Pfizer-BioNTech COVID-19 Vaccine
Introduction
- Last CDC vaccination recommendations updated as of December 9, 2022 to include bivalent vaccine doses for ages 6 mos-4 yrs.
- Omicron-containing booster vaccines (all booster doses now bivalent) should retain neutralization for original SARS-CoV-2, induce a strong response against BA.5 and induce broad cross-neutralization against future variants.
- Children ages 6–11 yrs: A 2-dose primary monovalent series and a one time single bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) >2 months after completion of primary series or the most recent monovalent booster dose with any vaccine.
- Pfizer-BioNTech COVID-19 Vaccine, Bivalent to be used for >5 years of age as a one-time only booster at least 2 months after either completion of primary vaccination with any monovalent vaccine, or receipt of the most recent booster dose with any monovalent vaccine.
- 5 yr olds who received a Moderna primary series can only receive a Pfizer bivalent booster as the Moderna bivalent vaccine is not approved yet for 5 yr olds.
- Children 5 yrs old: Use only Pfizer for bivalent booster after primary series as per 6-11 year olds.
- 5 year olds may also receive bivalent Pfizer vaccine >2 mos after completion of the Moderna primary series.
- 5 year olds may also receive bivalent Pfizer vaccine >2 mos after completion of the Moderna primary series.
- Ages 6 mos–4 yrs: monovalent Pfizer vaccine for the first and second doses, followed by 1 bivalent Pfizer vaccine as the 3rd primary dose >8 wks after the second monovalent primary series dose.
- A bivalent booster dose is not authorized either after a 3-dose monovalent series of Pfizer or a mixed monovalent-bivalent primary series.
- Only monovalent and not bivalent vaccines are authorized at this time for primary series doses in heretofore unvaccinated persons.
- The 2-month interval for a bivalent booster in the multiply boosted is arbitrary and considerable evidence on boosters in general indicates a longer interval is optimal; further study is required.
- See COVID-19, Vaccines for general vaccine indications, efficacy, duration of protection, choice an
Vaccine
- Type: Lipid nanoparticle (LNP) encapsulated mRNA
- Pfizer-BioNTech COVID-19 Vaccine, Monovalent (original strain). (Comirnaty, mRNA BNT162b2)
- Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original and Omicron BA.4/BA.5). Not branded at present.
Dose
- Available Pfizer vaccine vials in the US. Choice of vials (differential color-coding) should be under the supervision of a pharmacist.
Age indication |
Vaccine composition |
Primary series |
Booster dose |
||
Dose |
Injection volume |
Dose |
Injection volume |
||
6 mos–4 yr |
Monovalent (dose 1 & 2); Bivalent (dose 3) |
3 µg |
0.2 mL |
NA |
NA |
5–11 yr |
Monovalent |
10 µg |
0.2 mL |
NA |
NA |
>12 yrs |
Monovalent |
30 µg |
0.3 mL |
NA |
NA |
5-11 yrs | Bivalent | NA | NA | 10 µg | 0.2 ml |
>12 yrs |
Bivalent |
NA |
NA |
30 µg |
0.3 mL |
Schedule (normal host)
Age |
Number of primary Pfizer doses |
Number of bivalent booster doses |
Recommended bivalent booster dose |
Interval between 1st and 2nd primary dose* |
Interval between 2nd and 3rd primary dose |
Interval between primary series and booster dose |
6 mos–4 yrs |
3 doses Monovalent (dose 1 & 2); Bivalent (dose 3) |
None |
NA |
3–8 wks |
At least 8 weeks |
No further doses even if monovalent only received as primary series |
5 yrs |
2 |
1 (Pfizer 10 µg) |
Pfizer only |
3–8 wks |
NA |
>2 months |
6–11 yrs |
2 |
1 (Pfizer 10 µg) |
Pfizer or Moderna |
3–8 wks |
NA |
>2 months |
>18 yrs |
2 |
1 (Pfizer 30 µg) |
Pfizer or Moderna |
3–8 wks |
NA |
>2 months |
Storage
-
Store as follows (may vary by country):
- -90°C to -60°C (-130°F to -76°F): 12 mos
- -25°C to -15°C (-13°F to 5°F): Do not store
- 2-8°C (36-46°F): 10 wks
- 8-25°C (46-77°F): 12 hrs prior to dilution
- After first puncture: 2-25°C (36-77°F): Discard after 12 hrs
- Purple capped and vials with purple border label have different storage conditions
Toxicities
Contraindications
- Anaphylaxis or immediate allergic reaction (within 4h) to a previous dose of an mRNA vaccine or separately to a vaccine constituent including polyethylene glycol (PEG) or polysorbate.
