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Pfizer announced Friday that it would submit a request to the FDA Friday for its COVID-19 vaccine to be granted Emergency Use Authorization.Earlier this week, Pfizer said that a final analysis of trial results showed the vaccine is 95% effective.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a press release.Pfizer's two-shot vaccine has already been in mass production for months, and thousands of doses will be ready for delivery if and when the FDA grants authorization. Pfizer says that is on track to produce 50 million doses of the vaccine by the end of 2020 and plans to produce 1.3 billion doses of the vaccine in 2021.According to "Operation Warp Speed," the federal government's plan for distributing the vaccine, upon authorization, the drug will initially be rationed for high-risk populations and health care workers. Dr. Anthony Fauci, the nation's top infectious disease expert, says he believes a vaccine won't be widely available until April.On Wednesday, Pfizer announced that a final analysis of its vaccine candidate showed that of 40,000 participants who participated in the trial, 170 people had contracted the virus. Of those 170 people, 162 received only a placebo injection — meaning just eight out of the 20,000 people who actually received the vaccine contracted the virus.The company added Wednesday that there have been no safety concerns with the vaccine. In a randomized survey of 8,000 participants, only 2% reported suffering severe fatigue, and only 4% reported suffering severe headaches. Those who say they suffered side effects only experienced them briefly after vaccination.Pfizer's announcement comes as COVID-19 cases are spiking around the world. In the U.S. alone, about 2.5 million people have contracted the virus in the month of November alone. Hospitalizations linked to COVID-19 are at an all-time high, and deaths have begun to tick up in recent weeks. 2322

Planning on going swimming while on vacation this summer? The CDC said on Thursday that an estimated 27,000 people were sickened, and eight died, from swimming-related diseases from 2000 to 2014 in hotel pools and hot tubs. According to CDC figures, 1 out of 3 swimming-related disease outbreaks originated from hotels. The CDC says that Cryptosporidium (also known as “Crypto”), Pseudomonas, and Legionella caused most of the outbreaks in swimming venues. Of the 27,000 people sickened, the majority had Crypto, which is a parasite tough enough to survive even in properly maintained pools.“Swallowing just a mouthful of water with Crypto in it can make otherwise healthy kids and adults sick for weeks with watery diarrhea, stomach cramps, nausea, and vomiting,” said Michele Hlavsa, R.N., M.P.H., chief of CDC’s Healthy Swimming Program. “Chlorine cannot kill Crypto quickly. We need to keep it out of the water in the first place. Don’t go into the water, and don’t let your kids go into the water, if sick with diarrhea.”The CDC said if a pool, hot tub, or water playground is not cleaned properly, bacteria can grow and form a slime called biofilm on wet surfaces. Legionella and Pseudomonas can live in this biofilm. The CDC has offered the following tips to prevent getting sick while swimming:  1401

Over the past few weeks, the University of Farmington (Farmington), an undercover investigation run by Homeland Security Investigations (HSI), has been the focus of several media reports. These reports mischaracterized the purpose and rationale for the investigation, and I want to set the record straight. HSI is responsible for enforcing more than 400 federal statutes, including laws related to the student visa system. An estimated 1.2 million nonimmigrant students studied at more than 8,200 U.S. schools during 2018, promoting cultural exchange, providing billions of dollars to the U.S. economy, and contributing to research and development. Criminals and some students, however, exploit the student visa system, allowing foreign nationals to remain in the United States in violation of their nonimmigrant status.When a nonimmigrant student decides to enroll in a program of study in the United States, the student must abide by U.S. laws and regulations to maintain their nonimmigrant status. Above all, their primary purpose while in the United States must be to study. Every nonimmigrant student is required to "make normal progress toward completing a course of study" as a condition of maintaining their status. If they don't meet that standard, they are subject to arrest and removal from the country. The individuals who enrolled at Farmington, knowingly and willfully violated their nonimmigrant visa status and consequently were subject to removal from the United States.These individuals were not new to the U.S. student visa system; they were familiar with its requirements and their obligations. They secured visas to enroll in another U.S. school, and were already in the United States when they transferred to Farmington. In addition, prior to enrolling at Farmington, each prospective enrollee was informed that there were no classes, curriculum or teachers at Farmington. Despite this, individuals enrolled because they saw an opportunity to avoid any academic requirements and, instead, work full-time, which was a violation of their nonimmigrant status. Evidence, including video footage, audio recordings, and correspondence collected during the investigation supports that each prospective enrollee knowingly and willfully violated their nonimmigrant status.Farmington is a clear example of a pay-to-stay scheme, which is against the law and, not only creates a dangerous lack of accountability, but also diminishes the quality and integrity of the U.S. student visa system. Undercover investigations like this one provide law enforcement an inside look into how these networks operate, which was the primary purpose in establishing Farmington. The investigation provided HSI with a better understanding of how recruiters and others abuse the nonimmigrant student visa system. This, in turn, informs and improves DHS' efforts to uncover fraud at schools, provides insight into networks within the United States that facilitate such abuse, and serves as a deterrent to potential violators both in the short- and long-term.As sworn civil servants, HSI special agents will continue to uphold the Constitution and protect the country's borders and immigration laws. The rules and regulations that govern the student visa system help protect the country from individuals who seek to abuse the system or remain illegally in the United States. HSI is responsible for investigating these kinds of violations, which is precisely what it did by establishing Farmington to investigate a complex fraud scheme used across the country to undermine U.S. laws and individuals' safety. 3603

Police in Northern California say a nurse driving home from her shift at a hospital was assaulted after she encountered a group of protesters who say she intentionally drove into the crowd. Santa Rosa police say they are investigating but add that video evidence does not show that the woman purposely drove into about 100 people marching Saturday night. The woman told officers she was punched in the face by a man who followed her after she drove away from a “swarm” of people blocking her vehicle. Protesters initially said a teenager on a bicycle had been injured but no victims have come forward to police."SRPD officers met with several protesters who believed that the driver of the SUV intentionally drove through the crowd. There was some discrepancy as to how fast the vehicle was driving. Several protesters provided video footage of the incident to the officers on scene," police said in a statement. "The videos show the protesters taking over all lanes of traffic on Sonoma Avenue, heading eastbound. It also showed it was dark outside. In the videos, it is clear that the vehicle is approaching the crowd and you can hear several people yelling profanities at the driver. At one point, protesters surround the vehicle and the vehicle is struck by several unknown objects and a skateboard. Because the vehicles’ path was blocked by protesters, the driver tried to maneuver her way out of the crowd until her path was clear. There is no indication from the videos that the driver was trying to run over protesters on purpose."Video of the incident has not been released. 1591

PASADENA, Calif. (AP) — Police in California have launched an investigation after authorities received calls of six people showing signs of drug overdoses during a six-hour period in the same city. The Pasadena Star-News reported Pasadena officials say two patients died, three recovered and one remained in a hospital receiving treatment. Authorities could not say conclusively whether the two men who died succumbed to drug overdoses until they receive a coroner’s autopsy findings. Police say they believe the cases may involve fentanyl. Pasadena police spokesman Lt. Bill Grisafe calls the suspected overdose surge an anomaly not previously seen in Pasadena. 670

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