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University Vaccine Mandates Violate Medical Ethics
  + stars: | 2021-06-14 | by ( Aaron Kheriaty | Gerard V. Bradley | ) www.wsj.com + 0.00   time to read: +3 min
Schools have for decades required vaccination against infectious diseases, but these mandates are unprecedented—and unethical. Never before have colleges insisted that students or employees receive an experimental vaccine as a condition of attendance or employment. Even soldiers, whose rights are constrained when they join the service, aren’t being compelled to take a Covid vaccine. The FDA has issued such authorizations for three Covid vaccines, but it hasn’t fully approved any of them. Colleges’ vaccine mandates also ignore the huge number of students—thousands of them at Notre Dame—who have already recovered from Covid infection, and who thus possess natural immunity, which studies have suggested is more robust and durable than vaccine immunity.
Persons: aren’t, hasn’t, Notre Dame —, vaccinating Organizations: Covid, Food and Drug Administration, FDA, Notre Dame, Pfizer, FDA’s, Products Advisory, Colleges Locations: United States
U.S. FDA declines to approve Avenue's IV formulation of non-opioid painkiller
  + stars: | 2021-06-14 | by ( Reuters Staff | ) www.reuters.com sentiment -1.00   time to read: +1 min
REUTERS/Andrew Kelly/File Photo(Reuters) -Avenue Therapeutics Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve its intravenous formulation of non-opioid painkiller tramadol for a second time, sending its shares tumbling about 38%. The FDA has been pushing drugmakers to develop alternatives to opioid-based painkillers, as the United States grapples with the menace of opioid addiction. The health regulator in October declined to approve the intravenous formulation of the painkiller, stating it was not safe for the intended population. H.C. Wainwright analyst Joseph Pantginis, however, says that IV tramadol could still have a path forward. Tramadol was approved in the United States in 1995 as a non-controlled analgesic, under the trade name of Ultram, to be sold by drugmaker Johnson & Johnson.
Persons: Andrew Kelly, tramadol, Wainwright, Joseph Pantginis, Tramadol, drugmaker Johnson, Johnson Organizations: Food and Drug Administration, FDA, REUTERS, Therapeutics Inc, U.S . Food, Drug Administration Locations: White Oak , Maryland, U.S, United States
The Maryland-based biotech company Novavax reported Monday that its experimental Covid-19 vaccine is safe and 100 percent effective against moderate to severe disease. The company has already completed a Phase 3 trial in the U.K., but the U.S. trial results are required to apply for emergency use authorization in this country. The Novavax vaccine is given in two doses, 21 days apart. The Pfizer, Moderna and Johnson & Johnson vaccines all work by providing genetic instructions for the body to build the coronavirus's spike protein, which the immune system learns to recognize and fight. The Novavax vaccine can be stored in standard refrigerator temperatures.
Persons: Novavax, Biden, Joe Biden, William Schaffner, Dr, David Hirschwerk, Robert Wood Johnson, Julie Morita, Morita, Johnson Organizations: Food and Drug Administration, Vanderbilt University Medical Center, for Disease Control, Alpha, Robert Wood Johnson Foundation, Chicago Department of Public Health, NBC, Trump, FDA, Johnson, Pfizer, BioNTech, Moderna, CDC, Twitter, Facebook Locations: Maryland, U.S, Mexico, Nashville , Tennessee, Manhasset , New York, Brazil, South Africa, India, Moderna
Novavax Covid-19 Vaccine Is 90% Effective in Key Study
  + stars: | 2021-06-14 | by ( Peter Loftus | ) www.wsj.com + 0.00   time to read: +10 min
Despite the study results, Novavax said it needs much of that time to ensure that its manufacturing processes meet regulatory standards. Novavax started its late-stage, or Phase 3, trial of the Covid-19 vaccine in late December. Novavax said that the vaccine was 93.2% effective combined against the variants of concern and variants of interest in the study. One challenge conducting the study, Novavax said, was the availability of authorized vaccines. In all, about 5,000 people dropped out of the study, Novavax said, meaning the Covid-19 cases that were used to determine efficacy occurred among the remaining 25,000 study subjects, Dr. Glenn said.
