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Rationale for vaccination (contraindications/allergies/COVID-19 hx)
Is it better to take my chances w/ COVID-19 vs getting the vaccine? If over half of Americans are vaccinated, why do I still need to get it? Getting a COVID-19 vaccine is a safer choice1 - Individuals are encouraged to receive the earliest vaccine that's available to them
- While some people w/ COVID-19 can have very mild or no sx, it’s impossible to predict who those individuals might be
- COVID-19 has caused severe illness and led to death in many people. Although people who are older, obese or have other comorbidities are at highest risk for complications, younger people (w/o risk factors) can also become severely ill. In a study of >3,000 people ages 18 to 34 who were hospitalized for COVID btwn April 1 and June 30, 2020, 20% required ICU & 3% died2
- Delta variant. The predominant strain in the U.S. currently is the Delta variant, which causes more infections & spreads faster than earlier forms of SARS-CoV-1; some data suggest the Delta variant might cause more severe illness than previous strains in unvaccinated persons1
- Transmission of natural infxn: An individual w/ natural infxn risks transmitting it to family members or other contacts, who may in turn develop severe dz
- Risk of becoming a COVID long-hauler. Recovery from COVID may be problematic: A 2020 cohort study of more than 1,700 pts found that as many as 3 out of 4 people who recover from COVID have chronic complaints, incl fatigue, muscle weakness, and/or sleep disturbance for months afterward3
- We aren’t at herd immunity. Even if over half of Americans are vaccinated, that’s still not enough to get to herd immunity4
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
2 Cunningham JW, et al. JAMA Intern Med. Clinical Outcomes in Young US Adults Hospitalized With COVID-19. 2020. Sep 9;e205313. Accessed 1/20/21
3 Huang C, et al. 6-Month Consequences of COVID-19 in Patients Discharged From Hospital: A Cohort Study. The Lancet. 2021. Jan 16;397(10270):220-232. Accessed 1/20/21
4 Frequently Asked COVID-19 Vaccine Questions. JN Learning TM. August 16, 2021. Video Transcript. Accessed 8/19/21
Can I get vaccinated against COVID-19 while I am currently sick with COVID-19? This guidance also applies to people who get COVID-19 before getting their second dose of vaccine1 Footnotes 1 CDC 2021. Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
I had COVID-19 already. Do I need the vaccine? Should pts who’ve already had COVID-19 be vaccinated? - Yes. CDC recommends vaccination for persons w/ hx of COVID-19 because research has not yet shown how long individuals are protected from COVID-19 re-infxn after recovery from COVID-191
- Evidence is also emerging that people get better protection by being fully vaccinated compared w/ having had COVID-19. One study showed that unvaccinated people who already had COVID-19 are more than 2x as likely than fully vaccinated people to get COVID-19 again1
Should pts who’ve had COVID-19 & have long-haul sx (Long COVID-19) be vaccinated or could the vaccine make them worse? - Long COVID isn’t a contraindication to vaccination, and there are anecdotal reports that vaccination might help2
- However, at this point, public health experts don’t have the data to definitively know whether vaccination could make sx better or worse2
Vaccinated pts who later develop COVID-19: - Receipt of mRNA COVID-19 vaccine shouldn’t affect tx decision (incl use of monoclonal antibodies, convalescent plasma, antiviral tx, or corticosteroids) or timing of tx1
Pts who received COVID-19-targeted monoclonal antibodies or convalescent plasma: - Defer vaccination for ≥90 days, as a precautionary measure in the absence of data, to avoid interference of the tx w/ vaccine-induced immune responses1
Pts w/ hx of multisystem inflammatory syndrome in adults (MIS-A) or children (MIS-C): - Consider delaying vaccination until recovery from being sick & for 90 days after the date of diagnosis of MIS-A/MIS-C1
Pts who received other types of passive antibody tx not specific to COVID-19 (eg, IV immunoglobulin, RhoGAM): - COVID-19 vaccines can be given w/o regard to antibody product administration1
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
2 Frequently Asked COVID-19 Vaccine Questions. JN Learning TM. August 16, 2021. Video Transcript. Accessed 8/19/21
Contraindications/Cautions (allergic rxns) Contraindications of mRNA vaccines1 - Hx of severe allergic rxn (eg, anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components. Action: Don't vaccinate
- Hx of immediate allergic rxn (defined as any hypersensitivity-related s/sx [eg, urticaria, angioedema, resp distress such as wheezing, stridor] w/in 4h of administration of a vaccine or medication) of any severity to a previous dose of an mRNA vaccine or any of its components, incl polyethylene glycol (PEG). Action: Don't vaccinate unless evaluated/cleared by allergist/immunologist & vaccine can be given w/ 30 min of observation in a setting w/ advanced medical care
- Hx of immediate allergic rxn of any severity to polysorbate (due to potential cross-reactivity w/ PEG). Action: Don't vaccinate unless evaluated/cleared by allergist/immunologist and vaccine can be given w/ 30 min of observation in a setting w/ advanced medical care
- Note: Individuals w/ an immediate allergic rxn to the 1st dose of an mRNA vaccine shouldn't receive additional doses of either mRNA vaccine. Providers should try to determine whether rxns are immediate allergic rxns or other types of common rxns (vasovagal/post-vaccination side effects)
- Note: Previous hx of COVID-19 (symptomatic or asymptomatic) isn't a contraindication to vaccination, although CDC recommends that symptomatic pts defer vaccination until they are recovered & out of isolation
Precautions for mRNA vaccines1 - Hx of any immediate allergic rxn to any other vaccine/injectable tx (ie, IM, IV, or SC vaccines or therapies [excluding allergy shots]) but NOT related to mRNA vaccine components or polysorbate, as these are contraindications
- Persons w/ rxn to a vaccine/injectable tx that contains multiple components, one of which PEG, another mRNA vaccine component or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction
- Action: Counsel such pts re: unknown risks of experiencing a severe allergic rxn and balance risks against vax benefits. Perform risk assessment, consider deferral of vaccination and/or referral to allergy/immunology; observe for 30min if decision to vaccinate
Neither contraindications nor precautions to vaccination1 - Delayed, local injection-site rxns (eg, erythema, induration, pruritus) after the first mRNA vaccine dose are neither a contraindication nor a precaution to 2nd dose; reported in some pts, incl in Moderna clinical trial participants, beginning a few days through wk 2 after the 1st dose; sometimes quite large; not thought to represent anaphylaxis risk for 2nd dose (but prefer opposite arm for 2nd dose)
- Allergic rxns (incl severe allergic rxns) not related to vaccines, injectable tx, components of mRNA COVID-19 vaccines (incl PEG), or polysorbates, such as allergic rxns related to food, pet, venom, or environmental allergies, or allergies to oral meds (incl PO equivalents of injectable meds)
Allergy-related counseling points - In Pfizer-BioNTech clinical trials, potential allergic rxns occurred in 0.63% of vaccine recipients vs 0.51% of placebo. In the Moderna trials, the rates were 1.5% of vaccine recipients vs. 1.1% of placebo2
- While severe reactions to the Covid-19 vaccine are rare, nearly all cases of anaphylaxis, or life-threatening allergic reactions, occurred in women3
- However, after emergency authorization & distribution of the vaccines in the U.K. & U.S., reports emerged of severe allergic rxns (anaphylaxis); polyethylene glycol is currently suspected as the cause of such rxns
- Neither of the mRNA vaccines contains eggs, gelatin, latex, or preservatives1
- Vaccine providers should be trained to observe pts after COVID-19 vaccination to monitor for occurrence of immediate adverse rxns. Those w/ a hx of immediate allergic rxn (of any severity) to a vaccine or injectable tx or persons w/ hx of anaphylaxis due to any cause should be observed for 30 min; all other pts should be observed for 15 min1
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Talking to Recipients about COVID-19 Vaccines: Making a Strong Recommendation for COVID-19 Vaccination; Understanding and Explaining mRNA COVID-19 Vaccines; Answering Vaccine Recipients’ Questions. Updated 11/2/20. Accessed 1/7/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
CDC Director Statement on Pfizer’s Use of COVID-19 Vaccine in Adolescents Age 12 and Older. Released 5/12/21. Accessed 5/13/21
