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COVID-19 mRNA VaccinesFAQ for Clinicians and Vaccine Providers Version 7 / March 8, 2021The San Francisco Department of Public Health (SFDPH) is sharing this FAQ regarding administration of COVID-19 vaccines, to assist local vaccination providers in developing their own procedures. (See also Sample Protocols). This document is based on sources, knowledge, and recommendations current as of the date above but subject to change without notice. We will provide updates as new information emerges. Users should consult FDA, CDC, and CDPH sources for initial and updated guidance. 3/8/2021 UpdatesReflects 2/27/2021 FDA authorization and 3/3/2021 ACIP recommendations for use of Janssen vaccine Significant updates to information on vaccine consent, vaccine contraindications and precautions, completion of vaccine series with different products, which patients require a 30-min observation period post-vaccinationQuestionPfizer-BioNTechModernaJanssenConsent Written informed consent required?No, the EUA does not require specific consent for COVID-19 vaccination. Consent for treatment (general consent) is typically obtained before performing any medical procedure. Vaccination of minors less than 18 years of age requires consent (general consent for treatment) by the parent or legal guardian unless the minor is established to be an emancipated or self-sufficient minor per California code. Vaccine CompositionVaccines contain common allergens?None of the vaccines contain eggs, gelatin, latex, or preservativesVaccines contain animal, human or fetal tissue? None of the vaccines contain animal, human or fetal tissueSpecific components of each vaccine? Active IngredientNucleoside-modified messenger RNA (mRNA) encoding SARS-CoV-2 viral spike glycoprotein (S)Additional Ingredients((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholineCholesterolStabilizersPotassium chlorideMonobasic potassium phosphateSodium chlorideDibasic sodium phosphate dihydrateSucroseActive IngredientNucleoside-modified messenger RNA (mRNA) encoding SARS-CoV-2 viral spike glycoprotein (S)Additional IngredientsSM-102: heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoatePolyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG]Cholesterol1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]StabilizersTromethamineTromethamine hydrochloride Acetic acidSodium acetate SucroseActive IngredientRecombinant, replication-incompetent Ad26 vector, encoding a stabilized variant of the SARS-CoV-2 Spike (S) protein Additional IngredientsPolysorbate-802-hydroxypropyl-β-cyclodextrinCitric acid monohydrate Trisodium citrate dihydrate Sodium chloride Sodium hydroxide Hydrochloric acidEthanolWater for injectionWhat do these components do? The mRNA sequence is taken from the virus itself and causes cells to manufacture the spike protein of the coronavirus which the pathogen uses to latch onto a person’s cells and gain entry. Tiny lipid particles (“nanoparticles”) encase the RNA to protect it and help it gain entry to cells. The lipids stick to the RNA and help give structural integrity to the nanoparticles to avoid clumping. The lipids also give the vaccine material its whitish color. Stabilizers are included, which among other things help maintain the pH of the vaccine. Sucrose – regular sugar – safeguards the nanoparticles when frozen and keeps them from sticking together.Ad26 is an inactivated adenovirus vector that cannot reproduceIt contains a piece of DNA that instructs the body’s cells to make the COVID-19 spike proteinContraindications (see ACIP Appendix B) – do not vaccinateWhat are the contraindications?Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine, or to any of its componentsImmediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine, or to any of its components (including PEG)Note: per ACIP it’s a precaution, not a contraindication, if someone had a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction.Severe allergic reaction (e.g., anaphylaxis) after a previous dose of Janssen COVID-19 vaccine, or to any of its componentsImmediate allergic reaction of any severity to a previous dose of Janssen COVID-19 vaccine, or to any of its components (including polysorbate)Note: Per ACIP it’s a precaution, not a contraindication, if someone had a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction.How is immediate allergic reaction defined?Per ACIP - any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration.How is severe allergic reaction defined? ACIP defines this as a potentially