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Sars-Cov-2 Mrna (Tozinameran) Vaccine Dosage

Medically reviewed by Drugs.com. Last updated on Dec 9, 2021.

Applies to the following strengths: 30 mcg/0.3 mL

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for COVID-19

Primary Series: 30 mcg (0.3 mL) IM for 2 doses, administered 21 days apart

Booster Dose: 30 mcg (0.3 mL) IM at least 6 months after completing a primary vaccine series

Comments:
-A third dose administered at least 28 days following the first two doses of this vaccine is authorized for individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
-A single booster dose may be administered to patients as a heterologous booster in those who have received primary vaccination with another COVID-19 vaccine.

Use: Active immunization for the prevention of COVID-19 due to SARS-CoV-2

Usual Pediatric Dose for COVID-19

16 years and older:
-Primary Series: 30 mcg (0.3 mL) IM for 2 doses, administered 21 days apart

-Booster Dose: 30 mcg (0.3 mL) IM at least 6 months after completing a primary vaccine series

Use in children 12 to 15 years remains investigational use only

12 to 15 years: 30 mcg (0.3 mL) IM for 2 doses, administered 21 days apart

Comments:
-This drug is not approved by the FDA to prevent COVID-19 in patients younger than 16 years old. The FDA has issued an Emergency Use Authorization (EUA) for the use of this drug to prevent COVID-19.
-A third dose administered at least 28 days following the first two doses of this vaccine is authorized for individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
-A single booster dose may be administered to patients 16 years and older as a heterologous booster in those who have received primary vaccination with another COVID-19 vaccine.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: Active immunization for the prevention of COVID-19 due to SARS-CoV-2

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Autoimmune Conditions:
-No data are available on safety and efficacy in autoimmune conditions, although these people were eligible for clinical trials.
-No imbalances were seen in the occurrence of symptoms consistent with autoimmune conditions or inflammatory disorders in clinical trial participant receiving an mRNA COVID-19 vaccine compared to placebo.
-Persons with autoimmune conditions and no contraindications may be vaccinated.

History of Bell's Palsy:
-Cases of Bell's palsy were reported after vaccination in mRNA vaccine trials, but are not considered by the FDA to be above the frequency expected in the general population and has not concluded that these cases were causally related to vaccination.
-In the absence of evidence, persons with a history of Bell's palsy may receive an mRNA COVID-19 vaccine unless they have a contraindication.
-Report any occurrences of Bell's palsy to VAERS.

History of Guillain-Barre Syndrome (GBS):
-No cases of Guillain-Barre syndrome have been reported among mRNA vaccine recipients in clinical trials to date.
-With few exceptions, ACIP's general best practice guidelines for immunization does not list a history of GBS as a contraindication or precaution to vaccination.
-Persons with a history of GBS and no contraindications may be vaccinated.
-Report any occurrence of GBS after vaccination to VAERS.

History of Myocarditis or Pericarditis:
-Myocarditis and pericarditis have been reported, particularly after the second dose.
-Symptom onset has typically been within a few days of vaccination.
-Data from short-term follow-up suggests symptom resolution in most patients; information is not yet available on long-term sequelae.
-Consider the patients particular circumstances when deciding whether to vaccinate a patient with a history of myocarditis or pericarditis.
-The CDC has published clinical considerations relevant to myocarditis and pericarditis associated with administration of the Pfizer-BioNTech COVID-19 Vaccine (https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/myocarditis.html).

Immunocompromised Persons:
-Persons with HIV infection or other immunocompromising conditions, or taking immunosuppressive medications may be at increased risk for severe COVID-19.
-Data are not available to establish vaccine safety and efficacy in these populations.
-Persons with stable HIV infection were included in clinical trials, but data is limited.
-Immunocompromised individuals may be vaccinated if no contraindications to vaccination exist, but they should be counseled regarding the unknown safety and efficacy, as well as the potential for reduced immune response to vaccination and the need to continue following current guidelines to protect themselves from COVID-19.
-Re-vaccination after immune competence is regained is not recommended at this time.

