Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 3 of 8)

2.2 Administration Information

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

verify the final dosing volume of 0.3 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 purple caps contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.

2.3 Vaccination Schedule

Primary Series 5

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older.

A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise.6


5
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use, can be used interchangeably.
6
Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

3 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 vials with purple caps is 0.3 mL for individuals 12 years of age and older [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 with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. The observed risk is higher among adolescent males and adult 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 myocarditis, cases of pericarditis, 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. 7 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.


7
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

Primary Series

In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).

In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

Post Authorization Experience

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

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

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.

Primary Series

The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two 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) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 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).

In Study 2, all participants 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 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo.

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 of age 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.

Solicited Local and Systemic Adverse Reactions

Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group.

Solicited reactogenicity data in 16 and 17 year-old participants are limited.

Table 1:Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years of Age * – Reactogenicity Subset of the Safety Population
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Eight participants were between 16 and 17 years of age.
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
#
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
Þ
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

Pfizer-BioNTech COVID-19 Vaccine Dose 1 N § =2291 n (%)

Placebo Dose 1 N § =2298 n (%)

Pfizer-BioNTech COVID-19 Vaccine Dose 2 N § =2098 n (%)

Placebo Dose 2 N § =2103 n (%)

Redness #

Any (>2 cm)

104 (4.5)

26 (1.1)

123 (5.9)

14 (0.7)

Mild

70 (3.1)

16 (0.7)

73 (3.5)

8 (0.4)

Moderate

28 (1.2)

6 (0.3)

40 (1.9)

6 (0.3)

Severe

6 (0.3)

4 (0.2)

10 (0.5)

0 (0.0)

Swelling #

Any (>2 cm)

132 (5.8)

11 (0.5)

132 (6.3)

5 (0.2)

Mild

88 (3.8)

3 (0.1)

80 (3.8)

3 (0.1)

Moderate

39 (1.7)

5 (0.2)

45 (2.1)

2 (0.1)

Severe

5 (0.2)

3 (0.1)

7 (0.3)

0 (0.0)

Pain at the injection site Þ

Any

1904 (83.1)

322 (14.0)

1632 (77.8)

245 (11.7)

Mild

1170 (51.1)

308 (13.4)

1039 (49.5)

225 (10.7)

Moderate

710 (31.0)

12 (0.5)

568 (27.1)

20 (1.0)

Severe

24 (1.0)

2 (0.1)

25 (1.2)

0 (0.0)

Table 2: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 18 Through 55 Years of Age * – Reactogenicity Subset of the Safety Population
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N § =2291 n (%) Placebo Dose 1 N § =2298 n (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2 N § =2098 n (%) Placebo Dose 2 N § =2103 n (%)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose.
*
Eight participants were between 16 and 17 years of age.
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
#
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°C

85 (3.7)

20 (0.9)

331 (15.8)

10 (0.5)

≥38.0°C to 38.4°C

64 (2.8)

10 (0.4)

194 (9.2)

5 (0.2)

>38.4°C to 38.9°C

15 (0.7)

5 (0.2)

110 (5.2)

3 (0.1)

>38.9°C to 40.0°C

6 (0.3)

3 (0.1)

26 (1.2)

2 (0.1)

>40.0°C

0 (0.0)

2 (0.1)

1 (0.0)

0 (0.0)

Fatigue #

Any

1085 (47.4)

767 (33.4)

1247 (59.4)

479 (22.8)

Mild

597 (26.1)

467 (20.3)

442 (21.1)

248 (11.8)

Moderate

455 (19.9)

289 (12.6)

708 (33.7)

217 (10.3)

Severe

33 (1.4)

11 (0.5)

97 (4.6)

14 (0.7)

Headache #

Any

959 (41.9)

775 (33.7)

1085 (51.7)

506 (24.1)

Mild

628 (27.4)

505 (22.0)

538 (25.6)

321 (15.3)

Moderate

308 (13.4)

251 (10.9)

480 (22.9)

170 (8.1)

Severe

23 (1.0)

19 (0.8)

67 (3.2)

15 (0.7)

Chills #

Any

321 (14.0)

146 (6.4)

737 (35.1)

79 (3.8)

