COVID-19 Vaccine

How does the vaccine work to protect you against COVID-19?

• Both Pfizer and Moderna are manufacturing a vaccine using messenger ribonucleic acid (mRNA). mRNA is naturally found in humans; its role is to deliver instructions from DNA to cells about which proteins the cell needs to create. 
• The mRNA in the vaccine teaches the cell to make the virus’s spike protein – the main protein that is recognized by the body during the immune response. The body then produces antibodies against the virus’s spike protein. Those antibodies are then able to recognize the SARS-CoV-2 virus that causes COVID-19 if the recipient comes into contact with the virus and can more effectively clear the virus from the body and prevent severe infection.

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Did this vaccine go through a clinical trial?

• Yes. Operation Warp Speed is an effort to develop vaccines and therapeutics quicker than would normally be possible by running the three phases of these clinical trials in an accelerated time frame. The vaccine companies also start manufacturing on a large scale before the studies are done, betting that the vaccine will be effective. All the vaccines go through the normal steps, just in a much faster process, made possible, in part, by the large number of participants in each trial. 
• This six-minute video and the illustration below further explain these points.

How many people received the vaccine during the trials?

• The Pfizer vaccine study enrolled 43,538 participants. The Moderna vaccine study enrolled 30,000 participants.

What is the efficacy of the vaccines being considered for emergency use?

• Both vaccines were found to have an approximately 95% efficacy against developing serious COVID-19 disease after two doses were received. 

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 the data and information regarding EUA granted to COVID-19 drugs and vaccines.

Can I still get COVID-19 even if I am vaccinated?

• Possibly. The vaccine trials examined whether the vaccine prevented serious disease. You may be able to be infected and develop a more mild disease or an infection without symptoms, and you may be able to spread the virus. Additional studies are looking at both questions. 

This vaccine was developed in record time. Is it safe? 

• The vaccine is deemed to be safe based upon a rigorous evaluation of currently available scientific evidence. The most common reported adverse events were headaches, pain at the injection site, fatigue and a general feeling of unwellness. 

Has the vaccine been approved by the Food and Drug Administration (FDA)?

• 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.

Johnson & Johnson Vaccine FAQs

The Centers for Disease Control & Prevention and the Food and Drug Administration issued a recommendation to pause administration of the Johnson & Johnson single-dose COVID-19 vaccine out of an abundance of caution related to blood clot disorders. 

Why is administration of the Johnson & Johnson vaccine being halted?

The CDC and FDA report that as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. The CDC and FDA are reviewing data involving six reported cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine, which resulted in one death and one critical illness.

In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant (blood thinner) drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14, 2021, to further review these cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases. Until that process is complete, the agencies are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.

Additionally, Gov. DeWine has called for a pause in distribution of all Johnson & Johnson vaccines until the federal agencies can offer additional guidance.

What should I do if I got a Johnson & Johnson vaccine?

Anyone who has received the shot more than a month ago is outside of the window when these complications have occurred. As with all vaccines, it is important to monitor oneself for any adverse reactions after a shot and seek medical attention at the DeWeese Health Center or from your healthcare provider if a reaction occurs.

Any students with concerns about the Johnson & Johnson vaccine should reach out to University Health Services with their questions.

How would I know if  I am developing a blood clot?

The most common type of blood clot is in the leg, known as deep vein thrombosis. Cerebral venous sinus thrombosis is rare and symptoms are severe headache and other neurological symptoms. Other symptoms of blood clots be severe abdominal pain, leg pain, or shortness of breath. These likely would occur within three weeks after vaccination. Anyone experiencing these symptoms should contact their health care provider.

Why was Kent State University Health Services giving out the Johnson & Johnson shot?

The vaccines were provided to Kent State and numerous other universities in Ohio as part of a program developed by Ohio Gov. Mike DeWine to vaccinate as many college students as possible before summer break. The goal of this vaccine push was to stop the spread of COVID-19 by college students as they departed their campuses for the summer. Gov. DeWine has expressed his confidence that the Johnson & Johnson vaccine, after its review, will once again be used as an key part of Ohio’s vaccination plan.

Is this a concern for the other COVID-19 vaccines?

These side effects have not been seen with either the Moderna or Pfizer brand vaccines, which require two doses to be fully effective.

These complications are similar to ones seen with the Astra-Zeneca vaccine, which has not yet received FDA approval for emergency use in the U.S. However, is has been approved for use in other countries.

Will the Kent State vaccination clinics restart?

