December 2, 2020 NEWS FDA authorization of COVID-19 ERICK RAMBLINGS vaccines would set off a scramble By Gail Pritchard By Emily Kopp, CQ-Roll Call vaccine candidate — which ‘These meetings typically dently review the clinical data. Covid-19 isn’t going to get Erick down this holiday season! can be watched via livestream occur after FDA's determi- Even critics of the FDA un- Erick will still be having the annual Christmas drawing this WASHINGTON — The — is scheduled for Dec. 10. nation, but Department of year, but will be a live virtual drawing on Facebook. The event Trump administration's Experts emphasize the Health and Human Services der Trump question this step. will be Friday, 12/11, at 6 PM., “live” on Facebook. You can pledge to start shipping meeting will be important for Secretary Alex Azar indicated “There are likely hundreds sign up at “Bailey Rae Crosby-Erick Virtual Chamber Christ- COVID-19 vaccines "within establishing trust. he wants to speed things up. of career staff who touch a mas Drawing”. List your names, kid’s names and ages, and 24 hours" of a green light At an earlier meeting in "l'm working directly with candidate drug as it courses include a phone number. If you have any questions, contact, from the Food and Drug October, the group expressed CDC Director Robert Redfield Bailey Crosby, Monica Laster or Andrea Miller and they can Administration will lead toa concerns about whether there on how we could convene the its way through the regula- help you out! multi-step scramble during would be enough follow-up ACIP, hopefully, concurrent tory system. No hurriedly Erick PTO is holding a reverse raffle. Purchase a $10 the time between authoriza- safety data, and whether the with the FDA review," Azar ticket for a chance to win the 1st Place prize of $1000.00! assembled state committee tion and the first shots going vaccines will prevent severe said. "Every hour, every day Remaining prizes are: 2nd Place-$80.00; 3rd Place-$60.00; into arms. COVID-19 cases. matters." can reproduce this process," 4th Place-$40.00 & Sth Place-$20.00, Tickets will be sold ‘Any thumbs-up from the Experts say the early evi- Vanderbilt University said former FDA official Peter from November 17th through December 7th with only 300 EDA would kick-start the dence shared by the drugmak- infectious diseases expert Lurie, president of the Center total tickets to be sold. Beginning on November 30th, the distribution of 6.4 million vac- ers seems promising, though. William Schaffner, who has tickets will be drawn and eliminated daily. Those drawings will cine doses among 64 states, "The size of these trials is been affiliated with ACIP for for Science in the Public Inter- be posted on Facebook. The winners will be announced on territories and major cities, the size of any trial that would 25 years, said it's good to est, in a recent editorial. "But December 14th. based on population, Gen. be submitted for (standard ensure the FDA and ACIP can these shadow committees ‘The 6th Annual City of Erick 2019 Christmas Toy Drive is Gustave Perna has said. Perna approval). The only difference simultaneously "chew on the carry an unintended danger: in process now. Purchase a gift for a special boy or girl, new- co-leads Operation Warp is the length of the study is data." born to 15 years of age, and drop it off unwrapped at City Hall, Speed, the Trump administra- much shorter," said commit- But Schaffner said if ACIP ‘They could reinforce public Erick Library, C&K, First Bank or Dollar General by December tion's initiative on COVID-19 tee member Paul Offit, co- issues recommendations early, distrust." 15th. Also, if you know of families in need this holiday season vaccines and treatments. developer of the rotavirus vac- conditional on a vaccine's DISTRIBUTING DOSES please call Erick City Hall at 580-526-3924 or stop by the of- Here's what to expect over cine. "But then again, it has to authorization, that could risk fice. This event is sponsored by the Erick Emergency Services the next few weeks. be. You're not going to study undermining FDA's authority. After all this, Operation which consists of our fire department, police department and FDA REVIEW these vaccines for two or three “ACIP has always been Warp Speed officials say a our EMS services. Monetary donations are very welcome also. ‘he first step is a scientific years for a virus that's killed very careful in their discus- vaccine would go immediately Gifts will be delivered the evening of December 17th. review by the FDA. 250,000 people this year.” sions to say, "This preliminary Anniversary wishes go out to Lewis & Holly (Smith) Cun- FDA's evaluation will "So the question is have we data is in process of being to sites that public health de- ningham on 12/1. _I don’t show any more anniversaries for likely happen quickly because reduced a critical amount of investigated by the FDA, and partments designate through this week. If you know of any in December, please let me as part of the administra- uncertainty?" Offit said. "We'll we all have to remember this anew software system called know. tion's efforts to accelerate the drill down on these data to see vaccine hasn't been approved "Tiberius." Birthdays to celebrate for this issue (12/2-12/8) will be: process, the agency is already what the story is.” yet," Schaffner. 