VACCINE INFORMATION STATEMENT
Covid-19
Why get vaccinated?
SARS-CoV-2, or COVID-19, has dramatically changed the world since the WHO declared the pandemic on March 11, 2020. As of May 20, 2022, there have been over 521 million confirmed cases and over 6.2 million deaths around the world as a result of this virus.1 Symptoms of COVID-19 infection include fever/chills, cough, shortness of breath or difficulty breathing, fatigue, muscle and body aches, headache, new loss of taste or smell, sore throat, congestion/runny nose, nausea/vomiting, and diarrhea.2 Everyone is at risk of contracting COVID-19, but those with underlying medical conditions (including pregnancy) and people of advanced age are at the highest risk of severe complications. With the United States death toll recently surpassing 1 million people, vaccination is more important than ever.1
The COVID-19 vaccines currently available have been shown to be safe and effective at preventing hospitalizations and development of severe illness due to COVID-19, and can prevent infection in most cases. While natural immunity from COVID-19 infection does offer some protection, the risk of developing severe disease or complications still exists, whereas getting vaccinated has been shown to have better protection against getting re-infected with COVID-19. One study showed unvaccinated individuals had a 2.34x greater chance of getting re-infected versus individuals who were fully-vaccinated and had contracted COVID-19 in the past.3 COVID-19 vaccines and booster doses are currently available in the United States for all individuals aged 5 years and older.
Currently available vaccines:
– Moderna/Spikevax (mRNA vaccine; recommended for adults 18+ years of age)
– Pfizer-BioNTech/Comirnaty (mRNA vaccine; recommended for all individuals 5+ years of age)
– Novavax (protein subunit vaccine; recommended for all individuals 18+ years of age)
– Janssen (viral vector vaccine; no longer recommended; restricted to specific
populations)4
What’s considered “fully vaccinated”? Is it the same as being “up to date”?
According to the CDC, being fully vaccinated means that you’ve received a full primary series of your selected COVID-19 vaccine at least two weeks ago. This is usually two doses, but can be up to three if you are moderately/severely immunocompromised.5
Being up to date with your COVID-19 vaccination includes one booster for all individuals ages 5-49, as of May 20, 2022.4 You are considered up to date immediately after receiving your booster dose. Individuals aged 50+ and those who are moderately/severely immunocompromised are able to receive a second booster dose, but this is not required to be considered up to date at this time.5
For the following groups, you are considered both fully vaccinated AND up to date two weeks after completing your primary series since boosters are not yet recommended:
– Moderna in individuals <18 years of age
– Novavax in individuals >18 years of age
Who should not get this vaccine?
Moderna, Pfizer: Patients with history of severe allergic reaction/anaphylaxis to a previous dose of mRNA COVID-19 vaccine or any of its ingredients.6,7
Janssen: Patients with history of severe allergic reaction to any of the vaccine
ingredients, history of thrombosis with thrombocytopenia syndrome (TTS) or other clotting disorders.8
Novavax: Patients with a history of severe allergic reaction/anaphylaxis to any
component of the Novavax COVID-19 vaccine8
Risks of a vaccine reaction:
Like any medication or vaccine, the COVID-19 vaccines can cause side effects
following administration. Most side-effects of both the viral vector and mRNA vaccines are mild and go away in 1-2 days.
Most common side-effects include6,7:
– Redness, swelling, soreness at the injection site
– Fatigue
– Headache
– Muscle aches/joint pain
– Fever/chills
– Nausea
– Temporary menstrual cycle changes in women
– Swelling/tenderness of the lymph nodes under the arms
Severe reactions to the COVID-19 vaccine are exceedingly rare, but can be life-threatening if left untreated. The CDC and FDA continue to monitor the rates of the following conditions after COVID-19 vaccination and update their recommendations as needed to ensure patient safety9:
– Severe allergic reaction (anaphylaxis): Occurs in approximately 5 out every 1 million vaccine doses administered. Can occur in minutes to hours after injection, and can happen with any type of vaccine.
– Thrombosis with Thrombocytopenia Syndrome (TTS): Occurs in approximately 4 out of every 1 million doses of Janssen administered. TTS causes blood clots in large blood vessels and low platelet counts. This has been causally associated with 9 deaths, and most often occurs within two weeks of vaccine administration.
– Guillain-Barré Syndrome (GBS): Rare disorder where the immune system attacks the nervous system, causing muscle weakness and sometimes paralysis or permanent nerve damage in more severe cases. This can occur with any type of vaccine, but generally affects 3,000-6,000 individuals in the United States each year.10 With Covid-19 vaccines in particular, data analysis has shown that the rate of GBS in the first 21 days after vaccination was 21x higher with Janssen than with the mRNA vaccines, and that the mRNA vaccines show no increased risk of developing GBS.
-Myocarditis/Pericarditis: Inflammation of the heart muscle or outer lining of the heart. Most cases have been reported within a week of receiving the second dose of a mRNA vaccine, particularly in males between 12 and 24 years of age.12 Cases of myocarditis and pericarditis have also been reported in people who have received the Novavax Covid-19 vaccine. Most individuals who developed myocarditis or pericarditis responded well to rest and treatment and were able to return to normal activities quickly.
Responding to serious vaccine reactions:
Severe allergic reaction/anaphylaxis signs and symptoms12:
– Difficulty breathing or wheezing
– Drop in blood pressure, which can make you feel dizzy or weak
– Swelling of tongue/throat
– Generalized rash or hives
If any of these occur within minutes to hours of your vaccination and you think it is a severe allergic reaction, call 9-1-1 and head to your nearest hospital immediately. Otherwise, call your primary physician.
