Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 3 of 7)

2.2 Administration Information

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to off-white suspension. During the visual inspection,

  • verify the final dosing volume of 0.2 mL.
  • confirm there are no particulates and that no discoloration is observed.
  • do not administer if vaccine is discolored or contains particulate matter.

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with orange caps and labels with orange borders contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:

  • Each dose must contain 0.2 mL of vaccine.
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content.
  • Do not pool excess vaccine from multiple vials.

2.3 Vaccination Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age.

A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 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.

3 Pfizer-BioNTech Covid-19 Vaccine Dosage Forms and Strengths

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection.

After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and Administration (2.1)].

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

5.5 Limitation of Effectiveness

The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

6 OVERALL SAFETY SUMMARY

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.3 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc.

In a clinical study in children 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine containing 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (10 mcg modRNA), adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).


3
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

Post Authorization Experience in Individuals 12 Years of Age and Older

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 5 years of age and older in 3 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.

Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Study C4591007 (Study 3) is a Phase 1/2/3 multicenter, randomized, dose-finding, open-label (Phase 1) and multinational, saline placebo-controlled, observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 4,695 participants 5 through 11 years of age, of whom 3109 participants received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 1538 participants received placebo in Phase 2/3.

In Study 2 and Study 3, all participants 5 through 11 years of age, 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Tables 1 and 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine (10 mcg modRNA) and placebo in children 5 through 11 years of age.

Children 5 Through 11 Years of Age

In an analysis of Study 3 Phase 2/3, based on data up to the cutoff date of September 06, 2021, 2,268 participants [1,518 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA); 750 placebo] were 5 through 11 years of age. Of these, 2,158 (95.1%) [1,444 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 714 placebo] participants have been followed for at least 2 months after the second dose. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants [1,591 Pfizer BioNTech COVID-19 Vaccine (10 mcg modRNA) and 788 placebo], of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2 up to the cutoff date of October 8, 2021. The safety evaluation in Study 3 is ongoing.

Demographic characteristics in Study 3 were generally similar with regard to age, gender, race, and ethnicity among participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and those who received placebo. Among the 4,647 participants 5 through 11 years of age who received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA), 51.8% were male and 48.2% were female, 77.3% were White, 5.8% were Black or African American, 16.9% were Hispanic/Latino, 8.3% were Asian, and 0.4% were American Indian/Alaska Native.

Solicited Local and Systemic Adverse Reactions

The mean duration of pain at the injection site after Dose 2 was 2.3 days (range 1 to 11 days), for redness 2.2 days (range 1 to 10 days), and for swelling 2.2 days (range 1 to 10 days) for children in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group up to the cutoff date of September 06, 2021.

