Brand Name :
Comirnaty
Synonyms :
COVID-19 Vaccine, mRNA
Class :
Inactivated Viral Vaccine
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Brand Name :
Comirnaty
Synonyms :
COVID-19 Vaccine, mRNA
Class :
Inactivated Viral Vaccine
Dosage Forms & Strengths
frozen suspension concentrate, injection
It has to be diluted before administration
Multiple-dose vial with a purple lid and border (after dilution, each vial contains six [30-mcg] doses)
Indicated for COVID-19 Disease Prevention:
Full FDA clearance date: August 23, 2021)
Indicated for active vaccination against the coronavirus disease 2019 (COVID-19), which is brought on by the coronavirus 2 causing severe acute respiratory syndrome (SARS-CoV-2)
Primary 2-dose series:
0.3 mL (30 mcg) IM twice, given three weeks apart
provide a third main dosage at least 4 weeks following the second dose if the patient has a moderate or severe immunosuppression
Monovalent-Pfizer Vaccine
The Pfizer-BioNTech vaccine is a monovalent vaccine, which means it is designed to protect against a single strain of the SARS-CoV-2 virus
The vaccine may come in vials with either a purple cap (indicating that the vaccine needs to be diluted before use) or a gray cap (indicating no dilution is necessary)
Each dose of the vaccine contains 30 micrograms (mcg) of the vaccine in a volume of 0.3 milliliters (mL)
The vaccine is given in two doses, with the second dose administered 3 to 8 weeks after the first dose
A third dose (0.3 mL) may be given at least four weeks after the second dose for additional protection
Bivalent-Pfizer vaccine
For individuals 12 years of age and older, the vaccine was authorized for a two-dose primary series, with the second dose administered three weeks after the first dose
The vaccine was also authorized for a third dose as a booster shot for individuals 18 and older who had completed the two-dose primary series at least six months prior and were at increased risk of COVID-19 due to underlying medical conditions, occupational or institutional exposure or age
Booster Dose
At least two months following the first immunisation or the most recent booster dose with any authorized/approved monovalent COVID-19 vaccine, administer either the Pfizer or Moderna omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster
Dosage Forms & Strengths
frozen suspension concentrate, injection
requires diluting prior to administration
12 years old: Multiple-dose vial with a purple lid and border (after dilution, each vial contains six [30-mcg] doses)
Ages 5 to 11: Orange cap and label border multiple-dose vial (ten [10-mcg] doses per vial after dilution).
6 months to 5 years old: Maroon cap and label border (ten [3-mcg] doses per vial after dilution)
Indicated for COVID-19 Disease Prevention:
<6 Months: Safety and efficacy not established
6 to <5 years:
EUA revised 3-dose main series: December 8, 2022 0.2 mL (3 mcg; maroon cap and label border vial) (3 mcg; maroon cap and label border vial) IM
The first two doses are given three weeks apart, and the third dosage is given at least eight weeks following the second dose.
People who have not yet completed the Pfizer-BioNTech COVID-19 vaccine's 3-dose primary series or who have not yet received the third dose of their primary series may receive the (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series after receiving two doses of the monovalent vaccine.
The original (monovalent) Pfizer-BioNTech COVID-19 vaccine must be administered in a 3-dose main series before a booster dose of the updated bivalent vaccine may be administered
Individuals aged 4-5 years may get either a 3-dose primary series of Pfizer-BioNTech COVID-19 Vaccine (vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (vials with maroon caps and labels with maroon borders) for Dose 3, OR a 2-dose primary series of Pfizer-BioNTech COVID-19 (vials with orange caps and labels with orange borders)
5-11 years
EUA authorised a 2-dose main series on October 29, 2021. 0.2 mL (10 mcg; orange cap and label border vial) IM twice, given three weeks apart.
Patients with moderate to severe immunodeficiency: Give the third main dosage at least 4 weeks after giving the first.
Booster dose
Provide a bivalent COVID-19 vaccine booster dose using Moderna or Pfizer omicron BA.4/BA.5-adapted vaccines at least two months after receiving the first dose or the most recent booster dose of any monovalent COVID-19 vaccine that has been authorised or recommended
12-17 years:
Primary 2-dose series: 0.3 mL (30 mcg) IM twice, given three weeks apart
Having a moderate or severe immune suppression Third primary dosage should be given at least four weeks following the second.
