Coronavirus (COVID-19) Vaccine: Information and Updates

Clinical trials are underway to study immune responses to new variants of the SARS-CoV-2 virus as they arise. According to the CDC, all three COVID-19 vaccines authorized by the FDA offer protection against the delta variant. The vaccines are highly effective at preventing severe disease, hospitalization and death. However, no vaccine is 100% effective, and due to the high transmissibility associated with the delta variant, it is still possible for fully vaccinated people to become infected with COVID-19. Learn more about the delta variant and vaccine efficacy.

There are currently three COVID-19 vaccines authorized for emergency use: the Pfizer vaccine for ages 12-15, Moderna and Janssen (Johnson & Johnson) vaccines. All of the vaccines are proven to be nearly 100% effective in preventing severe illness, hospitalization or death from COVID-19.

• Learn more about the Pfizer vaccine.
• Learn more about the Moderna vaccine.
• Learn more about the  Janssen (Johnson & Johnson) vaccine.

EUA stands for Emergency Use Authorization. The FDA evaluates the safety and effectiveness of biologic products (vaccines, blood products and antibodies), drugs (antimicrobial and antiviral treatments and medications) and devices available to the public. In the event of a public health emergency, such as a global pandemic, the FDA can issue EUAs and authorize emergency use of products when their experts determine the benefits justify a shorter process and there are no approved alternatives. To issue an EUA for a product, certain FDA criteria must be met. EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked.

COVID-19 vaccines undergo a rigorous development and review process. The FDA approved the COVID-19 vaccines for emergency use because overwhelming evidence from clinical trials showed the known and potential benefits outweighed the known and potential risks.

In August 2021, the FDA granted full approval to the Pfizer vaccine for individuals ages 16 and over. It is still under EUA for individuals ages 12-15. The Moderna and Johnson & Johnson vaccines are still under EUA for all age groups.

The Food and Drug Administration (FDA) recently granted full approval to the Pfizer vaccine for individuals ages 16 and over.

• Learn more about the Pfizer vaccine.

Before a new drug, treatment or device receives FDA approval, it must goes through a process that includes clinical trials at various phases. The FDA defines products in phase I, phase II or phase III clinical trials as experimental. When a product is in a phase IV clinical trial, it is licensed and approved by the FDA.

Based on the FDA’s regulatory terminology, vaccines are considered experimental or investigational until they receive full approval.

The FDA granted full approval to the Pfizer COVID-19 vaccine in August 2021 for individuals ages 16 and over. This vaccine is no longer considered experimental for this age group. The Pfizer vaccine is still authorized for emergency use for individuals ages 12-15.

The Moderna and Johnson & Johnson vaccines are authorized for emergency use. The FDA authorized the vaccines for emergency use with the safety and effectiveness data from phase I and phase II studies.

Individuals ages 12 – 17 can receive the Pfizer vaccine, which was authorized by the FDA for individuals 12 and older. For individuals under 11 and under, we will continue to follow the guidance from the CDC and offer vaccinations to those appropriate to receive it.

You will be given a choice of vaccine manufacturer based on availability at the time of scheduling. This information may vary from week to week based on the vaccination supply provided to us by the state.

At this time, the state of Wisconsin is not requiring the COVID-19 vaccination for individuals.

Like many other health systems around southeast Wisconsin and the U.S., the Froedtert & MCW health network considers being fully vaccinated against COVID-19 to be a condition of employment. To keep everyone safe, our staff and providers are required to get vaccinated unless they qualify for a medical or religious exemption.

There is currently no data that suggests having an underlying health condition is a reason to avoid getting the vaccine.

In fact, those with an underlying illness or health condition are at an increased risk of developing severe side effects or hospitalization due to COVID-19.

If you have any condition that weakens your immune system, you may not have protection against COVID-19 infection. However, it is safe to receive the vaccine if you are immunocompromised. For instance, if you are infected with HIV, are on immunosuppressive medication, or a transplant recipient, there are no safety concerns but you may not get as strong a protective response.

You should address your individual concerns with your primary medical provider.

Find more information and answers to some common questions about COVID-19 and the vaccine for the following conditions or groups:

• Cancer
• Compromised Immune System
• Transplant

The vaccine is given through one or two shots in the arm, depending on which vaccine you’re given. The Johnson & Johnson vaccine only requires one dose. The Pfizer and Moderna vaccines require a second dose in order for the vaccine to work properly. The second dose will be given approximately 21-28 days after your first dose.

