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The Center for Disease Control (CDC) has issued a reminder to the public to stop washing and reusing condoms.The CDC said in a tweet that this reminder to all sexually-active Americans was sent out "because people do it." 229
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 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 death toll from a powerful explosion in Beirut Tuesday has reached 100 and is still climbing. At least 4,000 others were injured.While no one knows yet exactly how many people died in the blast, the destruction was so extensive that the shockwave was felt across the city.The blast, which began as a fire in a port warehouse, happened just after 6 p.m. local time.Beirut's emergency services were so overwhelmed that it was up to whoever could help to provide comfort to the injured. Open lots were turned into field hospitals.In an instant, lives were lost and livelihoods were destroyed."The whole house collapsed on us," one woman who survived the blast said.Following the explosion, Michel Haibe visited the site of what used to be his electrical goods store."Forty years," Haibe said. "War, we've seen woes of every kind, but not like this. As if the economic crisis, coronavirus, the revolution weren't enough, this tops them all."Life was already a struggle in Lebanon with its economy in freefall and the coronavirus on the rise. Now, the country's capital must dig out of another tragedy."We got here an hour ago, and as you can see, it's completely and utterly destroyed," bar owner Hadi Shahlawi said. "We've been open since last October and we've been fighting every month with different circumstances — the economic situation. It's catastrophic; what's happening in Lebanon is a catastrophe." 1417
The Food and Drug Administration is investigating an outbreak of Listeria that has killed at least one person.The FDA, CDC and public health officials are looking into ten cases of Listeria monocytogenes infections reported in Florida, Massachusetts and New York. One person has died, the only available information is that the person lived in Florida.Genome sequencing of the Listeria bacteria isolated from those infected shows the ten people in this outbreak are more likely to share a common source of infection, according to the FDA. Samples were taken from patients between August 6 and October 3.In interviews with nine of the infected people, they all reported eating Italian-style meats recently, like salami, mortadella, or prosciutto, according to the FDA.Public health investigators have not found a common type of deli meat or common supplier among the patients at this time.The patients in this outbreak range in age from 40-to-89 years old, and all of them needed to be hospitalized.Listeria can cause different symptoms, depending on the person and part of the body affected, according to the Centers for Disease Control and Prevention. Symptoms include headache, stiff neck, confusion, loss of balance, fever and muscle aches. 1251
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