1 of 10

Pfizer �USA Pediatric Vaccine Submission to FDA� for 5 to 11 year olds�

October 25, 2021

​

2 of 10

Vaccine Effectiveness – Pfizer Vaccine – 5 to 11

  • VE data from N~2250 participants (1518 vaccine recipients and 750 placebo recipients)
  • VE in those without prior evidence of SARS-CoV-2 infection from at least 7 days after Dose 2 was 90.7% (2-sided 95% CI: 67.7%, 98.3%).
    • Included 3 cases in the vaccine group and 16 cases in the placebo group
    • Signs and symptoms associated with cases in the vaccine group were mostly limited to mild respiratory tract symptoms
    • Signs and symptoms were more severe in the placebo group
    • Illness in placebo group reflected a higher incidence of multiple concurrent signs and symptoms for most participants
  • Results suggest vaccine offers protection to individuals particularly children with comorbidities who are at risk of severe COVID-19 disease.
    • No cases in the vaccine group and 3 cases in the placebo group occurred in children with reported baseline comorbidities.
  • No cases of severe COVID-19 and no cases of Multisystem inflammatory syndrome-children (MIS-C) reported as of the data cut-off date.

1

3 of 10

VE Study - 3 cases in Vaccine Arm

  • 1 participant each reported 2, 3, or 4 signs and symptoms of COVID-19
  • Fever was not reported in 3 cases in vaccine arm
  • Reported signs and symptoms in the vaccine group were:
    • New or increased cough: all 3 participants (100%)
    • Sore throat: all 3 participants (100%)
    • Headache: 1 participant (33.3%)
    • Nasal congestion or runny nose: 1 participant (33.3%)
    • Nausea or abdominal pain: 1 participant (33.3%)

​

2

4 of 10

VE study - 16 cases in Placebo Arm

  • 56.2% of cases reported 4 or more signs and symptoms of COVID-19, including 8 participants each (50.0%) with 5 or more symptoms
  • The reported signs and symptoms in the placebo group order of highest to lowest frequency were:
    • Fever: 10 participants (62.5%)
    • Nasal congestion or runny nose: 9 participants (56.3%)
    • New or increased cough: 8 participants (50.0%)
    • New or increased muscle pain: 8 participants (50.0%)
    • Sore throat: 8 participants (50.0%)
    • Fatigue: 5 participants (31.3%)
    • Chills: 4 participants (25.0%)
    • New loss of taste or smell: 4 participants (25.0%)
    • Headache: 4 participants (25.0%)
    • Diarrhea: 3 participants (18.8%)
    • Nausea of abdominal pain: 3 participants (18.8%)
    • New or increased shortness of breath: 1 participant (6.3%)

3

5 of 10

Side Effect Profile - Pfizer pediatric vaccine

  • Mild to moderate S/Es reported, two severe A/Es reported
  • Majority of S/Es arose during the first 1 to 2 days after dosing and resolving shortly thereafter
  • Most common local reaction was injection site pain (71%)
  • Most common systemic reactions included fatigue (39.4%), headache (28%), muscle pain (11.7%), and chills (9.8%)
  • Follow-up of at least 2 months after dose 2 for cohort

4

6 of 10

Serious Adverse Events/ Deaths/Withdrawals

  • Few serious AEs (SAEs), none of which were related to vaccine
  • No SAEs, deaths, or S/Es leading to withdrawal were reported in Phase 1 as of the data cut-off date of 16 July 2021 = 3 months of follow-up.
  • Lone Grade 3 A/E (Grade 3 pyrexia), reported in the 20 µg group that is not being used for licensed product

5

7 of 10

Acceptable profile – additional safety group

  • Supplemental safety expansion group data were analyzed from approximately 1500 vaccine recipients with a median follow-up time of 2.4 weeks after Dose 2.
  • Supplemental data demonstrate an acceptable safety profile, in alignment with safety data from the initial enrollment group for a total of 3,000 vaccinated participants contributing to safety data, with no cases of myocarditis/pericarditis reported to date.

6

8 of 10

Acceptable safety profile – myo/pericarditis

  • No cases of myocarditis/pericarditis were observed during the 3 months of follow-up for Phase 2/3 population
  • The estimated numbers of prevented COVID-19 cases and associated hospitalizations for 1 million vaccinated children 5 to < 12 years of age during the 120 days post-vaccination are ~33,600 and 170, respectively
  • 21 post-vaccination myocarditis cases would be expected for 1 million vaccinated children 5 to < 12 years of age
  • Looking separately at males and females, 43 myocarditis cases would be expected per 1 million fully vaccinated males and 4 cases would be expected per 1 million fully vaccinated females.

7

9 of 10

COVID-19 cases and associated hospitalizations

  • Given post-authorization experience and assuming 90% efficacy as shown in the descriptive clinical study, the estimated number of COVID-19 cases and associated hospitalizations prevented over 120 days per million of fully vaccinated children 5 to <12 years of age is ~33,600 and 170, respectively.

  • In contrast, the number of post-vaccination myocarditis cases (including myocarditis, pericarditis, and myo/pericarditis) expected in the same period of time per million second doses is 21 (assuming that children 5 to <12 years of age experience the same rates of post-vaccination myocarditis/pericarditis as adolescents 12 to 15 years of age in the US) (Section 4).

​

8

10 of 10

Pediatric Formulation – Pfizer Vaccine

  • Vaccine does not contain preservative
  • The vial stoppers are not made with natural rubber latex
  • For the 10-μg RNA dose, each 1.3-mL filled via vial must be diluted with 1.3mL 0.9% sodium chloride for injection to provide 10 doses at 10 μg RNA / 0.2 mL Injection volume
  • After dilution, the vials should be stored at 2°C to 25°C and should be used within 12 hours
  • Unopened vials may stored between 2° and 8°C for 10 weeks

9