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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's own medical advisers are criticizing the federal health agency for being slow to respond to a polio-like disease that's struck hundreds of children over the past six years."Frustrated and disappointed -- I think that's exactly how most of us feel," said Dr. Keith Van Haren, one of the CDC advisers on AFM and an assistant professor of neurology at the Stanford University School of Medicine.Van Haren and other doctors who care for these children say the agency has been slow to gather data and to guide pediatricians and emergency room physicians on how to diagnose and treat the children struck with the disease, acute flaccid myelitis."This is the CDC's job. This is what they're supposed to do well. And it's a source of frustration to many of us that they're apparently not doing these things," said Dr. Kenneth Tyler, a professor and chair of the department of neurology at the University of Colorado School of Medicine and another adviser to the CDC on AFM. 1022

The family of a Pennsylvania woman who died in jail in 2015 from heroin withdrawal symptoms was awarded .75 million in a wrongful death suit settlement this week, CBS News reported. Victoria "Tori" Herr, then 18, died on April 5, 2015, nine days after being arrested after police found drugs in the woman's apartment. Herr told police that she had consumed 10 bags of heroin a day. During her first four days in custody, Herr reportedly suffered from bouts of vomiting and diarrhea. She was treated with water and Ensure, but was unable to keep her fluids down. The result of those symptoms led her to cardiac arrest and to lose consciousness, CBS News reported. Herr's lawyers claimed that the Lebanon County Correctional Facility did not meet her basic medical needs, and then lied. "Anyone who looked at her would have known that she was very sick and that she needed attention," Herr's family lawyer Jonathan Feinberg told CBS. "There was a complete disregard for her needs, which can only be tied back to the fact that she was addicted to drugs."As part of the multi-million-dollar settlement, the jail's warden, nurses and other employees agree that there was no wrongdoing. To read CBS News' full report, click here. 1284
The flu vaccine may have an important benefit beyond protecting against influenza: It may also prevent heart attacks, especially in those at high risk, experts say."It's been a long time that people have recognized that association with flu season and development of a heart attack," said Dr. Kevin Schwartz, an infectious disease physician at Public Health Ontario.When it comes to preventing heart attacks in people with cardiovascular problems, experts have put getting the flu vaccine on par with long-term measures such as quitting smoking or taking one's medication for high blood pressure. 610
The end of July is expected to be a busy time for courts where eviction cases are handled across the country.As the funding from the CARES Act is closing in on its end so is reprieve for renters, who have had difficulty making their monthly rent payments.“There’s a lot of fear,” said attorney Zach Neumann. “People are really concerned about where they’re going to go when that [eviction] demand is placed on their door.”According to the U.S. Census Bureau Pulse Survey, approximately 30 percent of renters have little to no confidence that they can make their next housing payment.CBS News reported during the month of May, 20 percent of renters failed to pay rent on time.“I think you have people who are behind on their rent right now, who haven’t been able to make full payment,” said Neumann. “I think the bigger source of [eviction] filings is going to be in early September when we are definitively out of the CARES Act money window.”To help renters and homeowners with mortgages in Colorado, Neumann started the COVID-19 Eviction Defense Project in late March. He said after seeing people post on Facebook that they were worried about their payments, he put up a post saying he would help them free of charge. Overnight, he says he got more than 500 direct messages asking for his services.“I think the reason that this is going to lead to so many more evictions is because it’s longer-lasting,” said Neumann. “Also, the financial hit is uniform across groups of people.”To give renters more time, the CARES Act instituted a 60-day moratorium on evictions for people living in federally financed rentals, which covers 25 percent of all rentals in the United States, according to the Urban Institute. That moratorium is set to expire on July 26.Cities across the country also put their own eviction moratoriums into place, but many of those are set to expire at the end of July as well.Nine thousand evictions cases resumed in Memphis, once its moratorium ended last month. In Virginia, 12,000 eviction cases were filed when its moratorium was lifted.“There are people in serious crisis and our neighbors are suffering,” said Tammy Morales, who serves as a city commissioner in Seattle.In May, Morales introduced legislation banning landlords from using eviction history as grounds to deny tenancy to renters for up to six months after the pandemic. The bill passed in with all but one commissioner voting yes.“There are cascading effects of this crisis, and this is one piece that we are able to do at the local level to help people,” said Morales.“It’s harder to hold onto your job. It’s harder to keep your kids in school. It’s harder to maintain a workable level of health,” said Neumann about evictions. “What you see is after an eviction folks spend months and months unsuccessfully looking for housing.” 2826
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