Robert DittyDirector Ditty’s Home BakeryCastledawson”I hope the judges enjoyed what they saw, heard and ate,” says Robert Ditty. “And that they saw how much of myself I put into my business and how much I try to pay back the industry and my community for the support I have had from both.”The judges were in total agreement, describing Ditty as a “beacon in the industry” and a real example of a hands-on baker, whose strong personality is indelibly stamped on his business.Ditty’s parents bought the original, smaller, bakery in 1953 and he joined them in the 1970s. Since then, he has monitored the benefits of retail versus wholesale trade and steered the E3m (£2.64m) business to take advantage of both. His wholesale clients include high-end retailers, hamper and gift companies and Cathay Pacific, for which he makes long shelf-life oatcakes. He has two shops, in the market town of Magherafelt and the more rural Castledawson.Ditty’s is well known for its breads, including wheaten or brown soda bread, as well as its hotplate range, which includes soda farls and potato cakes. It does a “roaring trade” in what are known as wee buns; the 40-strong range includes fondant fancies and pineapple creams and sells approximately 7,000 per week. In high season, as many as 70 staff work across the bakery and two shops, and Ditty has set up a training schedule for them through the Belfast Bakery School.David SmartBakery directorGreenhalgh’s Craft BakeryLostock, Bolton, Lancashire”I’d like to think people view me as a baker with very exacting standards,” says Smart. “Yes, we produce in bulk, but everything is top quality and it’s our skilled staff who ensure that. There’s a fine balance between craft bakery and being a food supplier,” he adds. “We buy machinery to make a product, never adapt a product to a machine’s capability. It’s people who dictate what happens during each process.”With 60 shops across Cumbria, Cheshire, Merseyside and Oldham, and around 870 staff, Greenhalgh’s is renowned for its savouries and breads, the bakery also produces creams, desserts and cakes.The son of the founder, he started full-time over 30 years ago. As director his time is now split between the bakery and administration; his day starts at 6.30am on the shop floor. Smart’s greatest love is product development, “turning a traditional product on its side”Christopher FreemanManaging DirectorDunn’s BakeryCrouch End, LondonChristopher Freeman is the fifth generation of his family to work in the industry, joining the family business in 1973. “I always wanted to be a baker,” he says.He describes Dunn’s as a “traditional English takeaway bakery”, producing bread, morning goods, fresh creams, celebration cakes and patisserie. One of his favourite products is a crusty, seedy oven-bottomed bloomer loaf and he loves the innovative low-GI cranberry loaf. The local Budgens is the bakery’s single wholesale customer.Forty staff work in the business; around a dozen in the bakery. Freeman credits them as a major reason for the bakery’s success: “We try to get all our bakery staff through NVQ Level 2 and 3 and some of the shop staff have Bakery Skills Level 2 and even 3. They are experienced and skilled there’s not a make-up line in sight.” Freeman time is spent developing new products.
Within 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. “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 –
The Red Sox have decided to switch up their roster as they try to maneuver out of a rough start to the season.The defending World Series champions have activated catcher Sandy Leon and designated catcher Blake Swihart for assignment, the team announced Tuesday. Prior to tonight’s game against the New York Yankees, the Boston #RedSox announced the following roster moves: pic.twitter.com/ftRwcgWosV— Boston Red Sox (@RedSox) April 16, 2019MORE: Watch ‘ChangeUp,’ a new MLB live whiparound show on DAZNLeon’s primary purpose in returning from Triple-A Pawtucket will be to catch ace Chris Sale, who has struggled mightily in 2019. In three starts, he has an abysmal 9.00 ERA and is winless as he takes the mound Tuesday at Yankee Stadium.Sale and fellow starter Rick Porcello prefer Leon behind home plate. While Leon, who was the odd catcher out at the end of spring training, wasn’t a huge offensive power last season, he led catchers in 2018 with a 3.29 catcher’s ERA in 89 games. Christian Vazquez has been Boston’s primary starting catcher this season.Swihart, a first-round pick in 2011 and once a top prospect in the Red Sox farm system, has struggled with injuries since making his MLB debut in 2015. In 203 games with the Red Sox, he has slashed .255/.314/.365 with nine homers and 58 RBIs.The Red Sox are tied for last place in the AL East at 6-11 heading into Tuesday’s game against the Yankees (6-9).