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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 demand for mail-in ballots is surging. Election workers need training. And polling booths might have to be outfitted with protective shields during the COVID-19 pandemic.As officials prepare for the Nov. 3 election, one certainty is clear: It’s coming with a big price tag.“Election officials don’t have nearly the resources to make the preparations and changes they need to make to run an election in a pandemic,” said Wendy Weiser, head of the democracy program at the Brennan Center for Justice. “We are seeing this all over the place.”The pandemic has sent state and local officials scrambling to prepare for an election like few others, an extraordinary endeavor during a presidential contest, as virus cases continue to rise across much of the U.S.COVID-related worries are bringing demands for steps to make sure elections that are just four months away are safe. But long-promised federal aid to help cash-starved states cope is stalled on Capitol Hill.The money would help pay for transforming the age-old voting process into a pandemic-ready system. Central to that is the costs for printing mail-in ballots and postage. There are also costs to ensure in-person voting is safe with personal protective equipment, or PPE, for poll workers, who tend to be older and more at risk of getting sick from the virus, and training for new workers. Pricey machines are needed to quickly count the vote.Complicating matters is President Donald Trump’s aversion to mail-in balloting. With worrisome regularity, he derides the process as rigged, even though there’s no evidence of fraud and his own reelection team is adapting to the new reality of widespread mail-in voting.“As cases of coronavirus in this country rise, it’s vital that all voters be able to cast their ballots from home, to cast their ballots by mail,” said Sen. Amy Klobuchar, D-Minn.A huge COVID response bill passed by the House in May contains a whopping .6 billion to help states with their elections, but the Senate won’t turn to the measure until late July. Republicans fought a 0 million installment of election aid this March before agreeing to it.But key Senate Republicans seem likely to support more election funding, despite Trump’s opposition, and are even offering to lower a requirement that states put up “matching” funds to qualify for the federal cash.“I’m prepared not only to look at more money for the states to use as they see fit for elections this year, but also to even consider whatever kind of matching requirement we have,” said Roy Blunt, R-Mo., chairman of the Senate panel with responsibility for the issue. “We can continue to work toward an election that produces a result that people have confidence in and done in a way that everybody that wants to vote, gets to vote.”The pandemic erupted this spring in the middle of state primaries, forcing many officials to delay their elections by days, weeks and even months. They had to deal with a wave of poll worker cancellations, polling place changes and an explosion of absentee ballots.Voting rights groups are particularly concerned with the consolidations of polling places that contributed to long lines in Milwaukee, Atlanta and Las Vegas. They fear a repeat in November.As negotiations on the next COVID relief bill begin on Capitol Hill, the final figure for elections is sure to end up much less than the .6 billion envisioned by the House. That figure followed the recommendations of the Brennan Center to prepare for an influx of absentee ballots while providing more early voting options and protecting neighborhood polling places.Even before the pandemic, election offices typically work under tight budgets. Iowa Secretary of State Paul D. Pate, who serves as president of the National Association of Secretaries of State, said the group has been calling on the federal government to provide a steady source of funds, particularly to help address ongoing costs of protecting the nation’s election systems from cyberthreats.For Georgia’s primary last month, election officials spent .1 million of the roughly .9 million the state has received in federal funds. The money was used to send absentee ballot applications to 6.9 million active registered voters and print absentee ballots for county election offices. Some of it also was used to purchase PPE and secure drop-off boxes for counties.Meanwhile, the state elections division has seen a ,000 reduction for the current budget year as Georgia — like the rest of the nation — deals with a decline in revenues due to the pandemic.The state’s remaining federal funds will be used to help cover the costs of developing an online system for voters to request absentee ballots, a less expensive option than sending ballot applications to every voter, and exploring whether installing plexiglass dividers around voting machines could allow more voters in a polling place at one time.In Colorado, which is already a universal vote-by-mail state, the Denver election office has had to reduce its budget by 7.5%, which amounts to nearly 0,000. Jocelyn Bucaro, Denver’s elections director, said the federal funds sent earlier this year helped with purchasing PPE and other pandemic-related supplies.Iowa similarly spent its federal dollars on mail-in ballots and pandemic supplies, Pate said.Vote-by-mail veterans and vendors of the equipment, software, ballots and envelopes that will be needed in November say the window to buy them is quickly closing.“Right now, what I’m seeing in most places is just this kind of indecision. What are we supposed to be planning? Vote by mail or in-person or combination?” said Jeff Ellington, president of Runbeck Election Services, which prints ballots and the special envelopes used to mail them and also supplies high-volume envelope sorters.“Decisions just need to be made so people can start to put a plan into place,” he said.BlueCrest, a Pitney Bowes spinoff, sells high-volume sorting machines that handle up to 50,000 ballot envelopes per hour. That’s the kind of crunch big counties can expect to face on Nov. 3 in states including Wisconsin and Pennsylvania, where Rick Becerra, a vice president at the company, said he’s been talking to officials. The machines average 5,000 each.“I tell them the time is now,” he said.___Cassidy reported from Atlanta. Associated Press writer Frank Bajak in Boston contributed to this report. 6414

The first snowflakes flew into the lower 48 this week.A big winter storm blew through the higher elevations of western Montana and northern Idaho earlier this week, and now, a few of those snowflakes may fall in parts of western Wyoming and in the mountains of Utah and Colorado. 287

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

The CDC is now recommending “universal mask use” both indoors and outdoors whenever someone is not at their own home. This is the first time the agency has included indoor spaces in their recommendations for universal mask wearing.It comes as coronavirus cases in the U.S. continue to surge past 14 million positive cases and deaths climb above 277,000, with many states only beginning to see a potential second spike from Thanksgiving celebrations.In the CDC’s weekly report, they said with more time spent indoors with the colder weather, the ongoing holiday season and silent spread of the disease with about 50 percent of transmission happening from asymptomatic people, “the United States has entered a phase of high-level transmission where a multipronged approach to implementing all evidence-based public health strategies at both the individual and community levels is essential.”These include universal mask use, physical distancing, avoiding nonessential indoor spaces, increased testing, prompt quarantine, enhanced ventilation, and widespread vaccination coverage. The agency stresses “no single strategy can control the pandemic,” and all of these recommendations will be needed to break transmission chains.The CDC warns that indoor spaces and crowded outdoor spaces, especially where distancing is not maintained or consistent use of face masks is not possible, i.e. like when eating or drinking, “have been identified as particularly high-risk scenarios.”“Compelling evidence now supports the benefits of cloth face masks for both source control (to protect others) and, to a lesser extent, protection of the wearer,” the CDC guidelines now read. “Face mask use is most important in indoor spaces and outdoors when physical distance of ≥6 feet cannot be maintained. Within households, face masks should be used when a member of the household is infected or has had recent potential COVID-19 exposure.”Any indoor spaces should also have good ventilation, the CDC says. "For indoor settings, increased room air ventilation can decrease the concentration of small droplets and particles carrying infectious virus suspended in the air and, thereby, presumably decrease the risk for transmission."The World Health Organization recently updated their guidelines that everyone 12 and older should wear a mask outside, inside and even inside people’s own homes if they are poorly ventilated. They recommended that children ages 6-to-11 should wear a mask based on a “risk-based approach.”Earlier this week, the CDC said they recommend against traveling this holiday season to slow the spread of the coronavirus. They made a similar plea before Thanksgiving, however the TSA reported record-high airport screenings since the pandemic started. 2758