THIS VACCINE HAS NOT BEEN APPROVED OR LICENSED FOR CHILDREN 15 YEARS OR YOUNGER.

1
COVID-19 – PFIZER VACCINE RISK STATEMENT (VRS)

PFIZER COVID-19 VACCINE: Delivering Data on Infectious Diseases & Vaccines™

Short-Term Efficacy & Safety Data Available in other languages at

physiciansforinformedconsent.org/covid-19-vaccines

1. W
 HAT IS THE PFIZER COVID-19 5. IS THE VACCINE EFFECTIVE
VACCINE? IN CHILDREN?
The Pfizer COVID-19 vaccine is made from synthetic genetic The vaccine was authorized for use in children 12 to 15 years of age
material that is immersed in fatty substances, including cholesterol in May 2021, “although limited scientific information is available,” per
and polyethylene glycol (PEG). More specifically, modified RNA Pfizer,12 and was 93%–98% effective over a two-month observation
molecules that encode for a mutated spike (S) protein antigen period.6 The vaccine was authorized for use in children 5 to 11 years
of the Wuhan-Hu-1 SARS-CoV-2 strain, the original virus that of age in October 2021 and was 67%–98% effective over a two-
caused COVID-19, are immersed in lipid nanoparticles. The drug month observation period.4
is administered in two intramuscular doses (30 mcg each for
individuals aged 12 or older; 10 mcg each for children aged 5 to 11), In the clinical trial, there were zero cases of severe COVID-19 in
21 days apart.2-4 children who did not receive the vaccine. For adolescents 12 to
15 years of age, the FDA states, “There were no reports of severe
2. H
 OW WAS THE VACCINE STUDIED COVID-19 cases.”13 For children 5 to 11 years of age, the FDA states,
“None of these cases met the criteria for severe infection.”4 As such,
PRIOR TO OBTAINING FDA APPROVAL? the ability of the vaccine to prevent hospitalizations or deaths from
COVID-19 in children 5 to 15 years of age is not known.
The Pfizer COVID-19 vaccine was studied through nonclinical
data from rats and nonhuman primates, and a human clinical trial
comparing approximately 22,000 subjects who received the vaccine SHORT-TERM EFFICACY DATA
with 22,000 subjects who did not receive the vaccine (Table 1).5
About 42% of the subjects in the trial were observed for less than Observation period of 2 to 6
Enrolled subjects months (95% confidence interval)
four months after the second dose and 51% were observed for four
to less than six months after the second dose.6 Confirmed COVID-19 deaths4,11 NA*

Five times more vaccinated subjects were excluded from the Confirmed COVID-19 hospitalizations 8
NA*
clinical trial compared to subjects who did not receive the vaccine Confirmed COVID-19 (age 5–11, 0–2 months after second dose) 4
67%–98%
(311 compared to 60). The reason for those exclusions provided by
the U.S. Food and Drug Administration (FDA) is “other important Confirmed COVID-19 (age ≥12, 4–6 months after second dose)6 75%–90%
protocol deviations.” More specific reasons were not provided.7 Confirmed COVID-19 (age ≥12, >6 months after second dose)6 NA*

3. D
 OES THE VACCINE PREVENT Asymptomatic SARS-CoV-2 infection8 NA*

HOSPITALIZATIONS AND DEATHS? SARS-CoV-2 spread (transmission)8 NA*

Since the number of hospitalized cases of COVID-19 have not been SHORT-TERM SAFETY DATA
published in clinical trial documents, the vaccine’s ability to prevent
1 in 59 to 1 in 143 in vaccinated
hospitalizations from COVID-19 is unclear.6 See Table 1. Regarding Severe systemic reactions
6x–7x greater risk in vaccinated
deaths, the FDA states, “A larger number of individuals at high risk (age 5–11)4
3–8 cases for every 10 non-severe COVID-19 cases
of COVID-19 and higher attack rates would be needed to confirm
efficacy of the vaccine against mortality.”8 1 in 9 in vaccinated
Severe systemic reactions
6x greater risk in vaccinated
(age 12–15)22-24
7x more than non-severe COVID-19 cases
Of note, a study of a COVID-19 outbreak in July 2021 published in
Eurosurveillance observed that 100% of severe, critical, and fatal 1 in 6 to 1 in 19 in vaccinated
Severe systemic reactions
cases of COVID-19 occurred in vaccinated individuals.9 A Centers (age 16–55)6,11
8x–10x greater risk in vaccinated
for Disease Control and Prevention (CDC) study of another COVID-19 1x–3x more than COVID-19 cases of any severity
outbreak in July 2021 observed similar data and found that 80% of 1 in 14 to 1 in 30 in vaccinated
hospitalized cases were fully vaccinated.10 Severe systemic reactions
9x–11x greater risk in vaccinated
(age 56 or older)6,11
1x–2x more than COVID-19 cases of any severity

