COVID-19 Vaccinations by Ohio EMS Providers...•Produced by several manufacturers with varied...
38
COVID-19 Vaccinations by Ohio EMS Providers Ohio Department of Public Safety, Division of EMS Pfizer®/BioNTech® Edition
COVID-19 Vaccinations by Ohio EMS Providers...•Produced by several manufacturers with varied storage and dosing requirements •Requires two doses to obtain maximum protection •Vaccine
Welcome to the COVID-19 Vaccination for Ohio EMS Providers training module. This edition of the training module is focused on the Pfizer®/BioNTech® COVID-19 vaccine which is the first COVID-19 vaccine that has been approved by the Food and Drug Administration and the Centers for Disease Control and Prevention. As other COVID-19 vaccines are approved by the FDA, additional editions of COVID-19 Vaccinations by Ohio EMS Providers will be available for those specific products.
Mission
Provision of a foundation of knowledge based upon the Ohio EMS scope of practice and the recommendations from our federal and state public health organizations
Presenter
Presentation Notes
The goal of this presentation is to provide a foundation of knowledge based upon the Ohio EMS scope of practice and the recommendations from our federal and state public health organizations. Despite the variations in local or regional protocols and standard operating procedures that may exist, the State Board of Emergency Medical, Fire, and Transportation Services recommends this program, which contains training elements provided by the Centers for Disease Control and Prevention, for the administration of the COVID-19 vaccine by Ohio EMS personnel.
Objectives• Understand the transmission, signs, and symptoms of
Coronavirus Disease 2019 (also known as COVID-19 or SARS-CoV-2)
• Gain knowledge of the types of COVID-19 vaccine available and their respective indications, contraindications, and adverse effects
• Understand the required legal authorization, requirements, limitations, and liability protections regarding administration of immunizations by Ohio EMS providers
Presenter
Presentation Notes
Through completion of this training module, you should gain knowledge regarding signs and symptoms of novel Coronavirus 2019, also known as COVID-19, and how it is transmitted as well as the COVID-19 vaccines available and their indications, contraindications, administration, and adverse effects. You will also learn the legal authorization and requirements that permit Ohio EMS providers to administer the COVID-19 vaccine along with the associated limitations and liability protections.
Objectives• Gain knowledge of the need for partnership between with
local health departments and EMS agencies during a vaccination campaign and their respective roles and responsibilities
• Gain knowledge of the data to be collected and documented prior to, during, and after the administration of a vaccine to a patient
• Note the need for vaccination of healthcare workers as a measure of disease prevention
Presenter
Presentation Notes
We will highlight the need for partnership between local health departments and EMS agencies during a vaccination campaign and their respective roles and responsibilities as well as the data required for the patient’s medical record before, during, and after vaccine administration. As a measure to protect ourselves, vaccination is an effective measure for disease prevention in the healthcare workforce.
Coronavirus Disease 2019 (COVID-19)
•A new strain of Coronavirus never before seen in humans
•Highly contagious•Causes severe acute respiratory syndrome (SARS)•Declared a pandemic by the World Health Organization (WHO) on March 11, 2019
Presenter
Presentation Notes
Coronavirus 2019 is a new strain of the Coronavirus that has never been seen in human beings. As such, this novel virus is frequently referred to as COVID-19 as it causes Coronavirus disease. Coronavirus disease is a highly contagious viral illness that causes severe acute respiratory syndrome, better known as SARS. While the first confirmed case of COVID-19 in the world was noted in November 2018, the first confirmed case in the United States was in January 2019. COVID-19 was declared a pandemic by the World Health Organization on March 11, 2019.
