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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 is no longer abnormally dry, according to a new report from the U.S. Drought Monitor. The report shows a large swath of Southern California having no drought. Most of California, however, remains abnormally dry, according to the report. RELATED: Check today's San Diego County forecastThe report, out Thursday, comes days after much of Southern California saw copious amounts of rain. According to the National Weather Service, the San Diego International Airport measured nearly four inches of rain since October 1st. Meanwhile, Campo saw 6.45 inches of rain and Ramona totaled 5.55 inches during the same time period. Click here to view the full report. 701
SAN DIEGO (KGTV) - San Diego County is home to some of the most infamous houses in the country, with many deemed notorious because of the grisly murders, mysterious suicides, and eerie accidents, that have taken place there. 232
SAN DIEGO (KGTV) — Researchers at the University of California, San Francisco are working on a spray designed to block the novel coronavirus from hijacking cells in the body, like a biological mask or internal personal protective equipment.They’re doing it by borrowing a defense mechanism from an unlikely source: llamas.The team, led by UCSF graduate student Michael Schoof, engineered a synthetic molecule based on one found in a llama’s immune system that acts like an antibody but is one-tenth the size.Human antibody treatments, known as convalescent plasma, require a transfusion in a hospital setting. But this smaller molecule, called a nanobody, can be easily self-administered via an inhaler or nasal spray and rapidly manufactured using yeast, Schoof said.The scientists named their product AeroNabs. They say it could be an inexpensive intervention for treating and preventing COVID-19 while the world waits for a vaccine.“We don't know how effective vaccines will be. We don't know how long it will take to rapidly deploy them, so we envision this product as hopefully a bridge until there is widespread, effective vaccination,” Schoof said.Once a vaccine is available, AeroNabs could offer protection for individuals who are unable to be inoculated for health reasons, he said, or an early treatment option.The team is in talks with commercial partners and hopes to begin clinical trials soon.In the 1980s, Belgian scientists discovered that about half of the antibodies in camels, llamas and alpacas are shaped differently than the antibodies found in other mammals, including humans. Researchers later learned they could use a fragment of these oddly shaped camelid antibodies to bind to antigens.Those fragments are called nanobodies.Currently, there is only one FDA-approved drug that uses nanobodies. Caplacizumab was approved last year to treat a rare blood disorder.The team at UCSF sifted through billions of nanobodies to find one that binded best to the spike proteins on the coronavirus, then engineered it to stick even better.The coronavirus uses its spikes to enter cells and replicate; the spikes are essentially the pathogen’s key into the body. By coating the spikes with nanobodies or antibodies, the viral key no longer fits into the body’s receptors and the virus can’t get in.“This works in the lab. It needs to be translated into the clinic,” said Schoof.The team at UCSF still needs to figure out the best delivery method, whether it is a nebulizer, an inhaler or a nasal spray. 2524
SAN DIEGO (KGTV) -- San Diego County health officials Monday echoed Governor Gavin Newsom’s demand to close more businesses as coronavirus intensifies.The state announced Monday that it was closing indoor operations for places of worship, restaurants, wineries, movie theatres and family entertainment, zoos, museums, cardrooms, fitness centers, some offices, personal care services, hair salons and barbershops, and malls. All bars were also ordered to close."We are moving back into a modification mode of our stay-at-home order," Newsom said. The new order takes effect in San Diego at midnight Wednesday morning. The announcement comes as 419 more people throughout the county tested positive for coronavirus Monday. No new deaths have been reported.RELATED STORIESSan Diego County restricting COVID-19 testing amid supply shortageNewsom shuts down indoor activities across CaliforniaThe county also said it is focused on priority groups for coronavirus testing amid changes in testing supplies.See a list of priority groups below:Healthcare workers, first responders, other social service employees, and people in essential jobsOlder adultsPeople with chronic medical conditionsPeople living in a residential or group setting, such as a long-term care facility or shelterPeople exposed to infected individuals in places where COVID-19 risk is high 1360