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As questions arise over when a coronavirus vaccine should be granted FDA approval, the leaders of several major pharmaceutical companies announced they have signed a pledge not to rush the development of a vaccine.The companies, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, released a joint statement on Tuesday confirming the pledge.The pledge includes the following points:Always make the safety and well-being of vaccinated individuals our top priority.Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.There has been pressure on both the FDA and manufactures to develop and approve a vaccine for the coronavirus. There have been more than 190,000 coronavirus-related deaths in the US since March, and the economic impact of the virus has cost millions of jobs.While most developed countries have not had the same public health pain as the US, the economic impact of the virus has been felt worldwide. The International Monetary Fund estimates a nearly 5% loss in global GDP in 2020.In Russia, the country claimed to begin distributing a coronavirus vaccine despite US-based vaccine candidates likely being months away from being able to demonstrate efficacy.The pressure domestically has also ratcheted up as President Donald Trump has suggested a vaccine could be ready by this fall’s presidential election."We're going to have a vaccine very soon... maybe even before a very special date, you know what date I'm talking about,” Trump said on Monday.In late August, the CDC told states to begin to prepare distributing a vaccine by Nov. 1. But Surgeon General Jerome Adams said that just because states will be ready to help distribute a vaccine on Nov. 1 does not mean a vaccine will be ready by then."We've always said that we're hopeful for a vaccine by the end of this year or the beginning of next year,” Adams told Good Morning America."We want to make sure states are available to distribute it," he added.The companies signing on the pledge said that the FDA has strict protocols for vaccine candidates. A typical vaccine trial takes one to three years, but the companies believe only a safe and effective vaccine will be granted approval.“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the companies wrote in the pledge. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.” 3296

As scientists learn more about COVID-19, they are realizing that how people react to the virus could be based on the body's response to viruses like common colds.Meharry Medical College President Dr. James Hildreth says some studies are showing some individuals have T-cell responses to COVID-19 even though they never been exposed to it.He is talking about recent research revealing that some people may have immunity defenders called T-cells which could determine how their body reacts to COVID-19.According to the CDC, when the body fights an infection, the immune system remembers what it learned about how to protect the body against that disease.The body will retain a few specific T-cells known as memory cells - that will alert and help the immune system identify and produce antibodies to attack the foreign germ if it enters the body again."Viruses that look alike can sometimes elicit the same kinds of immune responses," said Hildreth.Hildreth says there are six strains of coronavirus that affect humans going back to the 1960s and some result in seasonal common colds.He says if you were infected with one of these viruses in the past it can determine the severity of the toll COVID-19 would take on your body now."There’s the possibility that a response to one of them gives you a partial to another because they have genetic similarities," said Hildreth.Hildreth says this doesn't mean a person has complete immunity to COVID-19."There’s strong evidence that you may not be immune to the virus, but you’ll have an immune response that recognizes SARS partially just because those two viruses look so much alike."Hildreth says this can help with treatments and even vaccinesThis story was originally reported by Kelsey Gibbs at WTVF. 1756

As we head into cold and flu season, you can expect things will be handled differently at workplaces, schools, day cares and medical offices because of COVID-19.Anyone with symptoms like a runny nose, a cough or sneezing will likely be asked to stay home.“So, I think there's going to be a requirement for any of these symptoms for employee health at the workplace to take a larger role in screening patients probably a lot more testing,” said Dr. Scott Joy, Chief Medical Officer at Englewood Primary Care.Joy spoke with us about how people should handle these symptoms during the COVID-19 pandemic. He recommends staying home for 24 hours when you have a cold without a fever.If you have a fever, isolate for up to six days or until you've been fever free for a full 24 hours. If you're coughing or sneezing more than four times in an hour, you should probably stay home and see a doctor.“We haven't had a metric like that before, so we're going to experiment with that data point and see what it does to our workforce and our clinic infection control over this season,” said Joy.Joy also reminds people to get the flu shot.A study in the New England Journal of Medicine found people who got the vaccine had 25% fewer episodes of upper respiratory infections than those who didn't. That means fewer sick days from work and fewer doctor visits.The hope is that COVID-19 measures like handwashing, mask wearing and watching your distance will lead to fewer respiratory infections overall. But should you experience those symptoms, you may be directed to urgent care centers instead.The idea is to keep doctor offices sterile, so people with chronic conditions and other issues feel safe coming in to see their primary care physician.“In the last couple of months, people that have been putting off their care, I just diagnosed a gentleman, new diagnosis with pancreatic cancer,” said Joy. “We're detecting breast cancer, heart disease blood pressure that is out of control.”Urgent care centers are equipped with personal protective equipment and are typically faster, and cheaper than a visit to a hospital emergency room. But you should call your doctor's office first to see what they recommend based on your symptoms. 2228

At a Monday afternoon hearing regarding records from the Florida Department of Children and Families, a judge ruled a three-page confidential investigative summary and 19 pages of background materials could be released regarding Nikolas Cruz.FULL COVERAGE: Parkland school shootingNames of non-DCF employees listed in those pages will be redacted, but their titles won't be.The records were released later Monday, showing the following: ?       DCF Adult Protective Services was called on Sept. 28, 2016 to investigate allegations that Nikolas Cruz was being victimized by his caregiver -- his adoptive mother.?       Following an investigation involving mental health counselors, school personnel, and law enforcement who had contact with Cruz, DCF found no indicators of abuse or neglect as alleged; 854

As the investigation continues into why a female shooter opened fire at YouTube headquarters, data show that it's rare for women to carry out such shootings -- making Tuesday's incident unusual.The shooting unfolded at the San Bruno, California, company premises when a woman shot and injured three people, and then apparently took her own life, officials said.She appeared to have killed herself with a handgun, San Bruno Police Chief Ed Barberini said. The woman has been identified as Nasim Najafi Aghdam, a 39-year-old from San Diego, California. 558

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