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SAN DIEGO (KGTV) — Regulators at the Food and Drug Administration said they found no red flags that would stand in the way of authorizing Pfizer’s COVID-19 vaccine on an emergency basis.FDA scientists independently confirmed Pfizer’s claim that its vaccine is 95 percent effective after two doses and said they found no serious safety concerns, according to documents released Tuesday.The FDA released the 53-page review ahead of a meeting this week by an outside group of vaccine experts that will advise the agency and vote on whether to recommend an emergency use authorization for the drug in people 16 and older. A San Diego doctor will be among the 30 voting members.Government regulators examined the vaccine’s efficacy in subgroups and found it remained highly effective regardless of age, gender, race and risk factors. The vaccine scored 91 percent or better in nearly every way the agency sliced the data.“The news is really outstandingly good in terms of efficacy,” said Dr. Christian Ramers of Family Health Centers of San Diego. “It’s kind of almost a dream come true to have something that's 90 percent efficacious. If you recall, the FDA was shooting for better than 50 percent.”Among adults who were aged 65 or older and obese, one of the highest risk groups for severe COVID-19, the vaccine was 100 percent effective. That means no one who got the vaccine got sick, only volunteers in the placebo arm who got salt water.Dr. Peter Chin-Hong, an infectious disease expert at UC San Francisco, noted that most influenza vaccines are between 40 and 60 percent effective. “So getting 90 percent and above in some groups is just staggering,” he said.Pfizer’s vaccine is administered in two doses staggered three weeks apart. The FDA’s review began providing protection after 10 days, and just one dose reduced cases by 52 percent.That could spark discussion about how to allocate scarce doses in countries with limited access; however, Dr. Chin-Hong said there are too many unknowns to skip the second shot.“We don't know how long that protection would last,” he said. “Given the history and experience with other vaccines, we know that you get a more durable level of antibodies after a second shot.”The FDA also examined side effects in detail. Regulators found the majority of people who got the vaccine experienced some kind of mild to moderate side effect that resolved within a few days. A moderate side effect interferes with, but does not prevent, daily activity.According to the data, 84 percent of recipients had a reaction at the injection site, 63 percent felt fatigue, 55 percent had a headache, 38 percent experienced muscle pain, 32 percent had chills, 23 percent had joint pain and 14 percent had a fever.“These are things you expect from a vaccine. It actually means that it's working,” Dr. Ramers said. “That’s your immune system learning from that vaccine how to fight that bad virus.”Because of the mechanics of how Pfizer’s mRNA vaccine trains the body to build an immune response, there is no way the vaccine can cause COVID-19, he noted. The vaccine does not contain actual virus or viral particles.The FDA also looked for signs of any serious side effects in the trial of 44,000 volunteers. The agency noted there were four cases of temporary facial paralysis called Bell’s palsy in the vaccine group and none in the placebo group.Despite the apparent imbalance, the FDA scientists noted the numbers were so small the cases could have been caused by something other than the vaccine. In a large group of people, a certain number of cases of Bell’s palsy are expected to occur because the disorder can be caused by several pathogens.The number of cases in the vaccine group did not exceed what regulators call the background rate, meaning the number of cases that would be expected to occur in the general public.Bell’s palsy is temporary and treatable. Actress Angelina Jolie announced in 2017 she experienced a bout of Bell’s palsy and fully recovered. 3997
SAN DIEGO (KGTV) -- San Diego Padres outfielder Tommy Pham is expected to miss 4-6 weeks after breaking a bone in his left hand during the team’s loss at Arizona Sunday.Padres skipper Jayce Tingler confirmed Pham’s injury during an appearance Monday on MLB Network Radio.The injury happened during Pham’s ninth inning at-bat in Sunday’s game. The left fielder/DH fouled off a pitch and then immediately shook his left hand in apparent pain.Following a visit from the trainer, Pham exited the game, forcing the Padres to put Greg Garcia in to finish the at-bat in the eventual 5-4 loss. The Friars' loss was their fifth in a row.At the time of his injury, Pham was the tied for the MLB lead in stolen bases with six and among the league leaders in walks. Pham was batting .207 with two home runs and nine RBI in 23 games played.Pham’s stint on the injured list opens up playing time in left field for Edward Olivares, Josh Naylor, Jurickson Profar, and Jorge Mateo. 972
SAN DIEGO (KGTV) -- San Diego Police are asking for the public’s help locating a suspect wanted for shooting and killing a 27-year-old woman.Police say Robert Reed reportedly shot Sylvianita Widman during an apparent road-rage incident on the 100 block of Meadowbrook Drive at 5:30 p.m. Monday.According to police, two cars were traveling north down Meadowbrook when they both stopped and the passengers got into an argument.RELATED: Woman dies after being shot in a Skyline intersectionWidman then reportedly approached Reed while he was in his car. That’s when police say Reed shot her.Reed is described as a black man, 38-years-old who is five feet, 11 inches tall with brown hair and brown eyes.Anyone with information is asked to call Crime Stoppers at (888) 580-8477. 786
SAN DIEGO (KGTV) - San Diego County electric vehicle drivers are eligible for a San Diego Gas and Electric bill credit.The EV Climate Credit break applies whether the owner drives an all-electric vehicle or plug-in hybrid.Last year, the bill credit was 0. This year’s credit will depend on the number of customers who apply and the amount of funding available.The sign-up period lasts through May 31.Get more information HERE. 437
SAN DIEGO (KGTV) - Recent changes at the border are being felt as President Trump considers a total border shutdown to combat the immigration crisis. Customs and Border Protection officials announced the reduction of the commercial lanes at Otay Mesa from 10 lanes to 8 Tuesday. “4 to 5 hours,” said one driver who added another man in his fleet took more than 6 hours to make it across Wednesday. Companies say drivers are missing deadlines or just skipping the day altogether to avoid the delays. “They lose millions,” said driver Benjamin Alfaro on the already cumbersome process taking even longer, “so if they don’t do that in the normal time of course they lose money. It’s a lot of pressure on everybody.” The President is expected visit the Southwestern border on Friday. 788