Known SARS-CoV-2 Exposure or COVID-19 Outbreaks:
-mRNA vaccines are not currently recommended for outbreak management or post-exposure prophylaxis.
-Because the median SARS-CoV-2 incubation period is 4 to 5 days, vaccination is unlikely to provide an adequate immune response within the incubation period or be effective in preventing disease following an exposure.
-Persons with a known COVID-19 exposure in the community/outpatient setting should not seek vaccination until their quarantine period has ended to avoid exposing healthcare personnel during a vaccination visit.
-Residents with known COVID-19 exposure living in congregate healthcare settings (e.g. long-term care facilities) where repeat exposure and transmission can occur for long periods may be vaccinated; precautions to limit mixing exposed individuals with other residents/staff should be employed.
-Residents with known COVID-19 exposure living in congregate healthcare settings who do not have symptoms of COVID-19 and are awaiting results of SARS-CoV-2 testing may be vaccinated.
-Where facility-wide SARS-CoV-2 testing is being conducted, attempt to allow test results to be received prior to vaccination to isolate those with SARS-CoV-2 infection, but do not wait for test results if that would delay vaccination. Vaccinate any persons without COVID-19 symptoms.
-Viral testing for acute SARS-CoV-2 purely for vaccine decision-making is not recommended.

Previous/Current SARS-CoV-2 infection:
-Clinical trial data indicate that mRNA COVID-19 vaccines are safe for persons with prior SARS-CoV-2 infection; offer vaccination regardless of previous infection.
-Defer vaccination for current SARS-CoV-2 infection until recovery from acute illness and criteria have been met to discontinue isolation; this applies to those infected after the first vaccine dose but before the second dose.

Previous Receipt of Passive Antibody Therapy:
-No data are available on safety and efficacy of mRNA COVID-19 vaccines in patients who received monoclonal antibodies or convalescent plasma for COVID-19 treatment.
-Based on the estimated half-life of such therapies, and evidence suggesting reinfection is uncommon in the 90 days after infection, defer vaccination for at least 90 days as a precautionary measure to avoid interference of antibody therapy with vaccine-induced immune responses; this recommendation is also for those receiving antibody therapy after the first vaccine dose but before the second dose - defer the second dose at least 90 days after antibody therapy.
-Antibody treatment not specific to COVID-19 treatment (e.g. intravenous immunoglobulin, RhoGAM) are unlikely to substantially impair a vaccine-induced protective antibody response, so there is no recommended minimum interval between these antibody therapies and mRNA COVID-19 vaccination.

Precautions

-This vaccine has full FDA approval for patients 16 years of age and older.
-This EUA is for the use of an experimental vaccine to prevent COVID-19 in patients from 12 years to 15 years of age.
-ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

CONTRAINDICATIONS:
-Known history of severe allergic reaction (e.g., anaphylaxis) to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 16 years; an EUA is in effect for the use of an experimental vaccine to prevent COVID-19 in patients from 12 years to 15 years of age; this drug is not recommended for use in younger patients.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-For intramuscular administration only. Do not inject IV, intradermally, or subcutaneously.

Storage requirements:
-Vials prior to dilution: The manufacturer product information should be consulted regarding storage and subsequent thawing of frozen vials.
-Vials after dilution: Store between 2C to 25C (35F to 77F) and use within 6 hours from time of dilution; discard any vaccine remaining in vial after 6 hours; do not freeze diluted vaccine (discard if frozen).

Reconstitution/preparation techniques:
-Requires dilution with sterile 0.9% Sodium Chloride Injection, USP, before administration
-The manufacturer product information should be consulted.

General:
-After dilution, vials contain six 0.3 mL doses of vaccine.
-Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial; if standard syringes/needles are used, the volume may not be sufficient to extract 6 doses from the vial.
-Each dose must contain 0.3 mL of vaccine.
-If the vaccine remaining in the vial cannot provide a full 0.3 mL dose, discard the vial; do not pool excess vaccine from multiple vials.

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