Answering Your Questions About the COVID-19 Vaccine
Sanford Health is ready when a COVID-19 vaccine gets approved. We are closely monitoring the development of several COVID-19 vaccines and actively planning for distribution once they become available. Ensuring the safety of any COVID-19 vaccine is our highest importance.
The Vaccine Approval Process
States will only distribute a COVID-19 vaccine if approved by the U.S. Food and Drug Administration (FDA) and/or through an Emergency Use Authorization (EUA). Any FDA or EUA approved COVID-19 vaccine will have clinical study data completed that has confirmed the effectiveness and safety of the vaccine for patients.
While the exact timing of an approved vaccine is still unknown, the Centers for Disease Control and Prevention (CDC) has asked each state to prepare plans for potential distribution. An initial COVID-19 vaccine by Pfizer may be available as early as December and will most likely be prioritized for critical populations, including front-line health care workers and long-term care workers. Once enough doses are available, they will be given to the general population as soon as possible.
Resources to learn more:
Understanding Emergency Use Authorization (EUA)
Public Health Emergency
Through an EUA, the FDA permits the use of an unapproved medical product, like the COVID-19 vaccine, when specific criteria are met and no alternative is available.
Declaring an EUA
An EUA allows for rapid, widespread distribution of a medical product or treatment to people across the U.S. before gaining full approval from the FDA during a public health emergency.
Duration of an EUA
An EUA lasts only for the duration of the declared emergency; however, the FDA can revise or revoke an EUA if found to be unsafe or ineffective at any time. If formal FDA approval is received, the EUA is removed.
To achieve EUA approval, the vaccine is independently evaluated to ensure it is safe and effective by the Vaccine and Related Biological Products Advisory Committee (VRBPAC) and CDC.
Research study data shows the COVID-19 vaccine is safe and effective on patients in long-term research studies, called phase III clinical trials.
FDA Full Approval
Research study data has proven the COVID-19 vaccine’s benefits outweigh any known or unknown potential risks and is effective at building immunity safely.
COVID-19 Vaccine FAQs
Why get vaccinated?
Vaccines help keep you healthy by reducing your chance of being infected by a serious or deadly virus. They use your body’s natural defense system (immune system) to help you safely develop immunity against a disease. Plus, vaccines protect you when you get vaccinated as well as others in your family and community by stopping the spread of diseases.
What is known about the COVID-19 vaccines in development?
Multiple COVID-19 vaccines are currently under development in the U.S., with four in large-scale clinical trials (phase III) as of Oct. 13, 2020. All but one of these vaccines require a two-shot series, which means you will need two shots at two separate times to get the full benefits of the vaccine.
Will the COVID-19 vaccine be safe?
Ensuring a COVID-19 vaccine is safe and effective is the top priority before it receives authorization or approval for widespread public use. A COVID-19 vaccine must have approval from the U.S. Food and Drug Administration (FDA) and/or through an Emergency Use Authorization (EUA) before being distributed within each state. To achieve approval, each COVID-19 vaccine will have research data completed that confirms it is safe and effective for patients.
Do I need to get the COVID-19 vaccine if I have already had and recovered from COVID-19?
At this time, there are no clear recommendations on whether people who have recovered from COVID-19 need to be vaccinated. Once a COVID-19 vaccine has been approved, we will know more and be able to provide clearer guidelines.
There is currently not enough information available to know how long someone who has recovered from COVID-19 is immune. Early evidence suggests that immunity from COVID-19 does not last long term, but more research will be needed to know for certain.
Will everyone be vaccinated against COVID-19 at one time?
While the exact timing of an authorized or approved COVID-19 vaccine is unknown, the Centers for Disease Control and Prevention (CDC) has asked each state to prepare plans for potential distribution. A vaccine by Pfizer may be available as early as December 2020.
At first, the COVID-19 vaccine will likely be given to certain groups at higher risk of infection, including front-line health care workers and long-term care workers. Once enough doses are available for everyone, the vaccine will be distributed to the general population.
Every effort is being made by the federal government and states to quickly make and distribute COVID-19 vaccines across the country. The goal is to ensure everyone can receive the COVID-19 vaccine as soon as large quantities are available. Sanford Health and other health care systems are partnering with states to ensure patients do not have to travel far to receive this lifesaving vaccine.
What does it take to reach herd immunity?
When a virus cannot spread because a large portion of the community is protected against it, this is called herd immunity. To achieve herd immunity, the majority of the population needs to be vaccinated against a virus. This protects those who are vaccinated as well as people who are unable to receive the vaccine or who do not respond to a vaccine, such as someone with a compromised immune system or an allergy to ingredients in the vaccine.
What can I do now to prevent getting COVID-19 since a vaccine is currently unavailable?
Stopping a global pandemic takes everyone working together. You can help prevent getting and spreading COVID-19 by wearing a mask to cover your mouth and nose when you are around others, practicing social distancing, covering your mouth when you cough or sneeze, washing your hands often, avoiding touching your face, and staying home when you are sick or have symptoms.