Communicating About COVID-19 Vaccination

(Updated January 14, 2021)

COVID-19 vaccines currently available for use either have an Emergency Use Authorization (EUA; in the U.S.) or an Interim Order (Canada). See our chart, COVID-19 Vaccines, for a comparison of available COVID-19 vaccines. The chart below answers common questions your patients may have about COVID-19 vaccination and includes talking points and strategies to address COVID-19 vaccine misconceptions.

Question

Answer/Pertinent Information

COVID-19 vaccines are being approved more rapidly than other vaccines. How can you reassure patients about this expedited approval process?

The COVID vaccine has been developed at a more rapid pace than what is normally seen with other vaccines. But this does NOT mean safety steps have been skipped.34 The vaccine development process has been expedited because of the pandemic (e.g., early funding to ramp up manufacturing, overlapping phases of trials).34

  • Operation Warp Speedb (U.S.) and International Coalition of Medicines Regulatory Authorities (ICMRA [Canada]) are helping ensure the rapid development process still adheres to safety and efficacy standards.11,28

COVID-19 vaccines are going through the same RIGOROUS approval process as other approved vaccines. Data are reviewed/analyzed by independent experts (i.e., not scientists employed by the manufacturer). The independent reviewer recommendations are then presented to the approving agency (e.g., FDA, Health Canada).50

Reassure patients that COVID-19 vaccine safety is a top priority.21,27 COVID-19 vaccines are being studied through phased testing to ensure safety and efficacy before they are made available to the public.

  • In addition to phase 1 and 2 trials, phase 3 trials are enrolling between 30,000 and 40,000 participants per trial.23 Trials are expanding the patient populations being studied. In the initial studies, most participants have been adults, including those with chronic conditions (e.g., diabetes, hypertension, cardiovascular disease, chronic respiratory disease).17,19 As we get further into the trial process, more trials will be including patients as young as 12 years old.23,42
  • Safety monitoring will continue even after vaccines are authorized or approved for use. Explain that in addition to standard vaccine monitoring additional monitoring will be done.
    • For example, in the U.S., V-SAFEa is a new smartphone-based healthcare checker to use after vaccination. It will use CDC text messages and web-based surveys to check in with recipients of a COVID-19 vaccine.17

Some of the COVID vaccines are utilizing new types of technology. How can you reassure patients these newer vaccines are safe?

Many COVID-19 vaccines are a new type of vaccine (e.g., messenger ribonucleic acid [mRNA], viral vectors).22,35

  • Explain to patients how COVID-19 vaccines work.22,35
    • mRNA vaccines (e.g., mRNA-1273 [Moderna], BNT162b2 mRNA [Pfizer/BioNTech]) give our cells a blueprint for how to make a piece of a SARS-CoV-2 “spike” protein (note this piece of the SARS-Co-V-2 “spike protein” is harmless to the vaccine recipient). This triggers an immune response. Once the blueprint is delivered, the messenger (mRNA) is broken down.
    • Vector vaccines (e.g., AZD1222 [AstraZeneca], Ad26COVS1 [Johnson & Johnson]) use a weakened version of a different live virus with a viral vector (genetically inserted material from COVID-19). The viral vector teaches the vaccinated person’s body to build cells to fight COVID-19.
  • Explain that mRNA and viral vector COVID-19 vaccines do NOT contain the SARS-CoV-2 virus.22,35
  • Reassure patients that mRNA vaccines do NOT affect a person’s genetic material (DNA).22
  • Reassure patients that scientists have been studying mRNA vaccines for >15 years.34 Even though COVID-19 vaccines will be the first mRNA vaccines to come to market, it is not new science. Over the years of studying mRNA vaccines (e.g., influenza, Zika, cytomegalovirus, rabies) researchers have been able to solve problems that previously kept these vaccines from coming to market (e.g., vaccine instability, inflammatory outcomes, modest immune response).22

What are some talking points to use with patients who may be hesitant to get vaccinated for COVID-19?

