COVID-19 Vaccine Information

UK HealthCare Vaccination Numbers (Mar. 5, 8 a.m.)

  •   71,580  People vaccinated to date
  •     4,190  Vaccinated yesterday
  •   38,238  Completed boosters
  • 110,356  Doses administered

PAGE CONTENTS
Approved COVID-19 VaccinesCOVID-19 Vaccine Basics | Phased COVID Vaccination | Employee Vaccinations | What We Know About the Vaccines | FAQs | Vaccine Safety Monitoring | Additional Resources


Approved COVID-19 Vaccines

Three COVID-19 vaccines have received emergency use authorization from the U.S. Food and Drug Administration – the Pfizer-BioNTech vaccine, the Moderna vaccine and the Janssen vaccine.

COVID-19 Vaccinations in the U.S., Centers for Disease Control and Prevention


COVID-19 Vaccine Basics

According to the Centers for Disease Control and Prevention, “COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness. Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of “memory” T-lymphocytes as well as B-lymphocytes that will remember how to fight that virus in the future.”

Their explanation goes on to say, “It typically takes a few weeks for the body to produce T-lymphocytes and B-lymphocytes after vaccination. Therefore, it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination and then get sick because the vaccine did not have enough time to provide protection.”  See: Understanding How COVID-19 Vaccines Work


National Academy of Medicine Phased Approach for COVID Vaccination

Chart with Phased Approach to COVID Vaccine Allocation


Employee Vaccinations

Our patients and their families put their trust and confidence in us to maintain an safe environment of care. Accepting vaccination against disease is another level of protection we can provide – along with mask-wearing, good hand hygiene and social distancing in this case – to ensure that we are not putting our patients, their loved ones or our own families in harm’s way.

Employee vaccination locations:

  • Employee Health, University Health Service
  • Kroger Field (enter at Blue Lot off Alumni Drive) Current Hours: Tues. – Fri., 9 a.m. – 7 p.m.; Sat. 9 a.m. – 6 p.m.
Vaccinated employees exposed to COVID-19

  1. Are fully vaccinated (i.e., two weeks or more following receipt of the second dose in a two-dose series, OR two weeks or more following receipt of one dose of a single-dose vaccine)
  2. Are within three months following receipt of the last dose in the series
  3. Have remained asymptomatic since the current COVID-19 exposure

Please see updated Guidance for Health Care Workers with Respiratory Illness or Exposure to COVID.



What We Know About the Pfizer-BioNTech & Moderna Vaccines

The following comparison chart was prepared by UK HealthCare Pharmacy Services:

Comparison of Pfizer and Moderna COVID Vaccines


Frequently Asked Questions

The following questions have been submitted by employees. Answers come from Hanine El Haddad, MD, medical director of infection prevention and control; Philip Almeter, PharmD, pharmacy services enterprise director; Ashley Montgomery-Yates, MD, associate chief medical officer for inpatient services; the U.S. Food & Drug Administration; and the U.S. Centers for Disease Control and Prevention.

Vaccine development and distribution

Q: Has the production and clinical trial process been shortened to speed up vaccine production?
A: No. All vaccine candidates follow strict clinical trial protocols set by the federal Food and Drug Administration, as is standard of all vaccines. In fact, COVID clinical trials have utilized a greater number of study participants than usual. Rather than running each segment of a trial consecutively, they are being conducted in parallel to one another, condensing years of work into months.

For example, production on the vaccine began before the conclusion of the Phase 3 clinical trial. If the vaccines are determined to be safe and effective, they will be ready for distribution. In the event that one or more vaccines are not safe for use, they will not be distributed. This presents a financial risk to the pharmaceutical companies but maintains human safety.

Q: What is an emergency use authorization (EUA)?
A: An emergency use authorization is a mechanism used by the federal Food and Drug Administration to allow for use of unapproved medical products during a public health emergency when there are no available alternatives. For the FDA to consider an EUA request for a vaccine intended to prevent COVID-19, safety and effectiveness data from Phase 1, 2 and 3 studies is required.

Q: How do COVID vaccines work?
A: As is the case with other illnesses such as influenza, COVID vaccination will help your body create antibodies to prevent contracting severe COVID disease. Even if you do become infected, chances are that you will not experience symptoms or they will be mild.