At this point, we don’t know. We will not distribute any additional Johnson & Johnson shots until the CDC and FDA offer additional guidance.

How else can I get a COVID-19 vaccine?

The state vaccine registration portal offers links to vaccine distribution sites throughout Ohio, including the vaccine clinics being offered by the Portage County Combined General Health District at the Kent State Field House on Tuesdays.

Students who had registered with University Health Services to receive the Johnson & Johnson vaccine at clinics at the ice arena on the Kent Campus will be contacted via email with an alternative place to receive a vaccine. Some regional campuses may have alternative vaccinations, including Moderna or Pfizer, to offer their students through health departments in their respective counties.

What should I do if I experience anxiety from this situation?

Kent State provides the following mental health support resources to our community members who may be in need:

• Step Up and Speak Out
• Wellness Resource Guide
• Counseling and Psychological Services

Additional COVID-19 Vaccine FAQs

Who is eligible to receive the vaccine?

• Currently in Ohio, vaccines are being provided to selected priority groups based on guidelines established by the state. As of March 29, all Ohioans age 16 or older will be eligible to receive a vaccine. If you are eligible to receive the vaccine through a COVID-19 vaccine provider in Ohio now or in the future, you are strongly encouraged to get it.
• Prioritization is guided by general principles and requirements set forth by federal and state governments. There will be phased groupings with high-risk individuals, including front-line healthcare workers and first responders in the initial phase.

If I had a positive COVID-19 test previously or have had a positive antibody test, should I still get the vaccine?

• Yes. Due to the severe health risks associated with COVID-19 and the fact that reinfection with COVID-19 is possible, you should be vaccinated regardless of whether you already had a COVID-19 infection. The Centers for Disease Control and Prevention (CDC) has stated that individuals who have had a diagnosed COVID-19 infection should still get the vaccine but suggests waiting 90 days post-illness.

Is it safe for me to get a COVID-19 vaccine if I would like to have a baby one day?

• According to the CDC, if you are trying to become pregnant now or want to get pregnant in the future, you may receive a COVID-19 vaccine when one is available to you.
• There is currently no evidence that COVID-19 vaccination causes any problems with pregnancy, including the development of the placenta. In addition, there is no evidence that fertility problems are a side effect of any vaccine, including COVID-19 vaccines, according to the CDC.
• Like all vaccines, scientists are studying COVID-19 vaccines carefully for side effects now and will continue to study them for many years.

If I am breastfeeding or pregnant, can I still get the vaccine?

• Manufacturers that are testing the vaccines in clinical trials so far have not included pregnant women or women who are breastfeeding. 
• Many individuals in these situations historically have not been studied in clinical trials and still receive vaccines. 
• The American College of Obstetricians and Gynecologists has stated that the vaccine should be available to pregnant and breastfeeding women if they choose to get it.

How many shots will I need to get? 

• Two doses of the COVID-19 vaccine separated by 21 or 28 days are required (as specified by the manufacturer).
• The COVID-19 vaccines are not interchangeable; recipients must receive the vaccine made by the same manufacturer for each dose. In the future, it is expected that additional manufacturers and guidelines will be available, including the potential for single-dose vaccines. 

If I choose not to get the vaccine right away, can I get it later if I change my mind?

• Yes. Once your group becomes eligible to receive the vaccine, you may receive it at any time, even if other groups become eligible. 

Should I get the vaccine if I am not feeling well?

• If you are not feeling well, it is recommended that you wait until you are feeling better to get the vaccine. If you have scheduled an appointment to receive the vaccine and are not feeling well on the day of vaccination, you should cancel and reschedule at a later date. 
• If you have a fever (100°F or greater), it is not safe to receive any vaccine.

What is the cost of the vaccine? 

• The government is providing the vaccine free of charge, and health plans are required to cover the cost of administration.

If I have had an allergic reaction to a vaccine in the past, should I still get the vaccine? 

• There is a remote chance that there could be a severe allergic reaction to the COVID-19 vaccine, which could include difficulty breathing, swelling of the face or throat, fast heartbeat, rash, dizziness and weakness.
• You should not get the vaccine if you had a severe allergic reaction to a past dose of a COVID-19 vaccine or any of the ingredients in the COVID-19 vaccine. 
• The CDC recommends a 15-minute observation period following vaccination for every person. People who have had severe allergic reactions or who have had any type of immediate allergic reaction to a vaccine or injectable therapy should be monitored for at least 30 minutes after getting the vaccine.

Is this vaccine like the flu vaccine? Will I need to get vaccinated again next year? 