Remind patients about the benefits of COVID-19 vaccination. Vaccination may:16

  • reduce illness severity if you become infected with COVID-19.
  • protect friends, family, co-workers, and close contacts from getting COVID-19.

Explain that the COVID-19 vaccine is one important tool in the toolbox to end the pandemic.16

  • Social distancing and masks reduce the chance of exposure to the coronavirus that causes COVID-19.16
  • Vaccination gets your immune system ready to fight COVID-19 infection if exposed.16
  • Vaccination is also an important step in the development of herd immunity.20
    • Herd immunity is when it is unlikely that a bacteria or virus can spread and cause disease because a large enough proportion of people are protected or considered immune.2 More data are needed to know how many people need to be protected to achieve herd immunity against COVID-19.2 Some predict that about 75% to 80% of the U.S. population would need to be vaccinated to achieve herd immunity.32
    • Caution patients that relying on natural immunity to achieve herd immunity to COVID-19 would mean hundreds of millions of people would have to recover from COVID-19 and during the time it would take for that many to recover, many more people could experience COVID-19 complications or death.51

Encourage vaccination as the safer path toward immunity.

  • There is no way to predict how severe a COVID-19 infection will be for anyone, and infections can be fatal.4,12,16
  • COVID-19 infection has been associated with long-term consequences, even in young healthy people (e.g., lung, heart, and memory problems; mood changes; kidney damage).4,5
  • Tell patients that we don’t know how long natural immunity (antibodies from exposure to the virus through infection) or vaccine-induced immunity (antibodies from vaccination) lasts.3 But explain that early evidence suggests that natural immunity does NOT last very long,2 and with the limited evidence available about vaccines, it appears it may last longer.46

What are the expected short-term adverse effects with COVID-19 vaccination?

Be transparent that patients may experience short-term adverse effects after vaccination (i.e., don’t sugarcoat or downplay these adverse effects). For other two-dose vaccines, this has been a well-received strategy in ensuring patients returned for their second dose (e.g., Shingrix vaccine).52

  • Note that younger patients may be more likely than older patients to experience side effects.41
  • Explain that most patients can expect mild to moderate pain or soreness at the injection site, while redness and swelling are significantly less common.15,18,33,41
  • Many patients will experience systemic reactions, within about two days of vaccination. These usually go away within a day or two.33 This is a normal response to a vaccine and means the body is building antibodies to prevent infection. Systemic adverse effects may be more likely with the second dose.7,41,55 Example systemic reactions and frequency over placebo with the BNT162b2 mRNA (Pfizer/BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines:1,41
    • fatigue/malaise 10% to 15% (first dose); 35% to 45% (second dose)
    • headache: less than 10% (first dose); 20% to 40% (second dose)
    • fever/chills: <10% (first dose); 10% to 20% (fever second dose); 20% to 42% (chills; second dose)
    • myalgia/arthralgia: ≤10% (first dose); 15% to 35% (second dose)

What can patients do to minimize expected vaccine adverse effects?

Help patients reduce and prepare for adverse effects. For example:

  • Some vaccine trials allowed the use of acetaminophen post vaccination.1,10,15,41 For example, up to 45% of participants (Pfizer/BioNTech) or 57% (Moderna) used a fever reducing medication (e.g., acetaminophen) after at least one of the mRNA vaccine doses.1,41 The impact of prophylactic use of acetaminophen was not evaluated in the Pfizer/BioNTech or Moderna vaccine trials. Some of the testing sites for the AZD1222 viral vector (AstraZeneca) vaccine did allow prophylactic and post-vaccination acetaminophen use (e.g., 1 gram prior to vaccination and continued every six hours for 24 hours after vaccination).15
    • All three studies found reduced adverse effects in those that used acetaminophen.1,15,41
    • Acetaminophen use with AZD1222 vaccine (AstraZeneca) did not impact immunogenicity.15
    • Currently the CDC supports use of antipyretic or analgesic meds (e.g., acetaminophen, ibuprofen) AFTER vaccination with an mRNA COVID-19 vaccine. However, use of prophylactic acetaminophen before vaccination with an mRNA COVID-19 vaccine is not recommended until we know more about the impact on immunogenicity.49
  • Suggest getting vaccinated when they will have a few days to rest and recover (i.e., on a Friday if they don’t work weekends). Similarly, healthcare facilities may want to stagger staff vaccinations in order to minimize personnel shortages in case people are unable to work for a day or two after vaccination.29

Have there been serious or unusual adverse effects from COVID-19 vaccination?