Q: The Pfizer success rate is roughly 95%. What was the approximate sampling population size for that success rate?
A:
According to Pfizer: The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of Nov. 13. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina can be found here. The trial will continue to collect efficacy and safety data in participants for an additional two years.

For the Moderna vaccine, the company reported efficacy rate of 94.5% based upon “data from an ongoing Phase 3 randomized,
double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants…. Efficacy in preventing confirmed COVID-19 occurring at least 14 days after the second dose of vaccine was 94.5.0% (95% CI 86.5%, 97.8%) with 5 COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group.” (page 5)

Q: If I decline initially, will I be able to accept vaccination at a later date?
A: 
You can change your mind later. However, should you decide later to accept the vaccine, you may not be able to receive it immediately. There could be a wait behind other prioritized groups.

Q: Has there been discussion on the timing of receiving the vaccine for employees that are working remotely?
A: These individuals have been invited to take the vaccine at the end of phase 1a.

Q: Will UK providers who work out of other facilities receive the vaccine at UK or the other facility?
A:
Vaccine doses are being allocated by the federal government based on geographic area. Those working out of other facilities should plan to get their vaccination at the facility where they are working.

Q: Will UK be prepared to provide BOTH vaccine doses once available?
A: Yes, we are prepared to provide both doses of the vaccine.

Q: Will we know which of the two vaccines (Pfizer/Moderna) we would be getting? How would you determine who gets which vaccine?
A:
If both vaccines are currently in supply when you schedule vaccination, you may have a choice. However, you are not guaranteed a choice. We will administer the vaccine we have.

Q: How can I know which of the approved vaccines is being administered? What if I’m comfortable with only one of the approved vaccines?
A: We will communicate which vaccine formulations are being offered.

Q: Will UK HealthCare front-line providers and staff be required to get the COVID vaccine?
A: At this point, the vaccine will be highly recommended by Employee Health but not required for employees.

Q: Will there be any cost to UK HealthCare employees for COVID vaccination offered through Employee Health?
A:
No. Earlier, the federal government announced that the COVID vaccine would be free to Americans but that providers could bill for its administration. UK HealthCare has decided we will not bill for COVID vaccines or their administration.

Q: What if I am unable to schedule my second Pfizer vaccine dose 21 days later (or 28 days for the Moderna vaccine)?
A: 
Guidelines specify that the Pfizer booster dose should not be given earlier than 21 days (or 28 days for the Moderna vaccine), but you have flexibility on when you schedule the second dose. Our recommendation is that you schedule the second dose as soon as vaccine supplies and your schedule allow. Maximum protection is achieved 7-14 days after the second dose.

Q: I’ve recently been positive for COVID. When can I consider being vaccinated?
A: COVID-19 vaccines are safe in persons who had previous COVID-19. Vaccination should be deferred until the person has recovered from the acute illness and they are out of isolation. There is no optimal window for vaccination after an infection, but since reinfection is extremely rare in the first 90 days following an infection, vaccination can be delayed, if desired, up to 90 days post infection.

If you want to pursue vaccination as soon as possible, you should meet these criteria:

  • No COVID symptoms for at least 14 days.
  • Released from isolation by the health department.

General vaccine efficacy and safety

Q: Is it possible to contract COVID-19 from the vaccines being produced?
A
: No. None of the vaccines currently in development use the live virus. Learn more from the Centers for Disease Control and Prevention.

Q: How can I be sure a COVID vaccine will be safe?
A: Clinical trials include a large number of participants in order to generate robust scientific information. Every trial is evaluated by an independent data-monitoring committee of scientists. The FDA will also make its own determination on vaccine safety and efficacy. If approved by the FDA, the Advisory Committee of Immunizations Practices will make recommendations to the CDC.

Once a vaccine passes all of this scrutiny, the FDA, CDC and the manufacturer will continue to conduct real-time safety monitoring following distribution. This allows experts to rapidly catch and assess any reported side effects and make timely vaccine alterations if needed.

Q: What are the side effects of vaccination? Have any serious adverse effects been reported?
A: 
On Feb. 26, the CDC National Center for Immunization & Respiratory Diseases, presented a COVID-19 Vaccine Safety Update to the FDA Vaccines and Related Biological Products Advisory Committee.