4. H
 OW EFFECTIVE IS THE VACCINE Pregnant/breastfeeding13 NA*
IN ADULTS? Immunocompromised13 NA*

Vaccine efficacy was calculated by observing the vaccination

status of 971 COVID-19 cases (including Alpha and Beta variants Not tested Insufficient data Evidence of Evidence of Evidence
of concern11), where a COVID-19 case was defined as the presence to prove efficacy short-term benefit declining efficacy of risk
or safety
of at least one COVID-19 symptom and a positive SARS-CoV-2 test
at least seven days after the second dose. In subjects 12 years or *No data provided by the FDA.
older, the vaccine was 93%–98% effective within two months of
Table 1: Short-term efficacy and safety data from the Pfizer COVID-19 vaccine clinical
the second dose. However, between two and four months after the
trial. The data show the vaccine was effective at preventing COVID-19 cases that
second dose, vaccine efficacy declined to 87%–93%, and between did not result in hospitalization. However, vaccine efficacy waned, and there were
four and six months after the second dose, vaccine efficacy declined insufficient data to show vaccine efficacy for hospitalized COVID-19 cases, fatal cases,
to 75%–90%.6 and asymptomatic cases. In addition, severe systemic reactions were observed.
 THIS VACCINE HAS NOT BEEN APPROVED OR LICENSED FOR CHILDREN 15 YEARS OR YOUNGER.1
COVID-19 – PFIZER VACCINE RISK STATEMENT (VRS)

6. W
 HAT ABOUT A BOOSTER DOSE? reactions occur in 1 in 6 to 1 in 143 vaccinated subjects. See Table 1
and Supplement 1.4,6,11,22-24 The clinical trial also found that 1 in about
1,100 vaccinated children 12 to 15 years of age had a grade 4 systemic
Between September 2021 and December 2021, the FDA granted reaction (fever greater than 104.0° F) after the first dose that required
emergency use authorization (EUA) for a booster dose of the an emergency room (ER) visit and withdrawal from the study.22
Pfizer COVID-19 vaccine for individuals 16 years of age or older.14,15
However, the clinical trial states, “Efficacy was not evaluated
for Phase 3 BNT162b2 booster group participants,” and vaccine
efficacy was inferred based on antibody levels observed in about Emergency Room
300 vaccinated subjects over a one-month time period.16
An ER visit occurred in 1 in about
7. DOES THE VACCINE PREVENT INFECTION 1,100 kids 12–15 years of age, within
one week of being injected with the
OR TRANSMISSION? COVID-19 vaccine.
The Pfizer clinical trial was not designed to observe asymptomatic
infection with SARS-CoV-2 or the effect of the vaccine on the spread Of note, approximately 3,400 or 8% of subjects 16 years or older
(transmission) of COVID-19. Consequently, the FDA states that “it experienced “suspected COVID-19” because they had symptoms
is possible that asymptomatic infections may not be prevented but were not confirmed by testing for SARS-CoV-2; two of these
as effectively as symptomatic infections” and “data are limited to cases required hospitalization, both of which were in the vaccinated
assess the effect of the vaccine against transmission of SARS- group. These cases could represent other influenza-like illness and
CoV-2 from individuals who are infected despite vaccination.”8 adverse events; 409 such cases occurred in the vaccinated group
Approximately 33% of SARS-CoV-2 infections are asymptomatic.17,18 within seven days of injection whereas 287 such cases occurred in
the unvaccinated group in the same time period. Only the cases that
Of note, a study of a COVID-19 outbreak in July 2021 published in were reported as serious were recorded as adverse events.8 In the
Eurosurveillance9 found that “all transmissions between patients clinical trial, only 5% of all illnesses suspected of being COVID-19
and staff occurred between masked and vaccinated individuals, were actually found to be COVID-19.
as experienced in an outbreak from Finland.” The authors stated
that the study “challenges the assumption that high universal After mass vaccination with the Pfizer COVID-19 vaccine began, the
vaccination rates will lead to herd immunity and prevent COVID-19 CDC recorded about 5,000 “health impact events” among 215,000
outbreaks.” A CDC study of another COVID-19 outbreak in July vaccinated subjects (1 in 43) that, similar to the definition of
2021 observed similar data and found that 74% of cases were fully severe systemic reactions in the clinical trial, prevented the ability
vaccinated.10 A Harvard study investigating COVID-19 cases across to perform normal daily activities, including work, and required
68 countries and across 2,947 counties in the U.S. found “there also medical attention.25
appears to be no significant signaling of COVID-19 cases decreasing
with higher percentages of population fully vaccinated.”19 Concerningly, post-EUA safety surveillance reports have identified
serious risks for myocarditis and pericarditis in subjects under age
40, within seven days of vaccination. In boys aged 16 or 17, after the
second dose of the Pfizer COVID-19 vaccine, the risk of myocarditis
or pericarditis is 1 in 5,000.16 Additionally, since the clinical trial
observed only about 1,100 vaccinated children aged 12 to 1512 and
1,500 vaccinated children aged 5 to 11,4 there were not enough
children included in the trial to be able to show the vaccine is safer
than the disease. As of Nov. 3, 2021, the chance of a child 17 years
or younger contracting SARS-CoV-2 and dying from COVID-19 was
1 in 126,000 or 0.0008%.26