life-threatening allergic reaction, e.g. anaphylaxis. See CDC: preparing for anaphylaxis.Are there any circumstances in which persons with history of PEG or polysorbate allergy could receive vaccine?Per ACIP, only after an evaluation by an allergist-immunologist determines that they can safely receive vaccine in a setting with advanced medical care available Can those with a contraindication to one vaccine get another vaccine? Per ACIPPersons with contraindications to one mRNA vaccine may NOT receive another mRNA vaccineContraindication to mRNA vaccine is a precaution to receiving Janssen vaccine; patient may be able to receive Janssen vaccine after consultation with an allergist-immunologist. If they already received 1 dose of mRNA vaccine and the decision is to proceed with Janssen vaccine, they should wait at least 28 days after the 1st dose of mRNA vaccinePer ACIPContraindication to Janssen vaccine is a precaution to receiving an mRNA vaccine (allergist-immunologist consultation recommended)Is there a CDC resource for questions about contraindications? US HCP can request a consultation from the Clinical Immunization Safety Assessment COVID-vax?project for a complex COVID-19 vaccine safety question, about individual patients residing in the USWhat is polyethylene glycol? Polyethylene glycol (PEG) is present in both mRNA vaccines. PEG is a primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy procedures, and is an inactive ingredient, excipient, or additive in many medications. Additionally, cross-reactive hypersensitivity between PEG and polysorbates (included as an excipient in some vaccines and other therapeutic agents) can occur. To look up whether PEG/Polysorbate is an ingredient, check package insert, the NIH Daily Med database, and/or Stone CA et al COVID-19 vaccines are the only currently available vaccines in the USA that contain PEG, though several vaccines contain polysorbate (more information can be found in CDC’s vaccine excipient summary).Janssen vaccine contains polysorbate-80, but not PEGPrecautions (see ACIP Appendix B) – weigh risks and benefits of vaccinationWhat are the precautions?History of any immediate allergic reaction to vaccines or injectable therapies (other than those listed in the contraindications) Contraindication to an mRNA vaccine is a precaution to Janssen vaccine (allergist-immunologist consultation recommended)Contraindication to Janssen vaccine is a precaution to mRNA vaccine (allergist-immunologist consultation recommended)Factors to consider in assessing risks and benefitsPer ACIP, several considerations can be used to conduct a risk assessment for mRNA COVID-19 vaccination:Risk of exposure to SARS-CoV-2 (e.g. resides in a congregate setting)Risk of severe disease or death due to COVID-19 (e.g. age, underlying medical conditions)Unknown risk of anaphylaxis (including fatal anaphylaxis) following mRNA COVID-19 vaccination in a person with a history of an immediate allergic reaction to other vaccines or injectable therapiesAbility of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxisWhich are NOT precautions? Per ACIP the following are not considered contraindications or precautions to vaccination:Allergies unrelated to vaccines or injectable therapies, such as allergies to foods, eggs, pets, oral medications, insect venom, latex, etc. People with only a delayed-onset local reaction (e.g., erythema, induration, pruritus) around the injection site area after the first vaccineVaccine AdministrationNumber of doses per vialPer FDA, after adding 1.8 mL of diluent to the Pfizer-BioNTech vaccine vial, the vial is considered to contain 6 doses of 0.3-mL per dose. Any remaining product in the vial that does not constitute a full 0.3-mL dose should not be pooled from multiple vials to create one. See FDA Q&A an 11th dose of 0.5-mL may be obtained from Moderna vials. Any remaining product in the vial that does not constitute a full 0.5-mL dose should not be pooled from multiple vials to create one.5 doses of 0.5-mL per doseAny remaining product in the vial that does not constitute a full 0.5-mL dose should not be pooled from multiple vials to create one.Two doses required?Two doses are necessary for full protection; though trial data suggests some protective benefit of a single dose, efficacy of a single dose has not been systematically evaluated.Single dose onlyCan more than one series be given? A complete vaccination series is 2 doses of mRNA vaccine, or 1 dose of Janssen. People are not recommended to get more than one complete series.Efficacy of getting just 1 dose?One dose of vaccine showed some but not full efficacy, starting around day 12-14 after vaccination (see Pfizer-BioNTech and Moderna trial info; but since the trials were not designed to evaluate this outcome the results are considered preliminary only).72-74% efficacy (US data) in preventing moderate-to-severe COVID-19Even higher efficacy in preventing severe COVID-19 (77-84%) and death associated with COVID-19 (93-100%)Target interval between doses? 