2 FDA 2021.
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Free full-text PDF
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Statement. Jan 4, 2021. Accessed 1/7/21
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/10/20. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/17/20. FDA Briefing Document. Moderna COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 2/26/21. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Free full-text PDF
3 Shimabukuro TT, et al. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the U.S. December 14, 2020 – January 18, 2021. JAMA. 2021;325(11):1101-1102. Accessed 4/6/21
Will the flu vaccine protect me? Can the COVID-19 vaccine interfere w/ other vaccines? Will the flu vaccine protect against COVID-19? - Although a flu vaccine won’t protect individuals from getting COVID-19, CDC highly recommends it: Flu shots can protect against getting influenza at the same time as COVID-19, thereby reducing risk of severe illness1
Can I get the COVID-19 vaccine at the same time as other vaccines? - CDC recommends that mRNA COVID-19 vaccines be administered alone, a minimum of 14 days before or after other vaccines1
- However, mRNA COVID-19 vaccines and other vaccines may be given closer together when 1) the benefits of vaccination outweigh the potential known risk of vaccine co-administration (eg, tetanus toxoid vaccine for wound mgmt., measles or hepatitis A vaccination during outbreak); or 2) to avoid barriers/delays to COVID-19 vaccination (eg, LTC facility residents/staff who receive influenza or other vaccines prior to admission/onboarding)1
- If a COVID-19 vaccine is inadvertently given w/in 14 days of another vaccine, there’s no need to repeat doses of either vaccine1
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
I was vaccinated outside the U.S. Do I still need the vaccine? It depends on the type of vaccine received
People vaccinated outside the U.S.: - w/ an FDA-authorized COVID-19 vaccine OR WHO-designated “emergency use” COVID-19 vaccine AND who have received all the recommended doses: Do not need any additional doses
- w/ an FDA-authorized COVID-19 vaccine but who’ve only received 1st dose (of a 2-dose series): Don't need to restart series, but they should receive the 2nd dose as close to the recommended time as possible
- w/ a WHO-designated “emergency use” COVID-19 vaccine, but who’ve only received 1st dose (of a 2-dose series): May be offered a complete FDA-authorized COVID-19 vaccine series
- w/ a COVID-19 vaccine that was neither an FDA-authorized nor a WHO-designated “emergency use” COVID-19 vaccine AND who received all/some of the recommended doses: May be offered a complete FDA-authorized COVID-19 vaccine series
The minimum interval btwn the last dose of a non-FDA authorized vaccine or a WHO-listed2 vaccine and an FDA-authorized COVID-19 vaccine is 28 days Only people who have received ALL recommended doses of an FDA-authorized or WHO-listed2 COVID-19 vaccine are considered “fully vaccinated” Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
2 WHO-designated COVID-19 vaccines for emergency use: list
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Children/Adolescents | Vaccine safety/side effects/administration
How safe are the vaccines for children ages 5 through 11 years old? Are the vaccines safe for children ages 5 to 11? Do they work? Why should I take the risk? - CDC now recommends the Pfizer COVID-19 Vaccine for children ages 5 through 11 years, based on an in-depth review of available safety, immunogenicity, and efficacy data1
- Children ages 5-11 will receive an age-appropriate dose of the Pfizer-BioNTech Vaccine that is 1/3 the dose that adolescents and adults receive
- After getting a COVID-19 vaccine, children may have some side effects similar to those seen in adults and w/ other vaccines; these side effects may affect a child's ability to do daily activities, but should go away in a few days
- In clinical trials of about 3,000 children, CDC reports that serious side effects were rare and self-limiting. COVID-19 vaccines have undergone – and continue to undergo – the most intensive safety monitoring in U.S. history
- The Pfizer COVID-19 Vaccine is over 90% effective at preventing COVID-19 in children ages 5 through 11 years old
- Getting your child vaccinated can help protect them against COVID-19--nearly 2 million cases of COVID-19 have involved children in this age group since the start of the pandemic
- While children are at lower risk of becoming severely ill w/ COVID-19 compared to adults, children can be infected w/ the virus & there's no way to tell in advance if a child will get a severe or mild case; some children have developed a rare but serious disease that’s linked to COVID-19 called multisystem inflammatory syndrome (MISC-C)1,2
- Vaccination also helps curb community transmission & disruptions to in-person learning and group activities
- Parents/caregivers can enroll their child in v-safe, a free and easy-to-use smartphone-based app and report any adverse events after vaccination to the Vaccine Adverse Event Reporting System (VAERS)
Footnotes 1 CDC 2021. Possible Side Effects After Getting a COVID-19 Vaccine. Updated 11/3/21. Accessed 11/5/21
2 AAP 2021. Multisystem Inflammatory Syndrome in Children (MIS-C) Interim Guidance. Last updated 2/10/21. Accessed 11/5/21
How safe are the vaccines for adolescents? Are the vaccines safe for adolescents btwn 12 and 18? Should I be concerned about reports that the vaccines might cause inflammation of the heart? - The vaccines are safe w/ rare exceptions. CDC and AAP recommend that children/adolescents ages 5 and older get vaccinated against COVID-19 (assuming no contraindications)1,2
- Results of studies by Pfizer and Moderna in adolescents—those between 12 and 18 yo—show that the vaccine was not only safe, but also effective3
