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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 City Council leaders Tuesday voted to approve a plan to fund three temporary housing shelters for the city's homeless.Council leaders voted 8-1 to approve the plan. Councilman David Alvarez was the only "no" vote.The largest shelter at 16th and Newton is scheduled to open by Dec. 1. The other two will open later in the month.The San Diego Housing Commission's plan will pour .5 million into three temporary bridge shelters currently under construction in San Diego, capable of providing shelter and support services to about 700 homeless individuals, according to City News Service.RELATED: San Diego business leaders want giant tents to house the homelessThe shelters are being installed at: 738

SAN DIEGO (KGTV) — San Diegans now have even more problems they can report by the touch of a button.The city is continuing to add categories to its "Get it Done" smartphone app, which launched in 2016. The app originally allowed San Diegans to report stormwater and street issues, but currently has nine categories, including code enforcement, graffiti, and even passport appointments.The city says it gets 10,000 reports per month on the app.RELATED: San Diego battles illegally painted red curbsIn August, the city added features that allow people to report cars parked longer than 72 hours, illegal dumping, and HAZMAT related issues. In the next year, the city will allow people to buy trash bins off the app, and to report suspected enforcement violations - such as illegal structures.The city says it requires personal information with a complaint to help verify the facts. "For us, if it's not easy to interact with the city, we're going to put that into 'Get it Done,'" said Alex Hempton, the city's project manager. RELATED: San Diego clean-up crews turn focus to fire-prone canyonsChris Cott, has used the app for years to report graffiti in San Diego. He says it helps to make sure the work gets done, even if it is on private property."When it gets done, it gets done right," said Cott, who paints over graffiti on public property. "It doesn't just get rolled over gray or something like that." 1444
SAN DIEGO (KGTV) - Rocks or BB pellets have hit more than a dozen taxis as they traveled near the San Diego International Airport over the past week, cab drivers told 10News.The attacks along Harbor Drive have left cracks in their windshields and dents in the vehicles’ sides, cabbies said.“It's life threatening and we are just shocked what's going on,” said cabbie Ahmad Saddat-Nejad.Saddat-Nejad, who has been driving for almost 30 years, said he has never had anything like these attacks happen.“My car was not even in motion. Suddenly, I hear ‘boom’. Somebody threw a rock,” he said, reporting an incident on Harbor Drive at Laurel Street.“It happened to five cars yesterday again,” said Alex Tegegne of the San Diego Taxi Association.Tegegne said the attacks occur every night after dark, from North Harbor Drive down the Embarcadero.“We start to say do we need a helmet, or what should we do now? Should we avoid going on Harbor? What can we do,” Tegegne told 10News.In all, 17 cabs have been targeted.“It is totally very scary, and the customers don't feel comfortable about it,” said Tegegne.Cab drivers say they can’t afford to lose those customers. The success of Uber and Lyft have taken a toll on the taxi industry.“We don't know if this thing is taking business from us. We are already on life support to begin with, but this will be another threat to our customers and also ourselves," Tegegne said.The threat could be enough to put drivers out of work.“He could have killed me and I’m scared of driving now. This is my living and how I’m supporting my family,” said Ezzaddin Fato.San Diego Harbor Police confirm the arrest of one suspect Saturday, but said another attack has happened since then. The Port of San Diego is also investigating the matter. 1776
SAN DIEGO (KGTV) – San Diego County Supervisor Nathan Fletcher and other local health and community leaders urged San Diegans to put their focus on the fight against the coronavirus instead of the restrictions placed on businesses due to the pandemic.During a Monday morning press conference, Fletcher specifically called out fellow Supervisors Jim Desmond and Kristin Gaspar, who have been pushing for reopenings.“In particular Supervisors Jim Desmond and Kristen Gaspar are inciting a fight between government and small business. They’re exploiting the pain and suffering that small businesses are going through as a result of a global pandemic as a wedge for political gain. It is reckless and irresponsible leadership,” Fletcher said.Fletcher’s comments come as San Diego County inches towards the possibility of moving from the red tier into California’s most restrictive purple tier.In response to Fletcher’s remarks, Gaspar issued this statement:“This morning Supervisor Fletcher held a hellfire and brimstone press conference in which he ironically and incorrectly blamed me for playing politics with COVID. Let me set the record straight: I have never supported any approach to re-opening that was not specifically supported by our Public Health Officer and clinical leadership team. Supervisor Fletcher knows this but prefers to continue spreading this false narrative because he is actively running a campaign against me. I measured the distance between our office doors, and it is 7 feet, so he and I can actually have a socially distanced conversation anytime he isn’t holding a press conference. I will continue to do my job protecting public health and working with small businesses and leave the politics to Supervisor Fletcher.”Desmond did not immediately respond to Fletcher’s comments.On Monday afternoon, numerous local business owners will rally in front of the County Administration Building and call on county leaders to take local control of San Diego County’s reopening plan. 2008
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