• The world is still learning how long immunity to the coronavirus lasts after a vaccination. Intensive monitoring and evaluation will continue after the vaccines are in use to determine if repeat immunizations will be needed.

Would there be any problems if I were to get the COVID-19 vaccine and the flu vaccine at the same time or in close proximity to one another?

• The CDC recommends that people wait at least 14 days before getting any other vaccine, including a flu or shingles vaccine, if you get your COVID-19 vaccine first. If you get another vaccine first, wait at least 14 days before getting your COVID-19 vaccine. If a COVID-19 vaccine is inadvertently given within 14 days of another vaccine, you do not need to restart the COVID-19 vaccine series; you should still complete the series on schedule. When more data is available on the safety and effectiveness of COVID-19 vaccines administered simultaneously with other vaccines, the CDC may update this recommendation.

Will university students, faculty and staff be required to receive a vaccine? 

• The COVID-19 vaccine will not be required at this time. The university will revisit this topic as more evidence accumulates regarding the longer-term safety and effectiveness of the vaccines and the vaccines are widely administered and available to all, and fully approved by the FDA. 
• Wearing face coverings, handwashing and physical distancing will continue to be a defense against the virus.

What are the side effects of the vaccine?

• The most common reported adverse events were headaches, pain at the injection site, fatigue and a general feeling of unwellness. 

Should I come to work if I experience side effects? 

• Some people in the clinical trial have experienced injection site pain or redness, fatigue, muscle/joint pain, headache and fever. These side effects may be more likely after the second dose of the vaccine. It is OK to come to work with very minor symptoms. All others should be reported to your doctor. Employees with a fever of 100°F or more will need to follow normal call-off procedures. 

How do I report side effects?

• The CDC is expanding its safety surveillance through the launch of a smartphone-based tool called v-safe that you can use to quickly tell the CDC if you have any side effects after getting the COVID-19 vaccine. It regularly collects text and email feedback. 
• For those who do not opt into v-safe, adverse events can be reported in the Vaccine Adverse Event Reporting System (VAERS). Co-managed by the CDC and the FDA, VAERS 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 appointment. 
• In the unlikely event of a serious or life-threatening concern, go to the emergency department of the nearest hospital or call 911. 

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. 

I LIVE IN THE RESIDENCE HALLS. DO I STILL NEED TO PARTICIPATE IN COVID-19 TESTING AFTER I RECEIVE THE VACCINE? 

• Yes. According to the CDC, all COVID-19 vaccines currently available in the U.S. have been shown to be highly effective in preventing COVID-19. COVID-19 vaccination works by teaching your immune system how to recognize and fight the virus that causes COVID-19, and this protects you from getting sick with COVID-19. However, some vaccinated people will still get COVID-19, although they may have no symptoms or a very mild illness. Scientists are still studying to determine if the vaccine will prevent you from spreading the virus to others as an asymptomatic carrier. For this reason, the university will continue to test all those who live in residence halls as a tool to prevent outbreaks and keep the entire community safe.

DO I NEED TO CONTINUE WEARING A FACE COVERING AFTER I RECEIVE THE VACCINE?

• Yes. Receipt of a COVID-19 vaccine will not change any requirements around face coverings and physical distancing at this time. Although COVID-19 vaccines are effective at keeping you from getting sick, scientists are still learning how well vaccines prevent you from spreading the virus that causes COVID-19 to others, even if you do not get sick. 
• If you are vaccinated against COVID-19, you may still be exposed to the virus that causes COVID-19. After exposure, people can be infected with or “carry” the virus but not feel sick or have any symptoms. Experts call this “asymptomatic infection.” 
• For this reason, even after vaccination, we need to continue to wear face coverings and maintain physical distance as we learn more about how COVID-19 vaccines work to prevent the vaccinated from spreading the virus to others.

IF I HAVE BEEN VACCINATED, DO I STILL NEED TO QUARANTINE AFTER I HAVE BEEN EXPOSED TO SOMEONE WITH COVID-19?

• According to guidance issued by the CDC on Feb. 10. 2021, vaccinated people exposed to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:
  • They are fully vaccinated and at least two weeks have gone by since receipt of the second dose in a two-dose series, or more than two weeks following receipt of one dose of a single-dose vaccine.
  • They are within three months following receipt of the last dose in the series.
  • They have remained asymptomatic since the current COVID-19 exposure.
• People who do not meet all three of the above criteria should continue to follow current quarantine guidance after exposure to someone with suspected or confirmed COVID-19.