Burden of Disease
CDC Data
INFLUENZAOctober 1, 2019 – April 4, 2020 (estimate)
COVID-19As of December 12, 2020
(One day following FDA approval of the first COVID-19 vaccine)
Illnesses 39 million to 56 million
Cases 15,718,811
Deaths 24,000 to 62,000 294,535
Presenter
Presentation Notes
This is data from the CDC on the 2019 to 2020 influenza season and the COVID-19 pandemic in the United States from the date of the first case in January 2019 until the day after the first COVID-19 vaccine was approved by the FDA. Although the number of illnesses from influenza exceed the number of cases of COVID-19, the number of deaths from COVID-19 is 5 to 12 times greater than deaths from seasonal influenza. The burden of disease, especially in terms of mortality, is significant.
COVID-19: Symptoms•Fever or chills•Cough•Shortness of breath or difficulty breathing
•Fatigue•Muscle or body aches
•Headache•New loss of taste or smell
•Sore throat•Congestion or runny nose
•Nausea or vomiting•Diarrhea
Presenter
Presentation Notes
The incubation period for COVID-19 is 2 to 14 days. The most common symptoms of COVID-19 infection are fever or chills, cough, and shortness of breath or difficulty breathing. Patients often report fatigue, muscle or body aches, headache, or a new loss of taste or smell. Sore throat, congestion, or a runny nose is common. Nausea, vomiting, or diarrhea can also occur especially in the pediatric population.
COVID-19: Transmission
•Airborne transmission via respiratory droplets•Close contact (within 6 feet)•Direct contact with infected surfaces•Asymptomatic carriers •Poorly ventilated or indoor environments
Presenter
Presentation Notes
The COVID-19 virus is transmitted by respiratory droplets. Respiratory droplets can spread long distances making close contact within 6 feet of others an avenue for transmission of disease. The COVID-19 virus is a hearty organism that can survive on surfaces for a longer period of time than most other viruses. Direct contact with surfaces can transmit the virus making frequent handwashing especially important. One of the challenges with COVID-19 is that asymptomatic carriers of the virus are vectors of transmission. Poorly ventilated and indoor environments inherently increase the concentration of virus present in the atmosphere regardless of whether or not the source of infection has symptoms or is completely asymptomatic.
Vaccination Administration by Ohio EMS Providers
•Route of administration is within the Ohio EMS scope of practice for the certificate holder
•Administration is pursuant to medical direction and training on the specific vaccine
•Adherence to the recommendations and instructions of the FDA
Presenter
Presentation Notes
On August 19, 2020, the State Board of Emergency Medical, Fire, and Transportation Services, which is also known as the EMFTS Board, passed a motion to address vaccination administration by Ohio EMS providers. Specifically, the Board recognizes that EMS certificate holders are permitted to administer vaccinations so long as the route of administration is within the scope of practice and the certificate holder administers the vaccine pursuant to medical direction and training on the specific vaccine, which includes adherence to the recommendations and instructions of the Food and Drug Administration.
Declaration of Emergency by the Governor
•Ohio Administrative Code 4765-6-03•Defined parameters or restrictions that may include, but are not limited to:oSpecific pathogen, illness, or other identified threats to public healthoAge of persons to receive the vaccineoOhio EMS certification levels authorized to participateoDuration of declared emergency
Presenter
Presentation Notes
An additional avenue to initiate mass vaccination by Ohio EMS providers is the declaration of an emergency by the Governor due to an event that affects the public health as cited in Ohio Administrative Code 4765-6-03. Declarations of emergency from the governor typically include specific parameters and restrictions in which Ohio EMS providers and public health agencies must follow. These may include, but are not limited to, the specific pathogen, illness, or other identified threats to public health, the age of the persons to receive the vaccine, the Ohio EMS certification levels authorized to participate, and the duration of the declared emergency.
Requirements•Appropriate training for the specified vaccine prior to participating in its administration
•Physician medical direction•Certified Ohio EMS providers may not exceed the Ohio EMS scope of practice authorized by the EMFTS Board regardless of any training and protocols provided by the local EMS medical director
Presenter
Presentation Notes
Regardless of the avenue that initiates vaccine administration by Ohio EMS providers, the basic requirements are the same. Appropriate training for the specified vaccine prior to participating in its administration must be completed, and there must be physician medical direction with the provision of written protocols. It is important to note that certified Ohio EMS providers may not exceed the Ohio EMS scope of practice authorized by the EMFTS Board regardless of any training and protocols provided by the local EMS medical director.
