Approved COVID-19 Vaccines | COVID-19 Vaccine Basics | Phased COVID Vaccination | Inpatient Vaccinations | 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.
- On Dec. 18, 2020, the FDA issued EUA for the Moderna vaccine. See: Moderna COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
- On Feb. 27, 2021, the FDA issued EUA for the Johnson & Johnson (Janssen) vaccine. See: Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
- On May 10, 2021, the FDA expanded EUA for the Pfizer-BioNTech vaccine to include adolescents 12 through 15 years of age.
- On Aug. 12, 2021, the FDA amended EUAs for both the Pfizer-BioNTech and the Moderna vaccines to allow for the use of an additional dose in certain immunocompromised individuals.
- On Aug. 23, 2021, the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. See: Pfizer-BioNTech Fact Sheet for Recipients and Caregivers
- On Sept. 24, 2021, the CDC recommended the following groups should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after completing their Pfizer-BioNTech primary series (i.e., the first 2 doses of a COVID-19 vaccine): 1) people aged 65 years and older; 2) residents aged 18 years and older in long-term care settings; 3) people aged 50–64 years with underlying medical conditions.
- On Sept. 24, 2021, the CDC also recommended the following groups may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least six months after completing their Pfizer-BioNTech primary series, based on their individual benefits and risks: 1) people aged 18–49 years with underlying medical conditions; 2) people aged 18–64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
- On Oct. 21, 2021, the CDC recommended those who have received the Moderna vaccine series six months or more earlier receive a booster shot if they fit into the following categories (same as Pfizer): 65 years and older; age 18 and older who live in long-term care settings; age 18 and older who have underlying medical conditions; and age 18 and older who work or live in high-risk settings, including health care workers. See: CDC Expands Eligibility for COVID-19 Booster Shots
- On Oct. 21, 2021, the CDC recommended those age 18 and older who received the Janssen (Johnson & Johnson) vaccine two months or more earlier receive a booster shot. See: CDC Expands Eligibility for COVID-19 Booster Shots
- As of Oct. 21, 2021, CDC recommendations now allow eligible individuals to choose which vaccine they receive as a booster dose. See: CDC Expands Eligibility for COVID-19 Booster Shots
- On Nov. 19, 2021, the CDC expanded eligibility for COVID-19 booster shots to all adults.
- On Dec. 9, 2021, the CDC expanded recommendations for COVID-19 boosters to 16- and 17-year-olds.
- On Jan. 31, 2022, the FDA approved the Moderna COVID-19 Vaccine previously authorized for emergency use. See: Spikevax and Moderna COVID-19 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
Inpatients at all UK HealthCare hospitals, as well as patients in the emergency departments, are being offered COVID vaccines as of July 21, 2021. COVID-19 vaccines are available at Chandler, Kentucky Children’s and Good Samaritan hospitals via FDA emergency use authorization:
Pediatric populations (12-17 years of age)
- Pfizer-BioNTech COVID-19 Vaccine
Adult populations (18 years of age and older)
- Janssen COVID-19 vaccine
- Providers will also have the ability to order other vaccines (i.e. Pfizer-BioNTech and Moderna) for the following cases:
- Second dose of Pfizer-BioNTech or Moderna is needed during inpatient admission.
- Patient will not receive Janssen but is willing to receive Pfizer-BioNTech or Moderna.
On Monday, Nov. 8, UK HealthCare began offering the following COVID-19 vaccine options for patients on inpatient units and within the emergency departments.
- Pfizer-BioNTech COVID-19 Vaccine
- Janssen COVID-19 Vaccine
These options will be available for ordering through the COVID-19 Vaccine order panel. Moderna booster doses will not be available for inpatient or ED administration. Patients who prefer to receive a Moderna booster dose can request an appointment after discharge by visiting ukvaccine.org.
The following patient populations are eligible for booster doses:
- People 18 years and older who completed their Janssen primary series at least two months ago.
- People 65 years and older (at least six months after their Pfizer-BioNTech or Moderna primary series).
- People 18-64 years of age with underlying medical conditions (at least six months after their Pfizer-BioNTech or Moderna primary series).