- Do not vaccinate with any mRNA vaccine
- History of a known diagnosed allergy to a vaccine component
Precautions
- Immediate allergic reaction (within 4h) to any other vaccine or injectable therapy not related to a component of mRNA-COVID-19 vaccines or polysorbate.
- Persons with a reaction to a vaccine or injectable therapy that contains PEG.
- History of MIS-C or MIS-A.
- History of myocarditis or pericarditis after a dose of an mRNA or Novavax COVID-19 vaccine, is a precaution to future doses of any COVID-19 vaccine but wait until episode is completely resolved.
- Myocarditis or pericarditis unrelated to mRNA or Novavax COVID-19 vaccination; administer any age-appropriate vaccine after the episode has resolved.
- Allergy-related contraindication to one type of COVID-19 vaccine is a precaution to the other types of COVID-19 vaccines
- Defer vaccination until resolution of a moderate or severe acute illness, with or without fever
Not Contraindications
- Food (including egg and gelatin), pet, insect, venom, environmental, latex, oral medications; any other history of anaphylaxis not related to vaccine or injectables.
- History of GBS in proximity to another vaccine.
Adverse Effects
- Similar safety profile when monovalent or bivalent vaccine is used as a 4th dose (2nd booster)
- Pain at the injection site, sometimes severe, occurs frequently
- Fatigue, headache, and myalgia common but are mild to moderate, occurring within 1–2 days of vaccination, and resolving within 1–2 days of onset.
- more frequent following dose 2 and among adolescents and younger adults compared with older adults.
- Myocarditis: 131 myocarditis cases reported to VAERS after 123 million mRNA booster vaccinations
- Risk primarily in adolescent and young adult males
- No increase in children ages 5–11 years following 1st booster
- Rates are lower following 1st booster dose vs. dose 2 of primary series (and lower following dose 1 vs. dose 2 of primary series)
- 8-week interval between the first and second primary series doses of Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines may be optimal for some people to reduce myocarditis.
Pregnancy
- Vaccinate according to standard recommendations if pregnant, breastfeeding, attempting or contemplating conception
- Pregnant and recently pregnant persons at increased risk for severe illness and the fetus is at increased risk
- Benefits outweighs risks of vaccination
- Antibodies are transferred to the newborn
- No contraindications to breastfeeding
Immunocompromised / HIV
Age |
Number of Pfizer primary doses |
Number of bivalent booster doses |
Recommended bivalent booster dose |
Interval between 1st and 2nd primary dose |
Interval between 2nd and 3rd primary dose |
Interval between primary series and booster dose |
6 mos–4 yrs |
3 doses Monovalent (dose 1 & 2); Bivalent (dose 3) |
NA |
NA |
3 wks |
>8 wks |
NA |
5 yrs |
3 |
1 (Pfizer 10 µg) |
Pfizer |
3 wks |
>4 wks |
>2 mos |
6-11 yrs |
3 |
1 (Pfizer 10 µg) |
Pfizer or Moderna |
3 wks |
>4 wks |
>2 mos |
>12 yrs |
3 |
1 (Pfizer 30 µg) |
Pfizer or Moderna |
3 wks |
>4 wks |
>2 mos |
- Self-attestation to moderately or severely immunocompromised status is acceptable
- New immunocompromise after a 2-dose mRNA primary series do not need additional primary doses; immunocompromised schedule for the booster dose.
- Revaccinate HCT or CAR-T-cell therapy recipients with an mRNA vaccine or Novavax >3 months after HCT or CAR-T-cell therapy
- Consider revaccination if 1 or more doses of vaccine (primary series and bivalent booster doses) received during short-course treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab) beginning at about 6 months after completion of therapy
- Administration of vaccines should not be delayed in patients on ongoing immunosuppressives
- Administer vaccine doses approximately 4 weeks before the next scheduled therapy for patients on ongoing B-cell-depleting therapies
Serologic Testing
- Antibody testing is not recommended to assess for immunity following COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person
- No correlates of protection are available and assays vary widely
- +ve IgG only minimally reassuring, -ve IgG unhelpful in patients whose ability to mount a B-cell response is uncertain
Comments
- Consider 15 minute observation period post-administration especially for adolescents.
- Consider 30 minute observation period post-administration if:
- allergy related contraindication to another COVID vaccine
- non-severe allergic reaction (within 4 hrs) to any previous COVID vaccine
- Anaphylaxis after non-COVID-19 vaccines or injectable therapies
- Age-appropriate vaccine product and dosage is based on age on the day of vaccination.
- a move from a younger age group to an older age group during the primary series, requires the vaccine product and dosage for the older age group
- Vaccines are not recommended for outbreak management or for post-exposure prophylaxis
- mRNA vaccines do not have a risk of modifying the vaccine recipient’s genetic makeup as mRNA does not enter cell nucleus where host DNA is located.