Thrombosis with thrombocytopenia syndrome (TTS) signs and symptoms13:
– Chest pain or pain/swelling in an extremity
– Numbness or weakness on one side of your body
– Sudden change in mental status
If any of these occur within two weeks of receiving a dose of the Janssen COVID-19 vaccine, call 9-1-1 and head to your nearest hospital immediately.
Guillain-Barré Syndrome (GBS) signs and symptoms14:
– Difficulty with eye muscles, vision
– Difficulty swallowing, speaking, or chewing
– Prickling, pins-and-needles sensations in the hands and/or feet
– Severe pain, particularly at night
– Coordination problems/unsteadiness
– Abnormal heart rate or blood pressure
– Problems with digestion or bladder control
If any of these occur within three weeks of your vaccination (particularly if it’s the Janssen COVID-19 vaccine), call 9-1-1 and head to your nearest hospital immediately.
Myocarditis/Pericarditis signs and symptoms15:
– Chest pain
– Shortness of breath
– Fluttering, pounding, or fast heart rate
If any of these occur within a week of your vaccination (particularly with Moderna, Novavax, or Pfizer vaccines) and are severe, call 9-1-1 and head to your nearest hospital immediately. Otherwise, call your primary physician.
Reporting serious vaccine reactions:
Unlike most vaccines, if reporting COVID-19 vaccine-related adverse events, you will submit your case to the Countermeasures Injury Compensation Program (CICP). Given that these vaccines were developed and authorized under the Public Readiness and Emergency Preparedness (PREP) Act, they fall into a different category than the general Vaccine Injury Compensation Program (VICP). To see a comparison of the CICP and VICP programs, please visit https://www.hrsa.gov/cicp/cicp-vicp. For individuals who believe that they have been injured as a result of COVID-19 vaccination can call CICP at 1-855-266-2427 or visit their website: https://www.hrsa.gov/cicp.
References:
1 World Health Organization Coronavirus (COVID-19) Dashboard. Last accessed May 23, 2022.
https://covid19.who.int/
2 CDC Symptoms of COVID-19. Last updated March 22, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
3 CDC Morbidity and Mortality Weekly Report (MMWR). Cavanaugh AM, Spicer KB, Thoroughman D, Glick C, Winter K. Reduced Risk of Reinfection with SARS-CoV-2 After COVID-19 Vaccination – Kentucky, May-June 2021. Published August 13, 2021.
https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm?s_cid=mm7032e1_w
4 CDC Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. Last updated May 20, 2022.
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.
html?ACSTrackingID=USCDC_2120-DM82546&ACSTrackingLabel=Updated%20Guida
nce%3A%20Interim%20Clinical%20Considerations%20for%20Use%20of%20COVID-1
9%20Vaccines&deliveryName=USCDC_2120-DM82546#considerations-Janssen
5 CDC Stay Up to Date with Your COVID-19 Vaccines. Last updated May 20, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html?s_cid=11747:what%20is%20up%20to%20date%20on%20covid%20vaccine:sem.ga:p:RG:GM:gen:PTN:FY22
6 FDA Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) For Use in Individuals 12 Years of Age and Older. Revised May 17, 2022.
https://www.fda.gov/media/153716/download
7 FDA Vaccine Information Fact Sheet for Recipients and Caregivers about SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older. Revised March 29, 2022. https://www.fda.gov/media/144638/download
8 FDA Fact Sheet for Recipients and Caregivers Emergency Use Authorization of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Revised May 5, 2022.
https://www.fda.gov/media/146305/download
9 CDC Safety of COVID-19 Vaccines: Selected Adverse Events Reported after COVID-19 Vaccination. Last updated May 16, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
10 CDC Questions and Concerns: Guillain-Barré Syndrome and Vaccines. Last updated August 25, 2021.
https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html
11 CDC Safety of COVID-19 Vaccines: Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Last updated November 12, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
12 CDC Allergic Reactions: Allergic Reactions after COVID-19 Vaccination. Last updated February 3, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html
13 CDC Advisory Committee on Immunization Practices (ACIP) Updates on Thrombosis with Thrombocytopenia Syndrome (TTS). Last updated December 16, 2021.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
14 NIH National Institute of Neurological Disorders and Stroke (NINDS): Guillain-Barré Syndrome Fact Sheet. Last updated April 25, 2022.
https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/guillain-barre-syndrome-fact-sheet
15 CDC Safety of COVID-19 Vaccines: Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Last updated November 12, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
9 FDA Fact Sheet for Recipients and Caregivers Emergency Use Authorization of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Revised May 5, 2022.
https://www.fda.gov/media/146305/download
10 CDC Safety of COVID-19 Vaccines: Selected Adverse Events Reported after COVID-19 Vaccination. Last updated May 16, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
11 CDC Questions and Concerns: Guillain-Barré Syndrome and Vaccines. Last updated August 25, 2021.
https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html
12 CDC Safety of COVID-19 Vaccines: Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Last updated November 12, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
13 CDC Allergic Reactions: Allergic Reactions after COVID-19 Vaccination. Last updated February 3, 2022.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html
14 CDC Advisory Committee on Immunization Practices (ACIP) Updates on Thrombosis with Thrombocytopenia Syndrome (TTS). Last updated December 16, 2021.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
15 NIH National Institute of Neurological Disorders and Stroke (NINDS): Guillain-Barré Syndrome Fact Sheet. Last updated April 25, 2022.
https://www.ninds.nih.gov/health-information/patient-caregiver-education/fact-sheets/guillain-barre-syndrome-fact-sheet
16 CDC Safety of COVID-19 Vaccines: Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Last updated November 12, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html