Persons: Novavax, , Gregory Glenn, T.J, Kirkpatrick, Stanley Erck, Erck, Biden, Johnson, wasn’t, Glenn, Peter Loftus Organizations: Novavax Inc, Wall, Health, U.S . Food, Drug Administration, Pfizer Inc, Moderna Inc, Pfizer, BioNTech, Moderna, FDA, D.C, GlaxoSmithKline, Johnson, AstraZeneca, National Institutes of Health, peter.loftus Locations: U.S, Mexico, Gaithersburg, Md, China, Covid, Washington, Chile, Brazil, India
Indian shares end higher as Reliance gains; inflation data in focus
  + stars: | 2021-06-14 | by ( Reuters Staff | ) www.reuters.com sentiment -1.00   time to read: +2 min
REUTERS/Francis Mascarenhas/File PhotoBENGALURU (Reuters) - Indian shares closed higher on Monday, boosted by conglomerate Reliance Industries Ltd and software major Infosys Ltd, while investors eyed more inflation data due later in the day. The blue-chip NSE Nifty 50 index ended 0.08% higher at 15,811.85, while the benchmark S&P BSE Sensex rose 0.15% to 52,551.53 at close. In Mumbai trading, Reliance Industries and Infosys were among the top performers on the Nifty 50, gaining 1.4% and 0.9%, respectively. Reliance shares have gained in five of the last eight sessions. Limiting gains was top Nifty 50 loser Adani Ports and Special Economic Zone Ltd, which slumped 8.5%.
Persons: Francis Mascarenhas, Lupin Organizations: REUTERS, Reliance Industries Ltd, Infosys Ltd, BSE, Reliance Industries, Infosys, Reliance, Economic, Ltd, National Securities Depository Ltd, Economic Times, Adani Enterprises, U.S . Food, Drug Administration, U.S Locations: Mumbai, India, BENGALURU, U.S, New Jersey, U.S . Federal
Sen. John Boozman cashed out of Johnson & Johnson, among other stocks. Rep. Scott Franklin, a Republican of Florida, just made some of the biggest stock moves of 2021 — at least among members of Congress. Johnson & Johnson has also experienced vaccine production issues. Meanwhile, Sen. Shelley Moore Capito's husband, Charlie Capito, sold up to $15,000 worth of shares in Wells Fargo on May 10. Energy stocks are hotRep. Mark Green, a Republican from Tennessee, made two stock purchases in motor fuel distributor CrossAmerica Partners.
Persons: Sen, Elizabeth Warren . Rep, Scott Franklin, John Boozman, Johnson, we've, Pramila, Elizabeth Warren, Chris Evans, , Republican Sen, Richard Burr of, Tom Malinowski, John Sarbanes of, Ilhan Omar, Minnesota, Janice Schakowsky of, Chuy Garcia, Mark Pocan, Bill Clark, Roth, Danny Johnston John Boozman, Walt Disney, Morgan Chase, Boozman, Elaine Chao, Mitch McConnell, Carlos Barria Mitch McConnell, Trump, Mitch McConnell of, Chao, Wells Fargo, Shelley Moore, Charlie Capito, Mark Green, Green, James Langevin, rollin, rollin ', Earl Blumenauer isn't, Ann Wagner, Wagner, Arthur Byrant Organizations: Massachusetts Democrat, Stock, Republican, Democratic Rep, New, Democratic, Chuy Garcia of Illinois, Getty, Florida Republican, Roth IRA, Viatris Inc, AT, T Inc, AP, Apple, Bank of America, Comcast, Walt, Intel, HP, Dynamics, Honeywell, Union Pacific, Johnson, and Drug Administration, Former, Reuters, Carlos Barria Mitch McConnell fam, Wells Fargo & Company, Energy, CrossAmerica Partners, Shell Midstream Partners, Generac Holdings, Congressional, Caucus, AutoZone Inc, Trempealeau County Justice Center Locations: Washington, Massachusetts, Richard Burr of North Carolina, New Jersey, John Sarbanes of Maryland, Janice Schakowsky of Illinois, Wisconsin, Florida, Arkansas, Wells, Mitch McConnell of Kentucky, Wells Fargo, Tennessee, Rhode Island, Generac, Oregon, Middle America, The Missouri, Trempealeau, La Crosse , Wisconsin
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. Additionally, the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants, Novavax said. The new data comes as federal officials say the U.S. has more than enough doses of Covid vaccines to finish vaccinating the entire American population. It's possible the U.S. could end up donating doses of the Novavax vaccine. Novavax said Monday it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021.