- People 18-64 years of age who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting (at least six months after their Pfizer-BioNTech or Moderna primary series).
Booster doses will be prepared and delivered by Central Pharmacy at both Chandler and Good Samaritan hospitals.
Please review the following tip sheets for providers and nursing staff:
- COVID-19 Vaccine Ordering Tip Sheet (requires SharePoint access)
- COVID-19 Vaccine Administration Documentation Tip Sheet (requires SharePoint access)
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.
Providers and staff are required to initiate a complete series of COVID-19 vaccination by September 15, 2021. For more information on this requirement, see COVID vaccination required for providers, staff, trainees and learners
Managers, see COVID-19 Vaccination Mandate Toolkit for details of how this requirement.
UK HealthCare COVID vaccination locations in Lexington:
First, second and booster vaccinations are now being given at multiple Lexington locations. Visit ukvaccine.org for locations, days and times.
There is no charge for COVID-19 vaccination at UK HealthCare and insurance is not required.
Sign up for an invitation to make an appointment at ukvaccine.org. Once you receive the invitation, you will be able to select a time and location.
For information on directions and parking, please visit ukvaccine.org. If you have questions or need assistance making an appointment, please call 859-218-0111.
- 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)
- Are within three months following receipt of the last dose in the series
- 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:
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. Additional questions regarding the vaccination mandate are on the UK HealthCare COVID-19 Vaccination Mandate Toolkit page.
Vaccine development and distribution
Q: Has the production and clinical trial process been shortened to speed up vaccine production?
A: No. All vaccine candidates followed strict clinical trial protocols set by the federal Food and Drug Administration, as is standard of all vaccines. In fact, COVID clinical trials utilized a greater number of study participants than usual. Rather than running each segment of a trial consecutively, they were 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.
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.
- Emergency Use Authorization for Vaccines Explained, FDA
- The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, FDA
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.
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, 2020 and enrolled 43,661 participants before seeking FDA approval. Approximately 42% of global participants and 30% of U.S. participants were from racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants were 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, in their application to the FDA, 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: 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: UK HealthCare is now offering the Pfizer and Johnson and Johnson vaccines and you may specify which you prefer.
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 your schedule allow.
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.
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.
Q: What is the status of vaccinations for 11 years and under?
A: Pfizer vaccines were approved for individuals 5-11 years old. The vaccine is a smaller dose than the vaccine for those over 12 years old and is given in two doses, three weeks apart.
Q: Have we heard if there will be a booster for those who were vaccinated at the beginning of the year?
A: On Nov. 19, 2021, the CDC expanded eligibility for COVID-19 booster shots to all adults.
Q: My first dose was in February. Has too much time lapsed to get the second dose?
A: It is not too late to get your second dose. Regardless of how much time has passed, fishing the series and getting the booster shot will increase the effectiveness of your vaccination.
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. Although some people experience flu-like symptoms after vaccination, that is a positive sign that the immune system has been activated and is not an indication that the person has COVID. 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. The CDC recommends COVID vaccination for pregnant, breastfeeding, those trying to get pregnant or those who might become pregnant in the future. See COVID-19 Vaccines While Pregnant or Breastfeeding. Also, 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.
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 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. We do not expect guidance on the administration of boosters for those currently fully vaccinated until 2022.
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.
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.”
Q: What about death from the vaccine?
A: Deaths following COVID-19 vaccination are exceedingly rare. Of more than 342 million vaccinations given in the U.S. between December 14, 2020, and July 26, 2021, there were 6,340 reports of death (0.0019 percent) and in those cases it is not clear that the vaccine was the cause. Your chances of dying from or having serious health effects from COVID-19 are significantly higher than the chances of an adverse effect from the vaccine. More information can be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html.
Q: If an employee has a child that tests positive to COVID, should the employee also quarantine?
A: If the employee is fully vaccinated, the employee does not need to quarantine but needs to be tested immediately and in 5-7 days. If the child is at home and unable to isolate, (ongoing exposure) then the employee should be tested weekly until the child is out of isolation. The employee should be vigilant about symptoms screening and prompt testing should any symptoms develop.
