States Vow Extra Scrutiny of Coronavirus Vaccine

first_imgWithin weeks, the Food and Drug Administration is expected to review safety and efficacy data for what may be the first Covid-19 vaccine in the United States, with hopes of immunizing some Americans soon after.But about a half-dozen states and the District of Columbia have planned an extra layer of scrutiny: committees that would vet any vaccine reviewed by the F.D.A., a step many public health experts and officials deem unnecessary given a federal review process they describe as meticulous.- Advertisement – Throughout the pandemic, Mr. Trump and his administration have been criticized for putting pressure on federal health agencies — including the F.D.A. and the C.D.C. — to ease restrictions and speed approvals for vaccines and unproven treatments, such as hydroxychloroquine.The White House initially opposed F.D.A. guidelines that called for gathering comprehensive safety data before the agency would issue an emergency authorization for a vaccine. (The guidelines would have made it nearly impossible to have one approved before the election.) Then, in early October, the administration relented.Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the F.D.A.’s transparency and guidelines helped assuage the fears of many public health experts who felt “the White House was putting their thumb on the scale in a very big way.”Now, he said, he was “absolutely confident in the F.D.A. process” and thought the state review committees were “absolutely unnecessary.” This past week, he was named to Mr. Biden’s coronavirus task force. The committees — most of them in states led by Democratic governors — are in part a response to the Trump administration’s handling of the pandemic and concerns that political considerations would influence vaccine approvals.“The people of this country don’t trust this federal government with this vaccine process,” Gov. Andrew Cuomo of New York said in September when announcing his state’s vaccine committee, led by a Nobel-winning virologist. State officials said they did not believe they would slow any vaccinations. They hoped to examine clinical trial data once it became available, conducting their reviews alongside the federal government.It may not even be possible for states to hold up a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former F.D.A. lawyers said that states would not be able to thwart distribution during a pandemic.Besides New York, officials in California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines offered for F.D.A. approval. Governors in Nevada, Oregon and Washington have joined California’s effort, with each state adding a representative to the panel.Safety and efficacy data will also be examined by two independent federal advisory committees of medical experts. One panel counsels the F.D.A.; the other offers recommendations to the Centers for Disease Control and Prevention, which sets guidelines and priorities on who should get a vaccine.“It’s an incredibly rigorous and intense process that is evidence- and science-based,” said Dr. Julie Morita, who has served on the C.D.C.’s advisory committee and is an executive vice president at the Robert Wood Johnson Foundation, a public health philanthropy.Dr. Morita said she thought the state committees would ultimately come to the same conclusions as the federal government, but worried about a lack of consistent messaging.“The last thing we need right now is any kind of miscommunication about what the recommendations are,” she said. “The more aligned everybody is, the better for the public.” Dr. Morita is now serving on President-elect Joseph R. Biden Jr.’s Covid-19 task force. The reviews are intended to help persuade a hesitant public to get shots once they are approved, several state officials said in interviews. Recent polls show that between a third and half of Americans would be reluctant to get a coronavirus vaccine.- Advertisement – State officials have said Mr. Trump’s loss in the election will not alter their plans for reviews. Indeed, the first F.D.A. authorizations may fall under Mr. Trump’s watch. Pfizer announced last week that its vaccine, developed with the German company BioNTech, appeared more than 90 percent effective in early data from clinical trials, and Moderna’s vaccine is close behind in the development process.Trust IssuesThe tension between states and the federal government illustrates a heightened politicalization of vaccines and their approvals, a process that is routinely accepted by physicians and public health departments across the country.“This has become a somewhat political conversation,” Dr. Mark Ghaly, California’s health secretary, acknowledged in an interview. He said the state’s review was intended “to give Californians additional confidence and trust in the system.”The state committee, named in October, is still deciding on a process, but it plans to assess some of the same data used by the federal advisory committees, according to Dr. Arthur Reingold, the group’s chairman.Dr. Reingold, head of epidemiology at the University of California, Berkeley School of Public Health, served on the C.D.C.’s advisory committee less than two years ago and said he had the “greatest respect” for it.