BNT162b2 COVID-19 Vaccine (BioNTech/Pfizer)

Kathryn Dzintars, Pharm.D., BCPS

VACCINE TYPE

  • The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 spike protein.
    • Two-dose series, given 21 days apart
  • The US FDA issued an Emergency for Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 16 years of age and older.
    • Mandatory requirements for the administration of BNT162b2 under the EUA are as follows:
      • The vaccine is authorized in patients ≥ 16 years of age.
      • The vaccination provider must give the individual receiving the Pfizer-BioNTech COVID-19 vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine.
      • Vaccine providers must include vaccine information to either the state’s or local jurisdiction’s Immunization Information System or other designated systems.
      • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
        • Vaccine administration errors whether or not associated with an adverse event
        • Serious adverse events including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects
        • Cases of a multisystem inflammatory syndrome (MIS) in children and adults
        • Cases of COVID-19 that result in hospitalization and death
      • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine to recipients.
  • There are no data on the interchangeability of COVID-19 vaccines. If the series is initiated with the Pfizer-BioNTech product, it should be completed with the Pfizer-BioNTech product.

INDICATIONS

ACIP RECOMMENDATIONS

  • On December 12, 2020, ACIP voted 11–0 (three recusals) in favor of the interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine for individuals ≥ 16 years of age.
  • The EUA fact sheet for recipients and caregivers should be provided to vaccine recipients, and recipients should be counseled on local and systemic reactions.

FORMS

Brand Name

Preparation

Manufacturer

Route

Form

Dosage

Cost

N/A

SARS-Cov-2 S-protein encoded mRNA + lipid nanoparticle vaccine

Pfizer-BioNTech

IM

Vial

0.3 mL IM on Day 0 and Day 21

N/A

PATHOGEN DIRECTED PROTECTION

  • COVID-19

DOSE/ADMINISTRATION

Adult PRIMARY SERIES

  • This is a series of 2 vaccines given 3 weeks apart. The first dose (0.3 mL) should be given on Day 0 and the second dose (0.3 mL) on Day 21.
  • There are no data on the interchangeability of the vaccines.
    • If you receive the Pfizer-BioNTech vaccine on Day 0, the series should be completed with the Pfizer-BioNTech product.
  • Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store them in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). Vials must be kept frozen between -80ºC to -60ºC (-112ºF to -76ºF) and protected from light until ready to use.
    • Alternatively, vials can be stored at -25ºC to -15ºC (-13ºF to 5ºF) for up to 2 weeks. These vials may be returned to -80ºC to -60ºC (-112ºF to -76ºF) one time, but the total cumulative time the vials are stored at -25ºC to -15ºC (-13ºF to 5ºF) is a maximum of 2 weeks.
    • If an ultra low-temperature freezer is not available, the thermal container can be used as temporary storage as long as it is continually filled with dry ice. Refer to the insert provided in the shipping container for re-icing instructions.
  • Thaw instructions for undiluted vials:
    • Refrigerator: Once in the refrigerator, the vial(s) will thaw in 2-3 hours. Thawed vials can be stored at [2ºC to 8ºC (35ºF to 46ºF)] for up to 5 days (120 hours).
    • Room temperature: For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Once thawed, vials are stable for 2 hours only.
    • Once vials have been thawed, they cannot be refrozen.
  • Stability once diluted:
    • After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution.
    • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
    • Any vaccine remaining in vials must be discarded after 6 hours.
    • Do not refreeze.

Adult BOOSTER

N/A

Pediatric PRIMARY SERIES

  • The EUA is valid only for patients ≥ 16 years of age.
    • This is a series of 2 vaccines given 3 weeks apart. The first dose (0.3 mL) should be given on Day 0 and the second dose (0.3 mL) on Day 21.

Pediatric BOOSTER

N/A

ADVERSE DRUG REACTIONS

GENERAL

  • Overall, the Pfizer-BioNTech vaccine is well-tolerated without serious adverse events reported to the FDA in the preliminary phase 3 trial information.
  • The incidence of adverse events is higher with the administration of the second dose of the vaccine.