Liability Protections
•Agent or employee of an Ohio EMS agency•Organization or employer that is not an Ohio EMS agency
•Federal declaration of emergency•Medical Reserve Corps (MRC)
Presenter
Presentation Notes
When an Ohio EMS provider administers a vaccine, the liability protection provided depends on how the certificate holder presents himself or herself to the public and the organization under which he or she is functioning at the time. If an Ohio EMS provider is functioning as an agent or an employee of an Ohio EMS agency at the time the vaccine is administered, the liability protections provided by the State of Ohio to certified Ohio EMS providers apply. There are organizations who employ persons who happen to possess an Ohio EMS certificate, but who function in a non-EMS job capacity. In this scenario, the certificate holder should not be presenting himself or herself to the public as an agent of an EMS agency or using the title of the EMS certification as their job title. Since the person providing care in this circumstance is not considered a paramedic or other EMS certificate holder while performing his or her job duties, the employer or supervising medical professional must decide if its personnel are following all health care laws and rules applicable to patient care. Since the State Board of Emergency Medical, Fire, and Transportation Services is not regulating their conduct, the Board cannot authorize any service they are providing and will not exercise any authority over the services that are provided. This also means that the immunity afforded to Ohio EMS certificate holders would not apply in this situation. In the event of a federal declaration of emergency from the U.S. Department of Health and Human Services, the Public Readiness and Emergency Preparedness Act provides immunity for all persons engaged in planning, distribution, or administration of countermeasures, including vaccines, with the exception of reckless or wanton behavior. Legal tort claims, federal or state, cannot be pursued in court. Individuals responding as a member of the Medical Reserve Corps, including EMS personnel, are protected under the Volunteer Act, with the exception of reckless or wanton behavior, and only if the Medical Reserve Corps has been officially requested and activated.
Partnership with Public Health•Local health districts are critical in the determination of:oData collection to identify geographic regions of prevalence and severity of diseaseoAppropriate dosing of vaccinesoAcquisition and storage of medical recordsoPrioritization of available resources to at-risk populationsoPoints of distribution of the vaccine
Presenter
Presentation Notes
Partnership and collaboration between local health districts, EMS agencies, EMS medical directors, and other medical professionals is essential during the development of policies, procedures, and protocols for a mass vaccination campaign. Local health departments play a critical role in the determination of the identification of geographic regions of prevalence and severity of disease, appropriate dosing of vaccines, acquisition and storage of medical records, prioritization of available resources to at-risk populations, and the determination of points of distribution of the vaccine.
COVID-19 Vaccine•COVID-19 vaccine is not made from the Coronavirus•Created with messenger RNA (mRNA)•Produced by several manufacturers with varied storage and dosing requirements
•Requires two doses to obtain maximum protection•Vaccine from other manufacturers are not interchangeable
Presenter
Presentation Notes
In the past, vaccines were manufactured with live, attenuated or partially inactivated formulations of the pathogen that caused the disease. Unlike other vaccines, the COVID-19 vaccine does not contain the COVID-19 virus or any components of the virus. COVID-19 vaccines contain messenger RNA, a manmade virus-like lipid nanoparticle that stimulates body to make antibodies against the virus, but is not capable of causing the infection. The messenger RNA in the vaccine varies by the manufacturer. As such, the storage requirements and dosing requirements and intervals vary. The currently available COVID-19 vaccines require two doses to achieve effective immunization. It is important to remember that the vaccines from other manufacturers are not interchangeable. In other words, the first and second doses of the vaccine administered must be from one manufacturer.