Mild

230 (10.0)

111 (4.8)

359 (17.1)

65 (3.1)

Moderate

82 (3.6)

33 (1.4)

333 (15.9)

14 (0.7)

Severe

9 (0.4)

2 (0.1)

45 (2.1)

0 (0.0)

Vomiting Þ

Any

28 (1.2)

28 (1.2)

40 (1.9)

25 (1.2)

Mild

24 (1.0)

22 (1.0)

28 (1.3)

16 (0.8)

Moderate

4 (0.2)

5 (0.2)

8 (0.4)

9 (0.4)

Severe

0 (0.0)

1 (0.0)

4 (0.2)

0 (0.0)

Diarrhea ß

Any

255 (11.1)

270 (11.7)

219 (10.4)

177 (8.4)

Mild

206 (9.0)

217 (9.4)

179 (8.5)

144 (6.8)

Moderate

46 (2.0)

52 (2.3)

36 (1.7)

32 (1.5)

Severe

3 (0.1)

1 (0.0)

4 (0.2)

1 (0.0)

New or worsened muscle pain #

Any

487 (21.3)

249 (10.8)

783 (37.3)

173 (8.2)

Mild

256 (11.2)

175 (7.6)

326 (15.5)

111 (5.3)

Moderate

218 (9.5)

72 (3.1)

410 (19.5)

59 (2.8)

Severe

13 (0.6)

2 (0.1)

47 (2.2)

3 (0.1)

New or worsened joint pain #

Any

251 (11.0)

138 (6.0)

459 (21.9)

109 (5.2)

Mild

147 (6.4)

95 (4.1)

205 (9.8)

54 (2.6)

Moderate

99 (4.3)

43 (1.9)

234 (11.2)

51 (2.4)

Severe

5 (0.2)

0 (0.0)

20 (1.0)

4 (0.2)

Use of antipyretic or pain medication à

638 (27.8)

332 (14.4)

945 (45.0)

266 (12.6)

Table 3: Study 2 – Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Reactogenicity Subset of the Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1802 n § (%) Placebo Dose 1 N =1792 n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2 N =1660 n § (%) Placebo Dose 2 N =1646 n § (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
#
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

Redness

Any (>2 cm)

85 (4.7)

19 (1.1)

120 (7.2)

12 (0.7)

Mild

55 (3.1)

12 (0.7)

59 (3.6)

8 (0.5)

Moderate

27 (1.5)

5 (0.3)

53 (3.2)

3 (0.2)

Severe

3 (0.2)

2 (0.1)

8 (0.5)

1 (0.1)

Swelling

Any (>2 cm)

118 (6.5)

21 (1.2)

124 (7.5)

11 (0.7)

Mild

71 (3.9)

10 (0.6)

68 (4.1)

5 (0.3)

Moderate

45 (2.5)

11 (0.6)

53 (3.2)

5 (0.3)

Severe

2 (0.1)

0 (0.0)

3 (0.2)

1 (0.1)

Pain at the injection site #

Any (>2 cm)

1282 (71.1)

166 (9.3)

1098 (66.1)

127 (7.7)

Mild

1008 (55.9)

160 (8.9)

792 (47.7)

125 (7.6)

Moderate

270 (15.0)

6 (0.3)

298 (18.0)

2 (0.1)

Severe

4 (0.2)

0 (0.0)

8 (0.5)

0 (0.0)

Table 4: Study 2 – Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Participants 56 Years of Age and Older – Reactogenicity Subset of the Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1802 n § (%) Placebo Dose 1 N =1792 n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2 N =1660 n § (%) Placebo Dose 2 N =1646 n § (%)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
#
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
Þ
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.