COMMON

  • Pain, redness, and swelling at the injection site.
  • Fever
  • Fatigue
  • Headache
  • Chills
  • Diarrhea
  • Muscle and joint pain

VACCINE/DRUG INTERACTIONS

  • No vaccine/drug interactions have been identified at this time.

CONTRAINDICATIONS

  • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

IMMUNE RESPONSE

  • The highest neutralization titers were obtained at day 28 and day 35, confirming the need for two-dose series. Dose #2 elicited a robust immune response.
  • Geometric mean titers (GMT) on day 28 or day 35 ranged from 1.7 to 4.6 times the GMT of convalescent serum in those aged 18 - 55 years, and 1.1 to 2.2 times the GMT in those aged 65 - 85 years.
  • The complete immune response is still being elucidated.

CLINICAL EFFICACY

  • An ongoing, multinational, placebo-controlled, observer-blinded safety and efficacy trial in individuals ≥ 16 years of age were randomized 1:1 to receive 2 doses, 21 days apart, of either placebo or the BNT162b2 vaccine.
    • The primary endpoints were vaccine efficacy against COVID-19 and safety.
    • 43,448 patients received injections (21,720 in the vaccine group; 21,728 in the placebo group).
    • There were 8 cases of COVID-19 disease onset at least 7 days after the second dose in those receiving active vaccine compared to 162 cases of COVID-19 disease in those patients assigned placebo.
      • This translates to 95% vaccine efficacy in preventing COVID-19 disease.
    • Similar vaccine efficacy was noted among subgroups, including age, sex, race, ethnicity and baseline body mass index.
      • It should be noted that despite no differences seen in these subgroups, 83% of the overall population in this trial were Caucasian.
    • The most common adverse effects were injection site pain, fatigue and headache.
    • The overall incidence of adverse effects was low, and similar between the vaccine and placebo groups.

OTHER INFORMATION

  • It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of multisystem inflammatory syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.
  • Frozen vials MUST be stored in ultra-low temperature freezers. Once thawed, stability is limited.

Basis for recommendation

  1. https://www.fda.gov/media/144413/download (3/5/2021 accessed)

    Comment:

    Fact Sheet for Providers administering vaccine: Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019.

References

  1. Walsh EE, Frenck RW, Falsey AR, et al. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N Engl J Med. 2020.  [PMID:33053279]

    Comment: This is the phase I, placebo-controlled, observer-blinded, dose-escalation trial conducted in the United States in which participants aged 18 - 55 or 65 - 85 were randomized to receive either placebo or one of two vaccine candidates (BNT162b1 or BNT162b2). The primary endpoint was safety, and immunogenicity was the secondary outcome. Vaccine responses elicited in both groups were similar in terms of dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples. The incidence of adverse effects was lower in the BNT162b2 subset, and this was chosen to move forward in the phase 2/3 study.

  2. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020.  [PMID:33301246]

    Comment: In this ongoing, multinational, placebo-controlled, observer-blinded efficacy trial, participants 16 years of age or older were randomized to receive 2 doses given 21 days apart of BNT162b2 or placebo. The primary endpoint was the efficacy of the vaccine against lab-confirmed COVID-19, as well as safety. 21,720 participants received the vaccine candidate while 21,728 received placebo. There were only 8 cases of COVID-19 disease that occured at least 7 days after the second dose of the vaccine compared to 162 cases in the group who received placebo, translating to 95% efficacy. Similar vaccine efficacy was observed across subgroups (age, sex, race, ethnicity, baseline BMI), although it should be noted that 83% of all participants were Caucasian. The incidence of adverse events was similar between groups, with the most frequently reported adverse events being injection site pain, fatigue, headache and diarrhea.

  3. Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep. ePub: 13 December 2020. DOI: http://dx.doi.org/10.15585/mmwr.mm6950e2

    Comment: MMWR report providing ACIP interim recommendations endorsing the Pfizer-BioNTech EUA from the FDA. The committee agreed that robust clinical trial data support the administration of the two-dose vaccine series on Day 0 and Day 21 for the prevention of COVID-19 disease in those 16 years of age and older.


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Last updated: March 5, 2021