Comirnaty by is a Other medication manufactured, distributed, or labeled by Pfizer Laboratories Div Pfizer Inc, Pfizer Inc, Pfizer Manufacturing Belgium NV, Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Pfizer Ireland Pharmaceuticals, BioNTech Innovative Manufacturing Services GmbH, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH, Pharmacia & Upjohn Company LLC, Exela Pharma Sciences, LLC.. Drug facts, warnings, and ingredients follow.
Dosage and Administration, Preparation for Administration: Plastic prefilled syringe is no longer available. (2.1) |
8/2024 |
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. (1)
Suspension for injection. A single dose is 0.3 mL. (3)
Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY. (4)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2024
For intramuscular injection only.
COMIRNATY Single Dose Glass Prefilled Syringes
COMIRNATY Single Dose Vials
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.
Administer the 0.3 mL dose intramuscularly immediately after preparation. For the prefilled syringe, administer the entire volume to deliver a single 0.3 mL dose.
Do not administer COMIRNATY to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY [see Description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY.
Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For COMIRNATY, 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 Centers for Disease Control and Prevention (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).
Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY [see Use in Specific Populations (8.6)].
An overview of clinical studies contributing to the safety assessment of COMIRNATY is provided in Table 1. Participants in these clinical studies received a 2-dose series, 3 weeks apart (referred to as a primary series) and subsequent doses referred to as booster doses.
Abbreviation: SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | ||||
|
||||
Study |
Age Group |
Vaccine Strain Composition |
Dosing |
Number of Participants |
Primary Series |
||||
Study 1 (NCT04380701) |
18 through 55 years |
Original* |
Primary series |
60 |
Study 2 (NCT04368728) |
12 through 15 years of age |
Original* |
Primary series |
1131† |
≥16 years of age |
Original* |
Primary series |
22026† |
|
Booster Dose |
||||
Study 2 (NCT04368728) |
12 through 15 years of age |
Original* |
1st booster |
825 |
18 through 55 years of age |
Original* |
1st booster |
306 |
|
Study 4 (NCT04955626) |
12 through 17 years of age |
Original* |
1st booster |
65 |
≥16 years of age |
Original* |
1st booster |
5081† |
|
Study 5 (NCT05472038) |
≥12 years of age |
Original and Omicron BA.4/BA.5‡ |
2nd booster |
726 |
Concomitant Administration |
||||
Study 8 (NCT05310084) |
18 through 64 years of age |
Original* |
2nd booster administered alone or concomitantly with Influenza Vaccine§ |
1128 |
Primary Series with COMIRNATY
Participants 12 through 15 years of age in Study 2: the most commonly reported adverse reactions (≥8%) following any dose were 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%), and injection site redness (8.6%).
Participants 16 through 55 years of age in Study 2: the most commonly reported adverse reactions (≥10%) following any dose were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
Participants 56 years of age and older in Study 2: the most commonly reported adverse reactions (≥10%) following any dose were pain at the injection site (78.2%), fatigue (56.9%), headache, (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
Booster Dose with COMIRNATY
Participants 12 years of age and older in Studies 2 and 4: the most commonly reported adverse reactions (≥5%) following administration of a first booster dose with COMIRNATY were similar to those reported by participants who received COMIRNATY in the primary series.
Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Participants 12 years of age and older in Study 5: the most commonly reported adverse reactions (≥5%) following administration of a second booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent were pain at the injection site (67.3%), fatigue (52.6%), headache (40.5%), muscle pain (24.6%), chills (18.0%), joint pain (13.3%), fever (5.3%), injection site swelling (5.3%), and injection site redness (5.3%).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
Primary Series With COMIRNATY
The safety of a 2-dose primary series of COMIRNATY was evaluated in participants 12 years of age and older in 2 clinical studies conducted in Germany (Study 1), United States, Argentina, Brazil, Turkey, South Africa, and Germany (Study 2). 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 and 36 participants, 56 through 85 years of age. Study 2 was a Phase 1/2/3 multicenter, randomized, saline placebo-controlled, double-blinded (Phase 2/3), dose finding-, vaccine candidate-selection and efficacy study that enrolled approximately 46,000 participants 12 years of age or older. Of these, approximately 2,260 participants were 12 through 15 years of age (1,131 COMIRNATY; 1,129 placebo) and 754 were 16 through 17 years of age (378 COMIRNATY; 376 placebo). In all, 44,047 participants in Phase 2/3 were 16 years of age or older (22,026 COMIRNATY; 22,021 placebo).
Study 2 included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Confirmed stable HIV infection was defined as documented viral load <50 copies/mL and CD4 count >200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months. HIV-positive participants are included in the safety population but are summarized separately in the safety analyses.
In Study 2, participants 12 years and older in the reactogenicity subset were monitored using an electronic diary for solicited local and systemic reactions and use of antipyretic medication after each vaccination. Participants were also monitored for unsolicited adverse events throughout the study (from Dose 1 through 1 month [all unsolicited adverse events] or through 6 months [serious adverse events] after the last vaccination). Tables 2 and 3 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following any dose of COMIRNATY.
Adolescents 12 Through 15 Years of Age
In Study 2, 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 through 15 years of age. At the time of the analysis of the ongoing Study 2 with a data cutoff of September 2, 2021, there were 1,559 (69.0%) adolescents (786 COMIRNATY and 773 placebo) 12 through 15 years of age followed for ≥4 months after the second dose.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received COMIRNATY and those who received placebo. Overall, among the adolescents who received COMIRNATY, 50.1% were male and 49.9% were female, 85.8% 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.
Local and Systemic Adverse Reactions Solicited in Study 2
In adolescents 12 through 15 years of age after receiving Dose 2, the mean duration of pain at the injection site was 2.5 days (range 1 to 11 days), for redness 1.8 days (range 1 to 5 days), and for swelling 1.6 days (range 1 to 5 days) in the COMIRNATY group.
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. | |||||
|
|||||
COMIRNATY† Dose 1 N‡=1127 n§ (%) |
Placebo Dose 1 N‡=1127 n§ (%) |
COMIRNATY† Dose 2 N‡=1097 n§ (%) |
Placebo Dose 2 N‡=1078 n§ (%) |
||
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) |
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. | |||||
|
|||||
COMIRNATY† Dose 1 N‡=1127 n§ (%) |
Placebo Dose 1 N‡=1127 n§ (%) |
COMIRNATY† Dose 2 N‡=1097 n§ (%) |
Placebo Dose 2 N‡=1078 n§ (%) |
||
Fever | |||||
≥38.0℃ |
114 (10.1) |
12 (1.1) |
215 (19.6) |
7 (0.6) |
|
≥38.0℃ to 38.4℃ |
74 (6.6) |
8 (0.7) |
107 (9.8) |
5 (0.5) |
|
>38.4℃ to 38.9℃ |
29 (2.6) |
2 (0.2) |
83 (7.6) |
1 (0.1) |
|
>38.9℃ to 40.0℃ |
10 (0.9) |
2 (0.2) |
25 (2.3) |
1 (0.1) |
|
>40.0℃ |
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) |
264 (24.5) |
|
Mild |
361 (32.0) |
256 (22.7) |
302 (27.5) |
170 (15.8) |
|
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) |
74 (6.9) |
|
Mild |
195 (17.3) |
82 (7.3) |
221 (20.1) |
53 (4.9) |
|
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) |
|
DiarrheaÞ | |||||
Any |
90 (8.0) |
82 (7.3) |
65 (5.9) |
44 (4.1) |
|
Mild |
77 (6.8) |
72 (6.4) |
59 (5.4) |
39 (3.6) |
|
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 medicationß |
413 (36.6) |
111 (9.8) |
557 (50.8) |
95 (8.8) |
Unsolicited Adverse Events in Study 2
In Study 2, 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 through 15 years of age. Of these, 634 (56.1%) participants in the COMIRNATY group and 629 (55.7%) participants in the placebo group had follow-up time between ≥4 months to <6 months after Dose 2 in the blinded placebo-controlled follow-up period with an additional 152 (13.4%) and 144 (12.8%) with ≥6 months of blinded follow-up time in the COMIRNATY and placebo groups, respectively.
