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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 Centers for Disease Control and Prevention is investigating a multi-state outbreak of campylobacter infections linked to contact with puppies sold through Petland, a national pet store chain.Campylobacteriosis, a common bacterial infection, can cause diarrhea, abdominal pain and fever, according to the CDC.As of Sept. 11, a total of 39 people have fallen ill in seven states, including 11 cases in Florida, five in Kansas, one in Missouri, 18 in Ohio, two in Pennsylvania, one in Tennessee and one in Wisconsin. There have been nine hospitalizations and no deaths reported. The first case within this outbreak occurred on September 15, 2016.Symptoms, which typically begin within two to five days after contact with the bacteria, last around a week, though some people don't experience any signs of illness.While many cases go unreported, about 14 cases for every 100,000 people are diagnosed each year in the United States, according to the CDC. Overall, campylobacteriosis -- which occurs much more frequently in the summer months than in the winter -- is estimated to affect over 1.3 million persons every year.Almost every patient recovers within five days without treatment, though drinking extra fluids is recommended. In rare cases, an infection can lead to complications, including paralysis and even death.People with weakened immune systems, such as infants, the elderly and people with cancer or other severe illnesses, are most at risk for a serious infection.People sickened in the current outbreak range in age from younger than 1 year to 64 years old.Most -- 28 of the 39 -- are female and 12 are Petland employees. Of the total, 27 either recently purchased a puppy at Petland, visited a Petland, or visited or live in a home with a puppy sold through Petland."The CDC has not identified any failures of Petland's operating system that would lead to any campylobacter infection," Elizabeth Kunzelman, a spokeswoman for the company, said in an email. "Last week the CDC advised Petland to 'continue to do what we are already doing' and to continue to educate customers and staff to sanitize their hands after handling our puppies."The CDC noted that no matter where a puppy comes from, it may carry a campylobacter infection. Petland is cooperating with the investigation, the government agency said.Kunzelman added that Petland has many sanitation stations in each store and has strict kennel sanitation procedures and protocols put in place by consulting veterinarians."Our extensive health warranty protects both our pets and our customers from bacterial, viral and congenital issues," she said.Most people become infected with campylobacteriosis through eating raw or undercooked poultry. Most infections are singular and not part of an outbreak.By contrast, outbreaks of campylobacteriosis are often linked to unpasteurized dairy products, contaminated water, poultry and produce. Sometimes, though, people get sick after coming into contact with the stool of an ill dog or cat.To avoid contamination from your pet, CDC recommends you wash your hands thoroughly after touching dogs, their poop, or their food. Extra care is needed so that children playing with puppies also wash their hands carefully. Pick up and dispose dog poop carefully, especially in areas where children might play. Finally, you need to contact your veterinarian if you see signs of illness in your puppy or dog.While puppies and dogs with a campylobacter infection might have diarrhea, vomiting, or a fever, just like humans, they also sometimes show no signs of illness.The investigation is ongoing, according to the CDC, which is working with the US Department of Agriculture's Animal and Plant Inspection Service, and several health departments. 3761

The coronavirus has ruined a lot of things, but Children's Hospital of Orange County, California, made sure that the virus didn't cancel prom.Choc Ball 2020 had everything, even a disco ball.“I will never forget asking our maintenance crew to help me hang some disco balls from our valet which has never happened before.” Kara Noskoff, a program coordinator for the Child Life department at Children's Hospital of Orange County, said.It's her job to normalize the hospital environment for kids of all ages. She helps throw the oncology ball, which is held every year, to recreate what teems might miss out on at school."It’s not like going to their school dance,” Noskoff said. “They’re in a room full of 200 plus people dancing and taking pictures and dressed up with the health care professionals that took care of them as well as their peers that all have the same scars.”Except it's 2020. And it almost didn't happen due to too many high-risk patients and too many high-risk exposures. But the staff at Children's Hospital decided happiness is important too.“Their mental health and growth and development is so important as well. I’m so proud of… our staff to see that bigger picture and push the boundaries a little bit and find a way to keep them safe but give them these things to look forward to,” Noskoff said.They turned what was supposed to be a huge party into a socially distanced, masked, drive thru experience complete with a theme. "Driving through the decades" had a photo booth, party favors, music and dancing. And it was everything that 17-year-old Veronica Larson could dream of.“There’s a bridge that crosses from the hospital into the employee parking and I looked up and all the nurses that had finished their shift were up in the bridge they were all cheering and clapping there was music playing,” Larson said.Cancer treatment is hard enough. Add in COVID-19 and its restrictions, and teens like Larson have struggled.