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The U.S. will pay more than billion for 100 million doses of a potential Covid-19 vaccine manufactured by Johnson & Johnson.The deal is one of several large agreements between the government and pharmaceutical companies as part of Operation Warp Speed, aimed at creating, testing, manufacturing and distributing a Covid-19 vaccine quickly.The Trump administration’s deal with Johnson & Johnson, announced Wednesday, allows for the purchase of an additional 200 million doses.Johnson & Johnson’s vaccine, developed by subsidiary Janssen Pharmaceutical Companies, has shown positive preclinical results. Testing of their vaccine is currently underway with human trials in the United States and Belgium.The Johnson & Johnson vaccine testing is reportedly behind some of the more advanced-stage potential vaccines, like those from Moderna, Pfizer and AstraZeneca, which have begun phase three human trials.“We greatly appreciate the U.S. government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson in a statement.The company says they are committed to global access to the vaccine following approvals, and has a goal of supplying 1 billion doses globally through the end of 2021. 1493
The sidewalk vendors who have set up shop along the Mission Beach boardwalk may soon have to a find a new place to sell their wares. It's part of a series of regulations a City Council committee advanced at its meeting Thursday. The vendors have come in waves after a new state law decriminalized the practice, reducing any fines to administrative. The city, as a result, is no longer enforcing its rules that conflict with the law. As such, the vendors have set up shop along Mission Beach and other areas with heavy foot traffic. On Thursday, the boardwalk had vendors selling jewelry, sports team beach bags, and even tobacco pipes. "I hope they don't take this area away from us, the tourists love us and we just love this area to set up and vend," said Tina Saito, who was selling the pipes and rock necklaces on the boardwalk. The state law blocks the city from instituting restrictions based on economics, so it can't stop a vendor from opening outside an established business. The city can, however, enact regulations based on public safety. As such, the city's proposed ordinance would require food vendors - like the ones that lined Balboa Park at Pride earlier this month - to have county health permits and a food handlers card. It would also restrict hours in parks, and place a summer moratorium on vending in Balboa Park. The city would also block vendors from popular areas like Newport Avenue in Ocean Beach, Garnet Avenue in Pacific Beach, the Mission Beach boardwalk, the La Jolla Shores boardwalk, and the area around Petco Park on Padre game days. Finally, it would disallow vendors from selling things like alcohol, drug and tobacco paraphernalia, and weapons. Saito, who sells the tobacco pipes, called that potential decision disappointing. The city economic development committee instructed staff to get more input on the rules from vendors before they go to the full council in September. 1923
The US Food and Drug Administration expanded?the list of drugs being recalled that contain valsartan. The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer. The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide. Not all of the drugs containing valsartan were affected.N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a?possible carcinogen by the US Environmental Protection Agency. It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions. It's a byproduct of the manufacturing of some pesticides and fish processing.The medicines that are now a part of this expanded list?in the recall are tablets sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).The FDA also published a list of valsartan products that are not currently recalled. Only the drugs suspected of being tainted with NDMA are on the recall list. If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn't on the label, you can call your pharmacy for those details.The recalled medicine is linked to a manufacturer in China. The substances were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, in eastern China, which said it notified authorities as soon as it identified the impurity."We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23," the company said in a statement to the Shanghai stock exchange last month.The FDA said on its website that it's working with drug manufacturers "to ensure future valsartan active pharmaceutical ingredients are not at risk."If you are worried that your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.To get a sense of what taking a tainted drug could mean, FDA scientists estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) from the recalled batches every day for four years, there may be one additional case of cancer."The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful," Dr. Mary Ann Bauman, a representative for the American Heart Association, said in July. "You don't want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first." 3690
The teenager who allegedly used a shotgun and a revolver to kill 10 people and wound 10 others at a Texas high school Friday admitted he didn't shoot people he liked and meant to kill the ones he did target, a probable cause affidavit says.Suspect Dimitrios Pagourtzis, 17, has cooperated with police, said Galveston County Magistrate Mark Henry said. Henry denied bail for the student, who is accused of capital murder of multiple people and aggravated assault on a public servant.Students at Santa Fe High School, not far from Houston in southeastern Texas, scrambled for safety after they heard shots just after class began Friday morning. Nine students and one teacher were killed, a law enforcement official told CNN.Pagourtzis said little during a video court appearance, answering "Yes, sir" when asked whether he wanted a court-appointed attorney. He was not asked to enter a plea.The probable cause affidavit says he told an investigator he spared people he liked because he wanted his story told.The alleged shooter used a shotgun and a .38 revolver that were legally owned by his father, Gov. Greg Abbott told reporters. Two school resource officers were on the campus and confronted the shooter "early on in the process," Abbott said.Live updates on the school shootingLatest developments? A student who survived being shot in the head tweeted: "I'm so greatful and blessed that god spared me today." Rome Shubert showed CNN affiliate KTRK where a bullet went in the back of his head and came out near his left ear.? A Pakistani exchange student, Sabika Sheikh, was killed, the county's embassy in Washington said.? One classmate told CNN the alleged shooter was "really quiet and he wore like a trench coat almost every day."? Abbott said investigators have found journals on a computer and cell phone owned by the suspect.? The governor offered his sympathies to the victims then called for lawmakers and others to come together to prevent more tragedies. "We need to do more than just pray for the victims and their families. It's time in Texas that we take action to step up and make sure this tragedy is never repeated ever again."