Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 3 of 6)
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 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, two-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 44,000 participants, 12 years of age or older. Of these, approximately 43,448 participants (21,720 Pfizer-BioNTech COVID-19 Vaccine; 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).
At the time of the analysis of Study 2 for the EUA, 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and 18,785 placebo) participants 16 years of age or older have been followed for a median of 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.
The safety evaluation in Study 2 is ongoing. The safety population includes participants enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Participants 18 years and older in the reactogenicity subset are 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].
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.
Local and Systemic Adverse Reactions Solicited in the Study 2
Table 1 and Table 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of participants 18 to 55 years of age included in the EUA safety population who were monitored for reactogenicity with an electronic diary.
Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants 56 years of age and older.
Across both age groups, 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.
| Pfizer-BioNTech COVID-19 VaccineDose 1N ‡=2291n § (%) | PlaceboDose 1N ‡=2298n § (%) | Pfizer-BioNTech COVID-19 VaccineDose 2N ‡=2098n § (%) | PlaceboDose 2N ‡=2103n § (%) | |
|---|---|---|---|---|
| Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. | ||||
| ||||
| 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 # | ||||
| 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) |
| Pfizer-BioNTech COVID-19 VaccineDose 1N ‡=2291n § (%) | PlaceboDose 1N ‡=2298n § (%) | Pfizer-BioNTech COVID-19 VaccineDose 2N ‡=2098n § (%) | PlaceboDose 2N ‡=2103n § (%) | |
|---|---|---|---|---|
| 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. | ||||
| ||||
| 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 # | ||||
| 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 Þ | ||||
| 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 ß | 638 (27.8) | 332 (14.4) | 945 (45.0) | 266 (12.6) |
| Pfizer-BioNTech COVID-19 VaccineDose 1 N †=1802n ‡ (%) | PlaceboDose 1N †=1792n ‡ (%) | Pfizer-BioNTech COVID-19 VaccineDose 2N †=1660n ‡ (%) | PlaceboDose 2N †=1646n ‡ (%) | |
|---|---|---|---|---|
| Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. | ||||
| ||||
| 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) |
| Pfizer-BioNTech COVID-19 VaccineDose 1N †=1802n ‡ (%) | PlaceboDose 1N †=1792n ‡ (%) | Pfizer-BioNTech COVID-19 VaccineDose 2N †=1660n ‡ (%) | PlaceboDose 2N †=1646n ‡ (%) | |
|---|---|---|---|---|
| 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. | ||||
| ||||
| 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 # | ||||
| 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) |
Unsolicited Adverse Events
Serious Adverse Events
In Study 2, among participants 16 to 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 = 7960, placebo = 7934), 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
Overall in Study 2 in which 10,841 participants 16 to 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 four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine.
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