A total of 1,113 (98.4%) participants 12 through 15 years of age originally randomized to COMIRNATY had ≥6 months total (blinded and unblinded) follow-up after Dose 2. An analysis of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date was conducted. Among participants 12 through 15 years of age who received at least 1 dose of study vaccine, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group.
In an analysis of all unsolicited adverse events reported during blinded follow-up from Dose 1 through 1 month after Dose 2, in adolescents 12 to 15 years of age, those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 vs. 2), and nausea (5 vs. 2).
In the analysis of blinded, placebo-controlled follow-up, there were no other notable patterns or numerical imbalances between treatment groups for specific categories of unsolicited adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY.
Serious Adverse Events
In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. In these analyses, 69.0% of study participants had at least 4 months of follow-up after Dose 2. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY.
Participants 16 Years of Age and Older
At the time of the analysis of Study 2 with a data cutoff of March 13, 2021, there were 25,651 (58.2%) participants (13,031 COMIRNATY; 12,620 placebo) 16 years of age and older followed for ≥4 months after the second dose.
Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received COMIRNATY and those who received placebo. Overall, among the total participants who received either COMIRNATY or placebo, 50.9% were male, 49.1% were female, 79.3% were 16 through 64 years of age, 20.7% were 65 years of age and older, 82.0% were White, 9.6% were Black or African American, 25.9% were Hispanic/Latino, 4.3% were Asian, and 1.0% were American Indian or Alaska Native.
Local and Systemic Adverse Reactions Solicited in the Study 2
In participants 16 through 55 years of age after receiving Dose 2, the mean duration of pain at the injection site was 2.5 days (range 1 to 70 days), for redness 2.2 days (range 1 to 9 days), and for swelling 2.1 days (range 1 to 8 days) for participants in the COMIRNATY group.
In participants 56 years of age and older after receiving Dose 2, the mean duration of pain at the injection site was 2.4 days (range 1 to 36 days), for redness 3.0 days (range 1 to 34 days), and for swelling 2.6 days (range 1 to 34 days) for participants in the COMIRNATY group.
Notes: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No Grade 4 solicited local reactions were reported in participants 16 through 55 years of age. |
||||
|
||||
COMIRNATY† Dose 1 N‡=2899 n§ (%) |
Placebo Dose 1 N‡=2908 n§ (%) |
COMIRNATY† Dose 2 N‡=2682 n§ (%) |
Placebo Dose 2 N‡=2684 n§ (%) |
|
Redness¶ | ||||
Any (>2.0 cm) |
156 (5.4) |
28 (1.0) |
151 (5.6) |
18 (0.7) |
Mild |
113 (3.9) |
19 (0.7) |
90 (3.4) |
12 (0.4) |
Moderate |
36 (1.2) |
6 (0.2) |
50 (1.9) |
6 (0.2) |
Severe |
7 (0.2) |
3 (0.1) |
11 (0.4) |
0 |
Swelling¶ | ||||
Any (>2.0 cm) |
184 (6.3) |
16 (0.6) |
183 (6.8) |
5 (0.2) |
Mild |
124 (4.3) |
6 (0.2) |
110 (4.1) |
3 (0.1) |
Moderate |
54 (1.9) |
8 (0.3) |
66 (2.5) |
2 (0.1) |
Severe |
6 (0.2) |
2 (0.1) |
7 (0.3) |
0 |
Pain at the injection site# | ||||
Any |
2426 (83.7) |
414 (14.2) |
2101 (78.3) |
312 (11.6) |
Mild |
1464 (50.5) |
391 (13.4) |
1274 (47.5) |
284 (10.6) |
Moderate |
923 (31.8) |
20 (0.7) |
788 (29.4) |
28 (1.0) |
Severe |
39 (1.3) |
3 (0.1) |
39 (1.5) |
0 |
Notes: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. No Grade 4 solicited systemic reactions were reported in participants 16 through 55 years of age. |
|||||
|
|||||
COMIRNATY† Dose 1 N‡=2899 n§ (%) |
Placebo Dose 1 N‡=2908 n§ (%) |
COMIRNATY† Dose 2 N‡=2682 n§ (%) |
Placebo Dose 2 N‡=2684 n§ (%) |
||
Fever | |||||
≥38.0℃ |
119 (4.1) |
25 (0.9) |
440 (16.4) |
11 (0.4) |
|
≥38.0℃ to 38.4℃ |
86 (3.0) |
16 (0.6) |
254 (9.5) |
5 (0.2) |
|
>38.4℃ to 38.9℃ |
25 (0.9) |
5 (0.2) |
146 (5.4) |
4 (0.1) |
|
>38.9℃ to 40.0℃ |
8 (0.3) |
4 (0.1) |
39 (1.5) |
2 (0.1) |
|
>40.0℃ |
0 |
0 |
1 (0.0) |
0 |
|
Fatigue¶ | |||||
Any |
1431 (49.4) |
960 (33.0) |
1649 (61.5) |
614 (22.9) |
|
Mild |
760 (26.2) |
570 (19.6) |
558 (20.8) |
317 (11.8) |
|
Moderate |
630 (21.7) |
372 (12.8) |
949 (35.4) |
283 (10.5) |
|
Severe |
41 (1.4) |
18 (0.6) |
142 (5.3) |
14 (0.5) |
|
Headache¶ | |||||
Any |
1262 (43.5) |
975 (33.5) |
1448 (54.0) |
652 (24.3) |
|
Mild |
785 (27.1) |
633 (21.8) |
699 (26.1) |
404 (15.1) |
|
Moderate |
444 (15.3) |
318 (10.9) |
658 (24.5) |
230 (8.6) |
|
Severe |
33 (1.1) |
24 (0.8) |
91 (3.4) |
18 (0.7) |
|
Chills¶ | |||||
Any |
479 (16.5) |
199 (6.8) |
1015 (37.8) |
114 (4.2) |
|
Mild |
338 (11.7) |
148 (5.1) |
477 (17.8) |
89 (3.3) |
|
Moderate |
126 (4.3) |
49 (1.7) |
469 (17.5) |
23 (0.9) |
|
