Efficacy and Safety

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The Center for Disease Control provides educational materials for the vaccines.

Has the vaccine been FDA approved?

  • The vaccine is receiving Emergency Use Authorization (EUA) from the FDA. Under the EUA process, in emergency situations when there are no adequate, approved and available alternatives, the FDA has the authority to authorize medical products for use under specified conditions before all the evidence that would be needed for full FDA approval is available.

What is an Emergency Use Authorization (EUA)?

  • An EUA is a legal mechanism that allows the FDA to authorize the use of a medical product to address public health emergencies if certain statutory criteria and scientific evidence are met. This video provides a brief overview.
  • The FDA will make publicly available all of the data and information regarding emergency use authorization granted to COVID-19 drugs and vaccines.

 

What are the side effects associated with getting the vaccine?

  • It is natural, and expected, for the body to have an immune response to a vaccine.
  • Some people in the clinical trial have experienced side effects, including injection site pain or redness, fatigue, muscle/joint pain and headache.
  • Side effects were more frequently reported after the second dose.
  • Just as you would with other vaccines, those who are immunized will be provided information about the vaccine’s risks and benefits, what to do in the case of an adverse reaction, and where to find additional information. A copy of the Emergency Use Authorization (EUA) will be provided at the appointment, as well as a Vaccine Information Sheet (VIS), as soon as it is available.
  • If you experience common side effects from the vaccine, it is still necessary to receive the second dose, if required, for the Moderna or Pfizer vaccine to be effective.

How do I report side effects?

  • At their appointment, vaccine recipients will be provided information on what to do in case in the case of an adverse reaction. 
  • The CDC is expanding its safety surveillance through the launch of a smartphone-based tool called V-SAFE that regularly collects text and email feedback.
  • For those who do not opt in to V-SAFE, adverse events can be reported in the Vaccine Adverse Event Reporting System (VAERS). VAERS is co-managed by the CDC and the FDA and serves as a national system for collecting and analyzing possible vaccine side effects.
  • If you have questions about symptoms, talk with your doctor or schedule a Telehealth Immediate Care appointment.
  • In the unlikely event of a serious or life-threatening concern, call 9-1-1.

What is V-Safe? Do I have to participate?

  • V-SAFE, or vaccine safety assessment for essential workers, is a smartphone-based text-to-web survey, and email-to-web survey active surveillance program for early vaccine recipients.
  • V-SAFE will perform health checks at two periods after vaccination. In the first week after vaccination, check-ins will occur daily. After that time, weekly check-ins will occur for six weeks following vaccination.
  • The system will provide telephone follow up to anyone who reports medically significant (important) adverse events.
  • Vaccine recipients will be provided details on how to participate in V-SAFE in their After Visit Summary (AVS). It is not required, but is encouraged.