“We have an unusual set of circumstances, and we are trying to respond to those circumstances,” Dr. Reingold said. “At the end of the day, these vaccines will not help us if people do not accept them.” Dr. Reingold said he thought the group would complete its review swiftly, given the experience of its members, some of whom also serve on the C.D.C.’s advisory committee. Pfizer has said it plans to ask the F.D.A. for emergency authorization this month. The application would include two months of follow-up safety data from “Phase 3” trials. Phase 3 marks one of the last steps in the development process, when tens of thousands of volunteers get a vaccine and wait to see if they become infected, compared with others who received a placebo.Those trials are large enough to reveal some rarer side effects or more severe problems that may not have surfaced earlier. By September, Pfizer’s trial had 44,000 participants, and no serious safety concerns have been reported.Once the F.D.A. receives an application for emergency use, it begins a review of the data and sends a summary of the information to its advisory committee, which eventually makes a recommendation to the agency.If the F.D.A. authorizes the vaccine, the C.D.C. advisory group meets to decide how the vaccines should be used and allocated.In interviews, members of several states acknowledged the committees’ expertise, insisting that their own assessments would not be duplicative.Officials in West Virginia and the District of Columbia said their aim was to communicate the safety and effectiveness of a vaccine to the public, not necessarily to approve or deny its use.“We recognize that those institutions have expertise and assets that we don’t have. It’s not to replicate that process,” said Dr. Deidre Gifford, Connecticut’s top public health official and co-chair of its vaccine committee. Dr. Gifford said her group — made up of a dozen doctors and health experts appointed by the governor — would examine the approval process to confirm that it has been typical, or as typical as it could be during a pandemic.center_img “We want shots in arms within 24 hours,” Mr. Mango said at a news briefing last month for Operation Warp Speed, the federal effort to secure a vaccine. “Any delay that the state wants to impose will be a delay in getting its citizens — its most vulnerable citizens — vaccines. We think it is actually counterproductive for them to talk about this.” – Advertisement – But some health officials and experts worry that the state reviews could instead create inconsistency and sow doubt about a crucial tool in stopping the global contagion.Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services, said state leaders were undermining the expertise of the F.D.A., which he called the “most rigorous organization in the world.” In an effort to address state officials’ concerns, the F.D.A. said last week that it would offer briefings on its vetting process and the basis for any decision to authorize a vaccine.Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, which reviews vaccines, said he wanted the process to be transparent and welcomed questions from state officials. He also said he had felt “buffered” by the F.D.A. commissioner, Dr. Stephen Hahn, from any White House interference. He added that F.D.A. physicians and researchers who assessed vaccines were “civil servants” and “not political appointees.” Similarly, in New York, the state committee would work as quickly as possible, said Gareth Rhodes, a member of Mr. Cuomo’s coronavirus task force and special counsel at the Department of Financial Services.The group will gather “whatever information they need to confidently make a recommendation to the Department of Health,” Mr. Rhodes said. That would include reviewing data made public through the C.D.C. and F.D.A. advisory groups, as well as getting information directly from vaccine makers.Mr. Cuomo, speaking with CNN on Friday, said the goal was “to give people confidence,” adding, “As soon as the F.D.A. approves it, we will have our panel approve it.”In an interview with The New York Times, Mr. Cuomo said if his state panel expressed confidence in the vaccine, he would be the first New York resident to receive it and his adult children would be vaccinated on television to reassure the public it was safe.Earlier that day, Mr. Trump attacked New York’s planned review, claiming that the state would not receive vaccines when they are first rolled out across the country.A Rigorous ProcessHealth experts who had been involved in recommending other vaccines said there was little reason for the public to doubt the approval process, which takes into account comprehensive clinical trials conducted by universities and other independent bodies. One of the main goals is to “reassure the public and the governor that it was free of political interference,” she said.Dr. Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr. Biden’s coronavirus team, described the state reviews as “a symbol of the utter breakdown in trust in the process,” and said he did not think they would reveal anything the federal reviews did not.“From a practical standpoint, it’s probably not going to be that important,” he said. “From a trust standpoint, it may be helpful.”Sheila Kaplan contributed reporting. – Advertisement –last_img read more

