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SAN DIEGO (KGTV) — In just days, Pfizer’s COVID-19 vaccine will go before a key group of scientific advisers to the Food and Drug Administration, and a San Diego doctor will be part of the process to cast an important vote.Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital, will serve as a voting member of the Vaccines and Related Biological Products Advisory Committee or VRBPAC when the body meets Dec. 10 to publicly vet Pfizer’s COVID-19 candidate.Dr. Sawyer is also a professor of clinical pediatrics at UC San Diego. He has served before on this outside advisory committee to the FDA, but the stakes have never been so high.“I mean this is a tough decision,” he said in an interview Friday. “We're weighing the benefit of a vaccine against the risks. And with any new product, we don't know the risks and we have to estimate based on the data we have.”Dr. Sawyer said he received Pfizer’s full Phase 3 data Friday morning, making him one of the first Americans outside the FDA to see the full details of the company’s large-scale clinical trial. The FDA is expected to release the data to the general public by Tuesday, two days before the public meeting.Sawyer will be one of about 20 outside vaccine experts from around the country on VRBPAC. The FDA hasn’t yet released a full roster of the doctors and scientists who will take part. The independent advisory committee will hear comments from Pfizer and the FDA and listen to public input before voting on whether to recommend emergency authorization.The marathon meeting is expected to last up to nine hours.“The FDA counts on this advisory committee to be an independent group of people who are looking at the same information they looked at and asking us what our concerns are, or whether we reached the same conclusion that their staff have reached,” he said.The meeting comes on the heels of a study by Pew Research that found lingering skepticism of the vaccine. Just 60% of Americans planned to get vaccinated as of the survey released Monday.“I do think that's going to change once this committee meets and the data is made public and we can all talk together as a community about what we know about the safety, and what we don't know, frankly,” he said.Dr. Sawyer was a member of VRBPAC for four years and briefly served as the acting chair in 2017.The committee meets a few times each year to make recommendations on the annual flu vaccine and other drugs.The committee’s vote is not binding. The job of the outside advisers is to issue a recommendation and the FDA can overrule them, but the agency rarely does. From 2003 to 2019, VRBPAC made 105 recommendations. The agency fully implemented 84% of VRBPAC’s recommendations and partially implemented 10%, according to Union of Concerned Scientists.That means when the committee votes Thursday, it’ll carry a lot of weight. The FDA is expected to announce its final decision shortly after the vote, possibly within hours.Dr. Sawyer said the advisers will make a decision following the process they traditionally do, based on all the knowns and unknowns. “And we’re going to weigh that against what we're going through right now,” he said. “Our hospitals are getting overwhelmed. Our ICUs are getting full.”“We really need to do something to intervene and the vaccine is the best thing we've got going,” he added. 3369

SAN DIEGO (KGTV) — Infectious disease experts say it may take months before the first doses of a COVID-19 vaccine reach an important population: kids.Some doctors worry it may already be too late to get a vaccine authorized for younger kids before the start of the next school year because of the time it takes to recruit children and conduct a new round of clinical trials.“Our children under 12 years of age are almost certainly going into next school year without a vaccine option available for them,” said Dr. Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta and associate professor at Emory University.Dr. Anderson said such a delay could further impact school reopenings and have resulting consequences on children’s mental health, among other concerns. He said the window is rapidly closing to get a vaccine authorized in time for children older than 12 unless more trials begin immediately.In October, Pfizer tested its vaccine candidate for the first time in 100 kids aged 12 to 15. Moderna is expected to begin testing in that age group in January, according to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. However, neither company has announced plans to begin testing their candidates in children under 12.That’s concerning to the American Academy of Pediatrics, which has been calling on vaccine-makers to include children in clinical trials since September. The AAP argues immunization is critical to stemming the pandemic.“We know that children can be infected with COVID-19 and can transmit it to others. To reduce the spread of this virus and control the pandemic as well as for their own safety, it’s crucial that children be included in the national vaccination program, and that vaccines are made available to children as soon as possible,” said Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, in another push last month.Although COVID-19 takes a more severe toll on older adults, children make up about 12 percent of the infections in the U.S. and recent studies have shown kids over 10 years old can transmit disease as efficiently as adults, the AAP noted.More than 1.3 million kids had been infected with COVID-19 as of Nov. 26.Experts say it’s important that drug companies test COVID-19 vaccines in children separately from adults.“Kids' immune systems are really different than adults. As any pediatrician will tell you, kids are not just small adults, their immune systems behave really differently,” said Dr. Christian Ramers of Family Health Centers of San Diego.Dr. Ramers said testing is needed to find the right vaccine dose for kids and see if there are any unexpected side effects.But there are challenging logistics in any pediatric trial. Since children’s immune systems change as they grow, vaccine-makers have to separate their trials into several age groups. That means more child volunteers are needed.“I mean it's more challenging, as an investigator myself for research, to enroll a kid into a study because you have to get permission [from parents],” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.Because parents have to sign off, experts say it can take much longer to enroll enough kids for a study.In a statement to ABC 10News, Pfizer said it is “working actively with regulators on a potential pediatric study plan.”“As we do with all vaccines which are initially studied in adult populations, we are following a careful, stepwise approach as we move down to younger age groups,” said Jerica Pitts, Pfizer’s director of global media relations.“Global regulatory agencies require evaluation of the candidate vaccine in pediatric populations. Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” she added.Could a vaccine become mandatory at schools?Once a vaccine is approved for kids, a lot of parents are wondering if and when it might become mandatory at California schools.The California Department of Public Health told ABC 10News several things would need to be in place before it would consider making a vaccine mandatory at either schools or child care facilities.The vaccine would need to reviewed and approved by the FDA and recommended for use in children by the federal Advisory Committee on Immunization Practices. The state would also look for a recommendation by the American Academy of Pediatrics, and there would need to be "sufficient vaccine supply to enable access for all children."READ MORE: Will California make the COVID vaccine mandatory at schools? 4602

