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Key Points
December 14, 2020
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In today’s Recommendations for Industry, we discuss a new COVID-19 county-level data set for predictive analyses – and address the vaccine question: What does FDA say about the safety of the Pfizer COVID-19 vaccine for those with allergies?
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On Friday, the FDA issued its first Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 Vaccine to be distributed in the U.S. The vaccine is currently on its way to locations around the world. In many locations in the U.S., the first doses will go to healthcare workers.
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This upcoming Friday, Drs. David Acheson & Ben Miller will be rounding up the year with SafetyChain Software for a final FSMA Friday 2020, “Navigating COVID Complexity in 2021 to Stay Resilient,” to discuss up-to-the-minute facts, the truth about vaccines, ways you can minimize disruption, and what to expect from COVID-19 in the new year. Sign up now!
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The CDC will be hosting a “What Every Clinician Should Know about COVID-19 Vaccine Safety” webinar today, Monday, December 14 from 1:00PM – 2:00PM ET, to discuss the safety of the vaccine, including how to enroll people into the vaccine and methods of checking-up on patients, afterward. Register or call-in here.
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As the distribution of the COVID-19 vaccine is underway, the CDC has released on “What to Expect at Your Vaccine Appointment”.
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On Sunday, the CDC updated its list of vaccine-related references. Refer to these resources on the CDC’s website.
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A biotech conference held in February 2020 in Boston, MA, is shown to be tied to more than 300,000 national and international COVID-19 infections, a recent Science article finds.
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While much of the world’s focus has been on COVID-19, with the food industry incorporating a range of worker protections, beneath this, momentum has built in the realm of food-related litigation. Not only were criminal convictions a focus of the USDA FSIS’s most recent quarterly enforcement report, but class-action lawsuits have continued to be of focus with Stericycle Expert Solutions anticipating lawsuits “to pass 2019’s total.” What lawsuits and actions happened in 2020 and what do they mean for you?
Recommendations for Industry
County COVID-19 Data Enables Predictive Analysis
TAG has further developed its COVID-19 matrices to include case rate, test positive rate, modeled effective transmission rate, and mobility data – down to the county level. These data are used to create a standardized county-level "risk-score" that allow for cross-county comparisons.
The data, which are updated on a daily basis, are available from October 2020 through the current date.
Through an analysis of this historical data, businesses can determine when an increase in a county's score might correspond to a rise in workforce illness, absenteeism, or potential supply chain disruptions. Additionally, these county-level scores can be used for prospective analyses looking at increases in absenteeism or supply-chain disruptions.
Following are two examples of the tables and graphics available through county-level data. Contact TAG today for more information!
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Vaccine FAQs
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Q. What does FDA say about the safety of the Pfizer COVID-19 vaccine for those with allergies?
A. FDA states that this vaccine is safe for people with any history of allergies, but not for those who might have a known history of severe allergic reaction to any component of the vaccine.
FDA provides further information in its Fact Sheet for Healthcare Providers administering the Pfizer vaccine under the EUA based on the fact that severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. These include:
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Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
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Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
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In Case You Missed It...
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We are starting a regular COVID-19 Vaccine Q&A to answer your questions and keep you updated as we move into the next vaccination phase of the pandemic.
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In Monday’s Recommendations for Industry, we provide an overview of vaccines along with status of the current COVID-19 vaccines developed or in development. Read the brief below, then link to the paper for the full story.
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As COVID-19 cases in the US top15 million and continue to surge, the CDC put out thoughts on travel related to the upcoming Holiday Travel Season:
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Travel can increase your chance of spreading and getting COVID-19. Postponing travel and staying home is the best way to protect yourself and others.
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You and your travel companions (including children) may feel well and not have any symptoms, but you can still spread COVID-19 to family, friends, and community after travel.
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Don’t travel if you are sick or test positive for COVID-19. Don’t travel with someone who is sick.
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Keep up to date with COVID-19:
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Please send us any questions, comments, and/or concerns! We are happy to talk with you.
OR call us at 1-800-401-2239
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