December 14, 2020
Dear Residents and Families,
The purpose of this letter is to communicate updates regarding our covid-19 reporting and the actions we continue to take to combat and protect our community.
On our December 8 update we informed you that we had 5 presumptive positive residents and we were waiting for their PCR test to confirm or deny the rapid positive test. The results took an extended period of time to receive and all 5 presumptive positives were confirmed as positive for Covid. This delay in second results did not change our original course of action, treatment, or residents’ time under transmission-based precautions.
All 5 residents are doing very well.
Between the end of last week and this weekend, we have identified an additional 3 residents who tested presumptive positive utilizing the POC rapid test. All 3 residents were swabbed a second time utilizing the PCR test and these PCR tests have been sent to our epidemiology lab for confirmation.
These 3 residents reside on our B2 unit. All 3 residents are doing well, and their families have been notified.
As a result of these 3 presumptive positive residents on B2, we have initiated transmission-based precautions for all residents on B2.
Consequently, B2 unit is closed to visitation until further notice.
Late last week we were also notified of 2 staff members who tested positive for covid. These 2 employees are home under self-quarantine.
Late last week we lifted transmission-based precautions for residents on the C1 unit. The families of these residents were notified that visitation was now available per the schedule that took effect on November 9.
York county’s positivity rate has increased to a staggering 18%. This means we will continue to test staff twice weekly and residents once per week.
The distribution of the Covid vaccination has begun. A few months back I signed with Walgreens Pharmacy to be our supplier/distributor of the Covid vaccination. Walgreens has been very active in their communication over the last week in preparation of the vaccine distribution. Consequently, over the last few days, I have called all responsible parties to seek verbal consent to administer the Covid vaccination to our residents. There are just a few families I am waiting to hear back from. Even fewer families and/or residents have declined the vaccination at this time.
I will be sending out in the mail 2 documents related to the Covid vaccination. These documents are the Walgreens’ Informed Consent for Vaccination and the Pfizer-BIOTECH Fact Sheet which is included at the end of this update.
I will not need the Informed Consent returned. We have documented all verbal consents and verbal declines. The intent of sharing this document is for transparency and for your knowledge only.
While I am unaware, at this time, which vaccine we will receive, and when, I am posting the Pfizer-BIONTECH Covid-19 Vaccine FACT SHEET at the end of this update.
It is my understanding that the Moderna Vaccination is also shipping to the Commonwealth. If or when I receive a fact sheet on the Moderno vaccination, I will also share this with you.
Since the start of this pandemic and as of 12/14/2020:
· We have 6 active positive covid-19 residents in-house. This is an increase of 2 since last reported. All 6 residents doing well.
· We have 3 presumptive positive residents awaiting PCR results. All doing well.
· We have had 11 residents expire who also had tested positive for Covid. This is an increase of 0 since last reported.
· We have had a total of 44 confirmed positive residents since the start of this pandemic. This is an increase of 6 since last reported.
· We have had 20 positive employees since the start of this pandemic. This is an increase of 2 since last reported.
· 3 employees currently home in self-quarantine due to positive Covid. All doing well.
We have and will continue to test our residents, who show any signs/symptoms. We believe this is in the best interest of our community. We are still very vigilant in our focus to protect and achieve the mitigation that we have achieved previously.
We appreciate your continued prayers and trust in the care and services we provide and for your understanding and support of any necessary adjustments as this situation evolves.
Please feel free to contact me at 717-633-4520 with any questions or concerns.
May God bless us all.
Daniel Pyle, LNHA
Administrator, Hanover Hall
FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 16 YEARS OF AGE AND OLDER
You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19. Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE? WHAT IS COVID-19? COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE? Tell the vaccination provider about all of your medical conditions, including if you: • have any allergies • have a fever • have a bleeding disorder or are on a blood thinner • are immunocompromised or are on a medicine that affects your immune system • are pregnant or plan to become pregnant • are breastfeeding • have received another COVID-19 vaccine
WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE? FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE? You should not get the Pfizer-BioNTech COVID-19 Vaccine if you: • had a severe allergic reaction after a previous dose of this vaccine • had a severe allergic reaction to any ingredient of this vaccine
WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN? The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle. The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.
HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE? The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE? In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: • injection site pain • tiredness • headache • muscle pain • chills • joint pain • fever • injection site swelling • injection site redness • nausea • feeling unwell • swollen lymph nodes (lymphadenopathy) There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include: • Difficulty breathing • Swelling of your face and throat • A fast heartbeat • A bad rash all over your body • Dizziness and weakness These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.
WHAT SHOULD I DO ABOUT SIDE EFFECTS? If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Website Fax number Telephone number www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985
WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE? It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES PFIZER-BIONTECH COVID-19 VACCINE? Currently, there is no approved alternative vaccine available for prevention of COVID-19. FDA may allow the emergency use of other vaccines to prevent COVID-19.
CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER VACCINES? There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING? If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19? No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19. KEEP YOUR VACCINATION CARD When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring your card when you return.
ADDITIONAL INFORMATION If you have questions, visit the website or call the telephone number provided below. To access the most recent Fact Sheets, please scan the QR code provided below. Global website Telephone number www.cvdvaccine.com 1-877-829-2619 (1-877-VAX-CO19)
HOW CAN I LEARN MORE? • Ask the vaccination provider. • Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html. • Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization. • Contact your local or state public health department.
WHERE WILL MY VACCINATION INFORMATION BE RECORDED? The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19
pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
Manufactured by Pfizer Inc., New York, NY 10017 Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-0.7