SAN DIEGO (KGTV) — Mission Valley is in store to get an additional nearly 30,000 homes by 2050, according to a new plan the City Council unanimously passed Tuesday.The council voted 9-0 to pass the Mission Valley Community Plan, which would increase the number of allowed housing units in Mission Valley to 39,200. Currently, the area has about 11,200 units. The idea is to change Mission Valley's underutilized strip malls into mixed-use developments, where housing and commercial are under the same roof. "That dream, that American dream, that middle class security that is created by home ownership is now vanishing for a large segment of the population, and we can do better," said Jonathan Frankel, who heads the Mission Valley Community Planning Group. But Mission Valley is currently one of the cities most congested areas. Currently, the city says 600 people live and work in Mission Valley, but 40,000 commute in daily. As part of the plan, the city would add bridges and roads, plus an additional trolley stop and bike and walking paths. It would allow the people who do live and work in Mission Valley to get where they need to go, without a car. "The Mission Valley Community Plan Update is a no-brainer that will increase desperately needed housing stock, improve amenities for residents and will help the city meet its climate action goals,” Councilman Scott Sherman said in a statement. “I appreciate my council colleagues for approving this important community plan update.”The city aims to turn Mission Valley into a transit environment to help with the region's housing crisis and its climate action goals, a staff report says. 1654

SAN DIEGO (KGTV) — Locals will no longer have to rely on trips to Harrah's Resort or Downtown Disney to satisfy their Earl of Sandwich fix.The sandwich shop's downtown San Diego spot, the county's first, is now open for hungry locals but will hold its grand opening Saturday, according to the shop. The new sandwich shop can be found at 690 1st Ave.A cult following has developed behind Earl of Sandwich, with its popular sandwiches like The Full Montagu (roast beef and turkey), The Original 1762 (roast beef and cheddar), and Holiday Turkey (turkey, cranberry sauce, and stuffing) sandwiches.RELATED: Michelin identifies several San Diego restaurants as 'hidden gems'The restaurant chain is named after John Montagu, the 4th Earl of Sandwich. Montagu has long been considered the inventor of the modern sandwich, ever since he is said to have requested the dish while putting in some long hours at the gambling table.But guests are locked into sandwiches at the stop. Earl of Sandwich also sells a variety of freshly tossed salads, wraps, desserts, and several on-the-go items.The shop is open from 7 a.m. to 8 p.m. Sunday - Friday, and opens at 10 a.m. on Saturdays. 1177

SAN DIEGO (KGTV) -- It's lasagna-making time in the Rosenblatt home and mom Angela and her adorable 5-year-old helper, daughter Stella, are whipping up a big batch for strangers in need.Angela says, "I think it's a very different message that we send when we put our heart, we put our soul, we put our time into providing a home-cooked meal for someone."Angela is part of the organization Lasagna Love, founded by Rhiannon Menn who first posted her idea on social media in May. Angela was one of the first ten to answer the call to spread love through cooking."It inspires a little bit of hope. It confirms hope giving it forward that somebody cared enough about you," says Angela.Angela makes about twenty lasagnas a week in her Del Cerro kitchen, which means she has given more than 500 so far. She says she started learning how to whip up great food when she was young. "Growing up in the restaurant industry you cook with what you've got," says Angela, "it's always made with love. It's always made with some really great ingredients, but it's what I can get so I can feed as many people as I can."Volunteers drop the meals off at people's doors for pandemic safety and recipients often make it clear just how thankful they are. That includes essential worker Abigail Eastman who says, "I'm very grateful to you guys in this time of pandemic. You guys are making a difference one lasagna at a time."Sometimes, there is no feedback. Angela says she understands why."It's embarrassing to a lot of people, that this is the first time they have never been able to maybe provide for their family, and you can't be doing this for a thank you."Certainly for Angela and the now 3,000-plus volunteers in 47 states feeding their communities, the true motivation is feeding the soul."I hope that is a lesson that I'm able to show to my daughter, that even though we're having a hard time we can continue to move through it and we can continue to show grace," says Angela.Angela doesn't always make lasagna. Sometimes it's other dishes such as casseroles, but it's all made with love. If you're interested in cooking, delivering, making a donation or you need help, visit https://www.lasagnalove.org/. 2205