The CDC is now recommending an additional dose of the COVID-19 vaccine for moderately to severely immunocompromised people who have received the initial two doses of the Pfizer or Moderna vaccine.

When scheduling your appointment to get your vaccine with the Froedtert & MCW health network, you will be presented with all options regarding which location and vaccinations we are currently offering. This information may vary from week to week based on the vaccination supply provided to us by the state. 

Yes, you may receive a vaccine if you have already had COVID-19 infection, are not acutely ill, and have met the CDC criteria for discontinuing isolation.

• At least 10 days have passed since symptom onset, and,
• At least 24 hours have passed since resolution of fever without the use of fever-reducing medications, and,
• Other symptoms have improved.

Currently there are no recommendations regarding the minimum time between infection and vaccination. If you have had a prior COVID-19 infection, you may delay vaccination for 90 days after the infection, since reinfection is not common during this time frame.

You can receive COVID-19 vaccines and other vaccines without regard to timing.

You can get a COVID-19 vaccine and other vaccines, including a flu vaccine, at the same time. Experience with other vaccines has shown that the way our bodies develop protection, known as an immune response, and possible side effects after getting vaccinated are generally the same when given alone or with other vaccines.

With flu season upon us, we encourage everyone to get both the flu vaccine and all COVID-19 vaccinations appropriate for them. The COVID-19 and flu vaccines train your immune system to protect you against completely different viruses. Getting a shot that protects you against one virus will not offer any protection against the other.

Vaccine doses will be offered at no cost. There is an administration fee to be vaccinated; however, it is covered by all health insurers. Froedtert & MCW health network will not bill uninsured patients for the administration fee. There will be no out-of-pocket costs to individuals for the vaccine or administration.

If you received your vaccination elsewhere and it is not showing up in your medical record, please check back later. We’re working to get your vaccination records from the state registry and will connect it to your account as soon as possible.

Mild to moderate side effects including fever, body aches and chills may occur in some people who receive a COVID-19 vaccine. Your arm may feel sore at the place where the shot was given for several days afterward.

• Review a complete list of known side effects of the Pfizer vaccine.
• Review a complete list of known side effects of the Moderna vaccine.
• Review a complete list of known side effects of the Janssen (Johnson & Johnson) vaccine.

While vaccines are safe and highly effective in preventing severe illness, hospitalizations and death from COVID-19, everyone should continue to take precautions to keep themselves and others safe. To maximize protection from COVID-19 and its much more transmissible Delta variant, and to prevent possibly spreading it to others, the CDC advises you wear a mask indoors in public if you are in an area of substantial or high transmission.

Masking provides an additional layer of protection for you, those close to you and the community, as well as our patients and staff when you are in our facilities.

Wearing a mask is especially important if you or a member of your household has a weakened immune system, is at increased risk for severe disease or is unvaccinated.

Pay special attention to laws, regulations or local guidance on where you will be required to wear a mask, regardless of vaccine status. This includes places like hospitals, health care settings and schools.

The CDC now recommends that pregnant women, those breastfeeding and those trying to get pregnant, get vaccinated against COVID-19. Pregnant and recently pregnant people are more likely to get severely ill with COVID-19 compared with non-pregnant people. Getting a COVID-19 vaccine offers you the best protection possible. If you have questions or concerns, we recommend talking with your primary care or OB provider.

We do not recommend taking over-the-counter pain medications, such as Tylenol or ibuprofen, before receiving the COVID-19 vaccine as it may alter your immune response. You may take over-the-counter pain medication after receiving the vaccine should you have symptoms such as fever or muscle aches. If you have additional questions regarding your medications, we recommend consulting your primary care provider or physician before scheduling your vaccination appointments.

If you had a recent surgery or have an upcoming surgery, you may still get the COVID-19 vaccine. You should talk with your provider to determine the right time for you to get vaccinated. To avoid any potential side effects that may impact your care plan, we recommend that you get the vaccine at least three days before your surgery or seven days after your surgery. If you are running a fever, your surgery may need to be delayed. We will not delay urgent or emergency surgeries due to vaccination.