Freezer Storage Requirements Ultracold: -80°C (-122°F) Normal freezer
Freezer Storage Limit 6 months 6 months
Refrigerator Storage Limit 5 days 7 days
Room Temperature Limit 6 hours 6 hours
Efficacy 95% 94%
Time interval for 2nd Dose 21 days 28 days
Presenter
Presentation Notes
Currently, there are two messenger RNA COVID-19 vaccines are being distributed in the United States. Unlike other vaccines that are available, these vaccines were granted Emergency Use Authorization, or EUA, by the FDA. The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radioactive, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. The first COVID-19 vaccine that was approved by the FDA and the CDC is a vaccine that is manufactured by a joint venture between Pfizer® and BioNTech®. The challenge with this vaccine is that it must be maintained during storage and transport at ultracold temperatures at – 80 degrees Centigrade which is – 122 degrees Fahrenheit. Freezers capable of maintaining such low temperatures are not available in every hospital or public health agency and are not routinely positioned at an EMS agency’s station or headquarters. When moved to a traditional freezer, the vaccine will remain stable and effective for 5 days. Once the frozen vaccine is thawed, it must be administered to patients within 6 hours. The efficacy, or the effective immunization rate, is estimated to be 95%. The second dose of the Pfizer®/BioNTech® vaccine should be administered 21 days after the first dose. On the other hand, the vaccine manufactured by Moderna® can be maintained in a traditional freezer at -18 degrees Centigrade during storage and transport. Once the vaccine is thawed, it must be administered to patients within 6 hours. The efficacy of this vaccine has been estimated to be 94%. The second dose of the Moderna® vaccine should be administered 28 days after the first dose.
COVID-19 Vaccination: Prioritized Populations
•High-risk healthcare workers•First responders (including EMS personnel)•Older adults living in congregate or overcrowded settings
•Persons at significantly higher risk due to comorbid or underlying conditions
Presenter
Presentation Notes
As the COVID-19 vaccine becomes available for distribution, there will not be enough of the vaccine to provide immunizations to all of the people who desire to receive it. Until the manufacturers are able to produce enough vaccine to meet the demand, the CDC has collaborated with multiple stakeholders and subject matter experts, including ethicists, to determine which sector of the population should be offered the COVID-19 vaccine first. The prioritized population for the first phase of COVID-19 immunization are healthcare workers who are at high-risk due to patient exposure, first responders which includes EMS personnel, older adults living in congregate or overcrowded settings, and persons at significantly higher risk due to comorbid or underlying conditions.
COVID-19 Vaccine: Considerations•Pfizer®/BioNTech® vaccine: Reported adverse reactions in persons with a history of severe allergic reactions
•COVID-19-positive persons: Advised to defer immunization for 90 days
• Immunocompromised patients•Vaccine safety has not be determined in pregnancy, lactation, and in children less than 16 years of age
Presenter
Presentation Notes
During the COVID-19 vaccine trials, it was noted that the Pfizer®/BioNTech® vaccine caused a small number of allergic reactions that required emergent treatment. These adverse reactions occurred in individuals with a history of severe allergic reactions, especially in those who have required epinephrine for anaphylaxis. For this reason, it has been suggested that persons with a history of severe allergic reactions be immunized with the Moderna® COVID-19 vaccine. All vaccine administrators should be trained and qualified to treat anaphylaxis or a severe allergic reaction. Epinephrine should be readily available at all times. For persons who have tested positive for COVID-19, it has been recommended that receipt of the COVID-19 vaccine be deferred for 90 days due to the unknown interference with vaccine efficacy that the presence of the virus or its antibodies may cause. In immunocompromised patients, the efficacy of the vaccine may be reduced due to the inability or reduced ability of the person’s body to produce or mount an antibody response. Due to the lack of research, the safety of the Pfizer®/BioNTech® COVID-19 vaccine has not yet been established in pregnancy, lactation and the effects on breastfed infants, and in children less than the age of 16 years.