- With efficacy close to 100%, the vaccines are actually more effective in this younger population than in adults3
- As w/ any vaccine, children can have some mild side effects like a sore arm or fatigue. In general, sx resolve w/in a couple of days3
- There’s no evidence that there are serious side effects in children3
- Since April 2021, there’s been more than a thousand reports to the Vaccine Adverse Event Reporting System of cases of myocarditis and pericarditis happening after mRNA COVID-19 vaccination in the U.S. However, these reports are rare, given the hundreds of millions of vaccine doses administered; confirmed cases have occurred mostly in male adolescents and young adults ≥16 yo, more often after getting the 2nd dose, & typically w/in several days after vaccination;1 most pts are able to return to normal daily activities after sx improve1
Footnotes 1 CDC 2021. Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination. Updated 6/23/21. Accessed 8/20/21
2 AAP 2021. COVID-19 Vaccines in Children and Adolescents. Committee on Infectious Diseases. Pediatrics. August 2021. 148(2)e2021052336. Accessed 8/20/21
3 Frequently Asked COVID-19 Vaccine Questions. AMA Ed Hub. TM JN Learning. TM August 16, 2021. Video Transcript. Accessed 8/19/21
How does dosage work for children ages 5 through 11? What if a child turns 12 between doses? Is it safe to administer w/ other vaccines, like flu? How does dosage work for children? What should a parent do if a child turns 12 after they get their first dose of the pediatric vaccine but before the second dose is due? Is it safe to administer w/ other vaccines, like flu? - Children ages 5 through 11 will receive an age-appropriate dose that is 1/3 of what adults and adolescents receive; unlike many medications, vaccine dosages are based on age (on the day of vaccination) & not size or weight
- If a child turns from 11 to 12 years of age in between their first & second dose, the second dose should be the Pfizer-BioNTech Vaccine for adults and adolescents
- However, if the child received the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 through 11 years for their second dose, they do not need to repeat the dose
- Children are still required to get 2 doses 3wk apart to be considered fully vaccinated
- If a pt is eligible, both flu and COVID-19 vaccines can be administered at the same visit. In addition to flu vaccine, the COVID-19 vaccine can be given with other vaccines as well
Is this Pfizer vaccine the same one that’s given to adults and adolescents? Is this Pfizer vaccine the same one that’s given to adults and adolescents? - It has the same active ingredients as the vaccine given to adults and adolescents, but children ages 5 through 11 will receive an age-appropriate dose that is 1/3 of what adults and adolescents receive; (the vaccine for children also comes in a different vial w/ different color cap)
- Smaller needles, designed specifically for children ages 5 through 11 will be used
- Children are still required to get 2 doses 3wk apart to be considered fully vaccinated
Is there a fertility/development concern w/ vaccinating children before they reach puberty? No. There is no evidence that any vaccines, incl COVID-19 vaccines, can cause female or male fertility problems.
Will children younger than 12 receive a vaccine card? Yes. All vaccine recipients, incl children ages 5 through 11 years, will receive a CDC vaccination card upon initial vaccination
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Adults | Vaccine safety/side effects (incl special population risks)
How safe are the vaccines? Are the mRNA vaccines safe? What about the Johnson & Johnson vaccine?
- Yes, w/ rare exceptions. The benefits of COVID-19 vaccination in preventing morbidity and mortality far exceed the risks of rare serious adverse events after vaccination, CDC has concluded based on an ACIP review of benefit-risk analyses1
- Over 357 million doses of COVID-19 vaccines have been given in the U.S. from 12/14/20 through 8/16/21
- Rare cases of Guillain-Barre syndrome (GBS; 7.8 per million doses) and thrombosis w/ thrombocytopenia syndrome (TTS; 3.0 per million doses) have been reported following receipt of the Janssen (Johnson & Johnson) COVID-19 vaccine1
- Rare cases of myocarditis have been reported following mRNA COVID-19 vaccination (3.5 per million second doses)1
- CDC found there was no increased risk for any of the conditions and that the estimated benefits of vaccination—prevention of COVID-19 and related hospitalizations, ICU admissions, and deaths—outweighed the risks of experiencing GBS, TTS, or myocarditis postvaccination1
- CDC encourages individuals to enroll in the agency’s free smartphone tool called v-safe that uses text messaging & web surveys to provide personalized health check-ins after pts receive a COVID-19 vaccination. V-safe also reminds pts to get their 2nd dose1
- FDA carefully reviews all safety data from clinical trials & authorizes emergency vaccine use only when the expected benefits outweigh potential risks2
- CDC’s Advisory Committee on Immunization Practices (ACIP) also reviews all safety data before recommending any COVID-19 vaccine for use. FDA & CDC will continue to monitor the safety of COVID-19 vaccines & make sure even very rare side effects are identified1,2
- Both mRNA COVID-19 vaccines and the Janssen vector-based vaccine were tested in large clinical trials and have good safety profiles2
Footnotes 1 CDC 2021.
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices – United States, July 2021. MMWR. August 13, 2021. 70(32);1094-1099. Accessed 8/18/21
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
Understanding Viral Vector COVID-19 Vaccines. Updated 3/2/21. Accessed 3/3/21
Janssen COVID-19 Vaccine (Johnson & Johnson) Questions. Updated 3/2/21. Accessed 3/3/21
