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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 charges against one of the three men in connection to a viral video of a shark being dragged behind a boat from July 2017 have been dropped.A Hillsborough County (Florida) judge dropped two felony counts of aggravated animal cruelty (third-degree felony) against Spencer Heintz Tuesday morning.According to the judge, the state dropped the charges because no evidence showed that Heintz, 23, broke the law and because he agreed to testify as a witness.Heintz, 21-year-old Michael Wenzel and 28-year-old Robert Lee Benac were all charged after a four-month-long investigation into the graphic video of a shark being dragged behind a boat.At this time, it is unknown if the charges against Wenzel and Benac will also be dropped.Wentzel and Benac still face the following charges: 824

The FDA warned the public on Thursday to not use hand sanitizers packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.The FDA said that some products are being packaged in items such as water bottles and food pouches, and may contain flavors such as chocolate or raspberry. The FDA said that ingesting alcohol-based hand sanitizers can cause significant cardiac injury, including death.The FDA said that one consumer bought a plastic bottle of hand sanitizer thinking it was water.“Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer,” the FDA said.“I am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages. These products could confuse consumers into accidentally ingesting a potentially deadly product. It’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning,” said FDA Commissioner Stephen M. Hahn, M.D. “Manufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers.“The FDA continues to monitor these products and we’ll take appropriate actions as needed to protect the health of Americans.” 1475

The Florida House on Wednesday passed legislation that would impose new restrictions on firearm sales and allow some teachers and staff to carry guns in school.The Marjory Stoneman Douglas High School Public Safety Act was spurred by the February 14 shooting in Parkland, Florida. The bill, which passed 67-50, now goes to Gov. Rick Scott. He has 15 days to sign it.Earlier in the day, Scott expressed reservations about the provision to arm school personnel. He vowed to review the bill "line by line" before signing it."The group that I'm going to be talking to -- the groups that I care most about right now because it impacted them so much -- is the families," Scott said.Speaking on behalf of the 17 families who lost loved ones in the shooting, Andrew Pollack, whose daughter was killed, urged Scott to sign the bill."We stand united in asking him to sign this historic bill into law," he said after the bill's passage."We thank the House and Senate for voting in favor of protecting our children, but more needs to be done and it's important for the country to unite in the same way the 17 families united in support of this bill."Scott also concerned about waiting period 1187

The coronavirus pandemic may have started earlier than previously thought, according to scientists from the CDC.A study from government scientists published November 30 appears to confirm what some health experts have suggested, patients infected with COVID-19 were in the US before the beginning of 2020.“The findings of this report suggest that SARS-CoV-2 infections may have been present in the U.S. in December 2019, earlier than previously recognized. These findings also highlight the value of blood donations as a source for conducting SARS-CoV-2 surveillance studies,” the report states.The first officially documented case of COVID-19 in the US was reported on January 19, a person who had returned to the US after traveling from China.The World Health Organization was alerted to the novel coronavirus by officials in Wuhan, China on December 31, 2019. The CDC researchers say further reports have identified a patient in Wuhan with COVID-19 symptoms as early as December 1, 2019.The study looked at more than 7,000 routine blood donation samples taken by the American Red Cross from people in nine states between December 13, 2019 and January 17, 2020.They found COVID-19 antibodies in 106 samples, mostly from the states of California, Oregon and Washington, from blood collected between December 13-16, 2019. Other samples that indicated COVID-19 antibodies were from Connecticut, Iowa, Massachusetts, Michigan, Rhode Island, and Wisconsin taken in early January 2020.“The presence of these serum antibodies indicate that isolated SARS-CoV-2 infections may have occurred in the western portion of the United States earlier than previously recognized or that a small portion of the population may have pre-existing antibodies that bind SARS-CoV-2,” the report states.Scientists acknowledge that patients presenting with what is now known as COVID-19 symptoms before mid-January would likely not have had clinical samples taken or kept because of how new the virus was. Therefore, the CDC used the existing repository collected by the American Red Cross during their routine blood donation process.“These specimens were previously archived for potential future studies to identify emerging transfusion-transmissible infections but were re-purposed for the present study,” researchers stated.Researchers caution that these results are subject to limitations. Although they detected antibodies, that does not mean they are “true positive” COVID-19 tests. In order to get a true positive, a different test would need to be a run. 2545

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