COVID-19 Vaccine Preparation and Administration
Presenter
Presentation Notes
The next section of this training module provides critical information on the preparation and administration of the COVID-19 vaccine.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Storage/Transport Requirements
•Supplied in multi-dose vials of an undiluted preservative-free suspension
•Delivered frozen in a thermal container from the manufacturer
•Cannot be refrozen once thawed
Presenter
Presentation Notes
Tozinameran®, the COVID-19 vaccine that is manufactured by Pfizer® and BioNTech®, is supplied in multi-dose vials that contain an undiluted preservative-free suspension. It leaves the manufacturer’s production site packaged in special thermal containers to maintain the suspension’s temperature as the vaccine suspension cannot be refrozen once it is thawed.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Storage/Transport Requirements•Maintain protection from light until use•Maintenance of frozen state at ultracold temperaturesoUltra-low temperature freezer at -80°C to -60°C
(-112°F to -76°F)oTemporary storage option: Re-icing with dry ice at
-90°C to -60°C (-130°F to -76°F)
Presenter
Presentation Notes
The vaccine suspension is highly photo- and temperature-sensitive. As such, the vials must be protected from light until the vaccine is to be used. The temperature of this vaccine must also be maintained at ultracold temperatures in freezers that are capable of maintaining interior temperatures in the range of -80 to -60 degrees Celsius which is equivalent to a range of -112 to -76 degrees Fahrenheit. Although it should be avoided as possible, a temporary storage option is to repeatedly surround the thermal containers with dry ice to maintain the vaccine at a temperature in the range of -90 to -60 degrees Celsius which is equivalent to -130 to -76 degrees Fahrenheit.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Preparation: Thaw•Under refrigeration at 2°C to 8°C (35°F to 46°F)oSmaller number of vials takes less time to thawoCan be stored in refrigeration up to 5 days (120 hours)
•At room temperature up to 25°C (77°F) for immediate useoCan thaw in 30 minutesoStorage limit is 2 hours
Presenter
Presentation Notes
Tozinameran® must be kept frozen at ultracold temperatures until it is definitely going to be used to vaccinate patients. If the temperature of the vial warms to above -60 degrees Celsius, the vial cannot be refrozen. During the preparation for administration to patients, the vaccine can be thawed by transitioning the vials from the ultracold freezer to a refrigerator that can maintain temperatures from 2 degrees to 8 degrees Celsius which is the equivalent of 35 degrees to 46 degrees Fahrenheit. The time to thaw the contents of the vials varies dependent upon the number of vials being thawed simultaneously. As an example, a carton of vials may take up to 3 hours to thaw where two or three vials will take a much shorter time to thaw. Regardless of the time it takes, once thawed, a vial of vaccine can only be maintained stored in a refrigerator for up to 5 days or 120 hours. For more immediate use, the vials can be safely thawed within 30 minutes at room temperatures up to 25 degrees Celsius which is equivalent to 77 degrees Fahrenheit. Once thawed by this method, the vaccine storage limit is 2 hours.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Preparation: Thawed Suspension•Gently invert the vial 10 times•Do not shake the vial•Contents is a white to off-white suspension possibly with white to off-white amorphous crystals
•Discard the vial if contents are discolored or other particles are seen upon inspection
Presenter
Presentation Notes
In addition to being sensitive to light and temperature, once thawed, the components in the suspension of Tozinameran® are fragile and can be damaged or destroyed by excessive physical force. To correct any settling of the suspension due to gravity, the vial should be gently inverted 10 times. The vial should never be shaken as any vigorous impact of the suspension to the interior of the vial can destroy the critical components of the vaccine. Once the vial has been gently inverted 10 times, the contents of the vial should be visually inspected. The suspension should have a white to off-white color possibly with white to off-white amorphous crystals. The vial should be discarded if the contents are discolored or if other particles are seen during inspection.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Preparation: Dilution•Attach a 21-gauge or smaller needle to a transfer syringe
•Draw up 1.8 mL of 0.9% sodium chloride injection (non-bacteriostatic normal saline) using aseptic technique
•This diluent is not supplied by the vaccine manufacturer
Presenter
Presentation Notes
The suspension of Tozinameran® must be diluted prior to administration to patients. The diluent to complete this step is not supplied by the vaccine manufacturer, and the availability of the recommended solution should be confirmed prior to thawing the vial. As agitation of the suspension can destroy its components, a 21-gauge or smaller needle should be attached to the transfer syringe as injecting through a larger gauge needle carries a higher risk of generating excessive force. The recommended diluent is non-bacteriostatic 0.9% sodium chloride injection which is normal saline that does contain preservatives. Using aseptic technique, 1.8 milliliters of this normal saline should be drawn up into the transfer syringe.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Preparation: Dilution•Cleanse the vial stopper with a single-use antiseptic swab