2 FDA 2021.
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Statement. Jan 4, 2021. Accessed 1/7/21
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/10/20. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/17/20. FDA Briefing Document. Moderna COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 2/26/21. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Free full-text PDF
How do we know that vaccines are safe long-term? Millions of people in the U.S. have received COVID-19 vaccines under the most intense safety monitoring in U.S. history1 Worldwide, hundreds of millions of doses have been given, w/ just a small number of serious safety concerns (1 or 2 per million)2 Historically, side effects to vaccines occur early-–in the first couple of weeks after receiving a vaccine, so researchers and regulators already have access to comprehensive data on the safety of vaccines2 Footnotes 1 CDC 2021. Safety of COVID-19 Vaccines. Updated 8/16/21. Accessed 8/20/21
2 Frequently Asked COVID-19 Vaccine Questions. AMA Ed Hub. TM JN Learning. TM August 16, 2021. Video Transcript. Accessed 8/19/21
Can I get the vaccine if I’m pregnant or breastfeeding? Is it safe for me to get a COVID-19 vaccine if I would like to have a baby one day? Vaccination should be offered to pregnant & lactating pts1 - CDC (ACIP) recommends COVID-19 vaccination for all people ages 12 years and older, incl those who are pregnant, lactating, trying to get pregnant now, or might become pregnant in the future
- There's currently no evidence that COVID-19 vaccination causes any problems w/ pregnancy, incl the development of the placenta1
- There's also no evidence that female or male fertility problems are a side effect of any vaccine, including COVID-19 vaccines1
- Any of the currently FDA-authorized COVID-19 vaccines can be administered to people in these groups; ACIP does not state a product preference; however, CDC recommends that women age <50 yo be aware of the rare risk of thrombosis with thrombocytopenia syndrome (TTS) after receipt of the Janssen COVID-19 vaccine and the availability of FDA-authorized mRNA vaccines for which this risk has not been seen
- Pregnant pts w/ COVID-19 are at increased risk for severe illness: Resp illness requires hospitalization in 5% to 6% of all SARS-CoV-2-infected pregnant women. Adjusted risk ratio in pregnant women vs nonpregnant pts was 3.0 for ICU admission, 2.9 for mechanical ventilation, and 1.7 for death);2 preterm birth risk also ranges from 10% to 25%, w/ rates as high as 60% among women w/ critical illness2
- Based on how mRNA vaccines work, experts believe they are unlikely to pose a specific risk to pregnant pts; although mRNA vaccines haven’t been studied specifically in pregnant pts, mRNA platforms used in the vaccines have been in development for the last 10y; similar mRNA vaccines have been used in clinical trials targeting other infxns such as Zika, as well as several types of CA (eg, breast, melanoma)2
- mRNA vaccines pose no risk to recipient of acquiring infxn from the vaccine & have potential benefits over live-attenuated virus vaccines, inactivated or subunit vaccines, & DNA-based vaccines2
- Remind pts that vaccination during pregnancy is already common to prevent maternal/infant morbidities from other infectious diseases (eg, influenza, Tdap vaccine)
- Routine pregnancy testing isn't required prior to receiving a COVID-19 vaccine
- All eligible persons should receive a COVID-19 vaccine or vaccine series. Obstetrician-gynecologists and other women’s health care practitioners should lead by example by being vaccinated and encouraging eligible pts to be vaccinated3
- Pregnant and lactating individuals should be vaccinated against COVID-193
- Women <50 yo, incl pregnant individuals can receive any FDA-authorized COVID-19 vaccine available to them. However, they should be aware of the rare risk of thrombosis w/ thrombocytopenia syndrome (TTS) after receipt of the Janssen COVID-19 vaccine & that other FDA-authorized COVID-19 vaccines are available (ie, mRNA vaccines)3
- Explain expected side effects as part of counseling pts, incl that they are a normal part of the body’s reaction to the vaccine & developing antibodies to protect against COVID-19 illness
- Claims linking COVID-19 vaccines to infertility are unfounded and have no scientific evidence supporting them. ACOG recommends vaccination for all eligible people who may consider future pregnancy3
- For pts who do not receive the vaccine, the discussion should be documented in the pt’s medical record. Address ongoing questions & concerns and offer vaccination again during subsequent office visits. Reinforce the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask3
- While a conversation w/ a clinician may be helpful, it isn't a requirement2,3
- Obstetrician-gynecologists are encouraged to assess & document pts’ COVID-19 vaccination status3
- Pregnancy testing isn't a requirement prior to receiving a COVID-19 vaccine1,3
- Vaccination of pregnant individuals w/ a COVID-19 vaccine may occur in any setting authorized to administer vaccines, incl clinical and community-based vaccination sites (eg, schools, community centers, and other mass vaccination locations)3
- COVID-19 vaccines may be administered simultaneously w/ other vaccines, incl w/in 14 days of receipt of another vaccine. This includes vaccines routinely administered during pregnancy, such as influenza & Tdap3
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Myths and Facts about COVID-19 Vaccines. Updated 7/7/21. Accessed 8/12/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
2 JAMA 2021. Adhikari EH, et al. COVID-19 Vaccination in Pregnant and Lactating Women. Viewpoint. JAMA. 2021. Published online 2/8/21. Accessed 2/18/21
3 ACOG 2021. Updated July 30, 2021. Practice Advisory. COVID-19 Vaccination Considerations for Obstetric-Gynecologic Care. December 20, 2020. Accessed 8/12/21
Are the vaccines safe if I have underlying medical conditions? Vaccination considerations for individuals w/ underlying medical conditions1 - Pts w/ underlying medical conditions can safely receive the COVID-19 vaccine as long as there are no contraindications to vaccination such as a severe allergic rxn to any of its components, per CDC
- Phase 2/3 clinical trials show similar safety and efficacy profiles in persons w/ underlying medical conditions, incl those that place them at increased risk for severe COVID-19, compared w/ persons w/o comorbidities
Pts w/ immunocompromise (eg, HIV, medications)1 - Pts who are moderately to severely immunocompromised are esp vulnerable to COVID-19 because they are more at risk of serious, prolonged illness;1 for this reason as of 8/13/21, CDC recommends an additional vaccine dose to make sure they have enough protection against COVID-19
- Immunocompromised pts should also be made aware of the potential for reduced immune response to the vaccine, & the need to continue to follow current guidance to protect themselves against COVID-19
Pts w/ autoimmune conditions1 - Individuals w/ autoimmune conditions may receive mRNA COVID-19 vaccines, however they should be made aware of the lack of safety data
- These individuals were eligible for enrollment in trials
Pts w/ hx of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)1 - Such pts may choose to be vaccinated, but no data exists on the safety & efficacy of COVID-19 vaccines in this population
- Other clinical considerations: clinical recovery from MIS-C or MIS-A (eg, return to normal cardiac fxn); personal risk of severe acute COVID-19 (eg, age, underlying conditions); level of COVID-19 community transmission & personal reinfection risk; timing of any immunomodulatory tx (for more info, see ACIP’s general best practice guidelines for immunizationhttps://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