Table 1: Study 3 – Frequency and Percentages of Participants With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 Years of Age – Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1511n § (%) PlaceboDose 1N , =748n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2N =1501n § (%) PlaceboDose 2N , =740n § (%)
Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Randomized participants who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose.
§
n = Number of participants with the specified reaction.
The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error.
#
Mild: ≥0.5 to ≤2.0 cm; Moderate: >2.0 to ≤7.0 cm; Severe: >7.0 cm.
Þ
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.
Redness #
Any (≥0.5 cm) 222 (14.7) 43 (5.7) 278 (18.5) 40 (5.4)
Mild 143 (9.5) 37 (4.9) 143 (9.5) 31 (4.2)
Moderate 79 (5.2) 6 (0.8) 132 (8.8) 9 (1.2)
Severe 0 0 3 (0.2) 0
Swelling #
Any (≥0.5 cm) 158 (10.5) 20 (2.7) 229 (15.3) 20 (2.7)
Mild 85 (5.6) 13 (1.7) 117 (7.8) 15 (2.0)
Moderate 72 (4.8) 7 (0.9) 112 (7.5) 5 (0.7)
Severe 1 (0.1) 0 0 0
Pain at the injection site Þ
Any 1119 (74.1) 234 (31.3) 1065 (71.0) 218 (29.5)
Mild 890 (58.9) 204 (27.3) 793 (52.8) 192 (25.9)
Moderate 225 (14.9) 30 (4.0) 267 (17.8) 26 (3.5)
Severe 4 (0.3) 0 5 (0.3) 0
Table 2: Study 3 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Children 5 Through 11 Years of Age – Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1511n § (%) PlaceboDose 1N , =748n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2N =1501n § (%) PlaceboDose 2N , =740n § (%)
Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose.
*
Randomized participants who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose.
§
n = Number of participants with the specified reaction.
The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error.
#
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
Þ
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
ß
Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours.
à
Severity was not collected for use of antipyretic or pain medication.
Fever
≥38.0℃ 38 (2.5) 10 (1.3) 98 (6.5) 9 (1.2)
≥38.0℃ to 38.4℃ 23 (1.5) 4 (0.5) 51 (3.4) 5 (0.7)
>38.4℃ to 38.9℃ 12 (0.8) 5 (0.7) 38 (2.5) 3 (0.4)
>38.9℃ to 40.0℃ 3 (0.2) 1 (0.1) 8 (0.5) 1 (0.1)
>40.0℃ 0 0 1 (0.1) 0
Fatigue #
Any 508 (33.6) 234 (31.3) 592 (39.4) 180 (24.3)
Mild 333 (22.0) 150 (20.1) 321 (21.4) 96 (13.0)
Moderate 171 (11.3) 83 (11.1) 260 (17.3) 83 (11.2)
Severe 4 (0.3) 1 (0.1) 11 (0.7) 1 (0.1)
Headache #
Any 339 (22.4) 180 (24.1) 420 (28.0) 138 (18.6)
Mild 249 (16.5) 131 (17.5) 281 (18.7) 93 (12.6)
Moderate 88 (5.8) 45 (6.0) 136 (9.1) 45 (6.1)
Severe 2 (0.1) 4 (0.5) 3 (0.2) 0
Chills #
Any 70 (4.6) 35 (4.7) 147 (9.8) 32 (4.3)
Mild 54 (3.6) 30 (4.0) 105 (7.0) 24 (3.2)
Moderate 16 (1.1) 5 (0.7) 40 (2.7) 7 (0.9)
Severe 0 0 2 (0.1) 1 (0.1)
Vomiting Þ
Any 33 (2.2) 11 (1.5) 28 (1.9) 6 (0.8)
Mild 26 (1.7) 11 (1.5) 27 (1.8) 6 (0.8)
Moderate 7 (0.5) 0 1 (0.1) 0
Severe 0 0 0 0
Diarrhea ß
Any 89 (5.9) 31 (4.1) 79 (5.3) 35 (4.7)
Mild 79 (5.2) 31 (4.1) 72 (4.8) 32 (4.3)
Moderate 10 (0.7) 0 7 (0.5) 3 (0.4)
Severe 0 0 0 0
New or worsened muscle pain #
Any 137 (9.1) 51 (6.8) 175 (11.7) 55 (7.4)
Mild 96 (6.4) 35 (4.7) 116 (7.7) 38 (5.1)
Moderate 40 (2.6) 16 (2.1) 58 (3.9) 17 (2.3)
Severe 1 (0.1) 0 1 (0.1) 0
New or worsened joint pain #
Any 50 (3.3) 41 (5.5) 78 (5.2) 27 (3.6)
Mild 34 (2.3) 31 (4.1) 57 (3.8) 20 (2.7)
Moderate 16 (1.1) 10 (1.3) 21 (1.4) 7 (0.9)
Severe 0 0 0 0
Use of antipyretic or pain medication à 217 (14.4) 62 (8.3) 296 (19.7) 60 (8.1)

Unsolicited Adverse Events

In the following analyses of Study 3 in children 5 through 11 years of age (1,518 of whom received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 750 of whom received placebo), 99.5% of participants had at least 30 days of follow-up after Dose 2.

Serious Adverse Events

In 1 group of participants (initial enrollment cohort) with a median of 2.3 months follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination. In a second group of participants (expansion cohort) with a median of 2.4 weeks follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination.

Non-Serious Adverse Events

In 1 group of participants (initial enrollment cohort), non-serious adverse events from Dose 1 through up to 30 days after Dose 2 up to the cutoff date of September 06, 2021, in ongoing follow-up were reported by 10.9% of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 9.1% of placebo recipients. In this group of participants, >99% had follow-up 30 days post Dose 2. In a second group of participants (expansion cohort) for which the median follow-up was 2.4 weeks (range 0 – 3.7 weeks), non-serious adverse events from Dose 1 through the cutoff date of October 8, 2021, were reported by 7.1% of Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) recipients and by 6.3% of placebo recipients.

In the initial enrollment cohort, from Dose 1 through 30 days after Dose 2, lymphadenopathy was reported in 13 (0.9%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 1 (0.1%) in the placebo group. In the expansion cohort from Dose 1 through the cut-off date, lymphadenopathy was reported in 6 (0.4%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 3 (0.4%) in the placebo group. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Adolescents 12 Through 15 Years of Age

In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents [1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo] were 12 through 15 years of age. Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose. The safety evaluation in Study 2 is ongoing.

Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native.

Unsolicited Adverse Events

In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2.

Serious Adverse Events

Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events

Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Participants 16 Years of Age and Older

At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose.

The safety evaluation in Study 2 is ongoing. The safety population includes participants 16 years and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020.

Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native.

Unsolicited Adverse Events

Serious Adverse Events

In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2.

Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

Non-Serious Adverse Events

In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Overall in a similar analysis in which 7,960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2.

The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.

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