Persons: Novavax, Dr, Gregory Glenn, Johnson, Biden Organizations: Biotech, Food and Drug Administration, Alpha, FDA, Pfizer, BioNTech, Moderna, Johnson, Centers for Disease Control, U.S, White House, Defense, AstraZeneca, Sanofi, Novavax Locations: United States, Mexico, U.S
Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine
  + stars: | 2021-06-14 | by ( Carl Zimmer | ) www.nytimes.com sentiment -0.77   time to read: +1 min
In the 29,960-person trial, the vaccine demonstrated an overall efficacy of 90.4 percent, on par with the vaccines made by Pfizer-BioNTech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100 percent at preventing moderate or severe disease. Despite these impressive results, the vaccine’s future in the United States is uncertain and it might be needed more in other countries. Novavax says it may not seek emergency authorization from the Food and Drug Administration until the end of September. The company’s chief executive, Stanley Erck, acknowledged in an interview that Novavax would probably win its first authorization elsewhere.
Persons: Johnson, Stanley Erck, Novavax Organizations: U.S ., Pfizer, BioNTech, Moderna, Johnson, Food and Drug Administration, European Union Locations: American, United States, Mexico, Britain, India, South Korea
Novavax said its coronavirus vaccine was 90% effective at preventing COVID-19. The biotech company Novavax said on Monday that its coronavirus vaccine succeeded in a final-stage clinical trial, demonstrating 90% efficacy at preventing COVID-19. It remains to be seen how the Novavax vaccine will be used in the US immunization campaign. Among the most vulnerable population — including older people and those with frequent exposure to the virus — Novavax's vaccine was 91% effective. Despite the uncertainty surrounding its use in the US, Novavax's COVID-19 vaccine program has been a remarkable and unlikely success story.
Persons: Novavax, Stanley Erck, Johnson, AstraZeneca's, Read, Rhonda Flores, Andrew Caballero, Reynolds, Novavax's, Bill Gates Organizations: Moderna, Pfizer, BioNTech, Centers for Disease Control, pharma, US Food and Drug Administration, AFP, Coalition for Locations: COVID, Mexico, Maryland, South Africa, Gaithersburg , Maryland
But private hospitals will still charge for vaccines, and it is unclear whether the government has enough stock of free vaccines. Private hospitals will continue charging for the vaccine, and the supply at government hospitals — where the vaccine is free — has been tragically low so far. From the start, India's vaccine drive has been terribly mismanaged, costing thousands of Indians their lives. Some of them could have been saved if the vaccine drive was better managed. Modi basically announced the second phase of the biggest vaccine drive in the world while knowing there wasn't sufficient stock available.
Persons: Modi, Peony, Narendra Modi, haven't, It's, Dinesh Ramkumar, Bharat, Covaxin Organizations: Covishield, AstraZeneca, US Food and Drug Administration Locations: India, , Rajasthan
Biotech Rally Sparked by Alzheimer’s Drug Has Staying Power
  + stars: | 2021-06-13 | by ( Charley Grant | ) www.wsj.com sentiment -0.99   time to read: +1 min
The Food and Drug Administration gave the green light to Biogen ’s drug Aduhelm on Monday. Eli Lilly , which has a similar Alzheimer’s drug under development, rallied 10% on Monday. Alzheimer’s has been a particularly confounding corner of drug research for decades; a 2018 analysis found that 146 experimental drugs had failed in clinical trials over the past 20 years. The FDA’s decision to approve Aduhelm despite significant concerns over its efficacy changes the outlook for those research efforts. Even the perception of a more forgiving regulatory agency is enough to spark fresh enthusiasm for biotech, and not only for companies with an Alzheimer’s program.