In the FDA’s review of the Pfizer-BioNTech application for emergency use authorization, a Safety Summary was provided on pages 43-44. The following is an excerpt:

“Local site reactions and systemic solicited events after vaccination were frequent and mostly mild to moderate. The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%); severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1, and were generally less frequent in adults ≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%). Among adverse events of special interest, which could be possibly related to vaccine, lymphadenopathy was reported in 64 participants (0.3%): 54 (0.5%) in the younger (16 to 55 years) age group; 10 (0.1%) in the older (>55 years) age group; and 6 in the placebo group. The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff. Bell’s palsy was reported by four vaccine participants. From Dose 1 through 1 month after Dose 2, there were three reports of Bell’s palsy in the vaccine group and none in the placebo group. This observed frequency of reported Bell’s palsy is consistent with the expected background rate in the general population. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to BNT162b2 vaccine.”

The FDA safety summary goes on to say, “The frequency of non-fatal serious adverse events was low (<0.5%), without meaningful imbalances between study arms.”

In the FDA’s review of the Moderna application for emergency use authorization, it concluded on page 45:

“Local site reactions and systemic solicited events after vaccination were frequent and mostly mild to moderate. The most common solicited adverse reactions were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%); 0.2% to 9.7% were reported as severe, with severe solicited adverse reactions being more frequent after dose 2 than after dose 1 and generally less frequent in adults ≥65 years of age as compared to younger participants. Among adverse events of clinical interest, lymphadenopathy was reported in 173 participants (1.14%) in the vaccine group and 95 participants (0.63%) in the placebo group. There was a numerical imbalance in hypersensitivity adverse events across study groups, with 1.5% of vaccine recipients and 1.1% of placebo recipients reporting such events in the Safety Set. There were no anaphylactic or severe hypersensitivity reactions with close temporal relation to the vaccine.”

In the FDA’s review of the Janssen application for emergency use authorization, it concluded on page 52:

“Local site reactions and systemic solicited events among vaccine recipients were frequent and mostly mild to moderate. The most common solicited adverse reactions were injection site pain (48.6%), headache (38.9%), fatigue (38.2%) and myalgia (33.2%); 0.7% and 1.8% of local and systemic solicited adverse reactions, respectively, were reported as grade 3. Overall, solicited
reactions were reported more commonly in younger participants. There were no meaningful imbalances in unsolicited adverse events in 28 days following vaccination between vaccine and placebo recipients in the safety subset.”

According to the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, “Vaccines can very rarely cause immediate hypersensitivity reactions (i.e. anaphylaxis, angioedema, and/or hives) usually within minutes, but up to several hours of vaccination in persons with allergy to a vaccine component. Also, vaccines can cause large local swelling reactions or nodules at the injection site due to delayed-type hypersensitivity reactions.”

Q: Do we understand the vaccine safety for those who have been COVID-positive and still have antibodies?
A: The recommendation is to get the vaccine due to evidence that COVID reinfection is possible.

Q: If I’m pregnant or nursing, should I get the vaccine?
A: Please discuss vaccination with your provider. See the Society for Maternal-Fetal Medicine statement on SARS-CoV-2 vaccination or American College of Obstetricians and Gynecologists statement on vaccinating pregnant and lactating patients against COVID-19. Also, see: CDC: Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States

Q: Do we know if the side effects of the vaccine are greater or less if you have had the virus?
A: At this time, we do not know. We will provide any updates as they become available.

Q:  If I’ve already had COVID, do I need vaccination?
A:  Yes. There is not enough evidence to indicate how long your existing antibodies would be protective.

Q: If I’m immunocompromised, should I be vaccinated?
A: Please discuss vaccination with your provider. Every immunocompromised patient is different, and your particular circumstances should be taken into consideration when making that decision.

Q: Can you draw a titer to determine if the vaccine was successful?
A:
At this time, the titer of protective antibodies following COVID vaccination is unknown. There are no recommendations to monitor the immunologic response with an antibody titer.