21 days after dose #128 days after dose #1N/AFlexibility in timing of dose #2?Per ACIP second doses should be scheduled and administered as close to the target interval as possible. Second doses administered within a 4-day grace period prior to the target day are considered valid. If it is not feasible to adhere to the recommended interval the second dose of either mRNA vaccine may be given up to 6 weeks (42 days) after the first dose; efficacy data are limited for doses administered beyond this window. Second doses given earlier than the grace period or more than 42 days after the first do not require restarting the series.N/AAre the vaccines interchangeable?No, but see below if extenuating circumstancesAll doses must be with the same mRNA product? Per ACIP every effort should be made to complete the series with the same product. In exceptional situations in which the first-dose product cannot be determined or is no longer available, the series may be completed with any available mRNA COVID-19 vaccine given at a minimum interval of 28 days to complete the mRNA series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the 2nd dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product.If doses of two different mRNA vaccines are given, no additional doses of either product are recommended.N/AWhat if there’s no mRNA vaccine available to complete the series? HYPERLINK ""Per ACIP in limited, exceptional situations where a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or different mRNA COVID-19 vaccine (e.g., due to contraindication), a single dose of Janssen COVID-19 vaccine may be considered at a minimum interval of 28 days from the mRNA COVID-19 vaccine dose. Patients who receive Janssen COVID-19 vaccine after a dose of an mRNA COVID-19 vaccine should be considered to have received a valid, single-dose Janssen vaccination—not a mixed vaccination series.(See contraindications/precautions for use of Janssen vaccine in people with a contraindication to mRNA vaccines.)Co-administration with other vaccines? Given the lack of data on efficacy and safety of co-administration, per ACIP an mRNA vaccine should routinely be administered alone with a minimum interval of 14 days before or after administration with any other vaccines. However a shorter interval is acceptableWhen benefits of vaccination are felt to outweigh potential unknown risks of vaccine co-administration (for example tetanus vaccination as part of wound management, measles vaccination during outbreaks, rabies post-exposure prophylaxis, etc.)Or to avoid barriers or delays in COVID-19 vaccination (for example patient being admitted to LTCF, who recently had flu shot, but now is being offered COVID-19 vaccine) If vaccines are administered within 14 days, doses do not need to be repeated for either vaccine. Need to screen out persons who received another vaccine within 14 days? COVID-19 vaccination is a priority. Ideally persons eligible for it could defer other vaccinations, if feasible. For those who wish to receive an mRNA COVID-19 vaccine, recent history of receiving another vaccine should not preclude this. After vaccine administration, counsel recipients to avoid getting any other vaccine for the next 14 days, and/or within 14 days before or after their second dose (if applicable). Preparation to manage severe allergic reactions including anaphylaxis ACIP guidance on recognition and management of anaphylaxis at vaccination sites is now available. Vaccination sites should have at least 3 doses of epinephrine on hand at any given time, in addition to other emergency equipment.Use as post-exposure prophylaxis? Per ACIP mRNA vaccine is not currently recommended for outbreak management or post-exposure prophylaxis, since immunity takes weeks to develop after vaccination, while the median incubation period of SARS-CoV-2 is 4-5 days. Thus vaccination is unlikely to prevent disease following exposure. When are people considered “fully vaccinated”? Starting 2 weeks after completing a 2-dose mRNA vaccine series, or 2 weeks after receiving a single-dose Janssen vaccine. Special PopulationsUnderlying medical