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The FDA said in a news conference on Friday that there have been “roughly" five adverse reactions to Pfizer’s coronavirus vaccine, which began distribution earlier this week.According to FDA and Pfizer officials, 2.9 million doses of the vaccine was distributed this week. Those doses mostly went to health care workers and those living and working in assisted living facilities. It’s unclear exactly how many of those 2.9 million doses have been administered, as of Friday.Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, told reporters on Friday that one of the five adverse events caused a serious reaction. Marks did not go into detail on the locations or conditions of all the cases. The FDA has not responded for a request for additional information.Marks said that a case in Alaska was the most serious of the reactions being investigated.“We will continue to watch these closely. It is difficult to talk about them without any kind of good certainty until we have more information on them,” Marks said.FDA officials said that it’s possible the reactions were from the vaccine’s active ingredient polyethylene glycol. According to government information, the ingredient can cause known side effects such as bloating, diarrhea, nausea, cramps, gas and hives.FDA administrator Dr. Stephen Hahn said that the vaccine’s monitoring program is working well.“One of the things the FDA does well and uniquely is really getting to the bottom to events like allergic reactions,” Hahn said.On Friday, a second vaccine received FDA authorization. The vaccine from Moderna received an emergency use authorization, which means the vaccine can now be administered outside of a clinical or hospital setting. 1736
The FDA issued an emergency use authorization for a saliva-based coronavirus test that has been used to identify COVID-19 cases by NBA players. Leading officials are calling the test a “game-changer.”The SalivaDirect test is said to be both rapid in its findings, and inexpensive. Yale said it doesn’t hope to commercialize the test, rather increase the country’s testing capabilities.“Widespread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Nathan Grubaugh, a scientist with Yale Public Health.Yale scientists say that the nasal samples are less invasive than swabbing, but are equally as accurate.“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”The test earned praise from members of the White House coronavirus task force.“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game-changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.” 1926
The Duke and Duchess of Sussex made their first public appearance Tuesday since they were married Saturday in a star-studded ceremony watched by millions around the world.Prince Harry and Meghan arrived at Buckingham Palace in London on Tuesday afternoon to attend a garden party in honor of Harry's father, Prince Charles, ahead of his 70th birthday.They newlyweds had delayed jetting off on their honeymoon in order to attend the garden party -- a gesture no doubt welcomed by Prince Charles, who accompanied Meghan part of the way down the aisle during the wedding at St. George's Chapel in Windsor Castle on Saturday. 629
The Farmers’ Almanac has released its wintertime forecast for 2020-21 on Monday, and said it is expecting a cold, snowy winter for much of the United States.Where it is normally cold enough to snow in the US, the Farmers’ Almanac predicts above average snowfall in most areas.From the Mississippi River to the east, the US is expected to see below normal temperatures. The northern Plains and Rockies will also see colder than average temperatures according to the almanac.The Pacific Northwest could see some of the most pleasant weather of the winter in the US, with mild and dry conditions expected there. The southwest is expected to see normal temperatures.Snow lovers, before you get too excited by the forecast, know that long-term forecasts have a tendency to be off.Last year, the Farmers’ Almanac predicted a “Polar Coaster Winter” for much of the US. Those predictions did not come to light, especially in the Midwest, which had a well above average winter.Still, the Farmers’ Almanac stands by its projections."Preparing people for the unexpected is more important than ever," states editor Peter Geiger, Philom. "Our job as editors of the Farmers' Almanac is to pass down valuable tips and advice to help our readers thrive, no matter the obstacles."To see more detail on the Almanac's forecast, click here. 1328
The founder and CEO of a fitness business in Phoenix says he intends to file a lawsuit against Governor Ducey in response to his executive order closing select businesses.The executive order said that as of 8 p.m. Monday night, gyms, bars, waterparks and tubing areas will all have to close to try to help slow the spread of the coronavirus.Tom Hatten, Mountainside Fitness CEO, said during a press conference Monday that the governor’s move is "arbitrary" and lacks clarity.“If this is truly as bad as we are being told, I don’t think health clubs closing tomorrow is going to solve the problem. I don’t think tubing is going to solve the problem,” Hatten said. “I don’t think closing a movie theater that hasn’t been open is going to solve the problem.”Hatten also called for unity from the governor, saying that if the governor is serious about coronavirus, the executive order shouldn't be limited to bars, gyms, and movie theaters.A representative for Mountainside Fitness says several other large gyms are taking part in the lawsuit as well, though that has not been confirmed with the other gyms.Dozens of members showed up to work out at Mountainside Fitness as soon as it opened Tuesday morning.Those like John Kiesewetter say they agree with the CEO's reasoning to remain open if other businesses aren't also forced to close. He says regular physical activity puts them in a better position to beat the virus."It seems to be unfair that things like casinos are still open but gyms, they are not. So, anyone who's healthier, who keep our distance, are the people who go to the gym and clean our equipment, so I think it was the right decision," Kiesewetter said.Governor Ducey said Monday that local authorities will have the ability to enforce the new rules, with a focus on educating the public.This story originally appeared on abc15.com. 1859