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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 erratic stock market just made a serious comeback.Fears about slowing earnings growth sent the Dow careening 549 points lower on Tuesday before the index raced back to life.By the closing bell, the Dow was only down 126 points, or 0.5%.Similarly, the Nasdaq closed down 0.4%, erasing the vast majority of a 2.6% plunge. The index also climbed out of a technical correction, a 10% decline from prior highs.The S&P 500 suffered its fifth straight loss. But the broad index finished just modestly lower after touching its weakest point in nearly four months.Market veterans saw little reason for the dramatic recovery -- other than the fact that stocks had gotten to oversold levels."It was an impressive day. We reversed on very little news," said Art Hogan, chief market strategist at B. Riley FBR.Hogan pointed to how the rebound was led by two of the most beaten-down corners of the market: homebuilders and chip makers.Stocks sold off early on Tuesday after major US companies reported gloomy results and guidance. Disappointing numbers from Caterpillar and 3M reinforced ongoing concerns about how long blockbuster profits can last, especially given tariffs and rising costs."Investors are skittish about whether we've seen a peak in earnings," said Mark Luschini, chief market strategist at Janney Capital Management. "It's a schizophrenic market environment where things that didn't matter suddenly do."It's been a scary month for investors. The Dow and Nasdaq are on track for their worst months since January 2016."The market is fragile," said Rich Guerrini, CEO of PNC Investments. "But we're telling our investors to relax. We're in a correction. I think the market does have some legs left."The CNN Business Fear & Greed Index slipped further into "extreme fear." A month ago the gauge of market sentiment was flashing "extreme greed."Wall Street was also spooked by extreme turbulence in China, the epicenter of the trade war. The Shanghai Composite dropped 2.3% overnight. The sell-off wiped out a chunk of Monday's spike, the benchmark index's best day since March 2016. 2114

The Federal Aviation Administration (FAA) has cleared the Boeing 737 Max to return to the skies, The Associated Press reports.The plane has been grounded in the U.S. since March 2019 after it was involved in two deadly crashes just months after initial orders for the model had been fulfilled. The two crashes — one which occurred in Africa, the other in Asia — killed a combined 346 people.In Congressional hearings last September, Boeing officials say the plane's software included a fatal flaw that caused a nosedive in certain situations.In addition to the human cost of the software error, the Boeing 737 Max has proven to be malignant for Boeing's business. According to CNN, Boeing says the grounding of the 737 Max has resulted in billion in direct costs. Boeing's stock fell 100 points between March 2019 and January 2020 — a massive loss even before the COVID-19 pandemic dragged the entire market down with historic losses. "These 20 months they took to look at every possible issue with the aircraft is more than enough time to make it safe to go back in the air," said Kevin Kuhlmann, an Aviation and Aerospace Science Professor at Metro State University. "It's no small undertaking to go through and develop this training, put the pilots through the training and absorb the cost of the training."In October, American Airlines announced it would begin using the plane on certain routes in late December, pending FAA approval. The company says it will provide flexibility to passengers who do not want to fly on the plane.Other airlines like Southwest say they won't be putting the plane back in rotation until April. 1641

The coronavirus pandemic put the country on pause, but now that some cities and states are opening back up, what will that mean for the future of events?Kamron Khan has a lot of thoughts about that question. The professional photographer owns Kamron Khan Photography based in Cleveland and usually photographs large events, with hundreds of people that are booked a year or more in advance.That was until the novel coronavirus pandemic hit, and suddenly she found that one event after the next was rescheduled indefinitely or canceled all together.“It’s been really tough from thinking I was going to have one of my best years ever to no income,” said Khan.Everything from the 2020 Olympics to the remainder of the NBA season, the lights of Broadway to the lights of Hollywood – big events, and events that are only big to those involved have been postponed or canceled around the world.Khan, despite the drop in income, said she understands the caution.“I'm very concerned because I get a lot of these events that people are having, are big life moments - weddings to baby showers - you have all of these different types of things and you want to celebrate and I get that, but sometimes people just need to take a step back and realize ‘Hey you know what, why don't we celebrate next year? Why don’t we just keep it small, wait for things to die down?’ And I in no way think anyone's overreacting, but I would rather overreact and cancel things now than to have things go downhill and then it be much worse,” said Khan.She said right now she has a hard time imagining when events with hundreds of people will be commonplace again.“Right now, I can't until [infections] really change and really start going down in a downward trend. I can't even think about having these large gatherings and I think a lot of people don't want to anyway. Even if we were allowed to,” said Khan.The Centers for Disease Control and Prevention issued guidance about big gatherings now and in the future. The CDC suggests that event organizers do things like provide supplies to prevent the spread of COVID-19, including hand sanitizer and disposable facemasks. The CDC also urged event organizers to discourage people who are vulnerable to the disease -- like older adults – from coming to events at all.The guidance also states that, “Organizers should continually assess, based on current conditions, whether to postpone, cancel, or significantly reduce the number of attendees (if possible) for mass gatherings.”Nick Borelli, a marketing and live event expert, said that at least in the next year or so, people should expect to see smaller, more local events. He said those first events will also likely have cultural significance – like a city’s celebration or a big concert – rather than a conference or trade show.Borelli also said that in order for people to gain confidence going to events again, any initial events would need to be successful - with no new infection clusters.“If [cultural events] happen, it will just happen with an increased amount of trust, knowing that people want things to be the way that they were. So there is the push for what the bias is a confirmation bias. They want things to be that way, they're just looking for it,” said Borelli.He also said that as far as virtual events go, it’s easy to see which events will likely stay virtual in the future by looking at how different industries are planning right now.“Weddings are being postponed with the hopes to come back as they were,” said Borelli. “Corporate is making a move to adjust things to the cliché of new normal, which at the very least, be a world of hybrid [partially online and partially in person] for quite some time and probably sticking to a percentage of that.”Those virtual events offer their own unique challenges and triumphs. There isn’t that real, in-person interaction, but there is the potential to reach more people who may not have been able to take time off or afford to go to a conference.Borelli also said right now offers a great opportunity to gather data about the events that are happening online right now – to better see what things work better virtually.“I think that depending on the data that we collect in this time, and then also in the time that comes next, we can potentially prove our value in a black and white way that we never able to before,” said Borelli.For those in the event industry right now Borelli acknowledged that there is pain and not everyone will survive. And for those who do survive, it will look and be different for a long time.Khan said her new normal will – among other things – mean wearing a mask for the foreseeable future.“For myself, I'll definitely be wearing a mask whether I'm photographing people inside or outside, I just want to,” said Khan. “Not just protect myself, but I want to show others how people look at me and realize I'm doing everything that I need to be doing.” 4928

The driver who plowed down pedestrians and cyclists on a New York bike path is a "soldier of the caliphate," the ISIS terror group said on its weekly newspaper, without providing evidence to back up its claim.The attack Tuesday killed eight people and left more than a dozen others injured."One of the Islamic State soldiers in America attacked on Tuesday a number of crusaders on a street in New York City," the al-Naba newspaper reported Thursday. 457