Is the COVID-19 Vaccine Approved by the FDA?
On Aug. 23, 2021, the FDA approved the use of the Pfizer-BioNTech COVID-19 vaccine for those 16 years and older. For those ages 12-15 years old, the Pfizer-BioNTech vaccine continues to have an emergency use authorization.
The Moderna and Johnson & Johnson COVID-19 vaccines remain under emergency use authorization.
What is an Emergency Use Authorization (EUA)?
The Federal Drug Administration (FDA) can allow the use of unapproved medication, vaccines or equipment to help diagnose, treat or prevent different types of health threats to protect the public health. There are still rigorous clinical processes, important health measures and scientific data that support an Emergency Use Authorization. For more information about a EUA, visit FDA.gov.
Are the COVID-19 vaccines safe?
The three vaccines that have been approved or approved for emergency use have been shown to be safe and effective based on clinical trial data with tens of thousands of people of all races, ages and gender. For more information about the safety of the vaccines, visit the CDC website.
There is large amounts of data on the safety of vaccines and clinical data supporting the use of vaccines. As with any medication there is rigorous safety and clinical processes designed to ensure safety and effectiveness. Once a vaccine is approved there are continued clinical studies and other measures in place to monitor the safety and efficacy.
Even after vaccination, continue to wear your face mask indoors, maintain social distance and wash your hands often.
What's the difference between the COVID-19 vaccines?
All the current approved vaccines have been shown to be effective at preventing symptomatic COVID-19. There are a few differences between each vaccine at this time.
- The Pfizer-BioNTech COVID-19 vaccine has been FDA approved for ages 16 years and older. The Pfizer-BioNTech COVID-19 vaccine has an emergency use authorization in individuals 12 -15 years old.
- The Moderna and Janssen (Johnson & Johnson) COVID-19 vaccine have an emergency use authorization in individuals 18 years and older.
Dosage: The dosing scheduling is different for each COVID-19 vaccine.
- The second dose of the Pfizer-BioNTech COVID-19 vaccine is given 21 days after the first dose.
- The Moderna COVID-19 vaccine is given 28 days after the first dose.
- The Janssen (Johnson & Johnson) COVID-19 vaccine is administered as a single dose.
The vaccines have been shown to be effective at preventing symptomatic COVID-19. In clinical trials, the Pfizer-BioNTech COVID-19 vaccine was shown to be 95% effective. The Moderna COVID-19 vaccine was shown to be 94.1% effective. The Janssen (Johnson & Johnson) COVID-19 vaccine has been shown to be 66-85% effective in preventing symptomatic COVID-19, based on severity and the number of days after vaccination.
All of the approved COVID-19 vaccines are shown to minimize your chances of getting infected, becoming very sick and spreading the disease to others. For more information about the COVID-19 vaccines, visit the CDC website.
Is one vaccine better than the others?
There are no head-to-head comparison studies between the three vaccines that have been given emergency use authorization. Clinical trials have proven each vaccine is very effective and safe at preventing severe disease, hospitalization and death related to COVID-19.
What are the side effects of the COVID-19 vaccines?
Each vaccine that have been approved for emergency use have been shown to be safe and effective. Any side effects usually end on their own within a few days. Common side effects that could be experienced are:
- Injection site redness, pain and swelling
- Chills, fatigue, headache, fever, muscle pain
These types of side effects are a sign that your immune system is doing exactly what it is supposed to do—working and building up protection to disease. If you have any questions after your first or second dose of the vaccine, please talk to your primary care doctor or visit the CDC website for information.
Will the vaccine give me COVID-19?
No, the vaccines will not give you COVID-19. The Pfizer-BioNTech and Moderna vaccines use a new type of vaccine using mRNA, not a live or weakened virus. It does not use the SARS-CoV2 virus and will not give you COVID-19. These vaccines work by teaching our cells to make a specific protein or part of a protein that will start an immune response. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our systems.
The Janssen (Johnson & Johnson) vaccine works differently. It is a vector vaccine that uses the adenovirus type 26 to help our bodies develop an immune response against COVID-19. The adenovirus type 26 is a common type of virus that has been modified so that it cannot cause illness.
More information can be found on the CDC website about how the COVID-19 vaccine works.
Should I get the COVID-19 vaccine?
Once the vaccine become available to you, you should consider receiving it. Talk with your doctor and they can help determine if there are any concerns for you based on your medical history. A vaccine can help protect you from getting seriously ill with COVID-19 and also protects those around you, especially those at high risk of serious complications caused by COVID-19.
The vaccine is another tool in our fight against COVID-19. It will remain important that we continue to wear masks, social distance, wash our hands frequently and practice other public health recommendations until it becomes safe again.
Will I still have to wear a mask and social distance if I get the vaccine?
Yes. It takes several weeks after your second COVID-19 vaccine dose for you to be fully protected. Taking precautions like wearing face masks, washing hands frequently and social distancing will help you stay protected. Even after you are fully protected, these steps will continue for some time after to ensure we continue to protect our families, friends and communities.
What’s the difference between a conventional vaccine and an mRNA vaccine?
Most vaccinations available today use a weakened, inactivated or modified virus to initiate an immune response. mRNA vaccines produced by Pfizer-BioNTech and Moderna work differently. They work by teaching our cells to make a specific protein or part of a protein that will start an immune response. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our systems. More information can be found on the CDC website about how the COVID-19 vaccine works.
If I’ve been infected with COVID-19 before, do I need a vaccination?
We do not know if a previous COVID-19 infection provides immunity. More studies will be needed to determine how long immunity lasts from previous infections. For more information, visit the CDC website.
What is the timing for the second dose of the COVID-19 vaccine?
There are two COVID-19 vaccines that have received emergency use authorization that require two doses for maximum protection.
- The Pfizer-BioNTech COVID-19 vaccine second dose is given 21 days after your first shot.
- The Moderna COVID-19 vaccine second dose is given 28 days after your first shot.
At this time, we are following the FDA authorized dosing schedule for the administration of the second dose of the COVID-19 vaccines.
The Janssen (Johnson & Johnson) COVID-19 vaccine is administered as a single shot and does not require a second shot.
I lost my vaccine card, how can I get a copy of my vaccination?
You can get a copy of your record through the Adventist HealthCare patient portal or by visiting Maryland’s Immunization Information System.
I am immunocompromised. Can I get a third shot?
The CDC recommends those that are moderately to severely immunocompromised receive a third shot of the Pfizer-BioNTech or Moderna COVID-19 vaccine at least 28 days after their second dose. The third shot should be the same as your first two shots. This includes those:
- Receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
View more information about COVID-19 vaccines and those immunocompromised from the CDC.
At this time, the CDC does not recommend a third shot or booster to anyone else.