Fever

≥38.0°C

26 (1.4)

7 (0.4)

181 (10.9)

4 (0.2)

≥38.0°C to 38.4°C

23 (1.3)

2 (0.1)

131 (7.9)

2 (0.1)

>38.4°C to 38.9°C

1 (0.1)

3 (0.2)

45 (2.7)

1 (0.1)

>38.9°C to 40.0°C

1 (0.1)

2 (0.1)

5 (0.3)

1 (0.1)

>40.0°C

1 (0.1)

0 (0.0)

0 (0.0)

0 (0.0)

Fatigue

Any

615 (34.1)

405 (22.6)

839 (50.5)

277 (16.8)

Mild

373 (20.7)

252 (14.1)

351 (21.1)

161 (9.8)

Moderate

240 (13.3)

150 (8.4)

442 (26.6)

114 (6.9)

Severe

2 (0.1)

3 (0.2)

46 (2.8)

2 (0.1)

Headache

Any

454 (25.2)

325 (18.1)

647 (39.0)

229 (13.9)

Mild

348 (19.3)

242 (13.5)

422 (25.4)

165 (10.0)

Moderate

104 (5.8)

80 (4.5)

216 (13.0)

60 (3.6)

Severe

2 (0.1)

3 (0.2)

9 (0.5)

4 (0.2)

Chills

Any

113 (6.3)

57 (3.2)

377 (22.7)

46 (2.8)

Mild

87 (4.8)

40 (2.2)

199 (12.0)

35 (2.1)

Moderate

26 (1.4)

16 (0.9)

161 (9.7)

11 (0.7)

Severe

0 (0.0)

1 (0.1)

17 (1.0)

0 (0.0)

Vomiting #

Any

9 (0.5)

9 (0.5)

11 (0.7)

5 (0.3)

Mild

8 (0.4)

9 (0.5)

9 (0.5)

5 (0.3)

Moderate

1 (0.1)

0 (0.0)

1 (0.1)

0 (0.0)

Severe

0 (0.0)

0 (0.0)

1 (0.1)

0 (0.0)

Diarrhea Þ

Any

147 (8.2)

118 (6.6)

137 (8.3)

99 (6.0)

Mild

118 (6.5)

100 (5.6)

114 (6.9)

73 (4.4)

Moderate

26 (1.4)

17 (0.9)

21 (1.3)

22 (1.3)

Severe

3 (0.2)

1 (0.1)

2 (0.1)

4 (0.2)

New or worsened muscle pain

Any

251 (13.9)

149 (8.3)

477 (28.7)

87 (5.3)

Mild

168 (9.3)

100 (5.6)

202 (12.2)

57 (3.5)

Moderate

82 (4.6)

46 (2.6)

259 (15.6)

29 (1.8)

Severe

1 (0.1)

3 (0.2)

16 (1.0)

1 (0.1)

New or worsened joint pain

Any

155 (8.6)

109 (6.1)

313 (18.9)

61 (3.7)

Mild

101 (5.6)

68 (3.8)

161 (9.7)

35 (2.1)

Moderate

52 (2.9)

40 (2.2)

145 (8.7)

25 (1.5)

Severe

2 (0.1)

1 (0.1)

7 (0.4)

1 (0.1)

Use of antipyretic or pain medication

358 (19.9)

213 (11.9)

625 (37.7)

161 (9.8)

From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med) , in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3.

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 7960 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 and presented in Tables 3 and 4. 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.

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.

Solicited Local and Systemic Adverse Reactions

The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group.

Table 5: Study 2 – Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age – Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1127 n § (%) Placebo Dose 1 N =1127 n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2 N =1097 n § (%) Placebo Dose 2 N =1078 n § (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
Mild: >2.0 to ≤5.0 cm; Moderate: >5.0 to ≤10.0 cm; Severe: >10.0 cm.
#
Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

Redness

Any (>2 cm)

65 (5.8)

12 (1.1)

55 (5.0)

10 (0.9)

Mild

44 (3.9)

11 (1.0)

29 (2.6)

8 (0.7)

Moderate

20 (1.8)

1 (0.1)

26 (2.4)

2 (0.2)

Severe

1 (0.1)

0 (0.0)

0 (0.0)

0 (0.0)

Swelling

Any (>2 cm)

78 (6.9)

11 (1.0)

54 (4.9)

6 (0.6)

Mild

55 (4.9)

9 (0.8)

36 (3.3)

4 (0.4)

Moderate

23 (2.0)

2 (0.2)

18 (1.6)

2 (0.2)

Severe

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Pain at the injection site #

Any

971 (86.2)

263 (23.3)

866 (78.9)

193 (17.9)