3 to 8 weeks between initial doses
Because to the low risk of myocarditis linked with mRNA, an 8-week interval may be ideal for certain individuals under the age of 12 years, especially for males between the ages of 12-39. vaccines for COVID-19
For those who are moderately or seriously immunocompromised, individuals older than 65, and those who require immediate protection due to greater worry about community transmission or risk of severe illness, a shorter delay (3 weeks) between doses 1 and 2 continues to be the recommended interval
Refer adult dosing
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
smallpox (vaccinia) vaccine, live
may increase the toxic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect when combined with vaccines
may decrease the therapeutic effect when combined with vaccines
may decrease the therapeutic effect when combined with vaccines
may decrease the therapeutic effect when combined with vaccines
may decrease the therapeutic effect when combined with vaccines
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect when combined with vaccines
it may reduce the therapeutic efficacy of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may decrease the therapeutic effect when combined with vaccines
may decrease the therapeutic effect of Immunosuppressants
may diminish the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
may enhance the adverse/toxic effect
may enhance the adverse/toxic effect
may enhance the adverse/toxic effect
may increase the immunosuppressive effect of immunosuppressants
The potential efficacy of vaccines may be reduced. (Inactivated/Non-Replicating)
may decrease the therapeutic effect of COVID-19 vaccine
may decrease the therapeutic effect of Immunosuppressants
Mechanism of action
The SARS-CoV-2 viral spike (S) glycoprotein is encoded by nucleoside-modified messenger RNA (modRNA), which is packaged in lipid particles to facilitate RNA transport into host cells and promote production of the S antigen.
causes the S antigen to be recognised by the immune system, providing COVID-19 protection
Spectrum
The COVID-19 mRNA vaccines currently authorized for emergency use by regulatory agencies such as the US FDA and the European Medicines Agency (EMA) are Pfizer-BioNTech and Moderna vaccines.
These vaccines use a small piece of genetic material called messenger RNA (mRNA) to instruct cells in the body to produce a harmless piece of the spike protein found on the surface of the SARS-CoV-2 virus, which causes COVID-19
The mRNA sequence for the Pfizer-BioNTech vaccine is:
5′-AUGUUUUCUUCCUGUCUUCGAUGUC-3′
The mRNA sequence for the Moderna vaccine is:
5′-AUGUUUUCUUCCUGUCUUCGAUGCU-3′
The difference between the two sequences is in the last three nucleotides, with the Pfizer-BioNTech vaccine having a UCG (coding for serine) and the Moderna vaccine having UCU (coding for leucine)
Frequency defined:
>10%
Aged 5-11 years
Dose 1:
Fatigue, mild-severe (0.3-22%)
Headache, mild-severe (0.1-16.5%)
Pain at the injection site, mild-severe (0.3-58.9%)
Dose 2:
Fatigue, mild-severe (0.7-21.4%)
Headache, mild-severe (0.2-18.7%)
Pain at the injection site, mild-severe (0.3-52.8%)
Aged 12-15 years
Dose 1:
Fatigue, mild-severe (1.3-34.1%)
Chills (0.4-17%)
Headache, mild-severe (1-32%)
Pain at the injection site, mild-severe (1-43.7%)
Worsened muscle pain (0.2-12.9%)
Dose 2:
Fatigue, mild-severe (2.4-42.%)
Headache, mild-severe (2-35%)
Pain at the injection site, mild-severe (0.6-42.5%)
Chills (1.8-20%)
Worsened muscle pain (0.5-18%)
Aged 16-55 years
Dose 1
Mild-severe headache (1.1-27.1%)
Mild-severe pain at the injection location (1.3-50.5%)
Muscle discomfort, mild to severe, new or exacerbated (0.5-12.2%)
Mild-severe fatigue (1.4-26.2%)
Mild-severe chills (0.5-11.7%)
Dose 2
Mild-severe pain at the injection location (1.5–47.5%)
Mild-severe headaches (3.4–26.1%)
Mild-severe fatigue (2.4-35.4%)
Moderate to severe chills (2.6-17.8%)
Joint pain, mild to severe, new or aggravated (1-11.9%)
Muscle pain, new or exacerbated, mild-severe (2.3-20.6%)
Aged≥56 years
Dose 1
Mild-severe pain at the injection site (0.2-55.2%)
Mild-severe fatigue (0.1-20.7%)
Mild-severe headaches (0.1-19%)
Muscle discomfort, mild to severe, new or exacerbated (1.1-15.5%)
Dose 2
Pain at the injection site, mild-severe (0.5-46.9%)
Mild-severe fatigue (0.1-26.7%)
Mild-severe headaches (0.7-24.9%)
moderate to severe chills (1.1–12.3%)
1-10%
Aged 5 to 11 years old
Dose 1
Redness at the injection site, mild to severe (5.2–9.5%)