•Gently add diluent to the vial•Prior to removal of the needle, aspirate 1.8 mL of air into the syringe to equalize the pressure inside the vial
Presenter
Presentation Notes
The stopper of the vial of vaccine should be cleansed with a single-use antiseptic swab. The 1.8 milliliters of diluent should be gently added to the vial. Following the addition of the diluent and prior to removal of the needle, 1.8 milliliters of air should be aspirated into the transfer syringe. The removal of this volume of air equalizes the pressure inside the vial and prevents damage to the fragile components of the vaccine.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Preparation: Dilution
•Gently invert the vial 10 times•Do not shake the vial•The diluted vaccine is an off-white suspension •Discard the vial if contents are discolored or contains particulate matter
Presenter
Presentation Notes
Once the diluent has been injected, the vial should be gently inverted 10 times again to fully mix the diluent into the suspension. Again, do not shake the vial. Upon visual inspection, the diluted vaccine is an off-white suspension. The vial should be discarded if the contents are discolored or if particulate matter is present.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Post-Dilution Procedure
•Record the date and time of dilution clearly on the label of the vial
•Store the vial at 2°C to 25°C (35°F to 77°F)•Discard any unused vaccine 6 hours after dilution
Presenter
Presentation Notes
The date and time of dilution should be recorded clearly on the label of the vial. Following dilution, the vial should be stored at a temperature of 2 degrees to 25 degrees Celsius which is equivalent to 35 degrees to 77 degrees Fahrenheit. Any unused vaccine must be discarded 6 hours after dilution.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Fact Sheet for Recipients and Caregivers
•FDA has authorized the emergency use and this is not an FDA-approved vaccine
•Recipient or their caregiver has the option to accept or refuse the vaccine
Presenter
Presentation Notes
Due to the fact that this vaccine was granted release under the Emergency Use Authorization, there is mandatory information that the Food and Drug Administration requires the vaccination provider to provide to vaccine recipients and their caregivers. The vaccination provider is the agency or individual who has received the vaccine for storage until its use. Typically, this is the public health agency, hospital, or clinic. Nevertheless, the EMS provider may be tasked to convey this information to the vaccine recipient or caregiver on behalf of the vaccination provider. The “Fact Sheet for Recipients and Caregivers” that is available on the Pfizer®/BioNTech® website contains all of the required information, and some vaccination providers will simply provide the patients with a copy of this document. Prior to receiving the vaccine, the individual receiving the vaccine must be informed that the FDA has authorized the emergency use of the vaccine and that it is not an FDA-approved vaccine and that the recipient or their caregiver has the option to accept or refuse the vaccine.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Fact Sheet for Recipients and Caregivers
•Significant known and potential risks and benefits the vaccine and the extent to which such risks and benefits are unknown
•Information about available alternative vaccines and the risks and benefits of those alternatives
Presenter
Presentation Notes
The individual must also be informed of the significant known and potential risks and benefits of the vaccine and the extent to which such risks and benefits are unknown. Lastly, the individual must be informed about the available alternative vaccines and the risks and benefits of those alternatives.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Vaccine Adverse Event Reporting System (VAERS)
•Vaccine administration errors whether or not associated with an adverse event
•Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
•Cases of COVID-19 that result in hospitalization or death
Presenter
Presentation Notes
According to the directives within the Emergency Use Authorization, the vaccination provider is responsible for mandatory reporting to the Vaccine Adverse Event Reporting System (VAERS). The events that must be reported are vaccine administration errors whether or not they are associated with an adverse event, cases of Multisystem Inflammatory Syndrome, also known as MIS, when it occurs in adults and children, and cases of COVID-19 that result in hospitalization or death. Multisystem Inflammatory Syndrome is a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. Symptoms include fever, low blood pressure, abdominal pain, vomiting, diarrhea, neck pain, rash, or fatigue. As an EMS provider rarely, if ever, tracks a hospitalized patient’s course, this mandatory reporting requirement should be the responsibility of the local health district or the healthcare agency serving as the vaccination provider.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Vaccine Adverse Event Reporting System (VAERS)• Serious adverse events (irrespective of attribution to vaccination)o Death o A life-threatening adverse event o Inpatient hospitalization or prolongation of existing hospitalization o Persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions o Congenital anomaly/birth defecto Important medical event that based on appropriate medical judgement may
jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
Presenter
Presentation Notes
In addition, serious adverse events must be reported to the Vaccine Adverse Event Reporting System even if those events are not attributed to the vaccine. These events include death, life-threatening adverse events, inpatient hospitalization or prolongation of an existing hospitalization, and persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. In addition, congenital anomalies and birth defects must be reported as well as any important medical event that, based on appropriate medical judgement, may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes in this list of serious adverse events.
The COVID-19 virus can be transmitted to others by asymptomatic carriers and can survive for a prolonged period of time on surfaces. During the vaccination process, it is imperative to protect all parties present, including the recipient and administrator of the COVID-19 vaccine as maintenance of social distancing within this scenario is not possible. Although not required by the FDA, it is highly advisable that the Ohio EMS provider administering the vaccine wear, at minimum, a face mask at all times although a surgical mask is preferred if available. The FDA and the Ohio Department of Health does not require COVID-19 testing of vaccine administrators prior to participating in a vaccination program; however, the agency that is administering the vaccine may elect to include this action within their policies and procedures. Likewise, the agency that is administering the vaccine may elect to require recipients and others who accompany the recipient to the vaccination site to wear face mask or a surgical mask upon entry to the facility. In an effort to protect all parties from infection, the person administering the vaccine should wash their hands thoroughly with soap and water or an alcohol-based waterless antiseptic before vaccine preparation, following vaccine administration, between patients, or any time the hands become soiled. While some healthcare organizations do not require gloves during the administration of vaccines unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has open lesions on the hands, we recommend that EMS providers wear gloves with each patient contact if they are available. If gloves are worn, they must be changed for each patient. All needlestick injuries should be reported immediately to the site supervisor for appropriate care and follow-up. Safety needles or needle-free injection devices should be used if available. Needles should not be recapped or cut before disposal. All used syringes and needles should be placed in puncture-proof containers, and empty or expired vaccine vials are should be disposed properly.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Vaccine Dosing and Administration•A multi-dose vial contains 5 doses of vaccine•Cleanse the vial stopper with a single-use antiseptic swab
•Using aseptic technique, withdraw 0.3 mL of vaccine from the vial
• Immediately administer the vaccine intramuscularly
Presenter
Presentation Notes
Once diluted, a multi-dose vial of Tozinameran® contains 5 doses of vaccine. To administer the vaccine to a patient, cleanse the vial stopper with a single-use antiseptic swab. Using aseptic technique, withdraw 0.3 milliliters from the vial, which will contain 30 micrograms of the vaccine, and immediately administer it intramuscularly to the patient.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Contraindications•Do not administer the vaccine to persons with a known history of a serious allergic reaction or anaphylaxis to the vaccine components
•Components of this vaccine are mRNA, lipids, potassium chloride, monobasic potassium phosphate, sodium chloride (salt), dibasic sodium phosphate dihydrate, sucrose
Presenter
Presentation Notes
There is one contraindication for Tozinameran® that has been cited by the Food and Drug Administration. This COVID-19 vaccine should not be administered to persons with a known history of a serious allergic reaction or anaphylaxis to the vaccine components. The components of this vaccine are messenger RNA, lipids, potassium chloride, monobasic potassium phosphate, sodium chloride (which is salt), dibasic sodium phosphate dihydrate, and sucrose.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Adverse Reactions• Injection site oPainoSwellingoRedness
Like most medications, including vaccines, Tozinameran® can cause adverse reactions. Adverse reactions are common side effects that are not life-threatening. They should not prevent the vaccine from being offered; however, the patient should be informed of these side effects prior to providing consent to receive the vaccine. The adverse reactions associated with this vaccine are pain, swelling, or redness at the injection site; fatigue, headache, muscle pain, chills, join pain, fever, nausea, malaise, and lymphadenopathy.