If the employee is not fully vaccinated and has a high-risk exposure, the employee has to be restricted from work for 10 days if possible and needs to be tested immediately and in 5-7 days. The employee’s supervisor might ask the employee to work if necessary if the employee’s symptoms are asymptomatic.
Regardless of vaccination status, everyone should continue to adhere to mask wearing and socially distancing (including when eating) if exposed and be vigilant about symptomatic screening. In the event of an exposure, an employee should talk to their supervisor for more details.
Q: After vaccination, how long does it take for the vaccine effects to be fully effective?
A: 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. It is possible for a vaccinated person to 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: 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.
If you have any further questions regarding COVID vaccination at UK HealthCare, please email them to firstname.lastname@example.org and we will update this Q&A accordingly.
Vaccine Safety Monitoring
COVID-19 EUA 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.
Centers for Disease Control and Prevention
- Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – Epidemiology of COVID-19 in the United States
- COVID-19 vaccines
- CDC Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020
- Proposed groups for Phase 1 vaccination
- Summary of work group considerations supporting vaccinating health care personnel in Phase 1a
Food and Drug Administration
- COVID-19 Vaccines
- Vaccine Development – 101
- Emergency Use Authorization for Vaccines Explained
- The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization
- Vaccines and Related Biological Products Advisory Committee
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA (Pfizer-BioNTech)
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – Emergency Use Authorization Overview and Considerations for COVID-19 Vaccines
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document – FDA (Moderna)
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Presentation – EUA Overview and Considerations for COVID-19 Vaccines (Moderna)
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Presentation- FDA Review of Efficacy and Safety of Moderna COVID-19 Vaccine EUA
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Briefing Document – FDA (Janssen)
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Presentation – FDA Review of Efficacy and Safety of Janssen COVID-19 Vaccine EUA
- COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
- COVID-19 Vaccine Information for Health Care Professionals
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- Pfizer-BioNTech
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – BNT162b2 Vaccine Candidate Against COVID-19
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – COVID-19 Vaccine Post-authorization Safety and Effectiveness Monitoring
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Presentation – Distribution Overview
- A Phase 1/2/3, Placebo-controlled, Randomized, Observer-blind, Dose-finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
- COVID-19 Vaccine U.S. Distribution Fact Sheet
- Pfizer vaccine safety data sheet
- COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
- COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document- Moderna
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document Addendum- Moderna
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Presentation Considerations for placebo-controlled trial design if an unlicensed vaccine becomes available
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Presentation – Emergency Use Authorization (EUA) Application for mRNA-1273
Janssen Biotech (Johnson & Johnson)
- COVID-19 EUA Fact Sheet for Recipients and Caregivers
- COVID-19 EUA Fact Sheet for Healthcare Providers
- JAMA Patient Page – Johnson & Johnson COVID-19 Vaccine
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Briefing Document – Janssen
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Briefing Document Addendum – Janssen
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Presentation – Emergency Use Authorization (EUA) Application for Ad26.COV2.S
Statements from medical groups
- AMA, AHA and ANA: An Open Letter to the American Public on COVID-19 Vaccines
- The American College of Obstetricians and Gynecologists: Vaccinating Pregnant and Lactating Patients Against COVID-19
- Society for Maternal-Fetal Medicine Statement: SARS-CoV-2 Vaccination in Pregnancy
- Joint Statement in Support of COVID-19 Vaccine Mandates for All Workers in Health and Long-Term Care, Jul. 26, 2021
- What Do We Know About The Potential COVID Vaccine Products to Be Released?, UK HealthCare
- COVID-19 Vaccines: Fact vs. Fiction, UK College of Pharmacy
- National Academy of Medicine phased approach to vaccine allocation for COVID-19
- Science Magazine: Absolutely remarkable’: No one who got Moderna’s vaccine in trial developed severe COVID-19
- The New England Journal of Medicine: An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
- The New York Times: How Moderna’s Vaccine Works
- American Society of Health-System Pharmacists COVID-19 Vaccine Candidate Tracking Table