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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 City of San Diego was awarded a million state grant that will help save food, save the planet, and save people. The city will use a majority of the grant to convert its composting system at the Miramar Landfill into a closed system. A news release from the city said that will reduce air emissions and continue to divert tons of food waste from the landfill.The City of San Diego currently keeps more than 100,000 tons of food waste out of the landfill by composting or making sure it’s diverted to food rescue non-profits before it’s thrown away.“It’s getting tossed because people don’t find the need for it or it’s got a slight cosmetic defect,” said Aviva Paley of Kitchens for Good, a food rescue that feeds hundreds of people a day by using food that could have been thrown away.“You can still make really good food with stuff that you just have to clean it up a little bit,” said Kitchens for Good Chef Trainer Theron Fisher.“It is so heartbreaking to see how much food goes to waste in this country,” said Paley.A portion of the state grant will allow Kitchens for Good to expand its operation. It fed 35,000 people in 2016. It would like to feed more than 50,000 by 2018.It would keep more food out of the landfill and feed more people who need meals. Paley said one in six San Diegans go hungry every day.Another benefit for the Kitchens for Good program: The cooks who prepare the meals are going through a 12-week training program to prepare them for culinary careers. Paley said most of the participants have overcome obstacles from crime and drugs to mental disabilities. The program opens them to a career they could otherwise never reach. 1718
The Department of Justice on Monday filed complaints against 11 individuals believed to be members of the?Central American migrant caravan, accusing them of illegally entering the United States.After a month-long journey by bus, train and on foot, about 100 migrants arrived at the San Ysidro port of entry on the US-Mexico border on Sunday evening, preparing to claim asylum. About 20 to 30 migrants spent the night inside an immigration processing center in Tijuana, Mexico.An organizer of the caravan vowed they would remain at the immigration processing center until "every last one" is admitted into the United States.Two Salvadorans, six Hondurans, and three Guatemalans face charges, a federal law enforcement official told CNN.Ten of them face a misdemeanor charge for allegedly entering the US illegally. Another individual is alleged to have entered the country after they were previously deported, and faces a felony charge.The probable cause statement alleges many of those charged were seen in an area known as Goat Canyon, about 4 miles to the west of the San Ysidro port of entry, on the US side of the border, the official said. Others were seen on the US side of the border about 2 miles west of San Ysidro in an area known as "W-8." 1263
The Confederate-themed Mississippi flag is drawing criticism from two big forces in the culturally conservative state. Walmart says it will no longer display the state flag because it includes the Confederate battle emblem. Displaying state flags inside stores is a common practice. “We know the design of the Mississippi state flag is being discussed by various stakeholders. While the issue continues to be discussed, we’ve made the decision to remove the Mississippi state flag from display in its current form from our stores," Walmart spokesperson Anne Hatfield said in an email statement.“We believe it’s the right thing to do, and is consistent with Walmart’s position to not sell merchandise with the confederate flag from stores and online sites, as part of our commitment to provide a welcoming and inclusive experience for all of our customers in the communities we serve," Hatfield continued. The Mississippi Baptist Convention is calling on lawmakers to remove the Confederate symbol from the flag because many people are “hurt and shamed” by it. The governing body for college athletics and other influential groups are calling for Mississippi to change its flag. Republican Gov. Tate Reeves says if the flag is going to be redesigned, it should be done in a statewide election. 1300
The critically acclaimed series Breaking Bad appears to be returning to television, this time in the form of a movie.Slash Film reports series creator Vince Gilligan is writing and executive producing the project.The film is said to be a sequel to the show's finale that aired in 2013, and will follow Aaron Paul's character Jesse Pinkman.Bryan Cranston, who plays the show's main character Walter White, also confirmed the existence of the film but says he has not read the script.There is no official release date for the film, but production will begin in New Mexico soon, Slash Film reports. 620