As the region’s trusted health care provider, Penn State Health continues to work in accordance with state and federal agency guidelines to distribute the COVID-19 vaccine to anyone ages 5 and older who wishes to receive it.
Medical experts from Penn State Health provide insight into vaccine development, safety, mRNA vaccines and the COVID vaccine.
Vaccines and safety
- U.S. Food and Drug Administration
- Centers for Disease Control and Prevention
COVID-19 Vaccine FAQs
This FAQ is intended to supplement guidance from the Centers for Disease Control and Prevention, U.S. Food and Drug Administration and the Pennsylvania Department of Health.
FAQs about doses beyond the primary series, third doses and booster doses
What is the difference between a third dose and a booster shot?
A third dose of the Pfizer or Moderna vaccine is part of the primary vaccine series for immunocompromised individual to enhance their antibody response to COVID-19 vaccination. Immunocompromised people ages 5 and older can receive a third dose at least 28 days after their second vaccine.
In contrast, booster shots provide an increase in antibody levels because antibody levels resulting from the primary series wane after several months.
Booster Dose #1: The U.S. Food and Drug Administration (FDA) has authorized a first booster dose for Pfizer and Moderna COVID-19 vaccines given at least five months after completion of the primary series in anyone ages 12 or older. The CDC endorsed the FDA’s decision and encourages all who are eligible to get their first booster shot, if they have not done so already.
For Johnson & Johnson’s Jansen COVID-19 vaccine, a first booster dose can be administered at least two months after the first dose of the Jansen COVID-19 vaccine to anyone over the age of 18. However, the CDC no longer recommends that people receive the Johnson & Johnson Jansen vaccine due to the risk-benefit ratio.
Booster Dose #2: The FDA has authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine for populations at higher risk for severe disease, hospitalization and death, including people ages 50 and older as well as individuals ages 12 and older who have compromised immune systems. The second booster doses can be administered at least four months after receiving the first booster dose of any COVID vaccine.
Mix-and-Match Boosters: The FDA has also authorized the use of a heterologous - “mix and match” - booster dose for the three currently available COVID-19 vaccines: Pfizer-BioNTech, Moderna and Johnson & Johnson’s Janssen COVID-19 vaccines. As an example, this means that eligible persons who initially received Johnson & Johnson’s Jansen COVID-19 vaccine may, after two months, receive a booster dose of the Pfizer, Moderna or Jansen COVID-19 vaccine.
Who is eligible for a third dose?
The Centers for Disease Control and Prevention (CDC) recommends that people with moderately to severely compromised immune systems receive third doses to ensure adequate protection against COVID-19. Not only are these individuals especially vulnerable to the illness, the two-dose series of the mRNA vaccines may not provide them with the same level of protection as it does for those who are not immunocompromised. Patients can receive a third dose 28 days after their second.
How can I get a third dose?
Penn State Health patients may call their primary care provider’s office to schedule an appointment in their doctor’s office or another Penn State Health primary care location. Additionally, anyone eligible can visit vaccines.gov to find where they can schedule a third dose.
Who is eligible for a booster shot?
The Centers for Disease Control and Prevention has recommended that anyone ages 12 and older get a booster shot five months after their initial vaccination series of either the Pfizer or the Moderna vaccine.
Previously, the U.S. Food and Drug Administration had granted emergency use authorization for booster shots for anyone age 18 and over who received the Johnson & Johnson’s COVID-19 vaccine to be administered at least two months after vaccination.
How can I get a booster shot?
Patients should visit vaccine.gov to review eligibility for a booster shot. Penn State Health patients may call their primary care provider’s office to schedule an appointment in their doctor’s office or another Penn State Health primary care location. Additionally, anyone eligible can visit vaccines.gov to find where they can schedule a booster shot.
FAQs about Evusheld
What is Evusheld?
Evusheld is a combination of two monoclonal antibodies - tixagevimab and cilgavimab - designed to prevent COVID-19 infection in vulnerable and immunocompromised individuals. Because a vaccination may not generate enough immune response in immunocompromised patients, they are still vulnerable to severe infection. Evusheld is a protective measure that provides additional immunity to help prevent COVID-19 in these high-risk patients.
Evusheld, which received emergency use authorization from the U.S. Food and Drug Administration in December 2021, does not replace vaccination against COVID-19 and is not given as treatment to patients who have COVID-19.
See the Fact Sheet for Patients, Parents and Caregivers for more information about this monoclonal antibody, particularly if you are eligible or are preparing to receive this treatment.
