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The Centers for Disease Control and Prevention was simply trying to warn Americans about the dangers posed by ticks and the diseases they spread. Instead, they ended up unintentionally ruining some of their followers' appetites.Tick-borne illnesses are on the rise, so the CDC has been pushing Americans to check for ticks after spending time outdoors. On Friday, the agency reminded its followers just how small those the pests can be, tweeting two photos of a poppy seed muffin."Ticks can be the size of a poppy seed. Can you spot all 5 ticks in this photo?" the CDC tweeted. 591
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 Boy Scouts of America is considering filing for bankruptcy, the Wall Street Journal reported Wednesday.Boy Scouts leadership has hired the law firm Sidley Austin LLP for possible chapter 11 bankruptcy filing assistance, people familiar with the matter told the Wall Street Journal.According to the newspaper, filing for bankruptcy would halt the many lawsuits the organization faces alleging inappropriate conduct by employees.In a statement released Wednesday "in anticipation of news reports that will speculate about the BSA's financial position," the Boy Scouts said no immediate decisions are expected."We are working with experts to explore all options available to ensure that the local and national programming of the Boy Scout of America continues uninterrupted," Michael Surbaugh, chief scout executive, said in the statement."We have an important duty, and an incredible opportunity, to focus as an organization on keeping children safe, supported and protected, and preparing youth for their futures through our nation's foremost program of character development and values-based leadership training."The statement acknowledged legal costs related to lawsuits against BSA alleging sexual or inappropriate conduct with boys."We believe (victims), we believe in fairly compensating them and we have paid for unlimited counseling, by a provider of their choice, regardless of the amount of time that has passed since an instance of abuse," the statement said.The-CNN-Wire? & ? 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved. 1576
The day after President Donald Trump signed a historic peace agreement with world leaders and attended a town hall event in Philadelphia, there are reports White House staff members may have tested positive for COVID-19.During his White House briefing on Wednesday, President Donald Trump confirmed that one person, who is part of the WH staff, tested positive for the coronavirus.A reporter for Globo, a Brazillian media outlet, who is part of the White House press corps tweeted Wednesday morning that she learned of the positive cases when the corps own testing was late. 582
The Department of Justice has issued a clarification after some social media users spread disinformation about the use of masks amid the coronavirus pandemic.As cases of COVID-19 spike throughout the country, several states, counties and cities have issued mandates requiring masks in public — and local media reports from across the country indicate that Facebook users in those areas may have seen a viral post containing inaccurate information.While regulations differ from state to state and city to city, many local governments have determined those with pre-existing conditions that would make wearing a mask difficult are exempt from the ordinances. But some viral Facebook posts indicate that the Department of Justice has required exemption cards for those who cannot wear masks.Many of the viral posts contain a screenshot of the "card," containing the Department of Justice seal and a reference to the "Freedom to Breathe Agency.""The Department of Justice has been made aware of postings or flyers on the internet regarding the Americans with Disabilities Act (ADA) and the use of face masks due to the COVID-19 pandemic, many of which include the Department of Justice's seal. These postings were not issued by the Department and are not endorsed by the Department," the DOJ said on its website.The Freedom To Breathe Agency refers to a private Facebook group opposed to government restrictions related to COVID-19 with about 7,000 members. A website listed on the "card" for the agency is not currently active.The Department of Justice recommends visiting Americans with Disabilities Act website for the latest updates from the department. 1661