? Retired Houston Police officer John Barnes was one of the people shot at Santa Fe High School, a hospital official said. Houston's police chief tweeted that he visited the hospital where Barnes was being treated and that Barnes was "hanging in there." The officer was working as a Santa Fe officer, a police union official tweeted.What we know about the shootingEarly morning attackGunfire erupted at the school, about 20 miles outside Galveston, not long after classes began around 7:30 a.m. CT, officials said. Authorities later found explosive devices -- including pipe bombs and pressure cookers -- in and near the school, the law enforcement official said.The suspect is believed to be a student. A second person -- also believed to be a student -- has been detained as well, Harris County Sheriff Ed Gonzalez said earlier.The male that Gonzalez described as a suspect was injured, a law enforcement official said on condition of anonymity.Investigators believe that the second person, an 18-year-old, may be an accomplice but not a shooter, a law enforcement official said.Two law enforcement officers are among the injured, according to a law enforcement source.One man is in critical condition with a gunshot wound in one of his arms, said David Marshall, chief nursing officer for University of Texas Medical Branch hospital.This is the 22nd US school shooting since the beginning of the year, and the third instance in eight days in which a gunman was on a school campus.Witnesses described students running from the school as they heard gunshots; they also described hearing an alarm at the school, though the sequence of events wasn't immediately clear.Authorities found explosive devices in the high school and in adjacent areas, said Walter Braun, Santa Fe Independent School District police chief. It wasn't immediately clear if any had exploded.Because the devices were found, Braun urged people in the city of about 13,000 people to "not touch any items that look out of place, and call 911" if they see something suspicious.Investigators Friday afternoon were searching a trailer where they believe the devices were assembled, a law enforcement source said.The school has been cleared of all students and staff, who have been directed to a nearby facility to reunite with their families, Braun said.Witness: Shooter fired gun in an art classAn armed person walked into an art class at the school and began firing what looked like a shotgun, a witness told KTRK.The witness told KTRK she saw a girl shot in the leg.Victims were being treated at three hospitals, authorities said. Eight people went to Clear Lake Regional Medical in Webster, Texas; two patients were treated at Mainland Medical Center in Texas City; and four patients went to John Sealy University of Texas Medical Branch in Galveston. It is unclear whether they were all wounded.Six of the eight patients at Clear Lake Regional were discharged by Friday afternoon.Witnesses describe hearing an alarm as well as gunfireAngelica Martinez, a 14-year-old student, told CNN she and her schoolmates were being evacuated at one point "like it's a fire drill.""We were all standing (outside), but not even five minutes later, we started hearing gunshots," she said. "And then everybody starts running, but, like, the teachers are telling us to stay put, but we're all just running away.""I didn't see anybody shooting, but like (the gunshots) were kind of spaced," Angelica said, adding she heard about four shots.A witness who spoke to KTRK also said she heard an alarm. She didn't specify if that was before or after the gunfire she described in the art class.She said she couldn't describe the shooter."I didn't look. I just ran," she said.Another student, Dakota Shrader, told CNN affiliate KPRC that she heard gunshots only after hearing an alarm in the school."I was in the history hallway, and as soon as we heard the alarms, everybody just started leaving following the same procedure as ... (a) practice fire drill," Shrader said, breaking into tears. "And next thing you know, we just hear ... three gunshots, loud explosions, and all the teachers are telling us to run."MaKenna Evans, a 16-year-old sophomore, told CNN she was in geometry class when the shooting started.First, she heard a fire alarm, she said. When the students got outside, her principal told them all to run.Evans said students hid behind a building across the street from the school.The high school has about 1,400 students, according to GreatSchools.org.Trump: Mass shootings have been 'going on too long in our country'Trump addressed the school shooting, saying that mass shootings have been "going on too long.""Unfortunately, I have to begin by expressing our sadness and heartbreak over the deadly shooting at Santa Fe High School in Texas," Trump said from the East Room of the White House. "This has been going on too long in our country. Too many years. Too many decades now."Trump said federal authorities are coordinating with local officials."We grieve for the terrible loss of life and send our support to everyone affected by this absolutely horrific attack," Trump said.Trump has ordered US flags at federal facilities be flown at half-staff.The-CNN-Wire 7385
The U.S. has now recorded more than 3 million new cases of COVID-19 in the month of November alone, according to a database kept by Johns Hopkins University.According to Johns Hopkins, the U.S. has recorded at least 3.1 million cases of COVID-19 since Nov. 1 — more than 25% of all the cases the country has seen since the pandemic began.The spike in cases has led to a concerning jump in virus-related hospitalizations across the country. According to the COVID Tracking Project, more than 83,000 people across the country are currently battling the coronavirus in a hospital — the most the country has seen since the pandemic began. The COVID Tracking Project reports that while the entire country is seeing a spike in hospitalizations, the Midwest and South have been hit particularly hard — 69% of all COVID-19 hospitalizations across the country have occurred in those two regions.The spike has led to a concerning increase in hospital resources. In some rural hospitals in the Upper Midwest, there aren't beds to spare.The COVID Tracking Project also reports that there has been a significant uptick in deaths since the start of November. Since Oct. 31, the 7-day average of daily deaths has increase from 810 to 1,470. The current rate of deaths per day hasn't been seen in the U.S. since mid-May. The concerning spike occurs as much of the country sees the weather turn colder ahead of winter months, and comes as Americans prepare to celebrate the holiday season — something health officials warn could further facilitate the spread of the virus. The CDC has recommended that Americans not travel to celebrate Thanksgiving with loved ones and recommends against hosting large gatherings this year.It also comes as several drug companies, including AstraZeneca, Moderna and Pfizer have all reported encouraging results from their COVID-19 vaccine trials. While the companies are all pre-producing millions of doses of the drugs prior to authorizaiton, health experts say they likely won't be widely available until spring 2021. 2049