How is Evusheld administered?
Evusheld - a combination of two monoclonal antibodies - is given in two consecutive, intramuscular injections, most likely in the gluteal medius (buttocks), during the same visit. Penn State Health is currently administering Evusheld in a limited number of infusion areas due to the need to monitor patients for one hour after the medication is administered.
Who is eligible for Evusheld?
Evusheld is intended for individuals who may not generate enough immune response to COVID-19 vaccination. These patients often have specific risk factors or medical comorbidities that additionally put them at high risk of developing severe COVID-19 illness. The U.S. Food and Drug Administration established the following criteria that patients must meet to receive Evusheld:
- Adults and children ages 12 years and older, weighing at least 40 kilograms (88 pounds), who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2, and:
- Who are moderately to severely immune compromised due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, or
- For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Patients who are interested in receiving Evusheld are encouraged to reach out to their doctor to determine their eligibility and schedule their appointment.
How can I get Evusheld?
Penn State Health patients who think they may be eligible to receive Evusheld can reach out to their doctor to determine their eligibility and schedule their appointment. Most appointments will be scheduled at a Penn State Health infusion center, although some providers are offering Evusheld in their clinics.
FAQs on vaccine safety
Are the mRNA vaccines safe?
It’s important to know that all of the steps necessary to bring a vaccine to the public have been followed for the Food and Drug Administration (FDA) authorized and approved COVID-19 vaccines. These vaccines have undergone the most intensive safety monitoring in U.S. history - no regulatory steps were skipped. These vaccines were able to be developed so quickly because scientists had a head start due to working on vaccines against two closely related coronaviruses: SARS and MERS. Scientists had also studied how to design platforms to make a new vaccine rapidly available. For example, mRNA vaccines have been studied over several decades against other viral infections, including Zika and influenza (flu). This type of vaccine introduces a small piece of mRNA into a person’s cells which instructs the cell to make a viral protein. Their body then makes an immune response to this protein and this protects them from serious illness. The mRNA is not incorporated into a person’s DNA and is inactivated in a couple of days. The Moderna and Pfizer/BioNTech vaccines each utilize this technology.
The vaccines went through rigorous testing prior to receiving Emergency Use Authorization (EUA) from the FDA. The EUA allowed the vaccines to be disseminated rapidly to stem the pandemic while the FDA completed additional steps to fully approve the vaccines. While under EUA, rigorous safety monitoring was conducted and over 217 million people in the U.S. have now been fully vaccinated according to the Centers for Disease Control and Prevention. Significant side effects have been exceedingly rare. In pregnant women receiving the vaccine, there is no evidence for increased risk of miscarriage or harm to the fetus. Similarly, fertility is not affected by COVID-19 vaccination. The FDA approved the Pfizer vaccine on Aug, 23, 2021, and the Moderna vaccine on Jan. 31, 2022.
You can find more detailed information on the vaccines:
- Pfizer-BioNTech COVID-19 vaccine fact sheet for recipients and caregivers
- Moderna COVID-19 vaccine fact sheet for recipients and caregivers
- Single-Shot Janssen COVID-19 vaccine from Johnson & Johnson
- *Note: The CDC no longer recommends that people receive the Johnson & Johnson Jansen vaccine due to the risk-benefit ratio.
- What to expect after getting a COVID-19 vaccine
What happens if I have a side effect from the vaccine?
Vaccines cause an immune response in the body which can sometimes cause flu-like symptoms such as body aches or even fever, chills and a headache. An immune response may be more likely to occur with the second dose of the Pfizer or the Moderna vaccine. Vaccinations with the Johnson & Johnson vaccine require only one dose.
Learn about the difference between a vaccine side effect and an adverse event.
The Centers for Disease Control and Prevention and the Food and Drug Administration encourage the public to report possible side effects (called adverse events) to the Vaccine Adverse Event Reporting System (VAERS) external icon. The CDC also has a new smartphone-based tool called v-safe to check in on people’s health after they receive a COVID-19 vaccine. When you receive your vaccine, you will receive a v-safe information sheet telling you how to enroll in v-safe. The CDC offers guidance related to side effects here.
What is an emergency use authorization (EUA)?
An Emergency Use Authorization, or EUA, allows the use of unapproved medical products in response to a declared public health emergency where there are no adequate, approved and available alternatives. An EUA for a COVID-19 vaccine allows vaccine distribution in the U.S. without a full FDA approval.
FAQs about pregnancy and other preexisting conditions
I have a preexisting health condition. Is it safe for me to have the vaccine?