Serious adverse effects from COVID-19 vaccination seem extremely rare. But it takes time and large numbers of people getting vaccinated before we may know more about possible adverse effects. Safety monitoring will continue even after a COVID-19 vaccine is approved.4

  • If a safety issue is identified, it will be evaluated to see if it is related to the vaccine.4 For example:
    • Bell’s palsy was noted more often in mRNA vaccinated patients than those who received a placebo. The rate of Bell’s palsy in vaccinated patients seems similar to the expected rate in the general population. Though, there is no suspected causal relationship, surveillance will continue as more vaccine doses are given.1,8
    • Transverse myelitis was noted in an AZD1222 (viral vector vaccine) trial. Monitoring for neurologic events will continue and will be provided to experts for review.60

There have been reports of severe allergic reactions including possible anaphylaxis, with the Pfizer/BioNTech COVID-19 vaccine.44,47,58 Anaphylaxis is a known, but rare side effect with any vaccine.44

  • Reassure patients that in general anaphylaxis due to a vaccination is rare.45 In fact, in the U.S. studies, 0.63% of vaccinated patients versus 0.51% of placebo patients reported possible allergic reactions in trials.45
  • The COVID-19 vaccines are contraindicated in anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.10,38,49,57,58
  • For patients with a history of severe allergic reactions, monitor patients receiving an mRNA COVID-19 vaccine for 30 minutes.47
  • Monitor all other patients for 15 minutes after receiving an mRNA COVID-19 vaccine.47

What are long-term safety concerns with COVID-19 vaccination?

More time and data are needed to assess long-term safety of the COVID-19 vaccines.

What are strategies to encourage patients to return for the second dose of their COVID-19 vaccination?

Stress the importance of completing the vaccination series with the same vaccine (COVID-19 vaccines are NOT interchangeable),36 if more than one dose is needed (most COVID-19 vaccines currently in development require two doses separated by a few weeks).2

  • Give patients vaccine cards with product specific information about the vaccine they received and second-dose reminders/date to return.48
  • Consider searching immunization registries if patients received their first dose somewhere else and they are not sure which vaccine they received. U.S. subscribers can review our Immunization Registry FAQs, to learn more about registry capabilities.

Help patients understand why two doses are used for many vaccines, including most of the COVID-19 vaccines.

  • Vaccines work by teaching the body to recognize and fight a specific foreign substance (e.g., virus, bacteria).26
  • Vaccines do NOT replicate in our bodies like viruses and bacteria do.26
  • Think of the first dose as a primer. The body is starting from scratch to recognize and fight the bacteria or virus.26
  • Think of the second dose as a booster. It provides the body another opportunity to learn how to respond, and to create even more memory cells against the bacteria or virus.26

Consider these tips to improve the likelihood patients will return for second doses:

  • Make a strong recommendation to return for second doses. This can be a powerful motivator.23
  • Utilize reminder systems within your computer systems.23
  • Have patients schedule their appointment for their second dose when they receive their first dose
  • Use technology to remind patients (e.g., apps, texts, emails, phone calls)

See our toolbox, Medication Adherence Strategies, for other adherence ideas.

What happens if the second COVID-19 vaccine dose is not given on schedule (too soon or too late)?

To get the most benefit from vaccination, adhere to recommended intervals between doses when possible.53

  • In general, when vaccine doses are given too close together, this can lead to a smaller immune response to the vaccine compared to when doses are given according to recommended schedules.53
  • For some vaccines, the series needs to be restarted if subsequent doses are delayed too long.54

For COVID-19 vaccines, it is too soon to know how early or late second doses will impact immunity.