Severe |
15 (0.5) |
2 (0.1) |
69 (2.6) |
2 (0.1) |
|
Vomiting# | |||||
Any |
34 (1.2) |
36 (1.2) |
58 (2.2) |
30 (1.1) |
|
Mild |
29 (1.0) |
30 (1.0) |
42 (1.6) |
20 (0.7) |
|
Moderate |
5 (0.2) |
5 (0.2) |
12 (0.4) |
10 (0.4) |
|
Severe |
0 |
1 (0.0) |
4 (0.1) |
0 |
|
DiarrheaÞ | |||||
Any |
309 (10.7) |
323 (11.1) |
269 (10.0) |
205 (7.6) |
|
Mild |
251 (8.7) |
264 (9.1) |
219 (8.2) |
169 (6.3) |
|
Moderate |
55 (1.9) |
58 (2.0) |
44 (1.6) |
35 (1.3) |
|
Severe |
3 (0.1) |
1 (0.0) |
6 (0.2) |
1 (0.0) |
|
New or worsened muscle pain¶ | |||||
Any |
664 (22.9) |
329 (11.3) |
1055 (39.3) |
237 (8.8) |
|
Mild |
353 (12.2) |
231 (7.9) |
441 (16.4) |
150 (5.6) |
|
Moderate |
296 (10.2) |
96 (3.3) |
552 (20.6) |
84 (3.1) |
|
Severe |
15 (0.5) |
2 (0.1) |
62 (2.3) |
3 (0.1) |
|
New or worsened joint pain¶ | |||||
Any |
342 (11.8) |
168 (5.8) |
638 (23.8) |
147 (5.5) |
|
Mild |
200 (6.9) |
112 (3.9) |
291 (10.9) |
82 (3.1) |
|
Moderate |
137 (4.7) |
55 (1.9) |
320 (11.9) |
61 (2.3) |
|
Severe |
5 (0.2) |
1 (0.0) |
27 (1.0) |
4 (0.1) |
|
Use of antipyretic or pain medicationß |
805 (27.8) |
398 (13.7) |
1213 (45.2) |
320 (11.9) |
Notes: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No Grade 4 solicited local reactions were reported in participants 56 years of age and older. |
|||||
|
|||||
COMIRNATY† Dose 1 N‡=2008 n§ (%) |
Placebo Dose 1 N‡=1989 n§ (%) |
COMIRNATY† Dose 2 N‡=1860 n§ (%) |
Placebo Dose 2 N‡=1833 n§ (%) |
||
Redness¶ | |||||
Any (>2.0 cm) |
106 (5.3) |
20 (1.0) |
133 (7.2) |
14 (0.8) |
|
Mild |
71 (3.5) |
13 (0.7) |
65 (3.5) |
10 (0.5) |
|
Moderate |
30 (1.5) |
5 (0.3) |
58 (3.1) |
3 (0.2) |
|
Severe |
5 (0.2) |
2 (0.1) |
10 (0.5) |
1 (0.1) |
|
Swelling¶ | |||||
Any (>2.0 cm) |
141 (7.0) |
23 (1.2) |
145 (7.8) |
13 (0.7) |
|
Mild |
87 (4.3) |
11 (0.6) |
80 (4.3) |
5 (0.3) |
|
Moderate |
52 (2.6) |
12 (0.6) |
61 (3.3) |
7 (0.4) |
|
Severe |
2 (0.1) |
0 |
4 (0.2) |
1 (0.1) |
|
Pain at the injection site# | |||||
Any (>2.0 cm) |
1408 (70.1) |
185 (9.3) |
1230 (66.1) |
143 (7.8) |
|
Mild |
1108 (55.2) |
177 (8.9) |
873 (46.9) |
138 (7.5) |
|
Moderate |
296 (14.7) |
8 (0.4) |
347 (18.7) |
5 (0.3) |
|
Severe |
4 (0.2) |
0 |
10 (0.5) |
0 |
Notes: Reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. The only Grade 4 solicited systemic reaction reported in participants 56 years of age and older was fatigue. |
|||||
|
|||||
COMIRNATY† Dose 1 N‡=2008 n§ (%) |
Placebo Dose 1 N‡=1989 n§ (%) |
COMIRNATY† Dose 2 N‡=1860 n§ (%) |
Placebo Dose 2 N‡=1833 n§ (%) |
||
Fever | |||||
≥38.0℃ |
26 (1.3) |
8 (0.4) |
219 (11.8) |
4 (0.2) |
|
≥38.0℃ to 38.4℃ |
23 (1.1) |
3 (0.2) |
158 (8.5) |
2 (0.1) |
|
>38.4℃ to 38.9℃ |
2 (0.1) |
3 (0.2) |
54 (2.9) |
1 (0.1) |
|
>38.9℃ to 40.0℃ |
1 (0.0) |
2 (0.1) |
7 (0.4) |
1 (0.1) |
|
>40.0℃ |
0 |
0 |
0 |
0 |
|
Fatigue¶ | |||||
Any |
677 (33.7) |
447 (22.5) |
949 (51.0) |
306 (16.7) |
|
Mild |
415 (20.7) |
281 (14.1) |
391 (21.0) |
183 (10.0) |
|
Moderate |
259 (12.9) |
163 (8.2) |
497 (26.7) |
121 (6.6) |
|
Severe |
3 (0.1) |
3 (0.2) |
60 (3.2) |
2 (0.1) |
|
Grade 4 |
0 |
0 |
1 (0.1) |
0 |
|
Headache¶ | |||||
Any |
503 (25.0) |
363 (18.3) |
733 (39.4) |
259 (14.1) |
|
Mild |
381 (19.0) |
267 (13.4) |
464 (24.9) |
189 (10.3) |
|
Moderate |
120 (6.0) |
93 (4.7) |
256 (13.8) |
65 (3.5) |
|
Severe |
2 (0.1) |
3 (0.2) |
13 (0.7) |
5 (0.3) |
|
Chills¶ | |||||
Any |
130 (6.5) |
69 (3.5) |
435 (23.4) |
57 (3.1) |
|
Mild |
102 (5.1) |
49 (2.5) |
229 (12.3) |
45 (2.5) |
|
Moderate |
28 (1.4) |
19 (1.0) |
185 (9.9) |
12 (0.7) |
|
Severe |
0 |
1 (0.1) |
21 (1.1) |
0 |
|
Vomiting# | |||||
Any |
10 (0.5) |
9 (0.5) |
13 (0.7) |
5 (0.3) |
|
Mild |
9 (0.4) |
9 (0.5) |
10 (0.5) |
5 (0.3) |
|
Moderate |
1 (0.0) |
0 |
1 (0.1) |
0 |
|
Severe |
0 |
0 |
2 (0.1) |
0 |
|
DiarrheaÞ | |||||
Any |
168 (8.4) |
130 (6.5) |
152 (8.2) |
102 (5.6) |
|
Mild |
137 (6.8) |
109 (5.5) |
125 (6.7) |
76 (4.1) |
|
Moderate |
27 (1.3) |
20 (1.0) |
25 (1.3) |
22 (1.2) |
|
Severe |
4 (0.2) |
1 (0.1) |
2 (0.1) |
4 (0.2) |
|
New or worsened muscle pain¶ | |||||
Any |
274 (13.6) |
165 (8.3) |
537 (28.9) |
99 (5.4) |
|
Mild |
183 (9.1) |
111 (5.6) |
229 (12.3) |
65 (3.5) |
|
Moderate |
90 (4.5) |
51 (2.6) |
288 (15.5) |
33 (1.8) |
|
Severe |
1 (0.0) |
3 (0.2) |
20 (1.1) |
1 (0.1) |
|
New or worsened joint pain¶ | |||||
Any |
175 (8.7) |
124 (6.2) |
353 (19.0) |
72 (3.9) |
|
Mild |
119 (5.9) |
78 (3.9) |
183 (9.8) |
44 (2.4) |
|
Moderate |
53 (2.6) |
45 (2.3) |
161 (8.7) |
27 (1.5) |
|
Severe |
3 (0.1) |
1 (0.1) |
9 (0.5) |
1 (0.1) |
|
Use of antipyretic or pain medicationß |
382 (19.0) |
224 (11.3) |
688 (37.0) |
170 (9.3) |
In participants with chronic, stable HIV infection the frequencies of solicited local and systemic adverse reactions were similar to or lower than those observed for all participants 16 years of age and older.
