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Pfizer announced Friday that it would submit a request to the FDA Friday for its COVID-19 vaccine to be granted Emergency Use Authorization.Earlier this week, Pfizer said that a final analysis of trial results showed the vaccine is 95% effective.“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,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a press release.Pfizer's two-shot vaccine has already been in mass production for months, and thousands of doses will be ready for delivery if and when the FDA grants authorization. Pfizer says that is on track to produce 50 million doses of the vaccine by the end of 2020 and plans to produce 1.3 billion doses of the vaccine in 2021.According to "Operation Warp Speed," the federal government's plan for distributing the vaccine, upon authorization, the drug will initially be rationed for high-risk populations and health care workers. Dr. Anthony Fauci, the nation's top infectious disease expert, says he believes a vaccine won't be widely available until April.On Wednesday, Pfizer announced that a final analysis of its vaccine candidate showed that of 40,000 participants who participated in the trial, 170 people had contracted the virus. Of those 170 people, 162 received only a placebo injection — meaning just eight out of the 20,000 people who actually received the vaccine contracted the virus.The company added Wednesday that there have been no safety concerns with the vaccine. In a randomized survey of 8,000 participants, only 2% reported suffering severe fatigue, and only 4% reported suffering severe headaches. Those who say they suffered side effects only experienced them briefly after vaccination.Pfizer's announcement comes as COVID-19 cases are spiking around the world. In the U.S. alone, about 2.5 million people have contracted the virus in the month of November alone. Hospitalizations linked to COVID-19 are at an all-time high, and deaths have begun to tick up in recent weeks. 2322

Paul Rudd put his money where his mouth is when it comes to thanking people for voting. Well, he put cookies in voters’ mouths, at least.The actor was at a Brooklyn area early voting location handing out baked goods to people waiting in line to vote in the rain.Brian Rosenworcel is a drummer for the band Guster and happened to be at the polling location when Rudd approached him. 389

Police in Osceola County, Florida said a man was locked up after he was accused of trying to kill sex offenders.Officers said he tried to set the men on fire.Jorge Porto-Sierra has been formally charged with four counts of attempted premeditated murder.Osceola County detectives said the 50-year-old confessed to deputies he tried to kill multiple people at the Friendly Village Inn on Irlo Bronson Memorial Highway.After his March 7 arrest, Porto-Sierra said he arrived at the motel to "barbecue all the child molesters on fire and kill them."WESH 2 News in Orlando confirmed at least two of the four victims are convicted sexual offenders.Witnesses told deputies Porto-Sierra made several threats, screaming, "I'm going to kill you, child molester," and allegedly began throwing gasoline on their front door.Porto-Sierra is accused of breaking a hotel window to pour gasoline inside.Witnesses said he was carrying a cigarette the whole time.Another couple said Porto-Sierra rammed their car and poured gas on it.When asked by deputies why he did not carry out his threats, Porto-Sierra said, "You got here too soon."Porto-Sierra remains behind bars at the Osceola County Jail.He's being held on no bond.  1219

Parents of children with special needs are grappling with uncertainty as the upcoming school year approaches. Many districts are trying to address special education learning while also preventing the spread of COVID-19 in schools."My son was diagnosed 8 months ago with ADHD inattentive disorder and this is for a child that lacks focus and has a hard time focusing. I say that it sounds very simplistic but for a child who has the issue, it's a neurological development issue," said Silvina Traba. Traba says her 7-year-old's disorder has made it difficult for him to learn to read. Right now, he's on a 504 plan, a document under the federal government that helps parents and schools work together to address a child's underlying disability. Her son is also being evaluated to be on an individualized education program, or IEP, which provides specific learning and special education services for students.When Traba's son had to do remote learning when schools shut down in the spring in New Jersey, he had a difficult time. At school, there are a number of things to help him learn."In a classroom setting there are physical things like a noodle chair that moves with the child or special pencils, a special device put on the desk for sensory processing," said Traba. Their family tried to provide some of the same physical adjustments at home but found his focus in front of a computer just wasn't there. Traba was told her son wasn't making enough academic progress."I'm seriously concerned that not having that person-to-person contact, face-to-face contact with the experts, the subject matter experts, we’re going to be in the same place come next summer where I’m going to be told he’s not really making progress despite having certain things in place," said Traba. She says the possibility of contracting COVID-19 also has her very scared to send him to school. Traba hopes that however her son's school decides to conduct learning this fall, they pay close attention to special needs children who need more than just a laptop and the right school supplies.Traba says there's a difference for her child doing face-to-face learning versus on a computer. "It is extremely difficult. He needs to be prompt and redirected continually to refocus. He needs to sometimes be prompted to take breaks in order to refocus and in person it's much easier for the instructor to notice him trailing off or to be able to redirect him. Sometimes it's simple like a physical touch on his desk or hand near him," said Traba.A number of school districts have said students in special education will be accommodated if they choose to do remote learning for the fall. Fulton County Schools in the Atlanta, Georgia area say the district will help families if any changes need to be made to a student's IEP. However, providing all special education programs as normal may not always be possible with distance learning.Annemarie Bohn is a special education teacher, and also has three children with varying special needs. She says remote learning can be difficult for teachers and staff who work in special education."It's really hard on teachers because teachers that work with students like this, they are constantly taking down data whether they're writing it down or not. They're constantly taking data because every teacher I know who’s ever worked in this field they're constantly working to try to work better with the student, so its a disability on the teachers as well," said Bohn. Plus, sometimes the pressure on parents to emulate the special instruction their student receives in class can be difficult and hard to attain.Bohn says there are some children in special education who actually fare better outside of a long day in the classroom because their disabilities are more visibly seen in-person and can make them feel overwhelmed. "A dyslexia student will say things or pronounce things incorrectly and they’ll see that response from other students when they pronounce things incorrectly. So that stress is taken out, that feedback is taken out and my children benefited from that," said Bohn.While some special needs students might actually benefit from remote learning, Bohn says others may see permanent loss of education, especially if they don't have the right supports at home. 4294

