Russia becomes first country to approve a COVID-19 vaccine, says Putin

first_imgPresident Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.The vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks, a source told Reuters last month. Speaking at a government meeting on state television, Putin dismissed those concerns, saying the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.”I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.He said he hoped mass production would start soon.Phase III trialThe vaccine’s approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.”It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” it said.Some international experts have also questioned the speed at which Russia approved its vaccine.”Normally you need a large number of people to be tested before you approve a vaccine,” said Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac’s COVID-19 vaccine in clinical trials.”In that respect, I think it’s reckless to do that [approve it] if lots of people haven’t already been tested.”Duncan Matthews, a professor of intellectual property law at Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “but safety must be the priority”.”The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach,” Matthews said in an emailed comment.More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic. At least four are in final Phase III human trials, according to WHO data. Topics :center_img Regulatory approval paves the way for the mass inoculation of the Russian population and authorities hope it will allow the economy, which has been battered by fallout from the virus, to return to full capacity.Kirill Dmitriev, head of Russia’s sovereign wealth fund, hailed the development as a historic “Sputnik moment”, comparable to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite.The vaccine will be marketed under the name ‘Sputnik V’ on foreign markets, he said. State media have trumpeted the news.But the speed at which Russia has moved, approving a vaccine before the final stages of clinical trials to test safety and efficacy are over, has worried some scientists, who fear Moscow may be putting national prestige before safety.last_img read more

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Broward School District Clears Parkland Administrators Despite Investigation Noting Failures

first_imgAs questions continue in the aftermath of the Parkland school shooting, the Broward School District recently cleared administrators at the school, even after an outside investigator blamed them for several procedural failures contributing to the 2018 massacre.A committee of district administrators did not find just cause on May 7 to discipline Ty Thompson, who was principal of Marjory Stoneman Douglas High School at the time of the shooting, or Assistant Principal Denise Reed. Both individuals were reassigned from the school last year.Jeff Morford, another assistant principal at the school who has retired, was also cleared of most of the allegations against him.However, he was given a letter of reprimand for mishandling a 2016 threat assessment of the student who would kill 17 people and injure another 17 on Feb. 14, 2018.Records obtained by the Sun Sentinel show that attorney Jennifer Ruiz, whose firm was contracted by the district to conduct a review, accused Thompson of failing to adequately supervise school employees.“The evidence shows that Mr. Thompson delegated away many of his own responsibilities or duties to his assistant principals, but failed to implement any type of system to oversee compliance,” she wrote.Ruiz adds that Reed and Morford botched the killer’s threat assessment, and that Morford also ignored various warning signs and provided testimony lacking credibility.A statement from Kathy Koch, the district’s chief communications officer, said Ruiz’s role was to research and present facts, which was was done “comprehensively and thoroughly.”Koch adds that the decision to determine whether there was cause for discipline was up to the committee.“The committee concluded there was not just cause,” the statement goes on to say.Lisa Maxwell, who represents the three administrators as executive director of the Broward Principals and Assistants Association, responds, “The investigator had no idea of how any of the processes actually work. All she did was try to be a rubber stamp for the statewide commission, and she failed miserably.”She described Ruiz as a “lawyer from Miami with no background in investigations, absolutely zero understanding of how schools operate.”Ruiz also completed investigations of Assistant Principal Winfred Porter and Security Specialist Kelvin Greenleaf.In the end, she found no cause to discipline Greenleaf. However, she determined that Porter, who oversaw the school’s security, failed to ensure staff knew how and when to activate emergency Code Red lockdown procedures.The Professional Standards Committee also overturned that recommendation and cleared Porter.The only employees who ended up facing any severe discipline were two security monitors whose contracts were not renewed in June 2018.The full investigation into Ty Thompson is available here. Notes from the Professional Standards Committee can be found here.The investigation of Denise Reed has three parts. Read Part 1, Part 2 or Part 2 supplement. Notes from the Professional Standards Committee can be found here.The investigation of Jeff Morford has three parts. Read Part 1, Part 2 or Part 2 supplement. Notes from the Professional Standards Committee can be found here.The full investigation of Winfred Porter is available here. Notes from the Professional Standards Committee can be found here.The full investigation of Kelvin Greenleaf is available here. Notes from the Professional Standards Committee can be found here.last_img read more

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Tiana Mangakahia announces breast cancer diagnosis

first_imgTiana Mangakahia, a point guard for Syracuse womens basketball, revealed she was diagnosed with Stage 2 breast cancer Tuesday morning in a release through cuse.com.  Facebook Twitter Google+ Published on July 1, 2019 at 12:02 pm Contact KJ: [email protected] | @KJEdelmancenter_img Mangakahia underwent various tests and a biopsy on Friday, June 14 before an official diagnosis came on Tuesday, June 18. AdvertisementThis is placeholder text“I know this will be tough, but I will get through it,” Mangakahia said in the release. “This is just the beginning for me and I will come out stronger. I have much more to accomplish and I hope to inspire others to overcome their own adversity just like I know I will.”The rising senior is coming off a season where she lead Syracuse in points (16.9) and assists (8.4). Mangakahia could’ve entered her name into the WNBA Draft, but she announced a return to SU for her senior season on April 1. In the release, Mangakahia thanked her support system that included head coach Quentin Hillsman, Syracuse wide receiver Trishton Jackson and director of athletics John Wildhack, among others. “I am heartbroken,” Hillsman said on Twitter. “Tiana is a tough lady. She will have the complete support of every associated of everyone associated with our program as he goes through her treatment. Tiana is a grinder and I know she won’t back down from this challenge.” Commentslast_img read more

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