Studies to date indicate the COVID vaccines have high rates of effectiveness and safety among all age groups (ages 12 and older) and demographics, with a very low rate of serious side effects including in people with a variety of pre-existing health conditions. Discuss your individual health history and concerns with your primary care provider to help you make an informed decision.
Can I get the COVID-19 vaccine if I’m pregnant? If so, does it matter what trimester I’m in?
Pregnancy is a known risk factor for severe COVID-19. The Centers for Disease Control and Prevention (CDC) states that women who are pregnant or were recently pregnant are more likely to get very sick from COVID-19 compared to those who are not pregnant. Additionally, women who have COVID-19 during pregnancy are at an increased risk of complications that can affect their pregnancy and developing baby. Both the CDC and the American College of Obstetricians and Gynecologists recommend that pregnant and lactating individuals be vaccinated against COVID. Clinical studies have shown that the vaccine is safe during pregnancy.
Does the COVID-19 vaccine represent any risk to fertility for women of child-bearing age?
There is no data to suggest that the vaccine has an effect on fertility. The COVID vaccine is recommended for women of childbearing age. If a woman becomes pregnant after the first dose, the second dose is recommended to be given per the usual recommendations. According to the CDC, women who are trying to become pregnant do not need to avoid pregnancy after receiving an mRNA COVID-19 vaccine. While studies are ongoing, there is no data that the COVID-19 vaccines may cause infertility and no credible scientific theories for how the COVID-19 vaccine may cause female infertility.
Can breastfeeding women receive the vaccine?
Per the CDC, there are no data on the safety of COVID-19 vaccines in lactating women or on the effects of mRNA vaccines on the breastfed infant or on milk production and excretion. mRNA vaccines are not thought to be a risk to the breastfeeding infant. Women who are breastfeeding may choose to be vaccinated.
The American College of Obstetricians and Gynecologists also provides guidance on COVID-19 vaccination in pregnant and lactating individuals.
FAQs about duration of effectiveness against infection and illness
Do the vaccines work to prevent COVID-19 disease and infection? Do I need a booster?
The COVID-19 mRNA vaccines remain very effective at preventing hospitalization, severe disease and death, which is what they were designed to do. However, these vaccines are less effective at preventing infection currently because the viral variant Omicron has the ability to escape from immunity developed by vaccination as well as immunity from previous infection.
New data released by the Centers for Disease Control and Prevention on Jan. 21 showed that a first booster dose of an mRNA vaccine is highly effective - 82% - at preventing COVID-19-associated emergency department and urgent care encounters and 90% effective at preventing COVID-19-associated hospitalizations. Because of these data, Penn State Health strongly recommends that everyone who is eligible for a booster should receive it as soon as possible.
The FDA has authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine for populations at higher risk for severe disease, hospitalization and death, including people ages 50 and older as well as individuals ages 12 and older who have compromised immune systems. The second booster doses can be administered at least four months after receiving the first booster dose of any COVID vaccine.
For specific data, guidance, side effects and more, please see the U.S. Food and Drug Administration’s fact sheets on the three COVID-19 vaccines:
- The Pfizer-BioNTech vaccine
- The Moderna vaccine
- Single-Shot Janssen COVID-19 vaccine from Johnson & Johnson*
*Note: The CDC no longer recommends that people receive the Johnson & Johnson Jansen vaccine due to the risk-benefit ratio.
If I get the vaccine, can I still be infected? How long does the vaccine protect me?
Studies have shown that the effectiveness of the COVID-19 vaccines does decline over time. The Centers for Disease Control and Prevention (CDC) recommends that everyone ages 18 and older to get a booster shot either five months after their initial Pfizer or Moderna series, or two months after their initial Johnson & Johnson’s Janssen vaccine. The CDC recommends that children ages 12–17 get a booster dose of the Pfizer vaccine at least five months after their initial series of vaccines. The CDC no longer recommends that people receive the Johnson & Johnson Jansen vaccine due to the risk-benefit ratio.
If I already had COVID-19, do I need the vaccine? Don't I have immunity?
Natural immunity from previous infection does not protect against reinfection from the Omicron variant compared to previous viral strains.
It is recommended that those who have COVID-19 get the vaccine, including a booster, to ensure that they have a more reliable, high level of protective immunity to prevent reinfection and serious illness. You should wait to get vaccinated or boosted until you are out of isolation from COVID infection. Checking antibodies against COVID is not necessary or recommended.