conditionsCOVID-19 vaccine may be administered as long as the person has no contraindications to vaccination.In trials, safety and efficacy was similar in people with some underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to people without comorbidities.ACIP expresses no preference among vaccines, for those with underlying medical conditionsImmune compromise (HIV infection, other immunocompromising conditions, or who take immunosuppressive medications or therapies)Per ACIP, vaccine may be safely administered to immunocompromised persons since none of the available vaccines contain live virus. Efficacy has not been established.For people planning to receive immunosuppressive therapies, ideally complete COVID-19 vaccination at least 2 weeks before initiation; but if this is not possible, people on immunosuppressive therapy may still be vaccinated.Antibody testing to assess immunity after vaccination is not currently recommended.Revaccination if immune competence is regained, is also not currently recommended.Autoimmune conditionsVaccine may be administered as long as the person has no contraindications to vaccination.History of Guillain-Barre syndromeVaccine may be administered as long as the person has no contraindications to vaccination.History of Bell’s palsy Vaccine may be administered as long as the person has no contraindications to vaccination.Cases of Bell’s palsy were reported in both the Pfizer-BioNTech and Moderna COVID-19 vaccine trials, however FDA considered these to be within the frequency expected in the general population and not causally related to vaccination.History of dermal filler use mRNA vaccine may be administered as long as the person has no contraindications to vaccination. (See adverse reactions re: swelling at the site of filler injection).Not an issue with Janssen vaccine.Pregnancy ACIP does not recommend that women of childbearing age be routinely tested for pregnancy prior to receiving COVID-19 vaccine. Women who are trying to become pregnant do not need to avoid pregnancy after receiving the vaccine.Data are currently lacking on COVID-19 vaccine safety and efficacy during pregnancy. Per ACIP, a pregnant woman may woman may choose to be vaccinated if she is part of a group recommended to get vaccine, such as healthcare personnel. Discussion with a healthcare provider can help make an informed decision. Considerations include the level of COVID-19 community transmission, personal risk of contracting COVID-19, potential risks of COVID-19 to mother and fetus, the efficacy of the vaccine, known side effects of the vaccine, and the lack of data about the vaccine during pregnancy. See also ACOG Practice AdvisoryPregnant people who experience fever following vaccination may be counseled to take acetaminophen as fever has been associated with adverse pregnancy outcomes. Pregnancy Registry?No, vaccinees should enroll in V-SafeYes, vaccinees should enroll by calling 1-866-MODERNA (1-866-663-3762).Vaccinees encouraged to enroll in pregnancy registry FeedingNo safety data available; Per ACIP, vaccines are not thought to be a risk to the breastfeeding infant. A lactating person who is part of a group recommended to receive a COVID-19 may choose to be vaccinated. See also ACOG Practice AdvisorySARS-CoV-2 Infection or ExposurePersons who previously had COVID-19Persons who already had COVID-19 were enrolled in the vaccine trials, as well as those who never had COVID-19. Per ACIP, vaccination should be offered regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection, as trial data suggest that vaccination is safe and effective in these persons. Need for SARS-CoV-2 testingPer ACIP, testing is not recommended for the purpose of vaccine decision-making.Persons who have COVID-19 right now Per ACIP, persons who are in their isolation period after being diagnosed with COVID-19 or testing positive for COVID-19, should not get the vaccine now. Instead, they should wait until they no longer have symptoms (if person had symptoms) and have met criteria for ending their isolation. Waiting period to get the vaccine after recovering from COVID-19? ACIP does not recommend delaying vaccination in these persons, but recognizes that, while vaccine supply is limited, some persons with recent documented acute SARS-CoV-2 infection may voluntarily choose to temporarily delay vaccination since their risk of reinfection is low initially but will increase with time following initial infection. Treatment with an antibody product containing COVID-19 antibodiesPer ACIP, due to the possibility that receiving