The world's first mRNA vaccine to defeat COVID-19 is now being distributed after being produced at unprecedented speed as part of the global effort to end the COVID-19 pandemic. Here's what healthcare providers need to know about the COVID-19 vaccine.
What is an mRNA vaccine?
Per the CDC, mRNA vaccines have strands of mRNA inside a special coating that protects the mRNA from enzymes in the body which would otherwise break it down. It also helps the mRNA enter the muscle cells near the vaccination site.
A concern that some have had about the mRNA vaccines is that they could change DNA, but the mRNA vaccine does not enter the nucleus of the cells.
mRNA can most easily be described as instructions for the cell on how to make a piece of the 'spike protein' that is unique to SARS-CoV-2. Since only part of the protein is made, it does not do any harm to the vaccinated person, but it is antigenic.
After the piece of the spike protein is made, the cell breaks down the mRNA strand and disposes of it using enzymes in the cell. The mRNA strand never enters the cell's nucleus or affects genetic material.
Once displayed on the cell surface, the spike protein causes the immune system to begin producing antibodies which means the immune system is primed to protect against future infection.
Provider Agreement
COVID-19 vaccination providers participating in the CDC COVID-19 Vaccination Program are required to sign a CDC COVID-19 Vaccination Program Provider Agreement. Providers are responsible for adhering to all requirements outlined in the agreement. Learn More
Vaccine Preparation and Administration
Per the CDC's instructions, the Pfizer-BioNTech COVID-19 vaccine requires mixing with sterile 0.9% sodium chloride (normal saline, preservative-free). Bacteriostatic normal saline or any other diluent should NEVER be used. Diluent will arrive separate from vaccine in an ancillary supply kit. No other diluent can be used.
The sterile 0.9% sodium chloride (normal saline, preservative-free) cannot be used for multiple doses. You must mix the vaccine using a new vial of diluent and a new vial of vaccine for each administration. You should also discard the diluent vial after mixing the vaccine.
Common Adverse Reactions
The most common adverse reactions reported after vaccination in clinical studies included:
- Pain at injection site (84.1%)
- Fatigue (62.9%)
- Headache (55.1%)
- Muscle pain (38.3%)
- Chills (31.9%)
- Joint pain (23.6%)
- Fever (14.2%)
- Injection site swelling (10.5%)
- Injection site redness (9.5%)
- Nausea (1.1%)
- Malaise (0.5%)
- Lymphadenopathy (0.3%)
Reimbursement
COVID-19 vaccination providers must administer COVID-19 vaccine regardless of the vaccine recipient's ability to pay COVID-19 vaccine administration fees or health plan coverage status. According to recent guidance from the Centers for Medicare and Medicaid Services (CMS), COVID-19 vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient. COVID-19 vaccination providers may not seek any reimbursement, including through balance billing, from the vaccine recipient. Learn More
For more information regarding the Pfizer-BioNTech COVID-19 vaccine, visit the CDC website.
*The above information was compiled from the CDC, CMS, and Harvard Health on December 15, 2020. As COVID-19 is a rapidly-evolving situation, visit the CDC's website for the latest information.
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