Persons: Eli Lilly, Alzheimer’s Organizations: Drug Administration, FDA, Nasdaq
A federal judge threw out a lawsuit filed by over 100 Houston Methodist employees. The judge said the workers were not being forced or coerced to take a vaccine. A federal judge tossed out a lawsuit from more than 100 hospital employees who sued Houston Methodist over its policy requiring all staff to be vaccinated against COVID-19. The hospital has already suspended 178 workers who have missed the vaccine deadlineThe exterior of the Houston Methodist Hospital is seen on June 09, 2021 in Houston, Texas. In a statement to Insider, Houston Methodist's president and CEO, Dr. Marc Boom, praised the hospital system's 26,000 employees who received the vaccine.
Persons: Lynn Hughes, Hughes, Jared Woodfill, Woodfill, Brandon Bell, Johnson, Marc Boom Organizations: Houston Methodist, COVID, Houston Methodist Hospital, Getty, Brandon Bell Houston Methodist, US Food and Drug Administration, FDA, Pfizer, BioNTech, Moderna, Houston Locations: Nuremberg, Houston , Texas
DeLuca devised a system that gave him the final say and even philandered with some franchisees' wives, two sources said. The class sizes were significantly smaller than other Val Verde schools, and it offered dedicated evening study sessions overseen by faculty. And even though it was largely staffed by Val Verde teachers and administrators, it was actually a boarding school. And even though it conferred a Val Verde diploma to graduates, Pegasus California School was really a private academy exclusively serving Chinese students in Qingdao, China. Read our full exclusive report on Pegasus California School here:Also read:Finally, here are some headlines you might have missed last week.
Persons: Matt Turner, Eric Piermont, Fred DeLuca, DeLuca, Frugality didn't, Li Jin, Shayanne, Hans Tung, Uzzaman, Tung, Skye Gould, Dr, David Knopman, Yan, Damien Maloney, Samantha Lee, — Matt Organizations: Insider's Business, Getty, Foods, Harlem, Greylock Partners, Pegasus Tech Ventures, GGV, US Food and Drug Administration, Mayo Clinic, Pegasus, Val, Pegasus California Locations: AFP, Val Verde, American, Qingdao, China
Testing Decline May Hamper Ability to Track Outbreaks Doctors in China report more severe cases in the latest outbreak. A health care worker holding a vial containing doses of the Johnson & Johnson coronavirus vaccine in Union City, N.J., in March. advised Johnson & Johnson on Friday that it should throw out the equivalent of 60 million doses. decided that an additional 60 million Johnson & Johnson doses should not be used. If and when the factory is allowed to reopen, Emergent will only produce the Johnson & Johnson vaccine, and only under Johnson and Johnson’s direct supervision.
Persons: Jim Wilson, We’re, , Susan Butler, Wu, Butler, Michael Osterholm, Mara G, Aspinall, Joseph Odelyn, Carissa Etienne, gasping, Richard Frechette, , Father Frechette, Elizabeth Campa, Zanmi Lasante, Ms, Campa, Jovenel Moïse, Le, Bruno Lemarquis, general’s, what’s, Lemarquis, Jacques Richard Miguel, Harold Isaac, Lindsey Wasson, ” Darby LaJoye, Johnson, Bryan Anselm, Dr, Peter Marks, Biden Organizations: San Francisco International, New York Times, United States, University of Southern, Infectious Disease, University of Minnesota, College of Health Solutions, Arizona State University, Associated Press, The New York Times, Pan American Health Organization, Luke, University Hospital of Mirebalais, United Nations, Passengers, Tacoma International Airport, Reuters, Transportation Security Administration, AAA, Disease Control, Prevention, ., Johnson, Food and Drug Administration, Emergent, AstraZeneca Locations: China, Moscow, Haiti, United States, United, U.S, University of Southern California, American, Associated Press Haiti, Covax, Port, Prince, Seattle, Covid, Air, Baltimore, Union City, N.J, tote
Judge tosses Houston hospital workers' lawsuit over vaccine requirement
  + stars: | 2021-06-13 | by ( Karen Freifeld | ) www.reuters.com sentiment -0.99   time to read: +2 min
An ambulance arrives at the Houston Methodist Hospital emergency room amid a coronavirus disease (COVID-19) outbreak in Houston, Texas, U.S., June 28, 2020. REUTERS/Callaghan O'Hare/File PhotoA U.S. federal judge has dismissed a lawsuit brought by 117 workers at a Texas hospital over its requirement that they be vaccinated against COVID-19. U.S. District Judge Lynn Hughes upheld Houston Methodist Hospital's policy mandating employees be vaccinated, in a ruling issued on Saturday. "Bridges can freely choose to accept or refuse a Covid-19 vaccine; however, if she refuses, she will simply need to work somewhere else." In a statement, Houston Methodist called the lawsuit frivolous and said it was pleased with the judge's decision.