Papa John won't leave Papa John's alone.The company has tried hard to distance itself from founder John Schnatter, who blamed the NFL for poor pizza sales last fall and then admitted using the N-word on a conference call this spring.Sales slumped, and Papa John's stock declined. CEO Steve Ritchie and the current leadership blame Schnatter, who stepped down as chairman in July.Schnatter told CNNMoney in an interview Tuesday that he's being scapegoated."You can't blame everything on two comments," he said. "I wish I had that kind of power, but I don't."Instead, Schnatter pinned the company's problems on Ritchie, who became CEO in January. Schnatter described him as a poor leader who has created a culture of intimidation at Papa John's, and let quality and customer service slip."We need new leadership," he said. "He struggles as a CEO.""Steve'll make a great executive somewhere else," he added. "He's just the wrong guy for the job."He described upper management under Ritchie as vindictive and controlling."People right now are scared to talk," he said.Schnatter, who is still the largest shareholder and owns almost a third of the company, insists he doesn't want to return as CEO. But he has mounted a scorched-earth campaign to drive Ritchie out of his job.In a letter to franchisees posted to his personal website on Monday, the founder said the company is struggling because of "rot at the top."In a statement, Papa John's called the accusations "untrue and disparaging," characterizing them as "a self-serving attempt to distract from the damaging impact his own words and actions have had on the company and our stakeholders.""John Schnatter also publicly supported Steve Ritchie's appointment as CEO at the end of last year," the statement said.Schnatter flipped that argument around."There's a little bit of a farce going on here," he said. "Steve Ritchie promises great things, and then bad things happen, and then he blames somebody else."Schnatter's lawyer Garland Kelley said the company allowed Schnatter's comments about the NFL and his use of the racial slur to be misrepresented in the press."There's a critical disconnect between what John actually says and how the company permits it to be portrayed publicly," Kelley said. "We think there's a reason this is occurring."In July, Forbes reported that Schnatter had used the N-word while on a conference call with his marketing agency."Colonel Sanders called blacks n-----s," Schnatter reportedly said during a training on how to avoid gaffes like the NFL comments. Forbes said Schnatter was complaining that Sanders didn't receive backlash, even though his comments were worse than Schnatter's own. KFC did not immediately respond to a request for comment.After the Forbes story broke, Schnatter apologized and resigned as chairman.On Tuesday, he described the conversation differently."I simply said, 'Colonel Sanders said what he said, and we're not going to say that,'" he said, adding that he regrets saying the slur."What I said was anti-racist," he added. "I don't talk that way.""I think the company has made the situation a lot worse," Schnatter said. "[The comment has] been misquoted, it's out of context, it's been portrayed in a way that's not truthful. But I'm still going to feel bad about that.""I love my employees. I love my franchisees," he said. "For anything that hurts them, then I'm going to feel bad about that, and I do."Schnatter also thinks his remarks about the NFL leadership have been misconstrued.Last year, some NFL players knelt during the National Anthem to protest treatment of black Americans, particularly by police. The protests sparked a controversy, and the NFL ultimately ruled that players can't kneel during the anthem."I felt like the situation was not a winning situation for the fans, the sponsors, the players and the owners," he continued.A few months after Schnatter called out NFL leadership, Papa John's ended its NFL sponsorship. Pizza Hut took its place.Papa John's is trying to put both comments, and Schnatter himself, behind it.The company is stripping Schnatter's image from its marketing materials and has taken the unusual step of approving a provision that would prevent him from gaining more control of the company.Ritchie went on a listening tour, mandated bias training for all employees and promised to increase diversity among staff. The company also launched a social campaign acknowledging customers' concerns.Papa John's has also commissioned an investigation into its diversity and inclusion practices.Asked whether the investigation would find any examples of misconduct by him, Schnatter said: "At the end of the day, I'm the principal owner of the company.""They've got to point bad results on somebody, and that's probably going to be me." 4908