Mild

467 (41.4)

227 (20.1)

466 (42.5)

164 (15.2)

Moderate

493 (43.7)

36 (3.2)

393 (35.8)

29 (2.7)

Severe

11 (1.0)

0 (0.0)

7 (0.6)

0 (0.0)

Table 6: Study 2 – Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose – Adolescents 12 Through 15 Years of Age – Safety Population *
Pfizer-BioNTech COVID-19 Vaccine Dose 1 N =1127 n § (%) Placebo Dose 1 N =1127 n § (%) Pfizer-BioNTech COVID-19 Vaccine Dose 2 N =1097 n § (%) Placebo Dose 2 N =1078 n § (%)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose.
*
Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Pfizer-BioNTech COVID-19 Vaccine (30 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.
Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity.
#
Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration.
Þ
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.
ß
Severity was not collected for use of antipyretic or pain medication.

Fever

≥38.0°C

114 (10.1)

12 (1.1)

215 (19.6)

7 (0.6)

≥38.0°C to 38.4°C

74 (6.6)

8 (0.7)

107 (9.8)

5 (0.5)

>38.4°C to 38.9°C

29 (2.6)

2 (0.2)

83 (7.6)

1 (0.1)

>38.9°C to 40.0°C

10 (0.9)

2 (0.2)

25 (2.3)

1 (0.1)

>40.0°C

1 (0.1)

0 (0.0)

0 (0.0)

0 (0.0)

Fatigue

Any

677 (60.1)

457 (40.6)

726 (66.2)

264 (24.5)

Mild

278 (24.7)

250 (22.2)

232 (21.1)

133 (12.3)

Moderate

384 (34.1)

199 (17.7)

468 (42.7)

127 (11.8)

Severe

15 (1.3)

8 (0.7)

26 (2.4)

4 (0.4)

Headache

Any

623 (55.3)

396 (35.1)

708 (64.5)

263 (24.4)

Mild

361 (32.0)

256 (22.7)

302 (27.5)

169 (15.7)

Moderate

251 (22.3)

131 (11.6)

384 (35.0)

93 (8.6)

Severe

11 (1.0)

9 (0.8)

22 (2.0)

1 (0.1)

Chills

Any

311 (27.6)

109 (9.7)

455 (41.5)

73 (6.8)

Mild

195 (17.3)

82 (7.3)

221 (20.1)

52 (4.8)

Moderate

111 (9.8)

25 (2.2)

214 (19.5)

21 (1.9)

Severe

5 (0.4)

2 (0.2)

20 (1.8)

0 (0.0)

Vomiting #

Any

31 (2.8)

10 (0.9)

29 (2.6)

12 (1.1)

Mild

30 (2.7)

8 (0.7)

25 (2.3)

11 (1.0)

Moderate

0 (0.0)

2 (0.2)

4 (0.4)

1 (0.1)

Severe

1 (0.1)

0 (0.0)

0 (0.0)

0 (0.0)

Diarrhea Þ

Any

90 (8.0)

82 (7.3)

65 (5.9)

43 (4.0)

Mild

77 (6.8)

72 (6.4)

59 (5.4)

38 (3.5)

Moderate

13 (1.2)

10 (0.9)

6 (0.5)

5 (0.5)

Severe

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

New or worsened muscle pain

Any

272 (24.1)

148 (13.1)

355 (32.4)

90 (8.3)

Mild

125 (11.1)

88 (7.8)

152 (13.9)

51 (4.7)

Moderate

145 (12.9)

60 (5.3)

197 (18.0)

37 (3.4)

Severe

2 (0.2)

0 (0.0)

6 (0.5)

2 (0.2)

New or worsened joint pain

Any

109 (9.7)

77 (6.8)

173 (15.8)

51 (4.7)

Mild

66 (5.9)

50 (4.4)

91 (8.3)

30 (2.8)

Moderate

42 (3.7)

27 (2.4)

78 (7.1)

21 (1.9)

Severe

1 (0.1)

0 (0.0)

4 (0.4)

0 (0.0)

Use of antipyretic or pain medication ß

413 (36.6)

111 (9.8)

557 (50.8)

95 (8.8)

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.

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