- Consider delaying vaccination until recovery from illness & for 90 days after MIS-C/MIS-A dx date
- Recognize that risk of reinfxn & thus benefit from vaccination might increase w/ time following initial infxn
- Consider referral to ID, rheumatology, or cardiology specialist if MIS-C or MIS-A assoc w/ confirmed SARS-CoV-2 infxn occurs after receipt of COVID-19 vaccine
Pts w/ hx of Guillain-Barre syndrome (GBS)1 - Such pts may receive mRNA COVID-19 vaccines
- To date, no cases of GBS have been reported following COVID-19 vaccination in trials
Individuals w/ a hx of Bell palsy1 - Cases of Bell palsy were reported in participants in mRNA vaccine trials, but FDA doesn’t consider these to be above the rate expected in the general population (and the agency hasn't concluded these cases were caused by vaccination)
- Persons w/ a hx of Bell palsy may receive an mRNA COVID-19 vaccine
Individuals being tested for TB infxn1 - Test for TB before or at the same time as mRNA COVID-19 vaccination, OR otherwise
- Delay for ≥4wk after completion of mRNA COVID-19 vaccination
After vaccination, current guidelines for prevention of spread of COVID-19 should be followed1 - Wearing a mask
- Stay ≥6 ft away from others
- Avoiding crowds
- Washing hands w/ soap & water for 20 sec or using hand sanitizer w/ ≥60% alcohol
- Follow CDC travel guidance
- Follow quarantine guidance after exposure to COVID-19
- Follow any applicable school or workplace guidance
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Healthcare Professionals: Preparing for COVID-19 Vaccination. Accessed 1/7/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Updated 8/13/21. Accessed 8/13/21
How do the vaccines work? Can a COVID-19 vaccine give me COVID-19? mRNA COVID-19 vaccine background1 | Pfizer-BioNTech, Moderna vaccines - In contrast to most vaccines which use weakened or inactivated versions of the dz-causing pathogen, mRNA vaccines take advantage of the process that cells use to make proteins to trigger an immune response
- The vaccines contain strands of messenger RNA inside of a special coating, which helps protect the mRNA from breakdown & helps it enter dendritic cells & macrophages in lymph nodes near the injection site
- The mRNA provides “instructions” for the cell on how to make a piece of the SARS-CoV-2 spike protein. Since only the protein is made, it doesn’t harm the person, but it is antigenic
- Once the spike protein is made, the mRNA is broken down by cellular enzymes. The mRNA never enters the cell’s nucleus or affects genetic material. This info should help counter misinformation that mRNA vaccines alter or modify one’s genetic make-up
- mRNA vaccine technology has been studied for over a decade. Early-stage trials of mRNA vaccines have been carried out for influenza, Zika, rabies, & CMV, but early challenges (such as instability of free mRNA, unintended inflammatory outcomes, & modest immune responses) thwarted their continued development. Recent advances have helped to overcome these challenges for the COVID-19 vaccines
viral vector COVID-19 vaccine background1 | Janssen COVID-19 vaccine (Johnson & Johnson, JNJ-78436735) - Whereas other vaccines use a weakened or inactivated form of the target pathogen to trigger an immune response, viral vector vaccines use a different—harmless—virus as a vector
- This modified virus delivers a gene that instructs cells to make a SARS-CoV-2 antigen called the spike protein, which triggers production of antibodies & a resulting immune response
- Viral vectors cannot cause infxn w/ COVID-19 nor w/ the virus used as the vaccine vector
- The genetic material delivered by the viral vector doesn’t integrate into a person’s DNA
- Viral vector vaccines have been well studied in clinical trials & used to respond to recent Ebola outbreaks
- Besides being used in vaccines, viral vectors have also been studied for gene therapy, to treat cancer, & for molecular biology research
Can the COVID-19 vaccines actually lead to infxn?
- None of the vaccines contain a live SARS-CoV-2 virus & thus don't carry a risk of causing COVID-19 in vaccinated persons1
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Healthcare Professionals: Preparing for COVID-19 Vaccination. Accessed 1/7/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
Understanding Viral Vector COVID-19 Vaccines. Updated 3/2/21. Accessed 3/3/21
Janssen COVID-19 Vaccine (Johnson & Johnson) Questions. Updated 3/2/21. Accessed 3/3/21
What side effects can I expect? Reassure pts that side effects (esp after 2nd dose) are a normal part of the body’s rxn to the vaccine & are a sign of developing immunity against COVID-19 illness1 - Warn pts they may experience soreness, redness, swelling and/or warmth at site of injection, in addition to fatigue, headache, & fever following vaccination
- Antipyretic/analgesics can be taken to treat any post-vaccination sx. However, at this time, CDC doesn’t recommend routine prophylaxis for the prevention of such sx
- Most systemic post-vaccination sx are mild to moderate, but some may affect a pt’s ability to do daily activities and occur w/in the first 3 days (typically resolve w/in 1-3 days of onset)
- Overall, the safety profiles of COVID-19 vaccines are reassuring & consistent w/ that observed from pre-authorization clinical trials
- Side effects were more common in women, according to analysis of first 13.7 million Covid-19 vaccine doses given in U.S.1
- Advise pt to contact you if: injection site redness/tenderness increases after 24h, or if side effects are worrisome or not subsiding after a few days
- Fever in pregnant pts: If a pregnant pt experiences fever following COVID-19 vaccination, CDC advises use of acetaminophen since fever is assoc w/ adverse pregnancy outcomes
- Advise pts to return for their 2nd dose even if they develop post-vaccination sx (unless they develop a contraindication to vaccination)
Reported side effects (data collected from V-safe)1 - Increase in reported side effects after 2nd dose
- 29% reported fatigue after 1st Pfizer-BioNTech shot, but 50% reported fatigue after 2nd dose
- Muscle pain increased from 17% after 1st dose to 42% after 2nd dose
- Chills & fever increased from 7% after 1st dose to 26% after 2nd dose
Local & systemic rxn w/ Pfizer & Moderna vaccines1
- local sx: approx 80%–89% of vaccinated persons developed ≥1 local sx after vaccination
- systemic sx: approx 55%–83% of vaccinated persons developed ≥1 systemic sx following vaccination
Local & systemic rxn w/ Janssen vaccine1 - local sx: approx 50% of vaccinated persons developed ≥1 local sx after vaccination
- systemic sx: approx 55% of vaccinated persons developed ≥1 systemic sx following vaccination
Pfizer-BioNTech COVID-19 vaccine adverse rxns:2 - Injection site rxns (84.1%)
- Fatigue (62.9%)
- Headache (55.1%)
- Myalgia (38.3%)
- Chills (31.9%)
- Arthralgia (23.6%)
- Fever (14.2%)
Moderna COVID-19 vaccine (mRNA-1273) adverse rxns:2 - Injection site rxs (91.6%)
- Fatigue (68.5%)
- Headache (63%)
- Myalgia (59.6%)
- Arthralgia (44.8%)
- Chills (43.4%)
- Lymphadenopathy (axillary swelling + tenderness in vaccination arm) (21.4% in participants <65 yo, 12.4% in those ≥65)
Janssen COVID-19 Vaccine (Johnson & Johnson) Ad26.COV2.S adverse rxns:2 - Injection site pain (48.6%)
- Headache (38.9%)
- Fatigue (38.2%)
- Myalgia (32.2%)
Severe adverse reactions, more frequent after the 2nd dose, occurred in:2 - 0.0%-4.6% of participants in Pfizer study, more frequent in adults <55 yo
- 0.2%-9.7% of participants in Moderna study, more frequent in adults <65 yo
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Healthcare Professionals: Preparing for COVID-19 Vaccination. Accessed 1/7/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
Shimabukuro T, et al. CDC COVID-19 Vaccine Task Force. COVID-19 Vaccine Safety Update. Advisory Committee on Immunization Practices (ACIP). January 27, 2021. Accessed 4/6/21