“I would be considered immunocompromised so I’m being extra careful but there are safe ways like this oncology ball, but I am able to see my peers and that’s one of the reasons why it was so important to everyone being able to have that interaction in such a time of isolation,” Larson said.Back in 2015, Larson was an aspiring gymnast. She suffered a pulled hamstring that led to exhaustion and then a diagnosis of leukemia. She was only 12 years old. Now, she's in remission and building back her strength. And found her way back into gymnastics as a coach.“My hair is growing back. I’m trying to rock the short hair,” Larson said.The medical staff at CHOC is a huge part of Larson's life. After all, they helped her apply for college from her hospital bed. The soon to be freshman at UCLA wants to go into pediatric medicine and credits the children's hospital that gave her so much life with helping her find her future.“Obviously it’s an area I’ve been involved in and I think I can make a difference there and I’ve met incredible people and I would love to be a part of a team of such amazing people,” she said.Amazing people who all got to be together, even if from a distance for one night, created an evening that was just as magical for the staff as it was for the patients.“The night itself blew me away it was beyond anything I could have imagined,” Larson said.Proof that the coronavirus can't steal joy, happiness, or prom. 3390
The Environmental Protection Agency blocked reporters from several news outlets from a national summit on Tuesday where Scott Pruitt, the agency's chief, was speaking.Journalists from CNN, the Associated Press and the trade publication E&E were barred by the EPA from entering the event, which was focused on harmful chemicals in water. A handful of other reporters from other news organizations, however, were allowed inside the event after having been previously invited by the agency.In a statement, Jahan Wilcox, an EPA spokesman, said the agency barred reporters from attending due to space limitations inside the venue. He said the EPA was able to accommodate only 10 reporters and that it provided a livestream "for those we could not accommodate.""This was simply an issue of the room reaching capacity, which reporters were aware of prior to the event," Wilcox said.A report published by The Hill, however, said a handful of seats in the press section remained vacant by the time Pruitt began speaking. A photo obtained by CNN also showed space for cameras.Additionally, the Associated Press said in a story that one of its reporters, denied entry, was grabbed by security guards and forcibly shoved out of the building after asking to speak to an EPA public affairs person. A CNN photographer saw the Associated Press journalist being shoved out of the building by a uniformed guard, and the Associated Press journalist recounted the incident to CNN immediately after it took place.When reached by phone and asked about the Associated Press report, Wilcox declined to comment to CNN beyond his original statement, which said he was "unaware of the individual situation that has been reported."CNN was also blocked from attending the summit. A CNN photographer was screened by security guards before the event and was waiting for an escort or further information. Wilcox arrived soon after and provided security with a list of news outlets and reporters, instructing them not to let anyone not on the list into the event. The CNN photographer then asked if he could enter the event and was told by security he couldn't.Separately, a CNN reporter and producer lined up with members of the public and presented their IDs and credentials, identifying themselves as reporters. The individual manning the door said he needed to ask the press office if they could be permitted to enter. A few minutes later, he returned and said the CNN journalists were not allowed in.In a statement, a CNN spokesperson said, "Today, CNN was turned away from covering the PFAS National Leadership Summit at the EPA after multiple attempts to attend. While several news organizations were permitted, the EPA selectively excluded CNN and other media outlets. We understand the importance of an open and free press and we hope the EPA does, too."Sally Buzbee, executive editor of The Associated Press, said in a separate statement, "The Environmental Protection Agency's selective barring of news organizations, including the AP, from covering today's meeting is alarming and a direct threat to the public's right to know about what is happening inside their government."Buzbee added, "It is particularly distressing that any journalist trying to cover an event in the public interest would be forcibly removed."The-CNN-Wire 3320
The elections board in Florida's Miami-Dade County has collected a set of mysterious ballots in the Opa-locka mail facility after Democrats raised concern about the uncounted votes.The uncounted ballots have emerged as one of many battles over the fiercely contested Florida elections that moved this weekend into a recount phase.Suzy Trutie, a spokesperson for the county's supervisor of elections, told CNN there were 266 ballots in the shipment and that the votes will not be counted. Florida law requires all ballots sent by mail to arrive at the election facility by 7 p.m. on Election Day, and these ballots did not meet that standard, Trutie said.The US Postal Service said in a statement on Friday that it was operating in "close coordination and partnerships with election officials at the local, county and state levels." But as of Sunday morning, it still did not confirm ballots had not been provided in time to local election officials. 957
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