New Mein Schiff 2 Delivered to TUI Cruises in Kiel

first_imgGerman cruise line TUI Cruises took delivery of New Mein Schiff 2, a next-generation cruise ship, in Kiel on January 22, 2019.Built at Meyer Turku shipyard in Finland, the ship was transferred to Kiel at the beginning of January for the final equipment due to icy weather in the Turku archipelago.The 111,500-ton newbuild is a sister ship to New Mein Schiff 1, delivered to the cruise company in April last year. Featuring a length of 315 meters and a width of 36 meters, New Mein Schiff 2 can accommodate 2,894 passengers and 1,092 crew onboard.“The commissioning of our new Mein Schiff 2 marks the successful end of our first expansion phase. Our sixth newbuild by Meyer Turku not only impresses with its design, its inner values are equally convincing: With the use of modern technologies we are setting standards for environmental protection,” Wybcke Meier, TUI Cruises CEO commented.With New Mein Schiff 2, Meyer Turku and TUI Cruises have further improved and refreshed the design of the ship.“For us it has been a thrill working with TUI Cruises on the design and construction of this ship. We have redesigned many of the areas of the ship, e.g. the Schau Bar and the restaurant area in front of the aft diamond structure,” Jan Meyer, CEO of Meyer Turku, said.The New Mein Schiff 2, which flies the flag of Malta, will be christened in Lisbon on February 9, 2019. The ship will be baptized during its maiden voyage between Bremerhaven and Las Palmas de Gran Canaria, with calls in La Coruña, Leixões, Lisbon, Cadiz and Arrecife.Take a closer look at the New Mein Schiff 2 in the video below:Due to the commissioning of the new ship, the previous Mein Schiff 2 was renamed Mein Schiff Herz this January. From February to March, the 77,302-ton vessel will undergo a dry dock overhaul in Marseille, France, TUI Cruises said.The 1997-built cruise ship will continue to be part of the TUI Cruises’ fleet until April 2022 when it will be handed over to the TUI’s UK’s subsidiary Marella Cruises.Image Courtesy: Meyer Turku; Video Courtesy: Unimedienlast_img read more

Boys Swimming Sectional Finals At Columbus North-Batesville’s Matt Weiler Qualifies For State Finals

first_imgMatt finished 3rd in the 50 yard freestyle with a time of 21.11.  He easily made the state cut time of 21.59.  The first three swimmers in the 50 free each broke the Sectional Record time of 21.12 in the event.  Weiler was also the sectional Runner Up in the 100 yard freestyle. The 2014 Boys Swimming Sectional Finals took place at Columbus North High School.Team Results.1. Columbus North-479, 2. Bloomington South-396, 3. Bloomington North-365, 4. East Central-235, 5. Columbus East-15,9 6. Batesville-147, 7. Edgewood-141, 8. Greensburg-104, 9. Lawrenceburg-74, 10. Milan-52, 11. South Dearborn-46, 12. Oldenburg Academy-4,0 13. South Ripley-30.Congratulations to Matt Weiler, who qualified for the Indiana State Finals in the 50 yard freestyle at the Columbus North Sectionals!  This is Matt’s second trip to the State Finals. Matt will be seated 5th in the entire state heading into the State Finals on Friday Feb 28, 2014. BHS Sectional Championship Finals Results.200 medley relay:  Weiler, Hatcher, Hawkins, Parker-5th:  4th fastest time in school history 1:43.94.50 free:  Matt Weiler 3rd place 21.11 STATE CUT  (5th fastest time ever at BHS)  seeded 5th at State Finals.100 fly:   Jacob Hawkins:  16th place 1:03.04  personal best time.100 free:  Matt Weiler:  Sectional Runner up 48.16, Thomas Hatcher 51.48-11th, Seth Parker 53.49-16th.200 free relay:  Weiler, Hunter, McKinley, Miller  1:35.53-5th place.  100 back:  Seth Parker-10th 1:02.42-personal best,  Jacob Hawkins 1:03.90-personal best.100 breast:  Thomas Hatcher-5th 1:02.72.400 free  relay:  Hunter, McKinley, Hawkins, Parker-7th 3:49.09.Congrats to area Swimmers on a job well done from The Sports Voice-Country 103.9 WRBI!Submitted by Batesville Coach TJ Greene.last_img read more