Unsolicited Adverse Events
Overall, 11,253 (51.1%) participants 16 years of age and older in the COMIRNATY group and 11,316 (51.4%) participants in the placebo group had follow-up time between ≥4 months to <6 months after Dose 2 in the blinded placebo-controlled follow-up period with an additional 1,778 (8.1%) and 1,304 (5.9%) with ≥6 months of blinded follow-up time in the COMIRNATY and placebo groups, respectively.
A total of 12,006 (54.5%) participants originally randomized to COMIRNATY had ≥6 months total (blinded and unblinded) follow-up after Dose 2.
In an analysis of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in participants 16 years of age and older (N = 43,847; 21,926 COMIRNATY group vs. 21,921 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were nausea (274 vs. 87), malaise (130 vs. 22), lymphadenopathy (83 vs. 7), asthenia (76 vs. 25), decreased appetite (39 vs. 9), hyperhidrosis (31 vs. 9), lethargy (25 vs. 6), and night sweats (17 vs. 3).
In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 58.2% of study participants had at least 4 months of follow-up after Dose 2. Among participants 16 through 55 years of age who received at least 1 dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. The higher frequency of reported unsolicited adverse events among COMIRNATY recipients compared to placebo recipients was primarily attributed to events that are consistent with adverse reactions solicited among participants in the reactogenicity subset (Table 6 and Table 7).
Throughout the placebo-controlled safety follow-up period, Bell's palsy (facial paralysis) was reported by 4 participants in the COMIRNATY group and 2 participants in the placebo 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. In the placebo group the onset of facial paralysis was Day 32 and Day 102. Currently available information is insufficient to determine a causal relationship with the vaccine. In the analysis of blinded, placebo-controlled follow-up, 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 COMIRNATY. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY.
Serious Adverse Events
Participants 16 through 55 years of age in Study 2 who had received at least 1 dose of vaccine or placebo (COMIRNATY = 12,995; placebo = 13,026), reported serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up as follows: 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. In a similar analysis, in participants 56 years of age and older (8,931 COMIRNATY group and 8,895 placebo group), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. In these analyses, 58.2% of study participants had at least 4 months of follow-up after Dose 2. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.
In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY.
First Booster Dose With COMIRNATY Following the Primary Series
12 Through 15 Years of Age
A subset of 825 Study 2 Phase 2/3 participants 12 through 15 years of age received a booster dose of COMIRNATY 11.2 months (median time, range 6.3 to 20.1 months) after completing the primary series and had a median follow-up time of 9.5 months up to a data cutoff date of November 3, 2022. The median age of participants was 14.0 years (range 13 through 15 years of age), 49.3% were male and 50.7% were female, 83.5% were White, 10.8% were Hispanic/Latino, 4.6% were Black or African American, 7.5% were Asian, and 0.4% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to those previously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy occurred in 8 (1.0%) participants who received a booster dose of COMIRNATY and in 9 (0.8%) participants who received COMIRNATY as a primary series.
12 Through 17 Years of Age
A subset of 65 Study 4 participants 12 through 17 years of age received a booster dose of COMIRNATY 13.3 months (median time, range 6.5 to 16.9 months) after completing the primary series and had a median follow-up time of 5.6 months up to a data cutoff date of July 14, 2022. The median age of participants was 14 years (range 12 through 17 years of age), 49.2% were male and 50.8% were female, 76.9% were White, 16.9% were Hispanic/Latino, 13.8% were Black or African American, 7.7% were Asian, and 1.5% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to those previously observed in participants receiving COMIRNATY as part of the primary series. There were no cases of lymphadenopathy reported in participants who received a booster dose of COMIRNATY.
16 Years of Age and Older
In Study 4, a double-blind placebo-controlled booster study, 5,081 participants 16 years of age and older recruited from Study 2 received a booster dose of COMIRNATY 10.8 months (median time, range of 5.0 to 12.6 months) after completing the primary series of COMIRNATY series and had a median follow-up time of 2.9 months based on data up to the cutoff date of February 8, 2022. The median age of participants who received COMIRNATY or placebo was 53.0 years (range 16 through 87 years of age), 49.1% were male and 50.9% were female, 79.0% were White, 14.9% were Hispanic/Latino, 9.2% were Black or African American, 5.5% were Asian, and 1.7% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to those previously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy occurred in 141 (2.8%) participants who received a booster dose of COMIRNATY and in 83 (0.4%) participants who received COMIRNATY as a primary series.
18 Through 55 Years of Age
A subset of 306 Study 2 Phase 2/3 participants 18 through 55 years of age received a booster dose of COMIRNATY 6.8 months (median time, range 4.8 to 8.0 months) after completing the primary series. These participants had a median follow-up time of 8.3 months up to a data cutoff date of November 22, 2021. Among the 306 participants, the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native.
Adverse reactions reported in participants receiving a booster dose of COMIRNATY were similar to those previously observed in participants receiving COMIRNATY as part of the primary series. Lymphadenopathy occurred in 16 (5.2%) of participants who received a booster dose of COMIRNATY and 83 (0.4%) in participants who received COMIRNATY as a primary series.
Second Booster With Pfizer-BioNTech COVID-19 Vaccine, Bivalent
12 Years of Age and Older
A subset of 107 Study 5 Phase 2/3 participants 12 through 17 years of age, 313 participants 18 through 55 years of age and 306 participants 56 years of age and older previously vaccinated with a 2-dose primary series and 1 booster dose of COMIRNATY, went on to receive a second booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Participants received a second booster dose 11.1 months (median time; range 5.4 to 16.9 months) after receiving the first booster dose and had a median follow-up time of 1.5 months up to a data cutoff date of October 31, 2022. The median age was 48.0 years, 42.7% were male, 57.3% were female, 80.6% were White, 11.4% were Hispanic/Latino, 5.9% were Asian, and 11.4% were Black or African American.
Local and Systemic Adverse Reactions Solicited in Study 5
Table 8 and Table 9 present the frequency and severity of reported solicited local reactions and systemic reactions, respectively, within 7 days of a second booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
In participants 12 years of age and older who received a second booster dose, the mean duration of injection site pain was 2.1 to 2.4 days (range 1 to 11 days), injection site redness was 1.5 to 2.5 days (range 1 to 4 days), and injection site swelling was 1.3 to 1.9 days (range 1 to 4 days), respectively.