Moreover, per the FDA, there are currently insufficient data to make
conclusions about the safety of the vaccine in subpopulations such
as pregnant and lactating individuals, and immunocompromised
individuals.13 Per Pfizer, the vaccine “has not been evaluated for the
No decrease in cases with increase in vaccination potential to cause carcinogenicity, genotoxicity, or impairment of
male fertility.”11 And, because all subjects were observed for only
two to six months, the long-term safety of the vaccine for any age
8. WHAT IS THE RISK OF A SEVERE SIDE group is not known.
EFFECT FROM THE VACCINE?
The Pfizer COVID-19 vaccine clinical trial found that the vaccine
causes severe (grade 3) systemic reactions, which include fever
greater than 102.1° F; vomiting that requires IV hydration; diarrhea
of six or more loose stools in 24 hours; and severe fatigue, severe
headache, severe muscle pain, or severe joint pain that prevents
Cancer Damage to genes Impaired fertility
daily activity.11,20 Trial data21 demonstrate that severe systemic

Supplement 1 and all references are available at physiciansforinformedconsent.org/covid-19-vaccines.

These statements are intended for informational purposes only and should not be construed as personal medical advice.
© 2021 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org. Updated Dec 2021.
 THIS VACCINE HAS NOT BEEN APPROVED OR LICENSED FOR CHILDREN 15 YEARS OR YOUNGER.1
COVID-19 – PFIZER VACCINE RISK STATEMENT (VRS)

SUPPLEMENT 1: RISK OF SEVERE SYSTEMIC REACTIONS

FROM THE PFIZER COVID-19 VACCINE
The Pfizer COVID-19 vaccine clinical trial found that the vaccine causes severe (grade 3) systemic reactions, which include fever greater
than 102.1° F; vomiting that requires IV hydration; diarrhea of six or more loose stools in 24 hours; and severe fatigue, severe headache,
severe muscle pain, or severe joint pain that prevents daily activity. Trial data21 demonstrate the following:

Children 5 to 11 years of age People 16 to 55 years of age

• A range of 1 in 59 to 1 in 143 vaccinated children suffered severe • A range of 1 in 6 to 1 in 19 vaccinated subjects suffered severe
systemic reactions within seven days of the second dose. systemic reactions within seven days of the second dose.
• There was a 6 to 7 times greater risk of a severe systemic • There was an 8 to 10 times greater risk of a severe systemic
reaction from the vaccine. reaction from the vaccine.
• There were 3 to 8 cases of severe systemic reactions observed • There were 1 to 3 times more severe systemic reactions
in the vaccinated group for every 10 cases of non-severe observed in the vaccinated group than COVID-19 cases of any
COVID-19 in the unvaccinated group. severity in the unvaccinated group.
Adolescents 12 to 15 years of age People 56 years or older
• 1 in 9 vaccinated adolescents suffered severe systemic • A range of 1 in 14 to 1 in 30 vaccinated subjects suffered severe
reactions within seven days of the second dose. systemic reactions within seven days of the second dose.
• There was a 6 times greater risk of a severe systemic reaction • There was a 9 to 11 times greater risk of a severe systemic
from the vaccine. reaction from the vaccine.
• There were 7 times more severe systemic reactions observed • There were 1 to 2 times more severe systemic reactions
in the vaccinated group than non-severe COVID-19 cases in the observed in the vaccinated group than COVID-19 cases of any
unvaccinated group. severity in the unvaccinated group.

to

=
=

Non-Severe COVID-19 Severe Systemic Reactions in Non-Severe COVID-19 Severe Systemic Reactions in
in Unvaccinated Group Vaccinated Group in Unvaccinated Group Vaccinated Group
(Age 5–11) (Age 5–11) (Age 12–15) (Age 12–15)

In the Pfizer COVID-19 vaccine clinical trial, zero unvaccinated In the Pfizer COVID-19 vaccine clinical trial, zero unvaccinated
children 5 to 11 years of age suffered a severe case of COVID-19. adolescents 12 to 15 years of age suffered a severe case of
In contrast, for every 10 cases of non-severe COVID-19 in the COVID-19. In contrast, for every 1 case of non-severe COVID-19
unvaccinated group, there were 3 to 8 cases of severe (grade 3) in the unvaccinated group, there were 7 cases of severe
systemic reactions in the vaccinated group. (grade 3) systemic reactions in the vaccinated group.

© 2021 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org.
 THIS VACCINE HAS NOT BEEN APPROVED OR LICENSED FOR CHILDREN 15 YEARS OR YOUNGER.1
COVID-19 – PFIZER VACCINE RISK STATEMENT (VRS)

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© 2021 Physicians for Informed Consent, an independent 501(c)(3) nonprofit educational organization.
All rights reserved. For more information, visit physiciansforinformedconsent.org.