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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 has issued eight cease-and-desist orders to College Area homes, including six affiliated with Greek life organizations, ahead of reported Halloween gatherings.The orders say the eight residences, "intends to hold large gatherings on October 30, 2020 - November 1, 2020 in blatant violation of the Order of the State Health Officer, the County Order of the Health Officer and Emergency Regulations, and CDPH's October 9, 2020 gathering guidance."If the residences hold large gatherings, the cease-and-desist letters say they may face, "actions necessary to enforce the orders and the gathering guidance," which can include criminal misdemeanor citations and a ,000 fine for each violation.RELATED: Stay-at-home advisory issued for San Diego State students over HalloweenGatherings in the state's Oct. 9 health order must include no more than three households.In a statement, County Public Health Officer Dr. Wilma Wooten said the county's livelihood is directly tied to the actions of all residents."We were compelled to take this action because there is a great deal at stake. Let me be very clear, the region’s livelihood hangs in the balance and is directly tied to our individual and collective actions. We are on the brink of moving to a more restrictive tier. Know that our place on one tier or another is not based on the state’s assessment, it is intrinsically tied to our personal and common efforts. The risk of contracting COVID-19 is increased when we come in contact with individuals outside our households. Every decision each of us makes should be guided by that knowledge," Wooten wrote.RELATED: Off-campus parties near San Diego State an issue for College Area residentsAs of Oct. 30, 826 off-campus SDSU students have tested positive for the coronavirus while 422 on-campus students have tested positive.San Diego State University issued a stay-at-home advisory for all students from Friday, Oct. 23, at 6 p.m. through Monday, Nov. 2, at 6 a.m. to discourage participation in any large gatherings over the holiday.The San Diego Police Department said in a release that they are aware of reported plans for Halloween parties in the College Area."The department will work together with SDSU where appropriate to respond to any calls for service regarding loud parties this weekend and will take appropriate action, including issuing citations," an SDPD statement read.As of Oct. 23, nearly 970 notices of alleged violations of the campus' COVID-19 policy had been issued.A statement from San Diego State said the campus is in full support of the county's actions:"SDSU is fully supportive of the cease and desist order Dr. Wilma J. Wooten issued to the region’s higher education community. Since last spring, SDSU has worked with county public health officials to encourage that all students, faculty and staff adhere to public health guidelines and our state’s public health orders. Students should not be hosting or attending parties and should not be attending any in-person gathering that is not in compliance with public health directives." 3106

SAN DIEGO (KGTV) - Recent rains have caused sewage-contaminated runoff to enter ocean water along Imperial Beach, San Diego County health officials announced Friday.An existing water contact closure of the Tijuana Slough National Wildlife Refuge coastline has been expanded to include all of Imperial Beach's coast, according to the San Diego County Department of Environmental Health.Due to recent rainfall, county health officials said sewage-contaminated runoff from the Tijuana River entered the Tijuana Estuary. Water samples and observations caused officials to believe the contamination has reached ocean water in the South Bay.Signs and warnings have been placed in the area until water samples indicate the ocean is safe for recreational use once again.RELATED COVERAGE: 792

SAN DIEGO (KGTV) — San Diegans have every opportunity to get moving as the new year gets underway.America's Finest City was recently ranked by financial website WalletHub as the ninth most active city in the U.S. The study examined 100 cities around the country, comparing them on metrics including the presence of fitness centers and sports facilities, costs of fitness memberships, trail availability, and share of inactive adults. The metrics were then organized under either "budget and participation" and "sports and outdoors."San Diego ranked first in fitness centers and sports centers per capita, seventh in baseball and softball diamonds per capita, 22nd in basketball hoops per capita, 16th in parkland acres per capita, and 30th in walking. Those rankings brought the city's budget and participation rank to 27 and sports and outdoors rank to eight.RELATED: 7 unique workouts in San Diego to start the year strongChula Vista was also ranked on the study, though at a distant 79, ranking 25th in budget and participation and 87 in sports and outdoors.So where is the most active city located, according to WalletHub? You'll have to fly over to Honolulu, Hawaii, where the city ranked first in sports and outdoors. While Honolulu ranked 47th in budget and participation, the prevalence of sports and fitness facilities sent the city to the top of the rankings.The only California city to score above San Diego was San Francisco, ranked third on the list. 1471

SAN DIEGO (KGTV) - San Diego County Congressman Duncan Hunter spoke Tuesday morning to a group of women who support him despite accusations that he and his wife misused campaign funds.“Women Volunteers in Politics” gathered for the speech at the Bali Hai restaurant on Shelter Island. The event was booked months before Rep. Hunter’s indictment.Hunter spoke to 10News before the event.“Leave my wife out of it, leave my family out of it. It’s me they’re after anyway. They’re not after my wife; they want to take me down, that’s what they’re up to. So let’s get this in the arena and have this settled,” said Hunter.Tuesday's statement was a change from Hunter's message the morning after the indictment was announced. When asked about the accusations levied against his wife, Hunter confirmed that she was in charge of campaign expenses but added, “That’ll come out in court. That’s for the court and for her.”DUNCAN HUNTER INDICTMENT: 949