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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 Police are investigating an attempted kidnapping after a man reportedly tried to grab a woman holding an infant in La Jolla Wednesday afternoon.Police say the woman was on the 5100 block of La Jolla Hermosa Avenue around 4:30 p.m. when a man walked by and grabbed her arm as she held a 1-year-old.The man then left the area on a bicycle that didn’t have any tires before ditching the bike and running away on foot.The woman, identified as the child’s nanny, received a scratch on her arm, but the baby is uninjured, police say.The suspect was arrested after running into the water and floating. Lifeguards helped police get the man out of the water. Police identified the suspect as 51-year-old Michael Hudson. Jail records show Hudson was booked on four counts, including felony kidnapping and battery.Hudson is being held on 0,000 bail. An Oct. 30 date has been scheduled for his arraignment. 935
SAN DIEGO (KGTV) - San Diego Police are looking for two suspects witnesses say were part of a brutal attack where a man beat another man to the ground and hit him in the head with a sledgehammer.Robert Kern was driving on his way to run errands around 2:45 p.m. when he saw a man with long blonde hair pulled into a ponytail, wearing a black shirt and jeans, start attacking another man.He said the men were in the middle of the intersection of the Westbound 94 on-ramp at Kelton Road. Kern said the man punched and kicked the other man to the ground, then used a sledgehammer, hitting the man's head.Kern said a good Samaritan stepped in and broke up the fight, that's when Kern snapped a couple photos for police and called 9-1-1.The man who was attacked was taken to a local hospital. Inside the ambulance the man was writhing in pain. Police said he was drunk and will be released Sunday night.Kern said the area is well known for homelessness and it's sad to see violence like that.Police are asking for the public's help in identifying the two people in the picture, if you have any information you can call anonymously at (888) 580-8477. 1172
SAN DIEGO (KGTV) — San Diego Mayor Kevin Faulconer and seven other California mayors are calling for the state to loosen restrictions on reopening large theme parks.The letter to Gov. Gavin Newsom requests that the state allow large theme parks to reopen with reduced capacity under the state's third reopening tier (orange/moderate) rather than the fourth (yellow/minimal).The letter stated that, "guidelines put forth by your Administration were released within the framework of prioritizing public health and safety for guests and employees. This is the right focus. However, economic and public health are not mutually exclusive goals.""We are concerned that the state's guidelines would push re-opening of large theme parks up to a year out, which would have significant negative impacts on hundreds of thousands of jobs, thousands of small businesses, and billions in operating revenue for our cities," the letter dated Oct. 30 stated.The letter pointed out San Diego, Los Angeles, and Anaheim as the most impacted cities.The letter is signed by Faulconer, Anaheim Mayor Harry Sidhu, Los Angeles Mayor Kevin Garcetti, San Jose Mayor Sam Liccardo, Fresno Mayor Lee Brand, Bakersfield Mayor Karen Goh, Riverside Mayor Rusty Bailey, and Santa Ana Mayor Miguel Pulido. The mayors' cities are either in the red or purple tier of the state's reopening plan.California's theme park guidance allows smaller theme parks to resume operations in the state's third reopening tier (moderate/orange) with a limited capacity of 25% or 500 visitors, whichever is fewer; only outdoor attractions; and ticket sales limited to visitors in the same county.All theme parks may resume operations in the state's fifth tier (yellow/minimal) with a limited capacity of 25%. Any open theme parks must implement a reservations system, screen guests for COVID-19 symptoms, and require face coverings throughout the park unless eating or drinking. 1932
SAN DIEGO (KGTV) -- Rideshare drivers all over California are on strike protesting recent pay cuts by both Uber and Lyft. A small but vocal group of the drivers gathered at the San Diego airport Monday morning, opting to take part in a statewide protest against the companies they say are taking money out of their pockets. Recently, Uber announced it would be cutting drivers wage from 80 cents per mile to 60 cents. Workers say that’s on top of other cuts they’ve dealt with over the years. Drivers who spoke with 10News say other states like New York require companies to pay a minimum rate of more than per hour. Uber and Lyft both issued statements after the protest.Uber said in part, “…we're introducing a new Quest promotion feature, while also changing the per minute, per mile and minimum fare rates. These changes will make rates comparable to where they were in September."Lyft told 10News: "We are always open to conversations around how we can make Lyft better for drivers, but what we hear from the majority is that this is a flexible option that works for them." 1090