Persons: Callaghan O'Hare, Lynn Hughes, Jennifer Bridges, Hughes, Jared Woodfill Organizations: Houston Methodist Hospital, REUTERS, COVID, U.S, District, Houston Methodist, U.S . Food, Drug Administration, The, Thomson Locations: Houston , Texas, U.S, Texas, United States, The U.S
Covid News: Judge Dismisses Houston Hospital Workers’ Lawsuit Over Vaccine Mandate Experts worry a steep drop in testing will making tracking U.S. outbreaks harder. Judge dismisses Houston hospital workers’ lawsuit over vaccination mandate. A health care worker holding a vial containing doses of the Johnson & Johnson coronavirus vaccine in Union City, N.J., in March. That mistake is most likely to blame for Emergent’s discovery in March that a batch of Johnson & Johnson vaccine had been contaminated with a key ingredient used to manufacture the AstraZeneca vaccine, the memo stated. decided that an additional 60 million Johnson & Johnson doses should not be used.
Persons: Chin Lee, Lynn N, Hughes, Jennifer Bridges, ” Judge Hughes, Bridges, , Marc Boom, Jared Woodfill, Jim Wilson, We’re, Susan Butler, Wu, Butler, Michael Osterholm, Mara G, Aspinall, Joseph Odelyn, Carissa Etienne, gasping, Richard Frechette, , Father Frechette, Elizabeth Campa, Zanmi Lasante, Ms, Campa, Jovenel Moïse, Le, Bruno Lemarquis, general’s, what’s, Lemarquis, Jacques Richard Miguel, Harold Isaac, Mauricio Lima, Moria, Johnson, Bryan Anselm, Dr, Peter Marks, Biden, Melina Delkic, ” Malcolm Clarke, it’s, Roy Cooper, Michael Gisser, Jodie, Mr, Cooper, Lauren Gibson, Buda Mendes, Jose Peseiro, Peseiro, ” Peseiro, Nelson Almeida, Argentina’s, , Roberto Firmino, Lucas Figueiredo, Jair Bolsonaro, Bolsonaro, Denis Grishkin, Sergey S, Sobyanin, Vladimir V, Putin, Rafael Nadal, Novak Djokovic, Felix Tshisekedi Organizations: Covid, Houston Hospital Workers, Houston Methodist Hospital, ., Houston Chronicle, Associated Press, District, Southern District of, Washington , D.C, Drug, for Disease Control, Houston Methodist, San Francisco International, New York Times, United States, University of Southern, Infectious Disease, University of Minnesota, College of Health Solutions, Arizona State University, The New York Times, Pan American Health Organization, Luke, University Hospital of Mirebalais, United Nations, Authorities, European Union, Johnson, Food and Drug Administration, Emergent, AstraZeneca, North Carolina State Fairgrounds, Breweries, Gov, Copa, Copa America, Brazil, Mane, Agence France, Copa América, CBF, EPA, Moscow News Agency, Reuters, Saudi Press Agency, Venezuelan national soccer team, Sunday, South American, Democratic, ” Reuters Locations: Moscow, Haiti, Baytown, Tex, ., Texas, Southern District, Southern District of Texas, United States, Washington ,, Maryland, U.S, Houston, United, University of Southern California, American, Associated Press Haiti, Covax, Port, Prince, Greece, Afghanistan, Lesbos, The New York Times ATHENS, Chios, Syria, Iraq, Baltimore, Union City, N.J, tote, Raleigh, N.C, Melina Delkic North Carolina, North Carolina’s, Charlotte, North Carolina, Brazil, Brasília, Venezuela, Caracas, Portuguese, Brasília ., Bolivia, South, Argentina, Colombia, Covid, Russian, epidemiologists, Russia, Saudi Arabia, Mecca, France, Canada, Democratic Republic of Congo, Kinshasa
S.Africa to analyse J&J vaccines made at U.S. plant halted over error
