COVID-19 Vaccine, Comirnaty : Uses, Side Effects, Interactions & More
Comirnaty (Pfizer-BioNTech) coronavirus disease 2019 (COVID-19) vaccine is currently being studied to prevent coronavirus disease 2019 caused by the SARS-CoV-2 virus. There is no FDA-approved vaccine to prevent COVID-19.
Information from clinical trials is available at this time to support the use of Comirnaty COVID-19 vaccine to prevent COVID-19. In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the Comirnaty COVID-19 vaccine. More information is needed to know how well Comirnaty COVID-19 vaccine works to prevent COVID-19 and the possible adverse events from it.
Comirnaty COVID-19 vaccine has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow adults and adolescents 12 years of age and older to receive it.
Talk to your doctor or vaccine provider about the risks and benefits of receiving this medication.
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 (lung) illness, but it can also 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, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.
How is the Comirnaty COVID-19 vaccine given?
The Comirnaty (Pfizer-BioNTech) COVID-19 vaccine will be given to you as an injection into the muscle in 2 doses, given 3 weeks apart. If you receive one dose of the Comirnaty COVID-19 vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.
What should you tell the person who is giving the vaccine?
Tell your vaccine provider about all of your medical conditions, including if you:
- have any allergies.
- have a fever.
- have a bleeding disorder or are taking a blood thinner such as warfarin (Coumadin, Jantoven).
- have a weakened immune system or are on a medicine that affects your immune system.
- are pregnant or plan to become pregnant.
- are breast-feeding.
- have received another COVID-19 vaccine.
- have ever fainted in association with an injection
- have had a severe allergic reaction after a previous dose of this vaccine.
- have had a serious allergic reaction to any ingredient in this vaccine.
What are the benefits of the Comirnaty COVID-19 vaccine?
In an ongoing clinical trial, the Comirnaty COVID-19 vaccine has been shown to prevent COVID-19 after getting 2 doses given 3 weeks apart. How long you are protected against COVID-19 is currently unknown.
What are the risks of the Comirnaty COVID-19 vaccine?
Side effects that have been reported with the Comirnaty COVID-19 vaccine include:
- injection site pain, swelling, and redness
- muscle pain
- joint pain
- feeling unwell
- swollen lymph nodes
There is a remote chance that the Comirnaty 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 Comirnaty 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 Comirnaty COVID-19 vaccine. Serious and unexpected side effects may occur. Comirnaty 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 1-800-822-7967or report online to https://vaers.hhs.gov/reportevent.html. Please include “Comirnaty 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 http://www.pfizersafetyreporting.comor at 1-800-438-1985.
- You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe.
Will the Comirnaty COVID-19 vaccine give me COVID-19?
No. The Comirnaty 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 Comirnaty COVID-19 vaccine. Remember to bring your card when you return.
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.
How can I learn more?
- Ask the vaccination provider.
- Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
- Visit FDA at http://bit.ly/3qI0njF.
- Contact your local or state public health department.
Can I be charged an administration fee for receiving the COVID-19 vaccine?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).
Where can I report cases of suspected fraud?
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
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 year from the date of receiving the vaccine. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427.
The American Society of Health-System Pharmacists, Inc. represents that this information about the Comirnaty COVID-19 vaccine was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that the Comirnaty COVID-19 vaccine is not an approved vaccine for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) to prevent COVID-19 in adults and adolescents 12 years of age and older. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about the Comirnaty COVID-19 vaccine are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about the Comirnaty COVID-19 vaccine is not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.
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Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.