Vaccine

It is the U.S. vaccine safety system's job to make sure that all vaccines are as safe as possible. Safety has been a top priority while federal partners have worked to make COVID-19 vaccines available for use in the United States.

The new COVID-19 vaccines have been evaluated in tens of thousands of individuals, who volunteered to be vaccinated and to participate in clinical trials. The information from these clinical trials allowed the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of the vaccines. These clinical trials were conducted according to rigorous standards set forth by FDA.

FDA has determined that the newly authorized COVID-19 vaccines meet its safety and effectiveness standards. Therefore, FDA has made these vaccines available for use in the United States under what is known as an Emergency Use Authorization.

Yes. Clinical trials provide data and information about how well a vaccine prevents an infectious disease and about how safe it is. The Food and Drug Administration (FDA) evaluates the data, along with information from the manufacturer, to assess the safety and effectiveness of a vaccine. FDA then decides whether to approve a vaccine or authorize it for emergency use in the United States.

After COVID-19 vaccines are approved or authorized for emergency use by FDA and recommended for public use, CDC will further assess their effectiveness. These real world assessments will compare groups of people who do and don't get vaccinated and people who do and don't get COVID-19 to find out how well COVID-19 vaccines are working to protect people.

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

Will on going assessments be conducted to determine if the vaccine protects people from severe COVID-19 illness?
Yes. Severe illness from COVID-19 is defined as needing care in a hospital or intensive care unit (ICU), needing to be on a ventilator, or dying due to COVID-19. Experts will assess how well COVID-19 vaccines protect people against severe illness using case-control studies among hospitalized patients. Experts also will use cohort studies of electronic health records to see if people hospitalized with COVID-19 received the vaccine or not.

Will the CDC continue to watch for problems with these new vaccines?

Yes. Even though no safety issues arose during the clinical trials, CDC and other federal partners will continue to monitor the new vaccines for serious side effects (known as adverse events) using many vaccine safety monitoring systems such as, Vaccine Adverse Event Reporting System (VAERS). Additionally, doctors are required to report any adverse reactions to the vaccine.

This continued monitoring can pick up on side effects that may not have been seen in clinical trials. If an unexpected side effect with the new COVID-19 vaccines is seen, experts can quickly study it further to determine if it is a true safety concern. Monitoring vaccine safety is critical to help ensure that the benefits of the COVID-19 vaccines continue to outweigh the risks for people who are vaccinated.

The current vaccine safety system is strong and robust, with the capacity to monitor COVID-19 vaccine safety effectively. Existing data systems can rapidly detect if a vaccine has any possible safety problems. These systems are being scaled up to fully meet the needs of the nation. Additional systems and data sources are also being developed to further enhance safety monitoring capabilities.

Will I have an allergic reaction to the vaccine?
Currently, the Centers for Disease Control and Prevention recommends that anyone with an allergy to "any component" of the Pfizer coronavirus vaccine not get the vaccine.

Those with a history of allergies, however, should consult with their doctor first. A history of severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy is a precaution, but not contraindication, to vaccination.

mRNA vaccines take advantage of the process that cells use to make proteins in order to trigger an immune response and build immunity to SARS-CoV-2, the virus that causes COVID-19. In contrast, most vaccines use weakened or inactivated versions or components of the disease-causing pathogen to stimulate the body's immune response to create antibodies.

mRNA can most easily be described as instructions for the cell on how to make a piece of the "spike protein" that is unique toCOVID-19. Since only part of the protein is made, it does not do any harm to the person vaccinated but it is antigenic (A molecule that is capable of binding to an antibody or to an antigen receptor on a T cell, especially one that induces an immune response).

After the piece of the spike protein is made, the cell breaks down the mRNA strand and disposes of them using enzymes in the cell. It is important to note that the mRNA strand never enters the cell's nucleus or affects genetic material.

How much does the vaccine hurt? Can it make you sick? 
Most people do not have serious problems after being vaccinated. We will understand more about mild side effects of the COVID-19 vaccine before we start to use it. However, your arm may be sore, red, or warm to the touch. These symptoms usually go away on their own within a week. Some people report getting a headache or fever when getting a vaccine. These side effects are a sign that your immune system is doing exactly what it is supposed to do. It is working and building up protection to disease.

How many doses of the vaccine are needed and why?
Nearly all COVID-19 vaccines being studied in the United States require two shots. The first shot starts building protection, but everyone has to come back a few weeks later for the second one to get the most protection the vaccine can offer.

If I already had COVID-19 and recovered, do I still need to get the vaccine when it is available? 
Preliminary research suggests that the vaccine will give you better protection than having had the virus. The CDC recommends that those who have had COVID-19 get the vaccine.

We know it will take some time before every Oregonian who wants to get the vaccine can get their two shots. Oregon Health Authority will follow a phased approach to ensure they provide the first vaccines to critical health care workers who work with COVID-19 patients.

In line with CDC guidance, OHA will be prioritizing frontline health care workers and long-term care residents and employees as the first group to receive the vaccine. This includes our doctors, nurses, janitorial staff, and others who have the potential for direct or indirect contact with COVID-19 patients or infectious materials.

Looking forward OHA has established a COVID-19 Vaccine Advisory Community Council that represents a diverse group of community members to help ensure we distribute the vaccine in a fair and equitable way for all the people of Oregon.

OHA has released guidance for Phase 1. You can view the guidance here: https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le3527.pdf