  + stars: | 2021-06-12 | by ( ) www.reuters.com sentiment -1.00   time to read: +2 min
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic//File PhotoSouth African health inspectors will carry out further checks on a batch of Johnson & Johnson (JNJ.N) COVID-19 vaccines following a contamination error earlier this year at the U.S. plant where the doses were produced, the health ministry said. "There is now a real possibility that they may not be, however this is for the regulator to rule on," a ministry statement said. read moreManufacturing at the Baltimore plant owned by Emergent Biosolutions Inc (EBS.N) was halted in April after the discovery that ingredients from AstraZeneca's (AZN.L) COVID-19 vaccine, also being produced at the plant at the time, had contaminated a batch of J&J's vaccine. read moreAn inspection by the FDA also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.
Persons: Johnson, Dado Ruvic Organizations: REUTERS, Johnson, U.S . Food, Drug Administration, FDA, Emergent Biosolutions Inc, Thomson Locations: U.S, South Africa, Baltimore
In this article LLYBIIBAduhelm by Biogen Source: BiogenThe FDA's approval of Biogen's Alzheimer's drug Aduhelm was a landmark moment in the life of Dr. Paul Aisen. One immediate challenge facing other teams working on a wider Alzheimer's drug pipeline, he said in a recent video call, would be to retain participants in ongoing trials, let alone attract new ones. "In most cases," he explained, many Alzheimer's sufferers will drop out of other drug studies to pursue treatment with the newly approved Aduhelm. The controversy surrounding the Biogen drug, including its potential cost, comes against a landscape of massive, unmet need for dementia treatment and a disease that costs the U.S. as much as $259 billion annually. That is why some dementia drug experts are focusing on the renewed attention and fresh financing rather than the potential negatives from the Biogen approval, according to Dr. Jeffrey Cummings, a neurologist at the University of Nevada, Las Vegas, who publishes an annual review of the Alzheimer's drug development pipeline.
Persons: Aduhelm, Dr, Paul Aisen, Aisen, Aaron Kesselheim, aducanumab, , Boehringer, Biogen, Jeffrey Cummings, Cummings, Eli Lilly's donanemab, Roche's, Eli Lilly, David Ricks, Biogen's Aduhelm, Lilly Organizations: Biogen, Therapeutic Research, USC, and Drug Administration, FDA, Harvard Medical School, Pfizer, Alzheimer's Association, University of Nevada, National Institutes of Health, pharma, CNBC Locations: San Diego, Las Vegas
Live Covid Live Updates: Moscow Orders Shut Down as Russia Battles New Wave of Cases Doctors in China report more severe cases in the country’s latest outbreak. Now, with Western countries emerging from lockdowns, Russia runs the risk of entering a vicious new wave of the virus. The regulator, in a statement issued on Friday evening, said that Emergent BioSolutions had made those doses at the same time as other batches of the Johnson & Johnson vaccine that were found to be contaminated with the harmless virus used to manufacture the AstraZeneca vaccine. U.S. regulators have put the Baltimore facility under a microscope since March, when they discovered that a major production mishap had resulted in the contamination of a batch of Johnson & Johnson vaccines. Commuters this month in New Delhi, which has been hit hard by the coronavirus pandemic.
