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SAN DIEGO (KGTV) — The Food and Drug Administration has released new guidelines to vaccine makers with added safety measures that experts say will push back the timeline, making the release of a COVID-19 vaccine before the election highly unlikely.The guidelines lay out what it will take for companies to secure a fast-tracked authorization for a vaccine, known as an emergency use authorization or EUA.The new guidelines require vaccine makers to follow the volunteers in their clinical trials for a median of two months after their final dose.It’s an important step to see if anyone has a bad reaction, says Dr. Christian Ramers of Family Health Centers of San Diego.“Some of the safety issues that people like me are concerned about might take months actually to develop,” Dr. Ramers said. “My analysis of this is that it's the FDA standing up and saying, ‘We're going to adhere to our rigorous scientific process.’”The White House had resisted the new guidelines from the FDA for more than two weeks. After their release, President Trump described them as a “political hit job.”“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote on Twitter Tuesday night.It’s hard to gauge exactly how the two-month buffer affect the vaccine timeline because clinical trials do not start all at once; volunteers are enrolled on a rolling basis. But Dr. Sydney Wolfe of the consumer group Public Citizen said the drug makers have offered clues.“The companies one-by-one are saying, ‘We can’t get anything in until the end of November or the end of December or the beginning of January,’ and that’s a relief,” he said.In a clinical trial, half of the volunteers get the vaccine and half get a fake drug called a placebo.The updated guidelines require companies to have an estimated effectiveness of at least 50 percent, meaning there are 50 percent fewer cases of infection in the group receiving the vaccine compared to the placebo group.The guidelines also instruct companies to have a plan to continue collecting data in their clinical trial even after they get an EUA and the vaccine hits the market.“The worst thing that could happen here is something meets that minimum bar of 50% efficacy, meaning it works pretty well, but then the bottom just falls out from these clinical trials and we don't get the information we need,” he said.Dr. Ramers was initially skeptical of fast-tracking a vaccine with an EUA rather than waiting for full approval since it’s only been done once before, but he’s supportive of the process under the updated guidelines.“I think that's the best way to balance speed and safety,” he said.Still, experts like Dr. Wolfe think going with an EUA over a full approval could backfire. He points out the new guidelines allow up to half of the people in the clinical trial to be tracked for less than two months after their final dose.“All things aren’t equal [between an EUA and full approval] because you don’t have all the information and B, people know that,” he said.Dr. Wolfe is concerned the public will be reluctant to roll up their sleeves and embrace the vaccine if it just has an emergency authorization. Now that the FDA has made the EUA guidelines more rigorous, he thinks waiting for full approval might take just a few more months.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates.Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data.However, Dr. Wolfe said the possibility of the president overruling the FDA is unlikely to have an impact now because the vaccine developers themselves have indicated they will follow the FDA guidelines.Additional reporting by Justin Boggs 4090

SAN DIEGO (KGTV) — Surveillance footage captured a man attacking a gas station customer in Kearny Mesa before fleeing.A 54-year-old man was paying for his coffee at the Mobil station at 8380 Clairemont Mesa Blvd. on Saturday just after 3 p.m., when the suspect began speaking to the man. Police said the suspect was not making any sense when he was speaking to the victim.Then for no reason, the man pulled a small wooden bat from a tool bag and began to hit the victim on the back of his head. He fled from the business, running southbound on Kearny Mesa Road, police say.RELATED: Surveillance video captures deadly crash in Chula VistaThe victim was taken to a local hospital where he was treated for a concussion, cut to his head, and broken finger.Police said the suspect was wearing a yellow construction helmet, black hooded sweatshirt with a yellow reflective vest over it, work gloves, dark pants, and work boots. He was holding a "Milwaukee" brand tool bag.The suspect was described as a white male in his 30s, with thin build, and a brown and red beard.RELATED: Surveillance cameras egging on more destructive teen pranks?If anyone has any information, they're asked to call San Diego Police at 858-495-7957 or Crime Stoppers at 888-580-8477. 1260

SAN DIEGO (KGTV) - The City of San Diego's Development Services division is still investigating the platform that collapsed at a Barrio Logan gym this weekend and injured 21 minors and a few adults. At least one minor is still in the hospital with a broken pelvis, we're told.A city spokesperson reported to 10 News on Tuesday that no further details would be released until the investigation is complete.On Monday, the spokesperson said there were definite code violations and missing permits at Vault PK parkour gym, where the incident happened. Whether the gym will face any penalties is still unknown. The gym has only been open for a few months. On a Facebook post, it appears much of the construction of the facility was done by the owner's immediate family.  On Monday, San Diego Police Department's media relations division confirmed that the incident is a civil matter and the department will not be recommending any criminal charges, including criminal negligence.  There is another Vault PK parkour gym in Torrance. We called the facility today. Someone answered the phone and said the facility is closed for inspections. No further details were given.  1222

SAN DIEGO (KGTV) - The man who jumped on stage during a Taylor Swift concert and assaulted a security guard was charged Monday with a deadly beating in the Midway area, police said. Christian Ewing, 29, was charged for the death of 57-year-old Gregory Freeman, according to SDPD Homicide Lt. Anthony Dupree. Officers got a 911 call about an assault near the Interstate 5 overpass at 3900 Rosecrans St. the evening of Dec. 5. A witness said a victim was on the ground and another man was hitting him with an object, investigators reported. RELATED: Taylor Swift concert crasher gets probation, ordered to stay away from SwiftPolice arrived at the scene to find Freeman suffering trauma to his upper body. He died three days later of his injuries. The suspect fled the scene, police said.Ewing was arrested on Dec. 21 for a parole violation and rebooked Monday on suspicion of murder. In 2015, Ewing jumped on stage at Petco Park as Taylor Swift was performing. Swift’s personal security guard, David Durkin, told Ewing he was not allowed to be in the area. During a struggle, Ewing seriously injured Durkin. RELATED: Taylor Swift concert crasher ruled mentally fit to stand trialWhen asked why he went up on stage, Ewing replied, "I love that girl," San Diego Police Officer John Clayton testified.Ewing pleaded guilty to assault and violently resisting an officer in the performance of his duties. He was sentenced to two years' probation, and was expected to be supervised by the Probation Department's mentally-ill offender unit. Prosecutors previously said Ewing had several arrests in multiple states, an active warrant for a theft-related offense out of Florida, and a felony conviction for transporting drugs from out-of-state. Dupree said both Ewing and Freeman were homeless.Ewing’s arraignment on the murder charge is scheduled for Dec. 27. Anyone with information about the Midway area assault is asked to call San Diego Police Homicide Unit at 619-531-2293 or Crime Stoppers at 888-580-8477. 2010

SAN DIEGO (KGTV) -- The Historic Balboa Theatre will be celebrating a milestone Monday night. The famed venue will host a party in honor of its 95th birthday. The celebration will pay special tribute to the USO in a performance produced by Ric Henry, a San Diego song-and-dance sensation. The musical review will depict the musical history of the USO from the 1940s to the present. RELATED: San Diego Padres launch Sycuan Stage concert venue at Petco Park's Park at the ParkThe event is also dedicated to the famous Wonder Morton Organ. The instrument, built in 1929, is one of only four such organs in the world. The celebration will be held at the theatre Monday, March 25 at 7 p.m. General admission is ; students and military service members can get in for . Children under 13 are invited to attend the event for free. Tickets can be purchased in advance from the Balboa Theatre box office. 909