COVID-19 treatment with a COVID-19 antibody-containing product (monoclonal antibodies or convalescent plasma) could interfere with development of an immune response to the vaccine, vaccination should be deferred at least 90 days after treatment. For those who receive passive antibody after the first dose but before the second dose, the second dose should be deferred for at least 90 days after treatment.Treatment with an antibody product NOT containing COVID-19 antibodiesPer ACIP, no need to defer vaccination, in persons receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM)Persons known to be recently exposed to COVID-19Per ACIP, exposure to COVID-19 is not a contraindication to vaccination. However, persons should not leave quarantine just to get a vaccine. Residents of congregate healthcare settings, such as SNF or LTCF, may be vaccinated at that location, and this would not create additional possibilities for exposing others. Healthcare personnel at SNF and LTCF are already in close contact with residents, and should continue to observe proper infection control procedures.Residents of other congregate settings, such as shelters, may be vaccinated in order to avoid missing opportunities for vaccination, but precautions should be taken to limit mixing of COVID-19 exposed residents with other residents or non-essential staff.For others living in the community who are in quarantine following COVID-19 exposure, vaccination should be deferred until the quarantine period has ended, in order to avoid exposing others during the vaccination visit.Does completion of vaccine series affect need to quarantine if exposed? Guidance for fully vaccinated people is emerging; see the ACIP guidance on this for more detail.Interpretation of Test Results in Vaccinated PersonsEffect on SARS-CoV-2 NAT or Antigen testsPer ACIP, prior receipt of COVID-19 vaccine will not affect the results of SARS-CoV-2 nucleic acid amplification or antigen tests. Effect on SARS-CoV-2 Antibody tests Per ACIP, currently available antibody tests assess IgM and/or IgG to spike or nucleocapsid proteins.COVID-19 vaccines encode the spike protein; thus a positive test for spike protein IgM/IgG could indicate either prior infection or vaccinationTo evaluate for evidence of prior infection in an individual with a history of COVID-19 vaccination, a test specifically evaluating IgM/IgG to the nucleocapsid protein should be used.Timing with TB testing Per ACIP, COVID-19 vaccine should not be delayed because of testing for TB infection. Tuberculin skin testing (TST) or blood testing (via interferon-gamma release assay i.e. IGRA) can be done either before or during the same encounter as the COVID-19 vaccine. Otherwise, TST and IGRA should be delayed > 4 weeks after completion of the vaccine series.Patients with active TB disease or an illness that is being evaluated as active TB disease can receive a COVID-19 vaccine. (ACIP notes that (+) TST or IGRA results are not required to diagnose active TB. See the ACIP guidance for more detail.After VaccinationObservation Period30 min:History of an immediate allergic reaction of any severity to a vaccine or injectable therapyHistory of anaphylaxis due to any causeContraindication to a different type of COVID-19 vaccine (for example, people with a contraindication to mRNA COVID-19 vaccines who receive Janssen viral vector vaccine should be observed for 30 minutes following Janssen vaccination)15 min: all othersShould dose #2 be skipped after a reaction to dose #1?If a person develops a contraindication to mRNA vaccination (e.g. severe allergic reaction) they should not receive another mRNA vaccine dose. See contraindications/precautions sections above for more detail.Local and systemic side effects are not a contraindication to receiving the second dose, and the person should be encouraged to complete the series. N/AIs it okay to take OTC meds to treat a vaccine reaction?What about for prevention?Yes: acetaminophen, naproxen, or ibuprofen are fine to treat symptoms. However, ACIP does not recommend routinely taking these drugs to prevent symptoms, due to lack of information on impact of use on vaccine-induced antibody responses.Adverse Reactions - Reporting and Management What is the definition of a serious adverse event?See Pfizer-BioNTech Fact Sheet See Moderna Fact SheetSee Janssen Fact SheetWhich adverse reactions must be reported to VAERS?Certain types of events in vaccine recipients must be reported by vaccination providers to VAERS:All vaccine administration errors, whether or not the error is associated