Note: Adverse Reactions were collected in the electronic diary (e-diary) from day of vaccination (Day 1) through Day 7 after the study vaccination. | |||
|
|||
Pfizer-BioNTech COVID-19 Vaccine, Bivalent* |
|||
12 Through 17 Years of Age N†=107 n‡ (%) |
18 Through 55 Years of Age n‡ (%) |
56 Years of Age and Older n‡ (%) |
|
Redness¶ | |||
Any (>2 cm) |
6 (5.6) |
21 (6.8%) |
11 (3.7%) |
Mild |
4 (3.7) |
16 (5.2%) |
7 (2.3) |
Moderate |
2 (1.9) |
5 (1.6) |
4 (1.3%) |
Severe |
0 |
0 |
0 |
Swelling¶ | |||
Any (>2 cm) |
8 (7.5) |
23 (7.4%) |
8 (2.7) |
Mild |
6 (5.6) |
19 (6.1%) |
5 (1.7) |
Moderate |
2 (1.9) |
4 (1.3) |
3 (1.0) |
Severe |
0 |
0 |
0 |
Pain at the injection site# | |||
Any |
75 (70.1) |
236 (76.1) |
172 (57.1) |
Mild |
45 (42.1) |
178 (57.4) |
147 (48.8) |
Moderate |
29 (27.1) |
58 (18.7) |
24 (8.0) |
Severe |
1 (0.9) |
0 |
1 (0.3) |
Note: Adverse reactions and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from day of vaccination (Day 1) through Day 7 after the study vaccination. | |||
|
|||
Pfizer-BioNTech COVID-19 Vaccine, Bivalent* | |||
12 Through 17 Years of Age N†=107 n‡ (%) |
18 Through 55 Years of Age N†=309 n‡ (%) |
56 Years of Age and Older n‡ (%) |
|
Fever | |||
≥38.0℃ |
10 (9.3) |
15 (4.9) |
14 (4.7) |
≥38.0℃ to 38.4℃ |
7 (6.5) |
9 (2.9) |
10 (3.3) |
>38.4℃ to 38.9℃ |
2 (1.9) |
6 (1.9) |
3 (1.0) |
>38.9℃ to 40.0℃ |
1 (0.9) |
0 |
0 |
>40.0℃ |
0 |
0 |
0 |
Fatigue¶ | |||
Any |
72 (67.3) |
189 (61.2) |
116 (38.5) |
Mild |
27 (25.2) |
83 (26.9) |
56 (18.6) |
Moderate |
45 (42.1) |
100 (32.4) |
56 (18.6) |
Severe |
0 |
6 (1.9) |
4 (1.3) |
Headache¶ | |||
Any |
54 (50.5) |
144 (46.6) |
92 (30.7) |
Mild |
28 (26.2) |
87 (28.2) |
62 (20.7) |
Moderate |
26 (24.3) |
55 (17.8) |
30 (10.0) |
Severe |
0 |
2 (0.6) |
0 |
Chills¶ | |||
Any |
25 (23.4) |
68 (22.0) |
36 (12.0) |
Mild |
19 (17.8) |
38 (12.3) |
21 (7.0) |
Moderate |
6 (5.6) |
28 (9.1) |
14 (4.7) |
Severe |
0 |
2 (0.6) |
1 (0.3) |
Vomiting# | |||
Any |
3 (2.8) |
6 (1.9) |
2 (0.7) |
Mild |
3 (2.8) |
5 (1.6) |
2 (0.7) |
Moderate |
0 |
1 (0.3) |
0 |
Severe |
0 |
0 |
0 |
DiarrheaÞ | |||
Any |
7 (6.5) |
33 (10.7) |
29 (9.6) |
Mild |
7 (6.5) |
27 (8.7) |
23 (7.6) |
Moderate |
0 |
5 (1.6) |
6 (2.0) |
Severe |
0 |
1 (0.3) |
0 |
New or worsened muscle pain¶ | |||
Any |
28 (26.2) |
94 (30.4) |
54 (18.0) |
Mild |
12 (11.2) |
47 (15.2) |
30 (10.0) |
Moderate |
16 (15.0) |
47 (15.2) |
24 (8.0) |
Severe |
0 |
0 |
0 |
New or worsened joint pain¶ | |||
Any |
13 (12.1) |
46 (14.9) |
36 (12.0) |
Mild |
9 (8.4) |
21 (6.8) |
20 (6.7) |
Moderate |
4 (3.7) |
25 (8.1) |
16 (5.3) |
Severe |
0 |
0 |
0 |
Use of antipyretic or pain medicationß |
36 (33.6) |
105 (34.0) |
74 (24.7) |
Unsolicited Adverse Events
Among participants 12 years of age and older, unsolicited adverse events were reported by 48 (6.6%) participants who received a second booster dose through 1 month after the booster dose. Lymphadenopathy occurred in 7 (1.0%) participants.
Concomitant Administration of COMIRNATY With Influenza Vaccine in Individuals 18 Through 64 Years of Age
In Study 8 (NCT05310084), a Phase 3 study, participants 18 through 64 years of age who received COMIRNATY concomitantly administered with Influenza Vaccine (Afluria Quadrivalent) followed 1 month later by saline placebo (n = 564) were compared to participants who received influenza vaccine with saline placebo followed 1 month later by COMIRNATY (n = 564).
Demographic characteristics in Study 8 among the participants in the concomitant administration and separate administration groups were similar with regard to age, sex, race, and ethnicity. Among the 564 participants in the concomitant administration group, the median age was 39.0 years (range 18 through 64 years of age), 36.9% were male and 63.1% were female, 79.1% were White, 12.9% were Asian, and 0.9% were Hispanic/Latino.
Solicited local and systemic adverse reactions were reported more frequently by participants who received COMIRNATY concomitantly with influenza vaccine, compared to participants who received COMIRNATY alone. The most common adverse reactions reported in the concomitant administration group and after COMIRNATY alone were injection site pain (COMIRNATY injection site) (86.2% and 84.4%, respectively), fatigue (64.0% and 50.8%, respectively), and headache (47.2% and 37.8%, respectively).
The following adverse reactions have been identified during postmarketing use of COMIRNATY, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Cardiac Disorders: myocarditis, pericarditis
Gastrointestinal Disorders: diarrhea, vomiting
Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)
Nervous System Disorders: syncope, dizziness
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
A developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of COMIRNATY [encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original)] on 4 occasions, twice prior to mating and twice during gestation. These studies revealed no evidence of harm to the fetus due to the vaccine (see Animal Data).
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals.
Data
In a developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included in a single human dose of COMIRNATY [encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original)] was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.
Risk Summary
It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Safety and effectiveness of COMIRNATY in individuals 12 through 17 years of age is based on safety and effectiveness data in this age group and in adults [see Adverse Reactions (6) and Clinical Studies (14.1)].
The safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been established. Evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests that a single dose of COMIRNATY would be ineffective in individuals younger than 6 months of age.
Of the total number of COMIRNATY recipients in Study 2 as of March 13, 2021 (N = 22,026), 20.7% (n = 4,552) were 65 years of age and older and 4.2% (n = 925) were 75 years of age and older [see Clinical Studies (14.1)]. In Study 4, of 5081 recipients who received COMIRNATY as the first booster dose, 23.1% (n = 1175) were 65 years of age and older and 5.2% (n = 265) were 75 years of age and older. In Study 5, of 726 recipients who received Pfizer-BioNTech COVID-19 Vaccine, Bivalent as the second booster dose, 21.9% (n = 159) were 65 years of age and older and 4.8% (n = 35) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these recipients and younger recipients.
The Centers for Disease Control and Prevention has published considerations related to COVID-19 vaccination for individuals who are moderately to severely immunocompromised (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html).
COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use.
Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2.
Each 0.3 mL dose of COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.
COMIRNATY does not contain preservatives.
The vial stoppers are not made with natural rubber latex.
The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.
COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. In a developmental toxicity study in rats with COMIRNATY [encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original)] there were no vaccine-related effects on female fertility [see Use in Specific Populations (8.1)].
In a post-hoc analysis in a subset of participants 18 through 85 years of age enrolled in Study 7 (NCT05004181), immunogenicity of a single 30 mcg dose of a Pfizer-BioNTech bivalent COVID-19 vaccine containing equal quantities of modRNA encoding the viral spike (S) glycoprotein for the Alpha and Delta SARS-CoV-2 variants [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Alpha and Delta)] was assessed in COVID-19 vaccine-naïve participants with evidence of prior SARS-CoV-2 infection (n = 262) compared to participants without prior SARS-CoV-2 infection who received 2 doses of COMIRNATY in Study 2 (n = 275). Among Study 7 participants, 253 were from study sites in South Africa and 9 were from study sites in the U.S. The immunogenicity of the bivalent Alpha and Delta vaccine is relevant to COMIRNATY because these vaccines are manufactured using the same process with differences only in the encoded spike proteins.
