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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 County reported 625 new coronavirus cases on Saturday, the region's second-highest daily increase of cases reported by officials.San Diego County's new cases reported a 6% positive rate out of 10,290 tests. Of the county's cases, 2,180 (9.4%) have needed hospitalization. Health officials add that 2.5% of all cases and 26% of hospitalized cases have been moved to the ICU.An additional six deaths due to COVID-19 were also reported, the county said. The deaths occurred between July 8 and July 16, and included four women and two men whose ages ranged from 60 to mid-90s. All had existing chronic conditions, the county said. The region's death toll is now at 478 deaths.DATA: See San Diego County's COVID-19 case dataThree new community outbreaks were identified on Friday, according to the county — one in a restaurant/bar, one in a gym, and one in a government setting. A community outbreak is considered three or more confirmed cases from the same place.As of Saturday, the county has 15 community outbreaks in seven days, more than double the trigger of seven community outbreaks in a week. 1133
SAN DIEGO (KGTV) - San Diego Mayor Kevin Faulconer signed off Thursday on his .3 billion 2020 budget previously approved by the super majority of the city council.The budget funds the largest infrastructure investment in San Diego’s history and includes more funding for homelessness programs, road repairs, tree trimming services and housing reform.Faulconer appeared to be most excited about the expansion of the Clean San Diego initiative, which aims to clear debris from across the city.The mayor announced during his signing ceremony that million will go toward the expansion of the CSD program, and more crews will be hired to clean up areas citywide 24 hours a day, seven days a week.“We’re restoring pride back in our neighborhoods with every cleanup job, and now we’re investing more resources into ‘Clean SD’ so we can do even more for our communities,” said Faulconer.Funding for the program was more than doubled from Fiscal Year 2019 after Faulconer requested an additional .5 million for its budget.Since the program started in May 2017, more than 3,600 tons of debris have been removed from neighborhoods, canyons, and the San Diego River.Other efforts in the program include an increase in street sweeping in the East Village, sanitizing sidewalks, and graffiti removal. 1302
SAN DIEGO (KGTV) - San Diego has long been on the leading edge for LGBTQ politics.Christine Kehoe was the first openly gay candidate elected in San Diego County. She won the City Council seat in District 3 in 1993.Since then, the seat has been held continuously by an openly gay person, the longest streak she knows of for any public office in the country.2020 could also be the year San Diegans elect the first openly gay mayor. Todd Gloria, who currently serves as the state assemblymember for the 78th District, briefly served as interim Mayor after Bob Filner resigned.10News reporter, Matt Boone, spoke to Kehoe about the history of LGBTQ politics in San Diego as well as significance of having so many openly gay candidates on the ballot. 752
SAN DIEGO (KGTV) — San Diego Humane Society officials are searching for the person responsible for abandoning a dog in a San Pasqual Valley canyon recently.A grove manager at Bandy Canyon found the neglected dog Friday, according to society officials. The male dog appeared to be an about 2-year-old pit bull mix.The dog was taken to the humane society's Escondido campus, where a veterinary team gave it IV fluids and placed it on a heated bed, as its temperature was low.Because of the dehydrated, neglected condition of the dog, the society's law enforcement arm has opened a felony animal cruelty investigation.Anyone with information is asked to call Crime Stoppers at 888-580-8477 or SDHS law enforcement at 619-299-7012.This week's incident is the third similar incident to occur in the last month. In February, nine puppies were found abandoned at Kit Carson Park in a dog food bag. Weeks later, two more dogs were found malnourished and left behind at Escondido's Mountain View Park."We want the public to know, anyone who needs help with their animals can bring them to us without judgment," Laurel Monreal, SDHS sergeant of humane law enforcement, said after the last incident. 1196