Q: I’m in the ENSEMBLE study for a different COVID vaccine. Can I take the Pfizer-BioNTech vaccine?
A: Contact Dr. Greenberg at 859-806-1759 if you are invited to receive the Pfizer vaccine and want to take it. You will be unblinded in the study to determine if you got the Janssen vaccine or received the placebo. It may not be safe to take both vaccines. If you received the placebo, you can take the Pfizer vaccine. Even if you get the Pfizer vaccine, you are encouraged to stay on the ENSEMBLE study.

Q: Should patients who receive monoclonal antibodies wait to be vaccinated?
A: The CDC has updated its clinical guidance to address this specific situation. The latest update includes a section on “Persons who previously received passive antibody therapy” (Dated 12/31) Ref: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.

“Currently, there are no data on the safety and efficacy of mRNA COVID-19 vaccines in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies, as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days (emphasis added) as a precautionary measure until additional information becomes available to avoid interference of the antibody treatment with vaccine-induced immune responses. For persons receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), administration of mRNA COVID-19 vaccines either simultaneously with or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair development of a protective antibody response. Thus, there is no recommended minimum interval between other antibody therapies (i.e., those that are not specific to COVID-19 treatment) and mRNA COVID-19 vaccination.”

 

After vaccination

Q: After vaccination, how long does it take for the vaccine effects to be fully effective?
A:
About seven to 14 days after the second dose.

Q: Do we know how long the vaccine will last? Will we have to be revaccinated each year like the flu shot?
A: At this time we do not know. As more time goes by, more data will emerge and we will provide more information as it becomes available.

Q: Why do folks who have received a vaccine need to wear a mask? Can we at least not have to wear the N95/PAPR and goggles?
A: Vaccination is protecting the individual who is vaccinated. Masks and social distancing are protecting others from you. At this point, it is not clear whether a vaccinated person might still spread SARS-CoV-2 to others.

There is not enough information currently available to say if or when the CDC will stop recommending that people wear masks and avoid close contact with others to help prevent the spread of the virus that causes COVID-19. Experts need to understand more about the protection that COVID-19 vaccines provide before making that decision. Other factors, including how many people get vaccinated and how the virus is spreading in communities, will also affect this decision.

Infection Prevention & Control will want to study all aspects of risk to employees and patients before making any changes to required PPE.

Q: Many articles state that a person should be off work the day after receiving the vaccine due to extreme side effects. How do you plan on addressing that?
A: Employees will not be scheduled for a day off, but if you are not feeling well, stay home and report to your manager.

Q: If there are side effects, is there a plan to spread out vaccinations across the health system? Will we administer those like we did flu this year by area?
A: We do not anticipate that everyone will 1) accept vaccination or 2) self-schedule at the same time, so some natural staggering will occur. We are not administering the COVID vaccine as we do the annual flu shots. Every person who accepts vaccination will then separately sign up for an available time and location to be vaccinated.

Q: If I need to take time off due to vaccine side effects, will I need to use my accrued sick time?
A:
Yes. Your sick leave should cover this and other instances where you are ill and need to stay home and recover.

Q: What if the side effects of the COVID vaccine cause me to fail the daily screening survey?
A:  Follow your area’s normal call-in policy and do not report to work if you have symptoms listed on the daily screening survey. Your symptoms can be due to the vaccine or COVID-19. You have two options: 1) complete the screening and immediately sign up for COVID testing, or 2) wait a day and see if your symptoms resolve completely – indicating they were likely due to vaccination. Certain symptoms like shortness of breath require immediate attention. Your supervisor may need you to work through symptoms such as fatigue or muscle aches. If you have fever, we want you to stay home.

 

Additional questions

If you have any further questions regarding COVID vaccination at UK HealthCare, please email them to covid19questions@uky.edu and we will update this Q&A accordingly.


Vaccine Safety Monitoring

COVID-19 Vaccine Adverse Event Reporting Process, UK HealthCare Pharmacy Services

V-safe is a smartphone-based tool from the CDC that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through v-safe, you can quickly tell the CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information. And v-safe will remind you to get your second COVID-19 vaccine dose if you need one.

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA). Its primary users are health care professionals, but any U.S. resident may use it to report an adverse event. VAERS serves as an early warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) that occur after vaccination.


Resources

Centers for Disease Control and Prevention

Food and Drug Administration

Pfizer-BioNTech

Moderna

Janssen Biotech (Johnson & Johnson)

Statements from medical groups

Other resources