Persons: Sergei Ilnitsky, Sergey S, Sobyanin, Mr, , Vladimir V, Putin, ” Mr, , ’ hesitancy, Lindsey Wasson, ” Darby LaJoye, Guan Xiangdong, , Chen Bin, Albee Zhang, Joshua Roberts, Brian P, Monahan, Steny Hoyer, Nancy Pelosi, Ms, Pelosi, Eraldo Peres, Venezuela’s, Jair Bolsonaro, Ambev, Tariq Panja, Jim Lo Scalzo, Johnson, Atul Loke, Donald J, Trump, Biden, Biden’s, coronavirus, Boris Johnson, Ghebreyesus, , Megan Specia, Fahad Organizations: U.S ., Workers, ., MOSCOW, Kremlin, Passengers, Tacoma International Airport, Reuters, Transportation Security Administration, AAA, Disease Control, Prevention, Getty, University, Delta, World Health Organization, Alpha, Health Commission, Guangzhou Municipal Health Commission, Maryland, CNN, Democratic, Centers for Disease Control, Republican, Copa América, Copa, Associated, South, Globo, Brazil, Associated Press, Conmebol, Venezuelan, team’s, Barranquilla Mayor's, Agence France, Argentina, Brazilian, Brazil’s, Mastercard, América, Johnson, Emergent, Health, AstraZeneca, Health Canada, Food and Drug Administration, New York Times, Group, The New York Times, Manufacturing, Innovation Center, Saudi Media Ministry, Saudi Press Agency, Saudi, Saudi Embassy, Twitter, of Hajj Locations: Moscow, Russia, China, Russian, epidemiologists, lockdowns, U.S, Seattle, Covid, Air, Wuhan, Guangzhou, Britain, Brazil, India, Delta, Seychelles, Mongolia, Shenzhen, Foshan, Washington, Venezuela, South American, Argentina, Colombia, Brasília, South America, Venezuelan, United States, Barranquilla, Canada, Baltimore, Md, Health Canada, New Delhi, British, Saudi, Saudi Arabia, Mecca . Credit, Mecca
A Baltimore factory that rendered useless 75 million doses of a coronavirus vaccine developed by Johnson & Johnson failed for weeks to seal off a preparation area for vaccine ingredients and allowed production waste to be hauled through the area, the Food and Drug Administration said in a memorandum analyzing the plant’s operations. The memo, posted on the agency’s website late Friday, offered the most extensive explanation to date of why regulators believe that tens of millions of doses of Johnson & Johnson’s vaccine produced at that factory must be discarded. advised Johnson & Johnson on Friday that it should throw out the equivalent of 60 million doses. That brought to 75 million the total number of doses that cannot be used because of concerns about contamination at a southeastern Baltimore plant, operated by Emergent BioSolutions, Johnson & Johnson’s subcontractor and a longtime government contractor. The vaccine-making factory has been shut for the past two months while regulators determine the cause of contamination that ruined many doses, whether it is safe to reopen the facility, and what to do with the equivalent of at least 170 million doses of vaccine that Emergent produced for Johnson & Johnson and AstraZeneca, another vaccine developer.
Persons: Johnson Organizations: Baltimore, Johnson, Food and Drug Administration, Emergent, AstraZeneca Locations: Baltimore
US STOCKS-S&P ekes out gains to close languid week
  + stars: | 2021-06-11 | by ( Stephen Culp | ) www.reuters.com + 0.00   time to read: +3 min
(For a live blog on the U.S. stock market, click or type LIVE/ in a news window.) Economically sensitive smallcaps and transports notched solid gains, outperforming the broader market. For the week, the S&P and the Nasdaq advanced from last Friday’s close, while the Dow posted a weekly loss. Much of the focus centered on Thursday’s consumer price data, which eased jitters over the duration of the current inflation wave. Among the 11 major sectors in the S&P 500, healthcare suffered the biggest percentage drop.