12/2-Janie Floyd & Avery Vanderpoel; 12/3-Jody Allen, Jr., accepting data on a rolling Hahn said after the ad- Azar said he doubted "Bvery jurisdiction will Vera Pierce, Megan Wreyford & Bruce Rodgers; 12/4-Brady basis. But the applications for visory committee makes its ACIP's recommendations have access immediately," Greer, Ethan Melton, Donald Holland, Janet Hanson & Jett emergency use authorization, recommendation, FDA may would significantly change Perna said. Snowden; 12/5-Arden Dorney; 12/6-Matt Miller & Gwen Gil- like any standard application, take a few days to digest the states' plans on where to send lum; 12/7-Jessie Laster, Macy Boyd Reinhardt, Perisha Hill will likely be thousands of advice and decide whether the vaccine, and does not ex- One red flag is that some & Larry Wilhelm; and on 12/8-Mary Jane Prather Dunlap, pages long, FDA Commission- to authorize the vaccine. pect the meeting to be a time- health systems say they aren't Perisha Bell, Randy Waters & Darla Rodgers. er Stephen Hahn confirmed to Operation Warp Speed co-lead consuming step. Azar noted prepared to distribute vac- Just a reminder; if you enjoy reading this column and USA Today. Moneef Slaoui has indicated that ACIP's recommendation would like to help keep it interesting, please call me at 580- FDA official Peter Marks, authorization could happen on any COVID-19 vaccine cines continually stored in 243-8923, or mail your news to me at P.O. Box 773, Brick, OK who leads the career scien- the same day as the VRBPAC is important for reimburse- frigid temperatures such as 73645, For your convenience, you can email your items to me tists reviewing the data, has meeting. ment. Under the 2010 health the Pfizer one. at gep2050ehotmail.com. ‘The new deadline to turn this col- said people should expect the PRIORITIZING POPULA- umn in is Friday by noon. Thanks to all of you who contribute process to take a few weeks. TIONS care law, private insurance Perna said Operation Warp as I really appreciate it very much! Have a great week! companies must cover vac- Speed has begun running On Nov. 20, Pfizer and its ‘The Advisory Committee cines recommended by ACIP partner BioNTech were the on Immunization Practices, drills on how to administer first to finish submitting all of without a copay. which guides the CDC on Meanwhile, states are the Pfizer vaccines, but these their data. vaccine schedules, also would For a COVID-19 vaccine, already operating off earlier drills have only been com- vote on how to prioritize recommendations by the Na- “we'll only be thinking about pleted with 10 of the total issuing (an emergency use populations in vaccination. tional Academies of Science, Like VRBPAC, the ACIP typi- 64 vaccine jurisdictions such authorization) if it's demon- Engineering and Medicine. strated clear and compelling cally holds its meetings openly “The final say will be up as states and cities. The CDC MARRIAGE LICENSES efficacy in a large, well-de- with opportunities for public to our governors," Azar said. published more guidance on None signed, phase 3 clinical trial comments. That could boost "We are not dependent on any storing and handling CO- similar to that which would confidence in the process. DIVORCES delay from ACIP in terms of VID-19 vaccines this week, be required to support an ap- ‘An ACIP working group on helping to advise states on Brittany Pharesn vs Stacey Phares proval. And that's because it's COVID-19 vaccines already which public health depart- Tommy Tucker vs Mary Tucker potentially going to be admin- spelled out broad goals: prioritization." ments awaited for months. istered to millions of individu- maximizing benefits and But if the clinical trial data Public health departments als, including healthy people," minimizing harms, promot- shared with ACIP indicates Marks said on an FDA podcast ing justice, mitigating racial the vaccine is less effective also are still billions short last month. and economic inequities, and in some populations, as is of the funding they want for EDA also provides the data ensuring transparency. The sometimes the case with older the unprecedented challenge. to a panel of independent working group said health people, that could mean big Redfield testified to Congress experts, the Vaccines and care personnel, essential differences between what that an estimated $6 billion is Related Biological Products workers, adults with high-risk MISDEMEANORS states are planning and what Advisory Committee, which medical conditions and adults needed, while health depart- State of Oka vs Jeffery C Harris Domestic assault & battery ACIP recommends. advises the agency on vaccine 65 years old or older should be Depending on where you ments are seeking $8 billion. State of Oka vs Jason R Hill Harassing & threatening electronic approvals. Although the com- first in line for shots. Asked whether broad communications live, any COVID-19 vaccine mittee's advice is non-binding, But the full