose dog died on a United Airlines flight in March has reached a settlement with the carrier, the family attorney and the airline said Thursday.The 10-month-old French bulldog named Kokito was inside an overhead bin on Flight 1284 from Houston to New York after a flight attendant told the passenger to put it there.When the plane landed at LaGuardia Airport, the dog was dead.The financial details of the settlement are confidential as part of the agreement, according to Evan Oshan, the attorney representing the Catalina Robledo family.United spokesman Charles Hobart said the airline began a comprehensive review of its animal transport policy and is collaborating with American Humane?to improve its practices. That group works to ensure the safety of animals."We are deeply sorry for this tragic accident and have worked with the Robledo family to reach a resolution," Hobart said.As a result of the incident, New York state Sen. Marisol Alcantara, a Manhattan Democrat, crafted legislation entitled Kokito's Law -- a new pet passenger bill of rights.Alcantera is the prime sponsor of the legislation, a measure is now in the state Senate Consumer Protection Committee.Among the proposals in the legislation are banning the placement of pets in overhead storage compartments, 1316
The Federal Bureau of Investigation has asked the public’s help in identifying members of a female gang who have been spotted in Middle Tennessee. The FBI said Felony Lane Gang members use rental cars with tinted windows to watch you and your car in parking lots at gyms, daycares or anywhere someone might leave a purse in a car.They have been spotted in Nashville, Mt. Juliet, Gallatin and several other towns around the Metro area.When they see an opportunity, they'll swipe IDs, credit cards and checkbooks. Then, they hand all of that over to prostitutes and drug users they recruit to impersonate victims.Those women take stolen checks and IDs to multiple banks to withdraw large amounts of money -- all before the victims have a chance to close their accounts.According to authorities, they use the farthest window from the teller in bank drive-thru lanes. This drive-thru lane is commonly known as the "felony lane," which is what inspired their nickname.Investigators said they’re known to use wigs and other disguises to impersonate their victims at banks. If you have information call the FBI office in Memphis at 615-232-7500. 1158
The damage wrought by Hurricane Irma has sparked a fresh wave of giving from corporate America.The extent of the destruction in Florida and the Caribbean isn't yet known, and Irma is still making its way toward Georgia as a tropical storm. It could be one of the costliest natural disasters in U.S. history.Corporate donations raised in the immediate aftermath of Hurricane Harvey, which struck two weeks ago, totaled about 0 million.A fundraising effort called Hand in Hand, backed by Verizon, Apple and other major companies, is hosting a televised fundraiser on Tuesday at 8 p.m. ET. Beyoncé and Oprah Winfrey are among the celebrities who have signed on.Here is a running list of all the ways companies have promised to help, both for Harvey and Irma relief.Apple: Donated million to the Red Cross in addition to pledging million for the Hand in Hand effort.Ashley Furniture: Promised to contribute products and subsidize furniture purchases up to million for hurricane victims in Texas and Florida.AT&T: Donating .4 million to relief efforts in the Caribbean and U.S. states hurt by Harvey and Irma. The company previously announced it would contribute at least 0,000 to help communities after Harvey.Bank of America: Donating more than .5 million to victims of the two storms, including 4,000 donated by bank employees, which the company matched.Citi: In the wake of Irma, the Citi Foundation committed a million donation to the Red Cross, bringing its total hurricane relief contributions to million.Dick's Sporting Goods: The company and its foundation have pledged a combined .5 million to hurricane relief. That includes .5 million worth of clothing and footwear and million "to rebuild and refurbish youth sports programs and facilities" in affected areas.Discover: Pledging million to American Red Cross. The company is also matching up to million in donations to the American Red Cross by its card members.Disney: Pledging .5 million in humanitarian aid for Florida, the Caribbean and other places hit by Irma. Says it raised almost million for Harvey relief.Goldman Sachs: Committed to giving 0,000 to organizations involved in the "immediate search, clean-up and recovery efforts" after Harvey struck the Gulf Coast. After Irma, the company promised 0,000 more.Home Depot: Pledged million for Harvey and Irma relief.Humana: Says its Humana Foundation will donate million to the Red Cross for Irma relief.IBM: Has pledged million. It says million will go toward Harvey relief and million toward helping Irma victims.JPMorgan Chase: Says it will donate million to support Irma relief in the U.S. and the Caribbean. Funding goes to the Red Cross, International Medical Corps and local nonprofits. Also donated million to Harvey relief.Lowe's: Committed to million for Irma relief in cash and "product donations," after donating another million for Harvey relief.Panda Express: Committed to raising million in stores and donating million.PayPal: A sponsor of Hand in Hand, PayPal is donating 0,000 to Save the Children and 0,000 more to the Red Cross for Irma relief. It's also launching a campaign to raise money from donors. A similar campaign for Harvey relief raised more than million from 81,000 donors.Qualcomm: Says it gave million to the Center for Disaster Philanthropy. Qualcomm gave million more to various disaster relief organizations after Harvey struck Texas.Target: Pledged up to million to Irma relief organizations, including the Red Cross, Habitat for Humanity, the Salvation Army, UNICEF and Save the Children. This is in addition to a .5 million donation for Harvey relief.UnitedHealthcare: Announced a donation of million for Irma relief, and also a 2-to-1 match for employee donations. It previously promised .3 million in "cash and medicines" after Harvey.Verizon: After announcing a million commitment after Harvey, Verizon said it would donate .5 million to Hand in Hand.Walmart: Has committed to donating up to million to hurricane relief.Wells Fargo: Pledged .1 million to Irma relief efforts in Florida and the Caribbean, nearly half to the Red Cross. The company said its customers have donated, via ATMs, nearly .7 million to the Red Cross for Harvey relief. 4337