Persons: Dow, ” Oliver Pursche, ” Pursche, Stephen Culp, Ambar Warrick, Devik, Matthew Lewis, Cynthia Osterman Organizations: U.S . Federal Reserve, Nasdaq, Wealthspire Advisors, Federal Reserve, University of Michigan’s, Benchmark U.S, Treasury, Drug Administration, Dow Jones, AMC Entertainment Locations: New York, Bengaluru
The Food and Drug Administration has told Johnson & Johnson to discard about 60 million doses of its Covid-19 vaccine that were produced at a troubled plant in Baltimore, according to two people familiar with the matter. But the FDA plans to allow Johnson & Johnson to distribute 10 million doses that were manufactured at the same facility, according to the two people familiar with the decision. The FDA’s decision to tell Johnson & Johnson to dump the vaccines was first reported by the New York Times. Following the inspection, the agency required Johnson & Johnson to take full control of the facility. Friday’s action followed a move earlier in the week by the FDA to extend the shelf life of Johnson & Johnson doses from three months to four and a half months.
Persons: Johnson, Dr, Peter Marks, ” Kathy Wengel, Organizations: Drug Administration, FDA, Johnson, FDA’s, Biologics, Research, New York Times, AstraZeneca, NBC News Locations: Baltimore, United States
On June 12, unemployed workers in Alaska, Iowa, Missouri and Mississippi will see their pandemic unemployment benefits shut off three months early, the first of 25 Republican-led states to slash federal benefits that would ordinarily expire in September. The Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020 provided a $300 weekly federal supplement on top of regular state unemployment benefits. Larry Hogan said in a statement June 1 as his state became the 25th to end the federal benefits. Combined federal and state unemployment benefits equal an average of about $650 a week, or around $16 an hour for full-time work. Oklahoma will cut off her family’s federal benefits on June 26.
Persons: It’s, Larry Hogan, , Jordan Motteler, can’t, Covid, , ” Motteler, Sherry Pratt, ” Pratt, Andrew Stettner Organizations: Republican, Relief, Economic Security, American, Labor, Century Foundation, GOP, Food and Drug Administration, Federal Reserve Bank of San, Workers Locations: Alaska , Iowa , Missouri, Mississippi, Maryland, Oklahoma, Sherry Pratt of New Hampshire, Federal Reserve Bank of San Francisco
WASHINGTON—The Food and Drug Administration is expected as early as Friday to clear for export 10 million doses of Johnson & Johnson ’s Covid-19 vaccine from a Baltimore factory that had been beset by contamination problems, according to people familiar with the situation. However, the agency has notified J&J that approximately 60 million doses of vaccine substance were not satisfactory and can’t be used, according to one of the people, a senior U.S. official. That leaves potentially 60 million more J&J doses that could get approved still. The release of the 10 million doses is expected to be the first of several steps to approve vaccine that was produced at the Baltimore plant run by Emergent BioSolutions Inc. before manufacture was halted by the FDA over quality shortfalls. The Emergent plant made vaccine for J&J and for AstraZeneca PLC, before an April 30 FDA inspection report concluded that the facility didn’t take proper measures to avoid cross-contamination between the two companies’ vaccine lines.
Persons: WASHINGTON, Johnson Organizations: Drug Administration, Johnson, The New York Times, Emergent BioSolutions Inc, FDA, Biden, AstraZeneca PLC Locations: Baltimore, U.S
Wall Street ekes out gains to close languid week
  + stars: | 2021-06-11 | by ( Stephen Culp | ) www.reuters.com + 0.00   time to read: +3 min
The Nasdaq gained the most among the three major indexes, while the bellwether S&P 500 squeaked its way to a second straight record closing high. For the week, the S&P and the Nasdaq advanced from last Friday’s close, while the Dow posted a small weekly loss. FILE PHOTO: The Wall St. sign is seen near the New York Stock Exchange (NYSE) in New York City, U.S., May 4, 2021. Among the 11 major sectors in the S&P 500, rebounding financial stocks and tech led the gainers, while healthcare suffered the biggest percentage drop. The S&P 500 posted 33 new 52-week highs and one new low; the Nasdaq Composite recorded 108 new highs and 16 new lows.
Persons: Dow, ” Oliver Pursche, ” Pursche, Brendan McDermid Organizations: YORK, U.S . Federal Reserve, Nasdaq, Wealthspire Advisors, Federal Reserve, University of Michigan’s, New York Stock Exchange, REUTERS, Brendan McDermid Benchmark U.S, Treasury, Drug Administration, Dow Jones, AMC Entertainment, NYSE Locations: New York, New York City, U.S
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