FDA Authorization of the Pfizer Vaccine for COVID-19

On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The Pfizer-BioNTech COVID-19 vaccine (the “vaccine”) will be marketed as Comirnaty for the prevention of COVID-19 in persons 16 years of age and older.  The vaccine continues to be available under Emergency Use Authorization (EUA) for use in persons 12 through 15 years of age and for administration of a third dose in certain immunocompromised individuals. This vaccine was developed by a genetic technology called synthetic messenger RNA (mRNA). mRNA vaccines are a new type of vaccine that DO NOT use the live virus that causes COVID-19. These types of vaccines give instructions for cells to make harmless “spike proteins” which are located on the surface of the COVID-19 virus. The immune system recognizes the foreign protein and builds an immune response by producing antibodies.
 
The U.S. government has purchased an additional 200 million doses of the vaccine from Pfizer for delivery from October 2021 through April 2022.  In addition, Pfizer and BioNTech will supply the US government with 500 million additional doses of the vaccine for donation the some of the world’s poorest countries. Distribution of the vaccine will continue to be at the direction of federal and state governments. Patients will incur no out-of-pocket costs for the vaccine, but healthcare professionals may charge an administration fee.
 
While the vaccine has been approved by the FDA for use in patients 16 years of age and older, it should be given in the given in the appropriate setting, in the context of a robust medication safety program, and only after informed consent is provided. Consider the following before administering the vaccine at your organization:
 

• Develop a policy and procedure. Assemble a multidisciplinary vaccine workgroup comprised of representatives from relevant disciplines to develop a policy and procedure for administering the vaccine and to ensure readiness. Consider using the organization’s influenza vaccine policy and procedure as a guide.
• Know the vaccine. Prior to administering the vaccine or any drug, ensure that providers and staff are familiar with the vaccine and its method/route of administration; dosing schedule; patient selection criteria; side effects including potential allergic reactions; warnings and contraindications; and storage considerations. For specific patient and provider information on the vaccine, see the Fact Sheet for Healthcare Providers Administering Vaccine and Fact Sheet for Recipients and Caregivers.
• Follow your state and local health department guidelines. The CDC has posted links to individual state interim jurisdiction COVID-19 vaccination playbook draft executive summaries.
• Administer in an appropriate setting. Administer the vaccine in a setting where it can be stored properly and where there are sufficient numbers of well-trained staff to manage adverse events including severe allergic reactions and to ensure patient safety. If you are considering administering the vaccine in a nontraditional setting such as a curbside clinic or temporary clinic, pay careful attention to screening for contraindications, infection control practices, storage, and preparation of the vaccine and patient/provider safety in this setting. For Centers for Disease Control and Prevention guidance on planning for alternative vaccination sites, see Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations and/or Considerations for Planning Curbside/Drive-Through Vaccination Clinics.
• Adhere to the recommended dosing schedule. Like many other vaccines, the Pfizer vaccine requires that two doses be administered three to four weeks apart. Given the fact that widespread vaccination efforts are underway in many traditional and nontraditional settings, there is concern that patients may be lost to follow-up for the second dose. In addition, some people may experience side effects from the first dose, which may discourage them from receiving the second dose. Massive public health education efforts will help inform people about the vaccine’s side effects and the importance of a second dose. However, individual providers play a vital role in educating patients, gathering accurate and alternate contact information, sending appointment reminders, and implementing a follow-up tracking system to maximize adherence to the vaccine dosing schedule. As always, good documentation of patient education and follow-up efforts is essential. For detailed information regarding vaccine dosing, refer to the Fact Sheet for Healthcare Providers Administering Vaccine and Fact Sheet for Recipients and Caregivers.
• Store the vaccine properly. Pfizer will ship the vaccine in specially designed temperature-controlled thermal shippers that utilize dry ice to maintain temperature conditions of -70oC ± 10oC. These containers can be stored for 15 days by refilling with dry ice. Each shipper will contain a GPS-enabled thermal sensor that will be able to track the location and temperature of each vaccine shipment. Once the facility has received the shipment, it is essential to maintain and document proper storage conditions. For detailed information regarding vaccine storage, refer to the Fact Sheet for Healthcare Providers Administering Vaccine.
• Obtain informed consent. Prior to receiving the vaccine, give the patient or his caregiver the manufacturer’s Fact Sheet for Recipients and Caregivers. The healthcare provider should have a discussion with the patient about the information contained in that document that emphasizes risks, anticipated benefits, and alternatives to the vaccine. The patient should also be advised, and should understand, that the vaccine is not FDA-approved and is investigational. Obtain the patient’s written informed consent. The discussion content, materials provided to the patient as part of the informed consent, and the signed consent form should be documented/preserved in the medical record.
• Report adverse events. Report all vaccination errors and serious side effects related to the vaccine to the Vaccine Adverse Event Reporting System (VAERS) and to the manufacturer.

 
Additional resources:

• The Centers for Disease Control and Prevention. Understanding mRNA COVID-19 vaccines. November 23, 2020. Accessed December 8, 2020.
• For a comprehensive list of resources from the CDC regarding COVID-19 vaccines see: The Centers for Disease Control and Prevention. Vaccines & Immunizations. COVID-19 Vaccination. https://www.cdc.gov/vaccines/covid-19/index.html. Updated December 11, 2020. Accessed December 11, 2020.

Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.