  • Feel comfortable giving the second dose of the Pfizer/BioNTech mRNA vaccine between 17 and 21 days after the first dose.49 Feel comfortable giving the second dose of the Moderna mRNA vaccine between 24 and 28 days after the first dose.49
    • If a dose is given earlier than day 17 (Pfizer/BioNTech) or 24 (Moderna), it is not necessary to repeat.49
    • If a dose is given later than day 21 (Pfizer/BioNTech) or 28 (Moderna), give the second dose as soon as possible. It is not necessary to restart the series.49
  • More data are needed before guidance can be given about how to handle early or late second doses of other COVID-19 vaccines being studied.

How long does it take to develop immunity after COVID-19 vaccination and how long does immunity last?

It usually takes a few weeks after any vaccination to develop immunity.35 See our chart, Vaccines for COVID-19, for specific timing to develop immunity for each of the available COVID-19 vaccines.

  • Though some protection may be provided with first doses of vaccines that require two doses, maximal protection does not seem to take effect until days to weeks after the second dose.10,41 Regardless, after vaccination, safety measures should still be used until we know more about real world protection from COVID-19.2,9

We still don’t know how long immunity after vaccination will last.12,34 Explain that we only have data for as long as the trials have been going on.9 Once we have more data about how long vaccine-induced immunity lasts, it will be possible to determine how often patients may need to be vaccinated against COVID-19 to maintain immunity.12

Can a COVID-19 vaccine cause a COVID-19 infection?

No.34 None of the COVID-19 vaccines currently in development use the live SARS-CoV-2 virus.6

Will COVID-19 vaccination lead to a positive COVID-19 test?

COVID-19 vaccination may lead to a positive test for COVID-19 antibodies (serology tests).6

COVID-19 vaccination will NOT lead to a positive test for active COVID-19 infection (molecular or polymerase chain reaction [PCR] tests and/or antigen tests).6

If vaccine supplies are limited, who will be prioritized for vaccination?

Vaccination may occur in multiple phases. Sub-prioritization within the phases may be needed when vaccine supplies are limited. For example:14,25,29

  • Phase 1a: healthcare workers and residents living in long-term care facilities
  • Phase 1b: people 75 years or older and frontline essential workers
  • Phase 1c: people between 65 and 74 years, people 16 to 64 with high-risk conditions (see below), essential workers not vaccinated in phase 1b
  • Phase 2: everyone 16 years and older, not vaccinated during phase 1

Per ACIP, there are currently four priority groups for COVID-19 vaccination if supply is limited. These priority groups include healthcare workers essential/critical workers (e.g., law enforcement, first responders, educators, grocery store workers, food manufacturers); people with certain underlying medical conditions that put them at risk for severe COVID-19 illness (e.g., cancer, chronic obstructive pulmonary disease [COPD], heart failure, severe obesity, type 2 diabetes); and people age 65 years and older.13

What do we know about COVID-19 vaccines during pregnancy?

There are currently little to no data available about the safety or efficacy of COVID-19 vaccines during pregnancy.1,8,29 The medication and vaccine approval process typically assesses safety and efficacy in healthy women of childbearing age, before testing them in pregnant patients.30

Though pregnant patients were excluded from initial trials, information about vaccine effects and possible adverse effects are being collected (and will be evaluated) in patients that became pregnant during clinical trials.1,8

Data emerge every day about COVID-19. Stay informed, use shared decision making, and think about the following when COVID-19 vaccination is being considered during pregnancy:30

  • What is known about the safety of available COVID-19 vaccines?
  • What are the risks to the pregnant patient and the fetus if infected with COVID-19?
  • Is the pregnant patient at high-risk of becoming infected with COVID-19 (i.e., front-line healthcare worker)?

Gynecology and obstetrics experts, as well as the CDC, support offering mRNA COVID-19 vaccines to pregnant and lactating patients. As more data become available, updates to these recommendations will be made.49,56,59

What do we know about safety and efficacy of COVID-19 in immunocompromised patients?

Patients who are immunocompromised were not included in early COVID-19 vaccine trials.