ACIP would may need to surmount one immunity is possible without State of Oka vs Kelly $ Humphreys DUS EDA follows most VRBPAC vote on more detailed recom- more hurdle before distribu- that distribution funding, State of Oka vs Andrew D Tackett Dumping trash recommendations. mendations on who receives ‘The VRBPAC meeting to priority specific to each FDA- tion. Some states, including Sen. Patty Murray, D-Wash., FELONIES discuss Pfizer and BioNTech's authorized vaccine. New York, plan to indepen- said, "I highly doubt it." State of Oka vs Richard Silva DUI. DUS State of Oka vs Jimmie L Brown Conspiracy. Possession of and bringing contraband into jail State of Oka vs John W Standingwater Possession of sto- Arizona certifies Biden’s Jen vehicle. Concealing stolen property. Removing proper or affixing improper license plate State of Oka vs Dylan D Spencer Grand larceny. Acquiring election victory over Trump proceeds from drug activity State of Oka vs Rickey D Larff Possession of CS. Acquiring proceeds from drug activity State of Oka vs Erika C Woods Possession of CS By Mark Niquette, Bloomberg by challenging the results in tories last week, and Georgia deadline. State of Oka vs Lasean D Woods “ News court and seeking to halt the made his win there official on ‘Trump has so far refused State of Oka vs Marcus D Dison Acquiring proceeds from certification in some states, Nov. 20. to concede, but he acknowl- drug activity Arizona certified Demo- despite what legal experts Biden's victory in Arizona edged during an interview State of Oka vs Terell D Davi crat Joe Biden's victory in have said is a lack of evidence. doesn’t qualify for an auto- Sunday on Fox News that the State of Oka vs AndyJ Wilson Assault & battery the state on Monday, dealing ‘Those tactics have met with matic recount because the fight to overturn his reelec- State of Oka vs Eric S Grigg “ the latest blow to President numerous court defeats. winning margin is greater tion defeat “probably” won't State of Oka vs Jimmy W Knight Donald Trump's campaign to Trump's personal attorney than the lesser of 200 votes or reach the U.S. Supreme Court, State of Oka vs Jamal R Randall Assault & battery overturn his defeat and leav- Rudy Giuliani is among those 1/10 of 1% of the difference which had been the goal of his State of Oka vs Rickey E Jeffries * ing Wisconsin as the last con- participating in a “fact-find- between the two candidates. legal team. State of Oka vs Robert R Nutt Possession of firearm tested battleground state to ing” meeting on Monday at a There's no provision for a ‘The president and his State of Oka vs Lakota K Reyes Domestic assault & battery formalize its election result. Phoenix hotel with Republi- losing candidate to request a lawyers have also been calling Biden won the state vote, can legislators and supporters recount, according to the sec- for Republican-controlled according to the official can- vass in Phoenix by Secretary to discuss “election irregulari- ties and fraud.” Giuliani was retary of state's office. Arizona legislatures in swing states to Republican Party Chairwoman ignore Biden's popular vote Subscvibevs Like of State Katie Hobbs. The Make the Difference part of a similar meeting last Kelli Ward has said the party victories and name compet- process was overseen by Gov. week in Pennsylvania that intends to file a challenge to ing slates of Trump electors, Doug Ducey, Attorney Gen- featured Trump calling in to the results of the election but several legislative leaders complain without evidence after the canvass is complete. have said that won’t happen $75 eral Mark Brnovich and state $50 Supreme Court Chief Justice that the election was fraudu- ‘The certification proceeded and legal experts say state Robert Brutinel. lent. after a Maricopa County judge legislatures can’t override the ‘The certification marks the Wisconsin is the last dismissed a lawsuit by the Ari- appointment of Biden electors official declaration that Biden contested battleground state zona Republican Party on Nov. after vote certifications. won the state and triggers the left to certify its results. That 19 that sought to force the ‘The U.S. General Services appointment of electors who process is set to begin later state’s most-populous county Administration has acknowl- will cast Arizona's 11 Electoral Monday afternoon after a to complete a hand-recount of edged Biden as the apparent College votes for Biden when recount requested and funded some ballots, despite having winner, and the president they meet on Dec. 14, unless a by Trump’s campaign in two no evidence of voter fraud or called on his agencies to 109 W. Broadway, Elk City court intervenes. It’s yet another loss in ef- largely Democratic coun- ties confirmed Biden's win. software errors, Democrats had accused the state GOP cooperate. That designation triggered a formal transition 580-225-3000 forts by Trump and his allies Pennsylvania, Michigan and to overturn his election defeat Nevada certified Biden’s vic- of trying to make the county miss the state’s certification process, giving the president- elect and his team access www.elkcitynews.com.com