Ammerman sisters keeping each other in check

first_imgFreshman Brittany Ammerman has already had a huge impact on the Badger offense with four goals and three assists in four games.[/media-credit]Siblings are notorious for being competitive with each other in basically everything. But not the Ammerman sisters.Now in her third season, junior Brooke Ammerman has proven to be a huge asset to the Wisconsin women’s hockey team. Freshman forward Brittany Ammerman is suiting up in cardinal and white alongside her sister, showing talent on the ice runs in the family.Last year Brooke led the team with 38 points and 20 goals and carried a target on her back all season. This year she’s starting out almost where she left off, with four points through four games. But little sister Brittany may be stealing her thunder with four goals and seven points on the season already.While Brooke may not be the Ammerman scoring the goals right now, she’s still proud of her little sister and is having fun with the experience.“It’s really fun,” Brooke said. “I’m really happy that she’s doing well and got those goals out of the way so the pressure is off. It’s really fun to play together. We’ve only played together once before. It’s easy to find each other, it’s easy to talk to each other. We’re sisters so we don’t take anything personally, so it’s really fun that way.”These sisters may be on the same team now, but growing up they didn’t have the opportunity. They both fell in love with hockey and discovered their talent for the sport, but they didn’t want to compare themselves to each other so they made a pact.“We got pretty good at hockey when we were younger and we made a pact that we wouldn’t compare each other and our family understood that,” Brooke said. “It made it easier for us to play with each other. It’s been pretty fun. It’s always joking. I’m really happy she was able to get those goals and have a great start to her freshman year and her career her.”There’s no denying it, both of the Ammermans have impressive resumes.In Brooke’s freshman year Wisconsin claimed its third national title in four years. Brooke put up 54 points with 27 goals that year, opening the door for what is already an impressive college career.Head coach Mark Johnson noted their achievements and how impressive the sisters are.“When they were growing up and up until they came here they were good players,” Johnson said of the sisters. “They were able to score goals and score at different levels. Brooke came in her freshman year and obviously showcased that she can put the puck in the net. If you ask her last year probably wasn’t a great year but she still ended up with 20 goals.”Brittany played with the 2009 U18 World Champion Team USA where she scored the first goal of the gold medal game. Not only does she have a knack for putting the puck in the net, she grew up surrounded by hockey.“This year Brittany came in with a similar resume,” Johnson said. “When she played for me in the under-18 tournament she scored goals. She’s showing right now in the early part of the season that she can get the puck in the net. If you have that disease as a player it’s a pretty good one to have.”With impressive resumes in tow, the sisters hope to find themselves and their team fighting for a national title.But Brittany feels like she wouldn’t have had so much success in her career so far if it weren’t for her older sister leading the way.“I think it’s great. I mean I couldn’t have done it without her because I’ve learned so much from her and have been able to watch her and play with her,” Brittany said. “We’re competitive on the ice when we go out against each other and work together, but we don’t compare each other ever.”This isn’t Johnson’s first time coaching sisters. While he has yet to meet Alev and Derya Kelter he coached Jocelyne and Monique Lamoureux on the Olympic team last year.Johnson believes having a sibling in the same sport is helpful and makes things more competitive, and that pushes them and only helps make them better.“I think it’s helpful in regards if you have a sister playing or a twin sister playing because then you have somebody to hang out with, somebody that can push you, somebody that you can go to the rink with, somebody you can do off ice conditioning with,” Johnson said. “It probably makes it easier to have a sibling that’s close that likes what you like to do so you can push one another.”last_img read more

UG launches new centre to boost lecturer-student relationships

first_imgThe University of Guyana on Wednesday launched its Centre of Excellence for Teaching and Learning at its Turkeyen Campus with the aim of providing an atmosphere for students and lecturers to work together.Education Minister, Nicolette Henry stated that the University has evolved into a tertiary institution that is more competitive as well as respected. She added that the University plays a pivotal role in being responsible for qualifying the country’s human resources.Education Minister Nicolette Henry and other officials and lecturers at the launch“This University has, over the years, been evolving into a more competitive and respected tertiary institution in the region and is certainly responsible for a lot that is required for this country’s human resource development. I believe that this achievement is no small part due to the emphasis that the University places and providing a dynamic highly student centred learning environment” she remarked.Additionally, the Education Minister noted that there is a greater need for diversification in higher educational levels as the country is becoming a petroleum-based economy.“On the eve of a petroleum-supported economy, there’s an unprecedented demand for a great diversification in higher education as well as increased awareness of its vital importance for sociocultural and economic development.”Vice-Chancellor and Principal of the University of Guyana, Professor Ivelaw Griffith in his remarks positively stated that project renaissance completion is the finished product of building partnerships.“So many things we have begun to do on project renaissance could not be done just by UG resources, Government of Guyana resources and so we’ve been building partnerships with academic institutions within and beyond Guyana” Professor Griffith stated.The launching of the centre together with the inaugural teaching and learning symposium was held under the theme “New era, new strategies to enhance teaching and learning as we journey along the renaissance road”.The Centre will fall under the School of Entrepreneurship and Business Innovation at the University of Guyana’s Turkeyen Campus.last_img read more