Evigrade

COVID-19 vaccine, mRNA (Pfizer-BioNTech)

mRNA SARS-CoV-2 vaccine

ATC code: J07BX03

Updated · Methodology

Indications

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Encodes full-length SARS-CoV-2 spike protein in lipid nanoparticles. After injection, maternal cells briefly synthesize spike, triggering IgG antibodies and T-cell response. mRNA degrades within days, does not integrate into DNA. 70–90% effectiveness against hospitalization in first 6 months, lower against infection.

Safety

Contraindications

  • Anaphylaxis to previous dose or components (PEG, tromethamine)
  • Myocarditis/pericarditis after previous dose (relative)

Serious adverse effects

  • Anaphylaxis (5 per million)
  • Myocarditis/pericarditis in young males (40 per million doses, ages 16–29, mostly after dose 2)

Common adverse effects

  • Injection-site pain (80%)
  • Fatigue (60%)
  • Headache (50%)
  • Myalgia
  • Fever (10–20%)
  • Axillary lymphadenopathy

Pregnancy: can you take COVID-19 vaccine, mRNA (Pfizer-BioNTech)?

Recommended in any trimester. Safe for mother and fetus per dozens of studies.

Breastfeeding: can you take COVID-19 vaccine, mRNA (Pfizer-BioNTech)?

Hale L1 · Compatible

Fully compatible. mRNA does not transfer to milk significantly. Spike antibodies protect the infant. Hale L1.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Annually in autumn with updated composition. In pregnancy – any trimester. Immunity by 2 weeks post-dose.

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Frequently asked

What is COVID-19 vaccine, mRNA (Pfizer-BioNTech) used for?

COVID-19 vaccine, mRNA (Pfizer-BioNTech) is evaluated for the following indications with varying evidence strength: COVID-19 prevention (evidence tier A), Vaccination during breastfeeding (evidence tier A), Maternal vaccination (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of COVID-19 vaccine, mRNA (Pfizer-BioNTech)?

Common side effects of COVID-19 vaccine, mRNA (Pfizer-BioNTech) (≥ 1 in 100): Injection-site pain (80%), Fatigue (60%), Headache (50%), Myalgia, Fever (10–20%), Axillary lymphadenopathy. See the Safety section for uncommon and serious reactions.

Is COVID-19 vaccine, mRNA (Pfizer-BioNTech) safe during pregnancy?

Recommended in any trimester. Safe for mother and fetus per dozens of studies.

Is COVID-19 vaccine, mRNA (Pfizer-BioNTech) compatible with breastfeeding?

Fully compatible. mRNA does not transfer to milk significantly. Spike antibodies protect the infant. Hale L1.

Who should not take COVID-19 vaccine, mRNA (Pfizer-BioNTech)?

COVID-19 vaccine, mRNA (Pfizer-BioNTech) is contraindicated in: Anaphylaxis to previous dose or components (PEG, tromethamine); Myocarditis/pericarditis after previous dose (relative). Full list in the Safety section.

Other drugs in this group

Hepatitis A vaccine, inactivated, Hepatitis B vaccine, recombinant, HPV vaccine, nonavalent, Inactivated influenza vaccine, Pneumococcal conjugate vaccine PCV20, Tdap – tetanus, diphtheria, acellular pertussis vaccine, MMR – measles, mumps, rubella vaccine (live), RSV vaccine, recombinant (maternal)