Table 10 presents demographic characteristics for participants in the immunogenicity analysis set.
|
||
Study 7 Single Dose of Bivalent Vaccine (Alpha and Delta) With Evidence of Prior Infection (N*=262) N† (%) |
Study 2 Two Doses of COMIRNATY‡ Without Evidence of Infection (N*=275) N† (%) |
|
Sex |
||
Male |
109 (41.6) |
113 (41.1) |
Female |
153 (58.4) |
162 (58.9) |
Age at Vaccination (Years) |
||
Mean (SD) |
42.9 (16.21) |
42.7 (16.08) |
Median |
41.0 |
40.0 |
Min, max |
(18,84) |
(18, 84) |
Race |
||
White |
4 (1.5) |
230 (83.6) |
Black or African American |
169 (64.5) |
25 (9.1) |
American Indian or Alaska Native |
0 |
2 (0.7) |
Asian |
0 |
7 (2.5) |
Other§ |
89 (34.0) |
11 (4.0) |
Ethnicity |
||
Hispanic or Latino |
5 (1.9) |
83 (30.2) |
Not Hispanic or Latino |
255 (97.3) |
192 (69.8) |
Not reported |
2 (0.8) |
0 |
The objective of this analysis was to assess noninferiority with respect to level of 50% neutralizing titer (NT50) and to the seroresponse rate to the reference strain induced by a single dose of the bivalent Alpha and Delta vaccine in COVID-19 vaccine-naïve participants with evidence of prior infection relative to participants without evidence of SARS-CoV-2 infection who received 2 doses of COMIRNATY.
Noninferiority of the reference strain immune response with respect to level of NT50 was met, as the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) was >0.67 (Table 11). Noninferiority of the seroresponse rate to the reference strain was not met, as the lower bound of the 2-sided 95% CIs for the difference in seroresponse rate of reference strain was -10.04%, below the noninferiority margin of -10% (Table 12).
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | |||||
|
|||||
Study 7 Single Dose of Bivalent Vaccine (Alpha and Delta) With Evidence of Prior Infection* 3 Weeks After Dose 1† |
Study 2 Two Doses of COMIRNATY‡ Without Evidence of Infection§ 1 Month After Dose 2† |
Bivalent Vaccine (Alpha and Delta) With Evidence of Prior Infection† / COMIRNATY Without Evidence of Infection§ |
|||
SARS-CoV-2 Neutralization Assay |
n¶ |
GMT# (95% CI#) |
n¶ |
GMT# (95% CI#) |
GMRÞ (95% CIÞ) |
Reference strain - NT50 (titer)ß |
262 |
17404.2 (15485.1, 19561.1) |
275 |
1328.1 (1183.1, 1491.0) |
13.12 (11.14, 15.45)à |
Abbreviations: CI = confidence interval; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | ||||||
|
||||||
Study 7 Bivalent Vaccine (Alpha and Delta) With Evidence of Prior Infection* 3 Weeks After Dose 1† |
Study 2 COMIRNATY‡ Without Evidence of Prior Infection§ 1 Month After Dose 2† |
Bivalent Vaccine (Alpha and Delta) With Evidence of Prior Infection* Minus COMIRNATY Without Evidence of Prior Infection§ |
||||
SARS-CoV-2 Neutralization Assay |
N¶ |
n# (%) (95% CIÞ) |
N¶ |
n# (%) (95% CIÞ) |
Difference %ß |
95% CIà |
Reference strain – NT50 (titer)è |
260 |
223 (85.8) (80.9, 89.8) |
275 |
249 (90.5) (86.5, 93.7) |
-4.55 |
(-10.04, 0.83)ð |
Study 2 is an ongoing, multicenter, multinational, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate–selection, and efficacy study in participants 12 years of age and older. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
In Study 2, based on data accrued through March 13, 2021, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of COMIRNATY or placebo. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.
Overall, among the total participants who received COMIRNATY or placebo, 51.4% or 50.3% were male and 48.6% or 49.7% were female, 79.1% or 79.2% were 16 through 64 years of age, 20.9% or 20.8% were 65 years of age and older, 81.9% or 82.1% were White, 9.5% or 9.6% were Black or African American, 1.0% or 0.9% were American Indian or Alaska Native, 4.4% or 4.3% were Asian, 0.3% or 0.2% Native Hawaiian or other Pacific Islander, 25.6% or 25.4% were Hispanic/Latino, 73.9% or 74.1% were non-Hispanic/Latino, 0.5% or 0.5% did not report ethnicity, 46.0% or 45.7% had comorbidities [participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease: defined as subjects who had at least 1 of the Charlson comorbidity index category or body mass index (BMI) ≥30 kg/m2], respectively. The mean age at vaccination was 49.8 or 49.7 years and median age was 51.0 or 51.0 in participants who received COMIRNATY or placebo, respectively.
Efficacy Against COVID-19
The population for the analysis of the protocol pre-specified primary efficacy endpoint included 36,621 participants 12 years of age and older (18,242 in the COMIRNATY group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. The population in the protocol pre-specified primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020.
For participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, vaccine efficacy against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0% (95% credible interval: 90.3, 97.6), which met the pre-specified success criterion. The case split was 8 COVID-19 cases in the COMIRNATY group compared to 162 COVID-19 cases in the placebo group.
The population for the updated vaccine efficacy analysis included participants 16 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 during blinded placebo-controlled follow-up through March 13, 2021, representing up to 6 months of follow-up after Dose 2. There were 12,796 (60.8%) participants in the COMIRNATY group and 12,449 (58.7%) in the placebo group followed for ≥4 months after Dose 2 in the blinded placebo-controlled follow-up period.
SARS-CoV-2 variants of concern identified from COVID-19 cases for this age group from this data cutoff include B.1.1.7 (Alpha) and B.1.351 (Beta). Representation of identified variants among cases in vaccine versus placebo recipients did not suggest decreased vaccine effectiveness against these variants.
The updated vaccine efficacy information is presented in Table 13.
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
|
|||
First COVID-19 occurrence from 7 days after Dose 2 in participants Without evidence of prior SARS-CoV-2 infection* |
|||
Subgroup |
Vaccine Efficacy %
|
||
All participants |
77 |
833 |
91.1 |
16 through 64 years |
70 |
709 |
90.5 |
65 years and older |
7 |
124 |
94.5 |
First COVID-19 occurrence from 7 days after Dose 2 in participants With or without* evidence of prior SARS-CoV-2 infection |
|||
Subgroup |
Vaccine Efficacy %
|
||
All participants |
81 |
854 |
90.9 |
16 through 64 years |
74 |
726 |
90.2 |
65 years and older |
7 |
128 |
94.7 |
Subgroup analyses of vaccine efficacy (although limited by small numbers of cases in some subgroups) did not suggest meaningful differences in efficacy across genders, ethnic groups, geographies, or for participants with obesity or medical comorbidities associated with high risk of severe COVID-19.
Efficacy Against Severe COVID-19
Efficacy analyses of secondary efficacy endpoints supported the benefit of COMIRNATY in preventing severe COVID-19. Vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 14) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COMIRNATY and placebo groups.
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, saturation of oxygen ≤93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired oxygen <300 mm Hg); Respiratory failure [defined as needing high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)]; Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or requiring vasopressors); Significant acute renal, hepatic, or neurologic dysfunction; Admission to an Intensive Care Unit; Death. Hospitalization; Admission to the Intensive Care Unit; Intubation or mechanical ventilation; Death. |
|||
Vaccine Efficacy – First Severe COVID-19 Occurrence |
|||
Vaccine Efficacy %
|
|||
7 days after Dose 2ß |
1 |
21 |
95.3 |
Vaccine Efficacy – First Severe COVID-19 Occurrence Based on CDC Definition |
|||
Vaccine Efficacy %
|
|||
7 days after Dose 2ß |
0 |
31 |
100 |
A descriptive efficacy analysis of Study 2 has been performed in 2,260 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of September 2, 2021.