Pfizer®/BioNTech® COVID-19 Vaccine(Tozinameran®)
Post-Vaccination Responsibilities• Include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system
•Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of the vaccine
Presenter
Presentation Notes
Following the administration of the vaccine, the vaccine provider must include the vaccination information in the state/local jurisdiction’s Immunization Information System, also known as the IIS, or other designated system that the jurisdiction utilizes as a database. In addition, the vaccine provider must provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of the vaccine. It is imperative to also inform that vaccine recipient that the second dose must be from the same vaccine manufacturer.
COVID-19 Vaccination: Benefits
•Provides protection to you via immunity•Protects the people around you, particularly those at high risk for severe illness from COVID-19
•Effective tool to help stop the COVID-19 pandemic
Presenter
Presentation Notes
The COVID-19 virus has caused an overwhelming number of illnesses and deaths throughout the world, including within the United States, and has placed significant stress upon our EMS systems and healthcare networks. While there are various treatments for this viral infection, there is no definitive cure. Adherence to social distancing, frequent handwashing, wearing a mask, and use of appropriate personal protective equipment prevents the spread of disease. However, none of these measures have the benefits of vaccination. Through immunization, the COVID-19 vaccination provides protection from the disease through immunity. Those who have acquired immunity through vaccination, in turn, protect the people around them, particularly those at high risk for severe illness from COVID-19. As there is no cure for COVID-19, vaccination is a valuable and effective tool to help stop the COVID-19 pandemic.
COVID-19 PandemicImpact on the Ohio EMS Workforce
•Stay home if you feel ill or have symptoms of COVID-19
•Don personal protective equipment•Face mask or surgical mask•Frequent hand washing•Social distancing•GET VACCINATED!!!
Presenter
Presentation Notes
The COVID-19 pandemic has had an impact on our EMS systems on multiple fronts. Sadly, the Ohio EMS community has experienced reductions in its workforce during this pandemic due to COVID-19-related deaths, illness, and unanticipated need to quarantine due to exposure to the others who have tested positive for the virus. There has never been a greater need for all of us to take measures to maintain our workforce by both protecting ourselves and protecting each other. If we do not care for ourselves, it is impossible for us to provide care to others who need care. Stay home if you feel ill or are exhibiting symptoms of COVID-19 infection. Don your personal protective equipment which, in the midst of the COVID-19 pandemic, includes a face or surgical mask. Engage in frequent handwashing and practice social distancing. All of these measures must be implemented at all times within your workplace including all areas outside of the transport vehicles such as time in the station between call responses. Most importantly, get vaccinated!
COVID-19 Vaccinations by Ohio EMS Providers
Ohio Department of Public Safety, Division of EMS
Presenter
Presentation Notes
Thank you for completing the Pfizer®/BioNTech® edition of the educational module for COVID-19 Vaccinations by Ohio EMS Providers. We hope that this program will support the partnership between the EMS workforce and public health agencies during the vaccination of the general public. If you have any questions or need assistance, please feel free to contact the Ohio Department of Public Safety, Division of EMS.