We know that people who are immunocompromised are at risk for severe illness from COVID-19.37

We also know that people who are immunocompromised may have a lesser response to vaccinations compared to patients who are immunocompetent.40

Per the CDC, it is acceptable to offer an mRNA COVID-19 vaccine to patients with immunocompromising conditions.49 Be sure to counsel these patients about the lack of data and the potential for a reduced immune resonese.49

For patients who opt not to receive the vaccine, counsel patients to continue to follow recommendations to reduce risk of infection (e.g., social distancing, hand washing) and wait until we have more vaccine data in these patient populations.39,49

Can COVID-19 vaccines be given with other vaccines?

There are no data available about safety or efficacy of coadministration of a COVID-19 vaccine and other vaccines.31

Initially, it may be best to separate vaccinations. This way adverse effects can be monitored and specifically linked to individual vaccines.

For mRNA COVID-19 vaccines, give alone or with a minimum of 14 days before or after other vaccines.49

Should someone who has COVID-19 or who was previously infected get vaccinated?

More data are needed to know if people who had COVID-19 will benefit from a COVID-19 vaccine.6 People may be advised to get vaccinated because COVID-19 is a significant health risk and there have been cases of reinfection.

Explain it is not harmful to get a COVID-19 vaccine if you have had COVID-19 in the past. Previous COVID-19 infection (with or without symptoms) is NOT a contraindication to COVID-19 vaccination.29

It may be reasonable for people with past COVID-19 infections to delay COVID-19 vaccination until closer to 90 days after infection (especially when vaccine supply is limited), as reinfection during this timeframe is rare.29,49

Defer vaccination with an mRNA COVID-19 vaccine until patients have recovered from the acute illness.49

There is NOT clear guidance on whether or not to give other COVID-19 vaccines being studied to someone currently infected with COVID-19. In general, for most vaccines moderate to severe illness is considered a precaution against vaccination, while vaccination during a mild illness (with or without fever) is not a precaution.43

How will U.S. pharmacists bill for COVID-19 vaccinations?

There will be no charge to patients for the COVID-19 vaccine (funded by the government). However, there may be an administration fee for vaccination.2

  • Regardless of the number of required doses, use the volume to be injected as the quantity (e.g., 0.5 mL), “1” as the days supply, “MA” as the professional services code, and $0.00 or $0.01 depending on the payer.

For COVID-19 vaccines that require two doses, use submission clarification code (SCC) of:24

  • “2” for the first dose (i.e., “other override” defined as, “used when authorized by the payer in business cases not currently addressed by other SCC values,” to indicate giving the first dose of a two-dose vaccine).
  • “6” for the second dose (i.e., “starter dose” defined as, “the pharmacist is indicating that the previous medication was a starter dose and now additional medication is needed to continue treatment,” to indicate giving the final dose of a two-dose vaccine).

Are safety precautions (e.g., masks, social distancing) still necessary after COVID-19 vaccination?

Yes.34 Until more is known about “real world” protection provided by COVID-19 vaccines, advise patients to:2

  • socially distance (stay at least six feet apart from other people)
  • practice good hand hygiene (e.g., hand washing/sanitizing)
  • wear a mask/face covering

It is too soon to know if COVID-19 vaccines will stop a person from spreading the virus, even people who are asymptomatic. For example, it may be possible that if someone was vaccinated and then exposed to the virus, though they might not get sick, they could still spread the virus to others.9

Implementation of safety precautions may change over time as we learn more about the protection provided by COVID-19 vaccination. The number of people who get vaccinated and virus spread in local communities may also play a role in determining this.2

  1. For more information about the V-SAFE monitoring system go to https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-09/COVID-03-Shimabukuro.pdf.
  2. Operation Warp Speed is comprised of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD).

Prepared by the Editors of Therapeutic Research Center (370101); Last modified January 14, 2021.

References

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Cite this document as follows: Clinical Resource, Communicating About COVID-19 Vaccination. Pharmacist’s Letter/Prescriber’s Letter. January 2021.

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