The vaccine efficacy information in adolescents 12 through 15 years of age is presented in Table 15.
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
|
|||
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection* |
|||
Vaccine Efficacy %
|
|||
Adolescents |
0 |
28 |
100.0 |
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age With or without evidence of prior SARS-CoV-2 infection |
|||
Vaccine Efficacy %
|
|||
Adolescents |
0 |
30ß
|
100.0 |
In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 16).
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis. |
||||||
|
||||||
COMIRNATY* | ||||||
12 Through 15 Years
|
16 Through 25 Years
|
12 Through 15 Years/
|
||||
Assay |
Time Point‡ |
Met Noninferiority Objective#
|
||||
SARS-CoV-2 neutralization assay - NT50 (titer)Þ |
1 month after Dose 2 |
1253.6 |
708.1 |
1.77 |
Y |
Effectiveness of a booster dose of COMIRNATY was based on an assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 reference strain (USA_WA1/2020) in Study 2 participants 18 through 55 years of age (n = 200 – 212) who had no serological or virological evidence of past SARS‑CoV‑2 infection up to 1 month after the booster vaccination. Analyses of NT50 1 month after the booster dose compared to 1 month after the primary series demonstrated noninferiority for both geometric mean ratio (GMR) [3.26 (97.5% CI: 2.76, 3.86)] and difference in seroresponse rates (percentage) [4.5% (97.5% CI: 1.0, 7.9)]. Seroresponse for a participant was defined as achieving a ≥4-fold rise in NT50 from baseline (before primary series).
In an analysis of a subset from Study 5, 105 participants 12 through 17 years of age, 297 participants 18 through 55 years of age, and 286 participants 56 years of age and older who had previously received a 2-dose primary series and 1 booster dose with COMIRNATY received a second booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. In participants 12 through 17 years of age, 18 through 55 years of age, and 56 years of age and older, 75.2%, 71.7% and 61.5% were positive for SARS-CoV-2 at baseline, respectively.
Analyses of NT50 against Omicron BA.4/BA.5 and against reference strain among participants 56 years of age and older who received a second booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in Study 5 compared to a subset of participants from Study 4 who received a second booster dose of COMIRNATY demonstrated superiority of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to COMIRNATY based on GMR and noninferiority based on difference in seroresponse rates with respect to anti-Omicron BA.4/BA.5 response, and noninferiority of anti-reference strain immune response based on GMR (Table 17 and Table 18).
Analyses of NT50 against Omicron BA.4/BA.5 among participants 18 through 55 years of age compared to participants 56 years of age and older who received a second booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in Study 5 demonstrated noninferiority of anti-Omicron BA.4/BA.5 response among participants 18 through 55 years of age to participants 56 years of age and older for both GMR and difference in seroresponse rates (Table 17 and Table 18).
The study also assessed the level of NT50 against the anti-Omicron BA.4/BA.5 and original SARS-CoV-2 strains pre-vaccination and 1 month after vaccination in participants who received a second booster dose (Table 19).
Abbreviations: GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | |||||||||
|
|||||||||
SARS-CoV-2 Neutralization Assay |
Sampling Time Point* |
Pfizer-BioNTech COVID-19 Vaccine, Bivalent† Study 5 |
COMIRNATY‡ Subset of Study 4 |
Age Group Comparison |
Vaccine Group Comparison |
||||
18 Through 55 Years of Age |
56 Years of Age and Older |
56 Years of Age and Older |
Pfizer-BioNTech COVID-19 Vaccine, Bivalent† 18 Through 55 Years of Age/≥56 Years of Age |
≥56 Years of Age |
|||||
n§ |
GMT¶ (95% CI¶) |
n§ |
GMT¶ (95% CI¶) |
n§ |
GMT¶ (95% CI¶) | ||||
Omicron BA.4/BA.5 - NT50 (titer)Þ |
1 Month |
297 |
4455.9 (3851.7, 5154.8) |
284 |
4158.1 (3554.8, 4863.8) |
282 |
938.9 (802.3, 1098.8) |
0.98 (0.83, 1.16)ß |
2.91 (2.45, 3.44)à |
Reference Strain – NT50 (titer)Þ |
1 Month |
- |
- |
286 |
16250.1 (14499.2, 18212.4) |
289 |
10415.5 (9366.7, 11581.8) |
- |
1.38 (1.22, 1.56)è |
Abbreviations: LLOQ = lower limit of quantitation; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline. If the baseline measurement is below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse. |
|||||||||
|
|||||||||
SARS-CoV-2 Neutralization Assay |
Sampling Time Point* |
Pfizer-BioNTech COVID-19 Vaccine, Bivalent† Study 5 |
COMIRNATY‡ Subset of Study 4 |
Age Group Comparison |
Vaccine Group Comparison |
||||
18 Through 55 Years of Age |
56 Years of Age and Older |
56 Years of Age and Older |
Pfizer-BioNTech COVID-19 Vaccine, Bivalent† 18 Through 55 Years of Age/≥56 Years of Age |
≥56 Years of Age Pfizer-BioNTech COVID-19 Vaccine, Bivalent† / COMIRNATY |
|||||
n§ |
N¶ (%) (95% CI#) |
n§ |
N¶ (%) (95% CI#) |
n§ |
N¶ (%) (95% CI)# | ||||
Omicron BA.4/BA.5 - NT50 (titer)à |
1 Month |
294 |
180 (61.2) (55.4, 66.8) |
282 |
188 (66.7) (60.8, 72.1) |
273 |
127 (46.5) (40.5, 52.6) |
-3.03 (-9.68, 3.63)è |
26.77 (19.59, 33.95)ð |
Abbreviations: GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein–binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | |||||||
|
|||||||
SARS-CoV-2 Neutralization Assay |
Sampling Time Point* |
Pfizer-BioNTech COVID-19 Vaccine, Bivalent† |
|||||
12 Through 17 Years of Age |
18 Through 55 Years of Age |
56 Years of Age and Older |
|||||
n‡ |
GMT§ (95% CI§) |
n‡ |
GMT§ (95% CI§) |
n‡ |
GMT§ (95% CI§) |
||
Omicron BA.4/BA.5 - NT50 (titer)¶ |
Pre- vaccination |
104 |
1105.8 (835.1, 1464.3) |
294 |
569.6 (471.4, 688.2) |
284 |
458.2 (365.2, 574.8) |
1 Month |
105 |
8212.8 (6807.3, 9908.7) |
297 |
4455.9 (3851.7, 5154.8) |
284 |
4158.1 (3554.8, 4863.8) |
|
Reference strain - NT50 (titer)¶ |
Pre-vaccination |
105 |
6863.3 (5587.8, 8430.1) |
296 |
4017.3 (3430.7, 4704.1) |
284 |
3690.6 (3082.2, 4419.0) |
1 Month |
105 |
23641.3 (20473.1, 27299.8) |
296 |
16323.3 (14686.5, 18142.6) |
286 |
16250.1 (14499.2, 18212.4) |
In Study 8 (NCT05310084), a Phase 3 multicenter, randomized, observer-blind study, 1,134 participants 18 through 64 years of age who had received 3 doses of COMIRNATY at least 3 months prior were randomized in a 1:1 ratio to receive either COMIRNATY concomitantly administered with Influenza Vaccine (Afluria Quadrivalent) followed 1 month later by placebo (Group 1, n = 568) or influenza vaccine with placebo followed 1 month later with COMIRNATY (Group 2, n = 566).