2 FDA 2021.
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Statement. Jan 4, 2021. Accessed 1/7/21
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/10/20. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/17/20. FDA Briefing Document. Moderna COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 2/26/21. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Free full-text PDF
If I don’t have side effects, is the vaccine working? Yes, the vaccine is working--many people don’t experience any side effects except for a sore arm1 In the Pfizer vaccine trials, about 1 out of 4 pts reported no side effects but were still protected from the virus1 In the Moderna trials, almost 1 in 5 pts (64 or younger) reported no reaction after the 2nd shot, but were still protected from the virus1 Nonetheless, it’s also true that younger people generally exhibit stronger immune responses compared w/ older persons & that women have stronger immune responses compared w/ men1 Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Safety of COVID-19 Vaccines. Updated 8/12/21. Accessed 8/17/21
Healthcare Professionals: Preparing for COVID-19 Vaccination. Accessed 1/7/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
Shimabukuro T, et al. CDC COVID-19 Vaccine Task Force. COVID-19 Vaccine Safety Update. Advisory Committee on Immunization Practices (ACIP). January 27, 2021. Accessed 4/6/21
Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Pfizer – BioNTech COVID-19 Vaccine. Updated 12/13/20. Accessed 4/6/21
Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Moderna COVID-19 Vaccine. Updated 12/20/20. Accessed 4/6/21
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Vaccine effectiveness (duration of protection/comparison of products/virus variants)
Can I get a breakthrough infection despite being fully vaccinated? - Yes. No vaccine is 100% effective. However, breakthrough infections, cases where individuals get infected after being fully vaccinated, happen much less often than infections in unvaccinated people1
- The most prominent strain in the U.S., the Delta variant, is highly contagious—more than 2x as contagious as previous variants; the Delta variant also seems to produce the same high amount of virus in both unvaccinated and fully vaccinated people, whereas previous variants typically produced less virus in the body of infected fully vaccinated people1
- The vaccines—both the mRNA (PfizerBioNTech and Moderna) and the adenovirus vector (J&J) vaccines offer good protection against severe disease and death from the Delta variant—assuming individuals are fully vaccinated2
- They offer less protection—but still a reasonable amount of protection—from actual infection w/ the highly transmissible Delta variant2
- Although we’ve limited pt outcome data on the J&J vaccine, we’re also not hearing about large numbers of breakthrough cases in the U.S. w/ individuals vaccinated w/ that vaccine2
- The great majority of breakthrough infections are mildly symptomatic, or symptomatic similar to a bad cold or the flu, typically lasting 2 or 3 days2
- While it’s possible for someone w/ a breakthrough infection to get hospitalized and even die–the chances are very low for fully vaccinated individuals–about 0.0003%2
Even if I’m protected from death & hospitalization, is there a chance I can develop long COVID? What if I’m asymptomatic--can I get long COVID? - Background: Post-COVID conditions—known as long COVID, long-haul COVID, or chronic COVID—are a wide range of new, returning, or ongoing health problems experienced ≥4wk after initial SARS-CoV-2 infection. Post-COVID conditions can occur in unvaccinated pts who’ve had varying degrees of illness during acute infxn, incl those who’ve had mild or asymptomatic infxns1
- Clinicians and researchers are still in the early stages of understanding post-COVID conditions1
- However, there’s a lack of good data around long COVID and breakthrough infxns; as of 5/1/21, CDC only tracks breakthrough infections that lead to hospitalization & death, but not all outcomes, such as long COVID
- Another data limitation—it’s possible that not enough time has passed to identify COVID long-haul pts following vaccinations that rolled out as recently as April 2021
- One peer-reviewed study of 1,497 fully vaccinated health care workers in Israel published July 28, 2021 in The New England Journal of Medicine, however, does suggest that long COVID can develop after vaccination. In this small study, 39 people had breakthrough infections. While most breakthrough cases were mild or asymptomatic, 19% had persistent sx (>6wk), incl fatigue, HA, muscle pain, and loss of taste & smell; access NEJM article
Even if I’m fully vaccinated, can I spread COVID-19 to others? - Yes. Fully vaccinated people with Delta-variant breakthrough infections can spread the virus to others
- However, the greatest risk of transmission is among unvaccinated people who are much more likely to contract, and therefore transmit the virus1
- There’s also evidence that vaccinated people appear to be infectious for a shorter period1
How long does protection last after being vaccinated? Will I need a booster shot? Am I still considered “fully vaccinated” if I don’t get a booster shot? - There’s evidence that over time, the protection that vaccinated individuals have against the virus wanes. This may also be due to emerging variants2
- Even though we don’t know for sure exactly how long protection lasts, we do know that at 6mo the level of protection remains high and actual protection could be much longer2
- To be optimally protected, the CDC says that a person needs to get a booster shot when and if eligible
- However, the definition of fully vaccinated has not changed and does not include the booster shot. Everyone is still considered fully vaccinated 2wks after their 2nd dose in a 2-shot series, such as the Pfizer-BioNTech or Moderna vaccines, or 2wks after a single-dose vaccine, such as the J&J/Janssen vaccine
Is one vaccine better than the other? - All 3 vaccines are considered to be highly efficacious. However, on December 17, 2021, CDC endorsed updated guidance from the Advisory Committee on Immunization Practices (ACIP), expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech) over the Janssen (Johnson & Johnson) COVID-19 vaccine
- CDC Director Dr. Rochelle Walensky signed off on the new policy following ACIP's unanimous vote, which cited concerns over the increased risk of potentially fatal thrombosis associated with the J&J vaccine
- The panel said that exceptions should be made for those who've had allergic reactions to mRNA vaccines, or where those vaccines are unavailable. Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to the J&J vaccine
- The currently authorized mRNA vaccines have comparable efficacy & similar safety profiles1,3
- Pfizer-BioNTech vaccine had a 95% efficacy in clinical trials, while the Moderna vaccine had a 94.5% efficacy for prevention on symptomatic COVID-19. Note: The trials didn’t evaluate for asymptomatic cases3
- Janssen's vector-based COVID-19 vaccine was 67% effective overall in preventing moderate to severe/critical COVID-19 ≥14 days after vaccination, and 66% effective in preventing moderate to severe/critical COVID-19 at ≥28 days after vaccination, per the FDA’s analysis of ongoing RCTs being conducted in South America, Mexico, and the U.S. (N=39,321)
- Regional differences in efficacy of the Janssen vaccine were noted, w/ the highest efficacy seen in the US (74.4%), followed by Latin America (64.7%), and South Africa (52.0%). Regional differences in circulating virus variants were also noted: in South Africa, 94.5% were of the B.1.351 lineage, while in Brazil, the P.2 lineage accounted for 69.4%
- Note: It’s important to consider differences in virus transmission and presence of virus variants btwn the time periods during which clinical trials of the mRNA vaccines (Moderna & Pfizer-BioNTech) and the vector-based (Janssen) were being conducted
Do the vaccines work well in older individuals? - Yes, similar efficacies have been observed among older participants in clinical trials1,3
- Severe adverse reactions were generally less frequent in older persons (>55 yo for the Pfizer-BioNTech vaccine, ≥65 for the Moderna vaccine) compared w/ younger persons1,3
- CDC will continue to monitor the effectiveness of the vaccines in individuals ≥65 due to known age-related immune system changes that result in older individuals not responding as well to vaccination as younger people1
Do the vaccines work against new variants of the virus, including the Delta variant? - The COVID-19 vaccines authorized in the U.S. are highly effective at preventing severe dz & death, incl against the latest Delta variant
