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The top U.S. public health agency stirred confusion by posting — and then taking down — an apparent change in its position on how easily the coronavirus can spread from person to person through the air.But officials at the Centers for Disease Control and Prevention say their position has not really changed and that the post last week on the agency’s website was an error that has been taken down.It was “an honest mistake” that happened when a draft update was posted before going through a full editing and approval process, said Dr. Jay Butler, the CDC’s deputy director for infectious diseases.The post suggested that the agency believes the virus can hang in the air and spread over an extended distance. But the agency continues to believe larger and heavier droplets that come from coughing or sneezing are the primary means of transmission, Butler said.Most CDC guidance about social distancing is built around that idea, saying that about 6 feet is a safe buffer between people who are not wearing masks.In interviews, CDC officials have acknowledged growing evidence that the virus can sometimes be transmitted on even smaller, aerosolized particles or droplets that spread over a wider area. Certain case clusters have been tied to events in which the virus appeared to have spread through the air in, for example, a choir practice. But such incidents did not appear to be common.Public health experts urge people to wear masks, which can stop or reduce contact with both larger droplets and aerosolized particles.But for months, agency officials said little about aerosolized particles. So when the CDC quietly posted an update Friday that discussed the particles in more detail, the agency’s position appeared to have changed. The post said the virus can remain suspended in the air and drift more than 6 feet. It also emphasized the importance of indoor ventilation and seemed to describe the coronavirus as the kind of germ that can spread widely through the air.The post caused widespread discussion in public health circles because of its implications. It could mean, for example, that hospitals might have to place infected people in rooms that are specially designed to prevent air from flowing to other parts of the hospital.But the CDC is not advising any changes in how far people stay away from each other, how they are housed at hospitals or other measures, Butler said.The CDC has come under attack for past revisions of guidance during the pandemic, some of which were driven by political pressure by the Trump administration.Butler said there was no external political pressure behind the change in this instance. “This was an internal issue,. And we’re working hard to address it and make sure it doesn’t happen again,” he said.In a statement released Monday, the CDC said the revisions to the “How COVID-19 Spreads” page happened “without appropriate in-house technical review.”“We are reviewing our process and tightening criteria for review of all guidance and updates before they are posted to the CDC website,” the statement said.At least one expert said the episode could further chip away at public confidence in the CDC.“The consistent inconsistency in this administration’s guidance on COVID-19 has severely compromised the nation’s trust in our public health agencies,” said Dr. Howard Koh, a Harvard University public health professor who was a high-ranking official in the Department of Health and Human Services during the Obama administration.“To rectify the latest challenge, the CDC must acknowledge that growing scientific evidence indicates the importance of airborne transmission through aerosols, making mask wearing even more critical as we head into the difficult fall and winter season,” Koh said in a statement.___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. 3964
The US Secret Service is investigating the vandalism of a sign at the Trump International Golf Club in West Palm Beach, Florida.The West Palm Beach Sheriff's Office told the White House press pool that the Secret Service is looking into red paint that was splattered on the sign outside of the entrance of the club. Crews were spotted cleaning the sign early Sunday morning.A spokesman for the Secret Service said they are "aware of the incident."West Palm Beach is a frequent getaway for President Donald Trump and his family. He was spotted at the golf club this weekend while in town residing at his nearby property, Mar-a-Lago over the Easter holiday. 693
The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274
The White House chief of staff says President Donald Trump has tested negative for the coronavirus ahead of Thursday night’s second and final presidential debate.Mark Meadows says Trump was tested onboard Air Force One while en route to Nashville, Tennessee, and tested negative.Biden’s campaign said Thursday that he, too, was tested Thursday and tested negative.The test comes after Trump’s bout with the virus, which put him in the hospital for three nights.Both campaigns had been required to certify that their candidates and VIP guests have tested negative ahead of the debates. But Trump and the White House have repeatedly refused to say whether Trump actually was tested before participating in the first.Trump was diagnosed with the virus two days later. 772
The White House said late Friday it is prepared to veto a bill proposed by House Democrats to infuse the cash-strapped Postal Service with funds.The White House’s announcement comes a week after President Donald Trump said he supported funding the Postal Service with Congressional funds. Last week marked a period of the Postal Service removing machines and collection boxes, as mail service has slowed for many across the country.The bill introduced by House Democrats would, in addition to providing funds, require the post office to maintain its current level of service, not close any locations and would lift a prohibition of overtime. Those measures would be in effect through at least the end of the year.According to the Congressional Budget Office, the bill would provide an estimated billion in funding for the post office.The White House pushed back in a policy memo, claiming that reports of slowdowns are an “overreaction.”“This bill misses an opportunity to improve USPS,” the White House said.“USPS does not need a billion bailout. It needs reforms that will return it to a trend of long- term financial self-sufficiency,” the White House added.The Trump administration said that USPS has enough funds to operate through August 2021. But during his Senate testimony on Friday, Postmaster Louis DeJoy said that the post office is losing billion on an annual basis.“Without change our losses will only increase in the years to come,” DeJoy said.The USPS has historically been self-sufficient. But declining volume and increased pension costs have cut into the service’s bottom line. But the post office remains a lifeline for many who rely on mail for medicines, important documents, and other supplies. 1736