Full-length spike (S)-binding IgG responses to COMIRNATY and influenza strain-specific hemagglutination inhibition (HAI) titers were assessed 1-month post-vaccination in each group.
The non-inferiority criteria (lower bound of the 2-sided 95% CI > 0.67) for the comparison of concomitant administration versus separate administration were met. The GMC ratio of full-length S-binding IgG levels of SARS-CoV-2 Wuhan-Hu 1 strain (Original) (Group 1/Group 2) was 0.83 [95% CI: 0.77, 0.89]. The GMT ratio (Group 1/Group 2) for the 4 strain-specific influenza HAI titers were H1N1 A/Victoria: 0.95 [95% CI: 0.83, 1.09]; H3N2 A/Darwin: 0.96 [95% CI: 0.85, 1.09]; B/Austria: 0.89 [95% CI: 0.77, 1.04]; B/Phuket: 1.00 [95% CI: 0.89, 1.13].
SARS-CoV-2 Wuhan-Hu-1 strain (Original) neutralizing GMTs were descriptively assessed in a subset of participants, 100 participants from Group 1 and 100 participants from Group 2.
The SARS-CoV-2 neutralization assay (NT50 titer) GMTs increased from baseline to 1 month after vaccination with COMIRNATY from 2755.9 to 6773.9 in Group 1 and from 2421.2 to 7886.6 in Group 2.
COMIRNATY is a suspension for intramuscular injection and is supplied as follows:
Regardless of presentation, during storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials, prefilled syringes, and cartons.
Storage Prior to Use
Glass Prefilled Syringes
Store COMIRNATY glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.
Single Dose Vials
COMIRNATY single dose vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Once received, frozen vials may be immediately transferred to the refrigerator at 2ºC to 8ºC (35ºF to 46ºF), thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Cartons of 10 single dose vials may take up to 2 hours to thaw at this temperature. Once thawed, they should not be refrozen.
Alternatively, single dose vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F).
Cartons of COMIRNATY single dose vials may be received at 2°C to 8°C (35ºF to 46ºF), and they should be stored at 2°C to 8°C (35ºF to 46ºF). Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.
The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.
Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling.
Inform the vaccine recipient or caregiver of the potential benefits and risks of vaccination with COMIRNATY.
Advise the vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.
This product's labeling may have been updated. For the most recent prescribing information, please visit https://fda.report/dailymed/.
INFORMATION FOR RECIPIENTS AND CAREGIVERS COMIRNATY (Cuh-mir'-na-tee) (COVID-19 VACCINE, mRNA) (2024-2025 Formula) |
This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider. |
What is COMIRNATY? COMIRNATY is a vaccine for use in people 12 years of age and older to protect against COVID-19. COMIRNATY may not protect all people who receive the vaccine. COMIRNATY does not contain SARS-CoV-2, the virus that causes COVID-19. COMIRNATY cannot give you COVID-19. |
Who should not get COMIRNATY? You should not get COMIRNATY if you had:
|
Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:
|
How is COMIRNATY given? COMIRNATY is given as an injection into the muscle. |
What are the possible risks of COMIRNATY? There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
Side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:
These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com. |
What if you are pregnant or breastfeeding? If you are pregnant or breastfeeding, discuss your options with your healthcare provider. |
What are the ingredients in COMIRNATY? COMIRNATY contains the following ingredients:
COMIRNATY does not contain preservatives. This Information for Recipients and Caregivers may have been updated. For the most recent Information for Recipients and Caregivers, please visit https://fda.report/dailymed/. If you have questions, talk to your healthcare provider or visit www.COMIRNATY.com or call 1-877-VAX-CO19 (1-877-829-2619). Manufactured for Manufactured by LAB-1587-3.0 US Govt. License No. 2229 |
Revised: 8/2024 |
COVID-19 Vaccine, mRNA
COMIRNATY®
Rx only
2023 – 2024 Formula
DO NOT DILUTE
Age 12y & older
Vial contains 1 dose of 0.3 mL
For intramuscular use.
US License No. 2229
BioNTech Manufacturing GmbH & Pfizer Inc.
NDC: 0069-2362-01
NDC: 0069-2362-10
COVID-19 Vaccine, mRNA
COMIRNATY®
2023 – 2024 Formula
Suspension for Intramuscular Injection
DO NOT DILUTE
10 Single Dose Vials
Each vial contains 1 dose of 0.3 mL
For 12 years of age and older
BIONTECH
Pfizer
Rx only
COVID-19 Vaccine, mRNA
COMIRNATY®
Rx only
2024 – 2025 Formula
DO NOT DILUTE
Age 12y & older
Vial contains 1 dose of 0.3 mL
For intramuscular use.
US License No. 2229
BioNTech Manufacturing GmbH & Pfizer Inc.
NDC: 0069-2403-01
NDC: 0069-2403-10
COVID-19 Vaccine, mRNA
COMIRNATY®
2024 – 2025 Formula
Suspension for Intramuscular Injection
DO NOT DILUTE
10 Single Dose Vials
Each vial contains 1 dose of 0.3 mL
For 12 years of age and older
BIONTECH
Pfizer
Rx only
NDC: 0069-2432-01
Rx only
COVID-19 Vaccine,
mRNA
COMIRNATY®
2024 – 2025 Formula
DO NOT FREEZE
Age 12y & older
1 dose of 0.3 mL
For intramuscular use.
US License No. 2229
BioNTech Manufacturing
GmbH & Pfizer Inc.
NDC: 0069-2432-10
COVID-19 Vaccine, mRNA
COMIRNATY®
2024 – 2025 Formula
Suspension for Intramuscular Injection
10 Single Dose Prefilled Syringes
Each prefilled syringe contains 1 dose of 0.3 mL
For 12 years of age and older
DO NOT FREEZE
BIONTECH
Pfizer
Rx only
COMIRNATY
covid-19 vaccine, mrna injection, suspension |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
COMIRNATY
covid-19 vaccine, mrna injection, suspension |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
COMIRNATY
covid-19 vaccine, mrna injection, suspension |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525) |
Registrant - Pfizer Inc (113480771) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Pfizer Manufacturing Belgium NV | 370156507 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) , MANUFACTURE(0069-2362, 0069-2403, 0069-2432) , PACK(0069-2362, 0069-2403, 0069-2432) , LABEL(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 174350868 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) , API MANUFACTURE(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Pfizer Ireland Pharmaceuticals | 985586408 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) , API MANUFACTURE(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
BioNTech Innovative Manufacturing Services GmbH | 537365801 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
BioNTech Manufacturing GmbH | 314382536 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
BioNTech Manufacturing Marburg GmbH | 313270335 | ANALYSIS(0069-2362, 0069-2403, 0069-2432) , API MANUFACTURE(0069-2362, 0069-2403, 0069-2432) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Pharmacia & Upjohn Company LLC | 618054084 | ANALYSIS(0069-2362, 0069-2403) , MANUFACTURE(0069-2362, 0069-2403) , PACK(0069-2362, 0069-2403) , LABEL(0069-2362, 0069-2403) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Exela Pharma Sciences, LLC. | 831274399 | ANALYSIS(0069-2362, 0069-2403) , MANUFACTURE(0069-2362, 0069-2403) , LABEL(0069-2362, 0069-2403) , PACK(0069-2362, 0069-2403) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMIRNATY 88942267 not registered Live/Pending |
BioNTech SE 2020-06-01 |