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Johnson & Johnson announced it has paused its coronavirus vaccine trials on Monday following an “unexplained illness” among one of its participants.Johnson & Johnson stressed that adverse events during trials are expected, and a pause gives researchers an opportunity to review all of the medical information before moving forward with the trial. Johnson & Johnson added that it’s not always immediately known if the affected person received a placebo or a study treatment.Among the trials paused was Johnson & Johnson’s multi-country “ENSEMBLE” vaccine, which entered Phase 3 testing in September. Johnson & Johnson said last month that its goal was to seek an emergency use authorization approval in early 2021.The FDA noted that a vaccine candidate must be at least 50% effective to receive emergency use authorization. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit.According to the FDA, a typical Phase 3 trial would take one to three years.“NIH is committed to supporting several Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic,” said NIH Director Francis S. Collins, M.D., Ph.D. “We also know that preventing this disease could require multiple vaccines and we’re investing in those that we believe have the greatest potential for success.” 1554

LA JOLLA (CNS) - A man was seriously injured Saturday when he lost control of his vehicle, which hit a median and rolled over a couple of times, police said.The man, 59, was driving a 2001 Toyota Tundra westbound in the 2500 block of La Jolla Parkway at about 6 a.m. when he experienced a possible medical condition, causing him to lose control of the vehicle, said Officer Tony Martinez of the San Diego Police Department."The vehicle veered to the left and struck the raised concrete median," he said. "The vehicle rolled over a couple of times and came to rest in the westbound No. 1 lane, facing east."The driver sustained a spinal fracture and he was taken to the hospital.Traffic Division officers responded to the scene and will be handling the investigation, Martinez said. 789

Just weeks after the fall term began, the California State University (CSU) system announced most classes across its 23 campuses would remain virtual throughout the spring term.In a letter to the campus community, Chancellor Timothy P. White notes health as one factor."We know far more about it [the pandemic] now than we did back in May. The virus continues to spread. There is no vaccine and there likely will not be one widely available any time soon. The summer increase in infections that was forecast in the spring happened as predicted, and it was larger than expected."White says the decision will also provide faculty and staff more time to better prepare for a virtual learning environment. “I wasn’t that surprised because the virus doesn’t look like it’s going away any time soon and the conditions for spring look like the conditions for fall, so from a public health perspective it makes sense," said Robert Kelchen, an associate professor of higher education at Seton Hall University in New Jersey.Kelchen has been tracking reopening plans across the country."The advantage of deciding early is colleges have a lot of time to prepare classes the way they want to be fully online and get it the best they can be," said Kelchen. But as colleges face massive financial hits while struggling to maintain enrollment, Kelchen says it’s unlikely other colleges will solidify spring plans this soon.“CSU isn’t as concerned about losing students to other colleges because there’s lots of demand to go to CSU; it’s not like some of the colleges, say in the northeast and Midwest, that are really concerned about having enough students. They’re in a position of strength," said Kelchen. Kelchen says small private colleges will struggle to survive the pandemic.“If the fall is any indication, there will be some colleges that will try to come back in person and then fail spectacularly right before or right at the beginning of the term," said Kelchen. A CSU spokesperson says dating back to March, they estimate about 0 million in forgone or returned revenue and unexpected costs across the 23 campuses. To mitigate some of these losses, as well as a 0 million reduction in state funding, some cost-cutting measures include a system-wide hiring chill and the elimination of non-essential travel.Kelchen says professors at his university have taken pay cuts. "For most colleges that will make it through, they’ll have to make cuts. They’ve already laid off quite a few people; they're going to cut academic programs that are either really small or really expensive to run, they’re going to not invest as much in facilities, students are going to have larger classes, they'll have fewer full-time faculty teaching them or part-time adjuncts. It will be a different experience because colleges are trying to save money, and students are also going to want to spend less money," said Kelchen. The news leaves some students with little hope for a normal college experience. “I really only got one good semester when everything was normal, and it was fantastic. I loved the school, I loved the professors, I loved the people," said Kelsey Santin, a transfer student at San Diego State University.After losing access to resources like the library and health center, Santin started a petition calling for reduced fees and tuition.“The quality is severely diminished. And that’s not to say the professors aren’t doing their best, it's just, you can’t expect to take the way that education has been worked for years and completely change it and just expect it to go without a hitch," said Santin. “We understand why the education needed to change, why the style had to change. But we don’t understand if the product changed, why wouldn’t the price change as well?"After losing her job during the pandemic, Santin decided to move home to the Bay Area to do her online classes. Her petition has nearly 5,000 signatures and counting. “I was hoping just to kind of get a coalition formed and maybe start a class action lawsuit in some way, shape or form, but I definitely want to get some momentum going before that,” said Santin. The law firm Bryan Cave Leighton Paisner says over 250 refund-related lawsuits are pending by university students across the country. But Christopher Schmidt, a class action lawyer at the firm, says it will be difficult for students to win these legal battles. He says students sign financial contracts, which likely did not promise in-person instruction. A CSU system spokesperson says all campuses continue to provide instruction and are working to help students earn a degree, and that thousands of faculty and staff members participated in professional development opportunities to better prepare to help students learn in a virtual environment. The spokesperson also notes that many of the services offered on campuses are now offered virtually, like access to health services or advisors. 4931

JAMUL (CNS) - A fire of unknown origin damaged a home in a back-country neighborhood west of Barrett Lake today and left a resident with burn injuries.The blaze in the 17000 block of Lyons Valley Road in Jamul erupted shortly before 3 p.m., according to Cal Fire.It took crews about an hour to fully subdue the flames, said Issac Sanchez, a fire captain with the state agency.Medics took a 25-year-old man to UCSD Medical Center in San Diego for treatment of burns of undisclosed severity.The cause of the fire was under investigation, Sanchez said. 557

KANSAS CITY, Kansas — A second company associated with Schlitterbahn has been named in a newly unsealed criminal indictment.Henry & Sons Construction is listed as a co-defendant in the murder case of 10 year old Caleb Schwab.The boy died on the Verruckt water slide in 2016.According to the indictment, Henry & Sons was the design and construction company for Verruckt.Reviews posted online by people who identify themselves as former employees raise safety concerns before the Schwab tragedy. On the job website Indeed.com, a person who identifies himself as a former welder for Henry & Sons submitted a February 2015 review for the company.The review claims management would ignore issues or "let them pass" like damaged work equipment.The welder also says managers wouldn't require a safety harness to work six feet off the ground and they "just wanted to get the job done no matter how risky it could be."Other review headlines include "Unsafe Working Environment", "Lack of Management Skills" and "Unorganized."At least one poster, however, gave the company five stars, calling it "an amazing place to work." The latest indictment states company owner Jeff Henry hired a man named John Hunsucker as a consultant for the operation and safety of Verruckt.But Hunsucker told investigators that while he could make suggestions, it was only Henry who made the decisions.The indictment further says Henry never asked Hunsucker to check if the water slide met industry safety standards, which the indictment claims in many ways it did not. 1587

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