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The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.___AP Medical Writer Lauran Neergaard contributed to this report.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5644

The COVID-19 pandemic has hit people of color particularly hard, and one new study says that may be because of racial disparities in treating high blood pressure.According to the American Heart Association's Scientific Sessions, one-third of disparities in treatment may be the result of racial inequalities in prescribing or increasing the dosage of new medications used in treating high blood pressure.The study found that blood pressure control rates are lower in Black patients compared to other racial groups. Black patients also had more missed opportunities for treatment and missed more clinic appointments."A doctor might think a patient is less likely less able to afford medications, and because of that, they choose to not prescribe a certain medication," said Dr. Valy Fontil, an assistant professor of medicine at UCSF and one of the researchers involved in the study. "Or, they might know this person doesn't have transportation to the clinic, and so sometimes it might even be well-intentioned."Fontil says more standardized treatment protocols would help eliminate the disparities and prevent missed opportunities to get someone the medication they need."Sometimes people present, and the main thing that they're there for is not for the blood pressure," he said. "So, the clinician just sort of kind of might ignore the blood pressure. So automating these sort of standardized treatments would tell the clinician that they — even if the patient's not here for blood pressure — you have to address it in some way."Previous studies have also shown Black patients have more apprehension about why someone is giving them more medication. Fontil says one solution is having the patient be part of the treatment decision making.Fontil adds that the increasing number of virtual visits for blood pressure issues could make the racial disparities even worse. 1876

The Cumberland, Wisconsin High School Class of 2018 got a special shout out from the local police department on an epic senior prank.The police department said on Facebook it was "one of the best senior pranks that Cumberland High School has seen."Students positioned an old junker strewn with loose bricks in front of what appeared to be a gaping black hole in the building's side, just outside the principal's office.It wasn't actually a hole, though. Using tape and a black tarp, the students created the illusion of damage, making it look like the car crashed into the side of the building. The back of the car said, "CHS Class of 2018."The best part? This prank included absolutely no damage at all to school property, which is why police singled it out."Hats off to the Cumberland High School Class of 2018 on your senior prank...Congratulations to all the seniors who are graduating," police said.This isn't the first time the tiny town of Cumberland has been in the viral spotlight. In fact, it's not even the first time this year.Back in January, the school district enlisted the help of former Backstreet Boys star AJ McLean to announce a snow day."Hey there Cumberland Beavers," McLean says in the video. "It's AJ from the Backstreet Boys. I hear you guys have some pretty nasty weather out there today. yeah, It's a snow day and here to 'tell you why' is Mr. Narges and the entire administrative team.""You're having a snow day," AJ sings.  It is unclear how the Cumberland school district got McLean's help, but the video canceling classes for the day caught the attention of people around the country -- it has since racked up nearly 70,000 views on YouTube. 1710

The excitement of two COVID-19 vaccines with more than 90 percent efficacy is undeniable.In November, both Pfizer and Moderna announced its scientists had developed vaccines with efficacy at or near 95 percent, but scientists are warning these vaccines are not the "silver bullet" to ending the pandemic.“We don’t want to give the public the impression that there’s an emergency use authorization and these vaccines become available in a small amount in December and we can go back to our pre-pandemic behavior,” said William Moss, executive director of the International Vaccine Access Center at Johns Hopkins.In June, the FDA released its vaccine guidelines, saying it would consider emergency use authorization for any vaccine testing with at least 50 percent effectiveness, so there is a reason for celebration, according to Moss, but only after certain questions about the vaccine are answered.Dr. Anthony Fauci has said the initial vaccines will prevent symptoms in those who become infected, rather than kill the virus itself. Moss says that means immunized people might be able to spread COVID-19 to others.He also wonders how long immunization will last. One year? Three years? Will booster doses be needed? They're all careful considerations that will only emerge once one is put into play, according to Moss.“It’s obviously tragic that the [COVID] cases are occurring that quickly, but it does help a vaccine trial because otherwise you just have to wait that much longer for samples to come in,” said Moss.The vaccine process has innovated how scientists and researchers approach these types of situations, however, according to Moss.In traditional vaccines, a small dose of the virus is injected into the body so the immune system can create antibodies. In the COVID-19 vaccine, though, both Moderna and Pfizer have used what is called messenger RNA (mRNA) where the virus’ genetic code is injected into the body so it can instruct cells on what antibodies to produce. Scientists say this way is faster, safer, and can create a stronger immune response as people are not exposed to the virus.“I suspect that if this all goes well and these vaccines are safe and continue to demonstrate 90 to 95 percent efficacy, we’re going to see other vaccines of a similar type,” said Moss. 2298

The defense rested its case Tuesday morning in the trial against former Trump campaign chairman Paul Manafort without calling any witnesses, setting the stage for closing arguments Wednesday morning.Manafort spoke for the first time in court during the trial, saying he will not testify.Manafort told Judge T.S. Ellis that he would not testify during a brief questioning at the podium before the jury was brought in the room. Manafort is not required to testify because of his Fifth Amendment rights against self-incrimination. Ellis made this clear during his brief conversation with Manafort."You have an absolute right to testify before this jury," Ellis said. "You have an absolute right to remain silent before this jury." 735