Muscle discomfort, new or aggravated, mild-severe (0.1-6.4%)
Mild-severe edoema at the injection site (0.1%–5.6%)
Mild-severe diarrhoea (0.7-5.2%)
mild-severe chills (1.1-3.6%)
Joint discomfort, mild-severe, new or worsening (1.1-2.3%)
Mild-severe vomiting (0.5–1.7%)
38°C fever (0.2–1.5%)
Dose 2
Redness at the injection site, mild to severe (0.2–9.5%)
Injection site swelling, mild-severe (7.5-7.8%)
Muscle discomfort, mild to severe, new or exacerbated (0.1-7.7%)
mild-severe (0.1–7%) chills
Mild-severe diarrhoea (0.5–4.8%)
Joint pain, mild to severe, new or exacerbated (1.4–3.8%)
38°C fever (0.1–3.4%)
mild-severe vomiting (0.1–1.8%)
Aged 12-15 years
Dose 1
Mild-severe diarrhoea (1.2-6.8%)
38°C fever (0.1-6.6%)
Joint pain, mild to severe, new or exacerbated (0.1-5.9%)
Mild-severe diarrhoea (0.5–5.4%)
Redness at the injection site, mild to severe (0.1–3.9%)
Mild-severe edoema at the injection site (2-4.9%)
Vomiting, mild-severe (0.1-2.7%)
Dose 2
Fever (38°C) (2.3-9.8%)
Joint pain, mild to severe, new or exacerbated (0.4–8.3%)
Mild-severe edoema at the injection site (1.6%–3.3%)
Mild-severe injection site erythema (2.4–2.6%)
Mild-severe vomiting (0.4–2.3%)
Aged 18-55 years
Dose 1
Mild-severe diarrhoea (0.1-8.7%)
Mild-severe new or worsening joint pain (0.2-6.9%)
Mild-severe edoema at the injection site (0.2%–4.3%
Redness at the injection site, mild to severe (0.2–3.9%)
38°C fever (0.3–3%)
mild-severe vomiting (0.2-1%)
Dose 2
Fever (≥38°C) (1.5-9.5%)
Mild-severe diarrhoea (0.2-8.2%)
Mild-severe edoema at the injection site (0.3%–4.1%
Redness at the injection site, mild to severe (0.4–3.4%)
mild-severe vomiting (0.1–1.6%)
Aged >56 years
Dose 1
Muscle discomfort, mild to severe, new or exacerbated (4.5-9.1%)
Mild-severe diarrhea (0.2-6.8%)
New or worsened joint pain, mild-severe (0.1-5.9%)
Chills, mild-severe (1.4-5.1 %)
Mild-severe swelling at the injection site (0.1%–4.3%
Redness at the injection site, mild to severe (0.2–3.5%)
38°C fever (0.1–1.1%)
Mild-severe vomiting (0.4%)
Dose 2
38°C fever (0.4–8.5%)
Mild-severe diarrhoea (0.1-6.7%)
Mild-severe edoema at the injection site (0.2%–4.3%
Injection site redness, mild-severe (0.5-3.5%)
<1%
Depression (0.5%)
Lymphadenopathy (0.3%)
Aged >56 years
Dosage 1 Mild-severe vomiting (0.4%)
Dosage 2 Mild-severe Vomiting (0.1-0.5%)
Post marketing reports
cardiac conditions: Pericarditis and myocarditis
diseases of the digestive system: diarrhoea and vomiting
abnormalities of the immune system: Anaphylaxis and other severe allergic and hypersensitive responses (eg, rash, pruritus, urticaria, angioedema)
Disorders of the muscles, bones, and connective tissues: Acute extremities pain (arm)
Contraindications
History of known severe adverse response (such as anaphylaxis) to any vaccination component
Caution
Pregnancy consideration: Insufficient data available
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology
Pharmacodynamics
Pharmacokinetics
Assessment of the vaccine’s effectiveness was based on illness cases that appeared seven days or more after dosage 2. With the second dosage, virus-neutralizing antibody activity peaked 7 to 14 days later
Administration
Administer IM in the lateral thigh or deltoid muscle. To lower the risk of shoulder damage associated with vaccination delivery, use optimal injection technique in the deltoid muscle (for instance, injecting in the middle, thickest region of the muscle). Avoid intradermal, subcutaneous, and intravascular injections. Adolescents and adults should receive their vaccinations while seated or laying down to minimise syncope-related injuries. If other vaccinations are being given at the same time, deliver each one at a different injection location
Pfizer-vaccine:
Prior to usage, vials with purple caps must be diluted; grey caps must not be diluted. Preferably, use a low dead-volume syringe and/or needle to extract dosages from the bottle. There might not be enough capacity in ordinary syringes and needles to accommodate all prescribed dosages. Do not combine any remaining partial doses in vials to make a full dosage
Patient information leaflet
Generic Name: COVID-19 Vaccine, mRNA
Why do we use COVID-19 Vaccine, mRNA?
COVID-19 vaccine, mRNA-Pfizer is an Inactivated Viral Vaccine used for active vaccination against the coronavirus disease 2019 (COVID-19), which is brought on by the coronavirus 2 causing severe acute respiratory syndrome (SARS-CoV-2) and also studies showed that it led to this potential treatment for pancreatic cancer
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