with an adverse event.Serious adverse events, whether or not the event is attributable to vaccination. This includes cases of COVID-19 that result in hospitalization or death, and episodes of anaphylaxis.Cases of multisystem Inflammatory Syndrome (MIS) in adults or childrenRefer to the Fact Sheets for Healthcare Providers for the definition of serious adverse events, and for details of reporting to VAERS. Can other events be reported to VAERS?Reporting is encouraged for any other clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at or by calling 1-800-822-7967.What if post-vaccination symptoms overlap with COVID-19 symptoms?Post-vaccination signs and symptoms might be challenging to distinguish from signs and symptoms of COVID-19 or other infectious diseases. Note that per CDC, cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell are not consistent with post-vaccination symptoms, and instead may be symptoms of SARS-CoV-2 or another infection.CDC has posted approaches to evaluating and managing new onset post-vaccination signs and symptoms in healthcare providers and in long-term care facility residents. Additional guidance for other persons or settings may be forthcoming.Was it an allergic reaction, vasovagal syncope, or an adverse reaction? CDC has posted a table to help differentiate these in patients who develop post-vaccination symptoms. See ACIP Appendix D How to recognize and manage anaphylaxis? ACIP has published a page on Management of Anaphylaxis after COVID-19 vaccination. Vaccination clinic staff should review this information in detail and be prepared to recognize and manage anaphylaxis. The page includes guidance on:Early recognition of anaphylaxisMedications and supplies for management of anaphylaxisHow to manage anaphylaxis at a vaccination siteThere are no contraindications to receiving epinephrine for the management of anaphylaxisPatients who experience anaphylaxis after the first dose of mRNA vaccine should not receive additional doses, and should be referred to allergy/immunology evaluationAnaphylaxis after COVID-19 vaccine should be reported to VAERSWhat reaction is associated with dermal fillers?Per ACIP, infrequently persons who have received dermal fillers may develop temporary swelling at or near the site of filler injection (usually face or lips) following a dose of an mRNA COVID-19 vaccine. Corticosteroid therapy may help; advise such persons to contact their healthcare provider for evaluation. N/AWhat about delayed-onset local reactions?Delayed-onset local reactions (e.g., erythema, induration, pruritus) around the injection site have been reported within 2 weeks of the first dose, some quite large. It is not known whether persons who experienced a delayed-onset injection site reaction after the first dose will experience a similar reaction after the second dose.Currently per ACIP, this is not a contraindication or precaution to the second dose. The second dose should be given using the same vaccine product as the first dose and at the recommended interval, and preferably in the opposite arm.N/AVaccination Errors – ACIP Recommendations In general how should vaccination errors be managed?Inform the recipient of the vaccine administration error.If the error affects CAIR data entry or VaccineFinder inventory, check with COVIDCallCenter@CDPH. about how to account for it. Report the error to VAERS, unless otherwise indicated in the table. Determine how the error occurred and implement strategies to prevent it from happening again. What are the recommendations for managing specific errors?See Appendix A at ACIPUpdate History1/2/2021 UpdatesReflects ACIP 12/30/2020 revisions on contraindications and precautions, timing of TB testing and COVID-19 vaccination, plus a few additional clarifications1/10/2021 UpdatesReflects ACIP 1/6/2021 clarifications on 4-day grace period for second doses, vaccine co-administration, passive antibody therapy, and management of anaphylaxis1/23/2021 UpdatesReflects ACIP 1/21/2021 clarifications re: dermal fillers, timing of 2nd doses, persons with history of SARS-CoV-2 infection, interchangeability of vaccine products, and a note about excipients FDA Q&A on obtaining 11th doses from Moderna vials 2/16/2021 UpdatesReflects ACIP 2/10/2021 clarifications re: administration errors, allergies to PEG, delayed local reactions, quarantine recommendations for vaccinated persons, and TB testing. Pfizer vaccine Fact Sheet for Healthcare Providers now specifies that each vial contains 6 doses ................
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