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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 coronavirus pandemic may have started earlier than previously thought, according to scientists from the CDC.A study from government scientists published November 30 appears to confirm what some health experts have suggested, patients infected with COVID-19 were in the US before the beginning of 2020.“The findings of this report suggest that SARS-CoV-2 infections may have been present in the U.S. in December 2019, earlier than previously recognized. These findings also highlight the value of blood donations as a source for conducting SARS-CoV-2 surveillance studies,” the report states.The first officially documented case of COVID-19 in the US was reported on January 19, a person who had returned to the US after traveling from China.The World Health Organization was alerted to the novel coronavirus by officials in Wuhan, China on December 31, 2019. The CDC researchers say further reports have identified a patient in Wuhan with COVID-19 symptoms as early as December 1, 2019.The study looked at more than 7,000 routine blood donation samples taken by the American Red Cross from people in nine states between December 13, 2019 and January 17, 2020.They found COVID-19 antibodies in 106 samples, mostly from the states of California, Oregon and Washington, from blood collected between December 13-16, 2019. Other samples that indicated COVID-19 antibodies were from Connecticut, Iowa, Massachusetts, Michigan, Rhode Island, and Wisconsin taken in early January 2020.“The presence of these serum antibodies indicate that isolated SARS-CoV-2 infections may have occurred in the western portion of the United States earlier than previously recognized or that a small portion of the population may have pre-existing antibodies that bind SARS-CoV-2,” the report states.Scientists acknowledge that patients presenting with what is now known as COVID-19 symptoms before mid-January would likely not have had clinical samples taken or kept because of how new the virus was. Therefore, the CDC used the existing repository collected by the American Red Cross during their routine blood donation process.“These specimens were previously archived for potential future studies to identify emerging transfusion-transmissible infections but were re-purposed for the present study,” researchers stated.Researchers caution that these results are subject to limitations. Although they detected antibodies, that does not mean they are “true positive” COVID-19 tests. In order to get a true positive, a different test would need to be a run. 2545

The FDA has given the final go-ahead to Pfizer-BioNTech's coronavirus vaccine.Shots will begin in a few days after the decision, but initial doses will be scare and rationed to health workers and nursing home residents and staff first. Enough vaccinations for the general population isn't expected until spring, prompting experts to urge the public to continue using face coverings and physically distance through the winter.Authorization had been expected Saturday morning, after an advisory panel recommended approval of the vaccine Thursday evening. According to reports, the agency was working to move it up to Friday evening.Friday morning, President Donald Trump lashed out at the Food and Drug Administration and its commissioner, Dr. Stephen Hahn, for not moving faster. Trump tweeted the FDA “is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!” 939

The City of San Diego was awarded a million state grant that will help save food, save the planet, and save people.  The city will use a majority of the grant to convert its composting system at the Miramar Landfill into a closed system.  A news release from the city said that will reduce air emissions and continue to divert tons of food waste from the landfill.The City of San Diego currently keeps more than 100,000 tons of food waste out of the landfill by composting or making sure it’s diverted to food rescue non-profits before it’s thrown away.“It’s getting tossed because people don’t find the need for it or it’s got a slight cosmetic defect,” said Aviva Paley of Kitchens for Good, a food rescue that feeds hundreds of people a day by using food that could have been thrown away.“You can still make really good food with stuff that you just have to clean it up a little bit,” said Kitchens for Good Chef Trainer Theron Fisher.“It is so heartbreaking to see how much food goes to waste in this country,” said Paley.A portion of the state grant will allow Kitchens for Good to expand its operation.  It fed 35,000 people in 2016.  It would like to feed more than 50,000 by 2018.It would keep more food out of the landfill and feed more people who need meals.  Paley said one in six San Diegans go hungry every day.Another benefit for the Kitchens for Good program:  The cooks who prepare the meals are going through a 12-week training program to prepare them for culinary careers.  Paley said most of the participants have overcome obstacles from crime and drugs to mental disabilities.  The program opens them to a career they could otherwise never reach. 1718

The Food and Drug Administration warned pregnant women on Thursday of using some pain and fever medications during the second half of pregnancies.According to the FDA, these nonsteroidal anti-inflammatory drugs can cause rare but serious kidney problems in the unborn baby, which can cause pregnancy-related complications. Nonsteroidal anti-inflammatory drugs include ibuprofen, naproxen, diclofenac, and celecoxib. The FDA added that its warning does not apply to low-dose aspirin.“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, M.D., acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”The FDA says that warnings on prescription nonsteroidal anti-inflammatory drugs already advise of complications past 30 weeks. The newest guidance calls on health care providers to only prescribe the lowest effective dose for the shortest period possible for women 20 to 30 weeks into their pregnancy.More information on the warning can be found here. 1259

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