- However, they are not 100% effective & some fully vaccinated people will become infected (called a breakthrough infection) and experience illness. For such people, the vaccine still provides them strong protection against serious illness & death
- Delta variant. The Delta variant called B.1.617.2 is the predominant strain of the virus in the U.S. Contributing to a surge of cases in India, the U.K. and now across the globe, the Delta variant causes more infections & spreads faster than earlier forms of SARS-CoV-2; some data suggest the Delta variant might cause more severe illness than previous strains in unvaccinated persons; fully vaccinated people w/ symptomatic Delta-variant breakthrough infections can spread the virus to others; however, vaccinated persons appear to be infectious for a shorter period; CDC continues to assess data on whether fully vaccinated people w/ asymptomatic breakthrough infections can transmit the virus to others
- UK variant. The UK identified a variant called B.1.1.7. w/ a large number of mutations in the fall of 2020; this more transmissible variant was first detected in the U.S. at the end of December 2020. In January 2021, experts in the U.K. reported that this variant may be assoc w/ increased risk of death compared to other variant viruses, but more studies are needed to confirm this finding
- South African variant. In South Africa, another variant called B.1.351 emerged independently of B.1.1.7.; cases w/ this variant, which shares some mutations w/ B.1.1.7., were reported in the U.S. at the end of January 2021
- Brazilian variant. In Brazil, a variant called P.1 emerged that was first identified in travelers from Brazil. It was first detected in the U.S. at the end of January 2021. This variant contains a set of additional mutations that may affect its ability to be recognized by antibodies
- COVID-19 vaccination (using the currently available vaccines) will not only prevent spread of the virus, but will also help curb its ability to mutate into new variants
Can taking NSAIDs/acetaminophen either before/after vaccination interfere w/ the vaccine’s immune response? - No. Although the CDC doesn’t recommend taking antipyretics/analgesics (eg, acetaminophen, NSAIDs incl ibuprofen) prophylactically to treat possible side effects, it’s OK for newly vaccinated individuals to take either med after vaccination to treat any side effects, provided they have no medical contraindications to the use of these meds1
- Similarly, individuals already taking antipyretic/analgesic meds for the tx of other medical conditions don’t need to stop doing so either before/after receiving the COVID-19 vaccine1
- Also, in studies on the Pfizer & Moderna vaccines, there was no prohibition on taking acetaminophen/ibuprofen, so some people likely did take these, and still the protection rate was >90%3
Footnotes 1 CDC 2022.
COVID-19 Vaccine Booster Shots. Updated 2/2/22. Accessed 2/23/22
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
What You Need To Know about Variants. Updated 8/6/21. Accessed 8/17/21
Delta Variant: What We Know About the Science. Updated 8/19/21. Accessed 8/20/21
Shimabukuro T, et al. CDC COVID-19 Vaccine Task Force. COVID-19 Vaccine Safety Update. Advisory Committee on Immunization Practices (ACIP). January 27, 2021. Accessed 4/6/21
Post-COVID Conditions: Information for Healthcare Providers. Updated 7/9/21. Accessed 8/25/21
2 Frequently Asked COVID-19 Vaccine Questions. JN Learning TM. August 16, 2021. Video Transcript. Accessed 8/19/21
3 FDA 2021.
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Statement. Jan 4, 2021. Accessed 1/7/21
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/10/20. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/17/20. FDA Briefing Document. Moderna COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 2/26/21. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Free full-text PDF
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Administration (boosters/cost/access/missed dose)
Who can get a booster shot? - If you initially received Pfizer-BioNTech OR Moderna, are ≥18 yo, and it’s been at least 5 mo after completing your primary COVID-19 vaccination series then Pfizer-BioNTech OR Moderna (mRNA COVID-19 vaccines) are preferred in most situations
- If you received Pfizer-BioNTech, are btwn 12-17 yo, and it’s been at least 5 mo after completing your primary COVID-19 vaccination series then you may only get a Pfizer-BioNTech COVID-19 vaccine booster
- If you received Johnson & Johnson’s Janssen vaccine, are ≥18 yo, and it’s been at least 2mo after receiving your J&J/Janssen COVID-19 vaccination, then Pfizer-BioNTech OR Moderna (mRNA COVID-19 vaccines) are preferred in most situations
When is the J&J/Janssen COVID-19 vaccine preferred as a booster shot? - If you've had a severe reaction after an mRNA vaccine dose or have a severe allergy to an ingredient of Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines)
- If you’ve otherwise remain unvaccinated for COVID-19 due to limited access to Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines)
- If you want to get the J&J/Janssen COVID-19 vaccine despite the safety concerns
What if I miss my 2nd dose? Can I switch vaccines for my 2nd dose? - It’s important to complete the 2-dose series of the mRNA vaccines to optimize protection & minimize public health risks, per FDA;3 (however, this doesn’t apply to the Janssen COVID-19 Vaccine, a vector-based vaccine that only requires a single dose administered intramuscularly)
- CDC now also recommends that people whose immune systems are compromised moderately to severely receive an additional dose of mRNA COVID-19 vaccine at least 28 days after the second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine; a third dose of the same mRNA vaccine should be used; however, if the mRNA vaccine product given for the first 2 doses is not available/unknown, either mRNA COVID-19 vaccine product may be administered; a person should not receive more than 3 mRNA vaccine doses
- Pts shouldn't be scheduled to receive their 2nd doses earlier than recommended (21 days apart for Pfizer-BioNTech, 28 days apart for Moderna). However, 2nd doses given w/in a grace period of 4 days earlier than recommended are still considered valid. Second doses inadvertently given earlier than the grace period shouldn't be repeated1
- Although 2nd doses should be administered as close to the recommended interval ( 21 days apart for the Pfizer-BioNTech vaccine & 28 days apart for the Moderna vaccine), if this isn’t possible, 2nd doses can be given up to 6wk (42 days) after 1st dose w/o having to restart the series. Even if vaccines are administered >6wk after 1st dose, there’s still no need to restart the series (although there’s limited data on the efficacy of mRNA COVID-19 vaccines given beyond this window)1
- Pts should complete their vaccine series w/ the same product as their first dose; the Pfizer-BioNTech & Moderna vaccines aren't interchangeable;1,3 however, CDC allows that in exceptional situations (eg, provider can’t determine which vaccine the pt received the first time or 1st-dose is no longer available) any available mRNA COVID-19 vaccine may be administered to complete the series as long as it’s done so w/in a minimum interval of 28 days after the 1st dose. If 2 doses of different mRNA COVID-19 vaccine products are administered, no additional doses of either product are recommended at this time
- Encourage pts to enroll in CDC’s VaxText,SM a free text message-based platform to receive COVID-19 vaccination 2nd-dose reminders as well as the smartphone tool v-safe that allows for personal check-ins following vaccination1
How does the Janssen COVID-19 Vaccine (Johnson & Johnson) differ from the other 2 available COVID-19 vaccines? - Only 1 IM dose vs 2 doses for the mRNA vaccines
- Doesn’t require ultracold storage so easier to distribute and store: uses a modified adenovirus (unable to cause illness), to deliver spike protein DNA that’s more stable than mRNA vaccines that rely on lipid nanoparticles requiring ultracold temps for storage/transport
Can I choose which vaccine I get? - Yes. All currently authorized and recommended COVID-19 vaccines are safe and effective. However, on December 17, 2021, CDC endorsed updated guidance from the Advisory Committee on Immunization Practices (ACIP), expressing a clinical preference for individuals to receive an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech) over the Janssen (Johnson & Johnson) COVID-19 vaccine
Is the vaccine free?
