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The FDA announced on Friday that it has issued an emergency use authorization for a second coronavirus vaccine. Its approval comes just one week after the FDA gave an emergency use authorization for a similar vaccine by Pfizer. That vaccine began distribution earlier this week. Moderna’s vaccine has been hailed as a medical breakthrough. The vaccine has been considered 94.1% effective against the virus. According to Moderna, none of the thousands who were given two shots of the vaccine had severe COVID-19 symptoms. That is compared to 30 patients who were given a placebo who had symptoms.In order to obtain an emergency use authorization, the FDA weighed the vaccine’s benefits against possible side effects. An emergency use authorization is not a full FDA approval, but it allows those outside of a clinical or hospital setting to obtain the vaccine. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn said in a statement. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”According to Moderna, approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.While the vaccine could nearly eliminate the number of hospitalizations and deaths associated with the virus, the shot might result in some symptoms.In an interview with CNN last month, Operation Warp Speed chief scientific adviser Moncef Slaoui said that 10 to 15% of those immunized had noticeable side effects.“Most people will have much less noticeable side effects. That frankly -- in comparison to a 95% protection against an infection that can be deadly or significantly debilitating -- I think is an appropriate balance," he told CNN. 2648

The Federal Aviation Administration issued an emergency directive for inspections of certain Boeing 737 planes due to recent reports of engine shutdowns.The FAA issued an emergency airworthiness directive on Thursday for certain Boeing 737s that have been in storage for more than a week.According to the directive, a certain engine valve may be responsible for four recent reports of engine shutdowns. Agency officials suspect that the valve may become corroded during storage, causing it to remain stuck in the open position.The directive requires that any Boeing 737-300, -400, -500, -600, -700, -700C,-800, -900, and -900ER that have been in storage for a week or longer undergo an inspection before being put back into use. The directive also requires inspections for any of those Boeing models that have completed "less than 10 flight cycles" at the time of the directive after coming out of storage.The inspection order was released the same day that CNBC reported that Boeing told lenders to expect fewer deliveries of its 737 Max planes that initially expected. The 737 Max, a plane Boeing has been developing for years, was grounded in 2019 after a series of crashes. 1185

The cast and crew of "Parks and Rec" are reuniting for a political cause.Amy Poehler and other stars of the show will participate in a virtual town hall on Thursday to raise money for the Democratic Party of Wisconsin.Series creator Michael Schur is also slated to make an appearance.The event is scheduled to begin at 8 p.m. CT, and anyone who donates money will be able to participate in a Q&A at 8:30 p.m., the group stated on its website.In April, the cast came together to raise money for Feeding America. 522

The entire cast of the "Guardians of the Galaxy" films signed an open letter in support of James Gunn, the director of the series' first two films.Gunn was recently fired as the director of the upcoming third movie after it was revealed he made a number of offensive jokes on Twitter between 2008 and 2012.We are not here to defend his jokes of many years ago but rather to share our experience having spent many years together on that set making Guardians of the Galaxy 1 and 2. The character he has shown in the wake of his firing is consistent with the man he was every day on set, and his apology, now and from years ago when first addressing these remarks, we believe is from the heart, a heart we all know trust and love," the letter reads in part.The letter was signed by actors Dave Bautista, Bradley Cooper, Vin Diesel, Sean Gunn, Karen Gillan, Pom Klementieff, Karen Killan, Christ Pratt, Zoe Saldana and Michael Rooker.Read the letter in its entirety in the tweet below.  1005

The E. coli outbreak linked to romaine lettuce has sickened 43 people in 12 states, the US Food and Drug Administration said Monday.The FDA said that the ongoing outbreak is linked to the "end of season" harvest in some parts of California -- but the agency still says people should not eat any romaine lettuce.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.An additional 22 people in Canada are also ill, so the FDA is coordinating its investigation with the Canadian health and food safety authorities, the agency said.When the outbreak was announced last week, the FDA and the Centers for Disease Control and Prevention warned consumers to stay away from all romaine lettuce, but the FDA said the investigation was focused on California and Mexico."Over the Thanksgiving holiday, the FDA continued to investigate the outbreak," according to a statement from FDA Commissioner Dr. Scott Gottlieb. "Our investigation at this point suggests that romaine lettuce associated with the outbreak comes from areas of California that grow romaine lettuce over the summer months, and that the outbreak appears to be related to 'end of season' romaine lettuce harvested from these areas. The involved areas include the Central Coast growing regions of central and northern California."Lettuce growing and harvesting in the winter months is taking place in California and Arizona's desert regions and Florida, as well as Mexico. Currently, the FDA investigation does not implicate lettuce from any of these areas.While the romaine supply undergoes a "clean break" to ensure all the contaminated lettuce is effectively gone from the market, the FDA has asked producers and distributors to provide clear labeling with the lettuce's date and origin in the future.A task force within the lettuce industry has also been established to determine better solutions for labeling long-term in order to help with tracing."Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date," Gottlieb said. "Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown. If it does not have this information, you should not eat or use it."If consumers, retailers and food service facilities are unable to identify that romaine lettuce products are not affected -- which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation -- we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase."Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the FDA. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill. 3450