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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 devastation brought about by this hurricane season creates a new set of headaches for President Donald Trump and an already overwhelmed Congress -- and underscores the urgent need to resolve the financial crisis that had battered Puerto Rico and the US Virgin Islands before the recent storms and floods arrived.The President and Congress can no longer ignore their duty to rescue millions of Americans living in our tropical territories. The standard range of the Federal Emergency Management Agency and other disaster recovery programs will cover a good chunk of the storm damage, but the need for financial rebuilding is every bit as necessary as the new homes, roads and power grid the islands need. 730

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 coronavirus outbreak has put a hold on many things over the last few months, including some elective surgeries.When Nohely Uriostegui and her husband, Jose Pava, found out they were pregnant with a little boy, they were ecstatic. Then, the unfortunate news: their baby had spina bifida."After that, she said we’re going to do a test. You might be eligible for an in-utero surgery," said Uriostegui.That means surgery while the baby is still in the womb, and it had to be performed before 26 weeks of pregnancy. Everything was set up to go in Chicago until a phone call came from her doctor."He said, 'You know what? Based on COVID, everybody here on the team doesn’t feel like it’s an essential type of surgery,’" recalled Uriostegui.The same situation was unfolding for all types of patients around the country. Those hoping surgery could help their chronic pain were told they’d have to endure it for months longer. Organ transplant candidates were forced to wait as well. For Nohely and Jose, a delay meant they might miss their window to help their baby. But then, hope from three states away in Colorado."For this family, the clock was ticking. She had until she was 26 weeks to have fetal intervention, and that was literally five days, four days away. And they had to get from Chicago to here, be evaluated, have surgery set up to be performed, and so, we were able to do that for them," said Colorado Fetal Care Center surgeon Dr. Ken Liechty.The couple decided to travel to Colorado to have the procedure done."I got there on the 4th; my surgery was set for Monday, April 6, which was the exact same date that I was going to get it done in Chicago, and it was one day before I hit the 26-week mark," said Uriostegui."It’s open fetal surgery on the fetus as the actual patient," said Dr. Liechty. "We excise the cyst, we put the spinal cord back into the spinal canal."Doctors then put the muscle back over to seal it, close the skin over it, and then close the uterus. Without the in-utero surgery, Dr. Liechty says 90 percent of babies with spina bifida have a shunt put in to decompress the brain. However, that likely wouldn’t have been the only surgery he would have needed."These shunts fail, they can get infected, they can have all kinds of problems, they average seven surgeries at least for these shunts in their first few years of their life," said Dr. Liechty.In the time of this pandemic, that could mean more waiting as hospital beds begin to fill back up with coronavirus patients."COVID-19 caused a lot of places around the country to reexamine what cases could be done in their facilities, and a number of fetal centers are actually located in adult centers," said Dr. Liechty.Those places are filling up faster than children's hospitals, causing families like Uriostegui and her husband to almost miss opportunities to help their children before they even enter the world."The neurosurgeon over there actually said to us last time, that if you were to look at him, you would have never guessed that he’s born with spina bifida or that we went through this whole journey," said Uriostegui. 3126
The good news is Americans are getting COVID-19 test results back, on average, a day faster than they were over the summer. The troubling news, according to experts, is that it is still taking three days on average for Americans to find out their COVID-19 status and this is not quick enough to help with contact tracing and quarantine efforts to slow the spread.Researchers from several universities, including Harvard, Northeastern, Northwestern and Rutgers universities, have been collecting data and conducting surveys for months since the beginning of the coronavirus pandemic.“Prompt test results constitute the foundation of a successful COVID-19 containment strategy,” researchers state at the beginning of their paper.Data now shows, of the participants who got a test for the coronavirus in late September, the average wait time was 2.7 days.In early August, the group announced their survey data showed the average wait time nationwide was 4.1 days. More than 30 percent of participants reported, at the time, they didn’t get test results back until four days or longer.The percentage of people getting results within 24 hours is also increasing; the September survey showed 37 percent of people getting results back in one day, compared to 23 percent over the summer.“Rapid turnaround of testing for COVID-19 infection is essential to containing the pandemic. Ideally, test results would be available the same day. Our findings indicate that the United States is not currently performing testing with nearly enough speed,” researchers said.Disparities still exist for Americans who are Black or Hispanic. Although wait times are shorter for these groups as well compared to summer numbers, they are still, on average, a day or more longer than white test takers.In the latest survey, Black Americans reported waiting an average of 4.4 days for results, and Hispanics reported waiting 4.1 days. By comparison, white and Asian Americans reported wait times of 3.5 and 3.6 days on average, respectively.Also troubling for trying to control the spread of the coronavirus, the data shows how many of those who tested positive had some sort of conversation about contact tracing.“Only 56% of respondents who received a positive COVID-19 test say that they were contacted for the purpose of contact tracing,” the survey found.The survey talked to more than 52,000 people across all 50 states and the District of Columbia. 2434
来源:资阳报