- The vaccine itself is free, but vaccination providers can charge an administration fee; vaccine providers can bill the pt’s public or private insurance, or for uninsured pts, the Health Resources and Services Administration’s Provider Relief Fund1
- Medicare Part B covers FDA-approved COVID-19 vaccines1
Footnotes 1 CDC 2022.
COVID-19 Vaccine Booster Shots. Updated 2/2/22. Accessed 2/23/22
Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety. Updated 2/22/22. Accessed 2/24/22
Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. Media Statement. Released 8/18/21. Accessed 8/18/21
Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/20
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
COVID-19 Vaccines for Moderately to Severely Immunocompromised People. Updated 8/13/21. Accessed 8/13/21
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Post-vaccination: Now what?
Do I still need to quarantine after vaccination if I’m exposed to someone w/ COVID-19? - No. Fully vaccinated individuals who’ve had close contact (w/in 6 ft for a cumulative total of 15min or more over a 24-hr period) to someone w/ suspected or confirmed COVID-19 need not quarantine unless they have sx, which may appear 2-14 days after exposure to the virus
- However, fully vaccinated people should get tested 3-5 days after their exposure, even if they don't have sx, & wear a mask indoors in public for 14 days following exposure or until their test result is negative; such individuals should isolate for 10 days if test results are positive
Do I still need to mask/social distance after getting the full dose of the vaccine? - In general, Americans who are fully vaccinated don’t need to wear a mask or social distance 6 feet apart in outdoor settings EXCEPT in areas w/ high numbers of COVID-19 cases. In such areas, CDC recommends that individuals consider wearing a mask in crowded outdoor settings and for activities w/ close contact w/ others who are not fully vaccinated
- CDC also recommends (as of 7/27/21) that fully vaccinated individuals wear a mask in public indoor settings in areas of substantial or high transmission to maximize protection from the Delta variant & prevent possibly spreading it to others; fully vaccinated people might choose to mask regardless of the level of transmission, esp if they or someone in their household is immunocompromised or at increased risk for severe dz, or if someone in their household is unvaccinated
- Fully vaccinated = ≥2wk after receiving ALL recommended doses of an FDA-authorized COVID-19 vaccine (Pfizer, Moderna, or Janssen [J&J]) or WHO-designated COVID-19 vaccine are considered fully vaccinated for purposes of U.S. public health guidance
- People who have a condition or are taking medications that weaken their immune systems may NOT be protected even if they are fully vaccinated. They should continue to take all precautions recommended for unvaccinated people, incl wearing a well-fitted mask, until advised otherwise by their healthcare provider
- CDC continues to recommend that fully vaccinated individuals continue 1) to mask and physically distance when going to doctors, hospitals or long-term care facilities like nursing homes; when traveling (by bus, plane, train or other public transportation), or while in transportation hubs (eg, airports, bus stations); and when in prisons, jails, or homeless shelters and 2) abide by existing state, local, or tribal laws & regulations as well as local business & workplace guidance
- Fully vaccinated people who develop sx should get tested and still use masks, and stay home and away from others
- Fully vaccinated individuals traveling w/in the US: Do not need to get tested before or after travel or self-quarantine after travel
- Fully vaccinated international travelers arriving in the U.S.: Still are required to get tested w/in 3 days of their flight (or show documentation of recovery from COVID-19 in the past 3 mo) and should still get tested 3-5 days after their trip
Will prior receipt of an mRNA vaccine affect COVID-19 test results? - Prior vaccination won't affect SARS-CoV-2 viral tests (NAAT or antigen tests)1
- Since the Pfizer-BioNTech & Moderna vaccines encode the spike protein, a positive test for spike IgM/IgG could indicate either prior infxn or vaccination1
- To evaluate for prior infxn in an individual w/ hx of mRNA vaccination, CDC recommends evaluating for IgM/IgG to the nucleocapsid protein (rather than spike protein)1
- Antibody testing isn’t currently recommended to assess immunity following mRNA vaccination or to assess need for vaccination in unvaccinated persons1
How does one prove they’ve been vaccinated? - A COVID-19 vaccination card (or printout) is provided to all vaccinated individuals1
- The card includes the name of the vaccine administered, date it was given, & location of administration
COVID-19 Vaccination Record Card Does the CDC keep track of who has been vaccinated? - No. CDC doesn't maintain nor monitor a person's vaccination records1
- Although the federal government doesn't mandate vaccination for people, whether a state or local government or employer can require or mandate COVID-19 vaccination depends on state or other applicable law1
What if I was in the clinical trial for the Novavax vaccine? Am I considered fully vaccinated? - CDC considers participants in the Novavax PREVENT-19 Phase 3 trial to meet criteria to be fully vaccinated 2wk after they have completed the vaccine series; if they didn’t receive the full 2-dose series, pts should be encouraged to follow current prevention measures and offered an FDA-authorized or approved vaccine series; company press release
Footnotes 1 CDC 2021.
Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Updated 8/11/21. Accessed 8/12/21
Possible Side Effects After Getting a Covid-19 Vaccine. Updated 8/6/21. Accessed 8/17/21
Dooling K, et al. ACIP COVID-19 Vaccines Work Group. Phased Allocation of COVID-19 Vaccines. ACIP Meeting. December 20, 2020. Free full-text PDF
Vaccine Recipient Education. Updated 11/2/20. Accessed 8/17/21
Frequently Asked Questions about COVID-19 Vaccination. Updated 8/11/21. Accessed 8/17/21
What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine. Updated 12/13/20. Free full-text PDF
Interim Public Health Recommendations for Fully Vaccinated People. Updated 7/28/21. Accessed 8/17/21
When You’ve Been Fully Vaccinated. How To Protect Yourself and Others. Updated 7/27/21. Accessed 8/1/21
2 FDA 2021.
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Statement. Jan 4, 2021. Accessed 1/7/21
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/10/20. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 12/17/20. FDA Briefing Document. Moderna COVID-19 Vaccine. Free full-text PDF
Vaccines and Related Biological Products Advisory Committee Meeting. Published 2/26/21. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Free full-text PDF
Your Guide To Masks. Updated 8/13/21. Accessed 8/17/21.
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