Expert evidence regarding Comirnaty (Pfizer) COVID-19 mRNA Vaccine for children
Expert statement regarding
Comirnaty—COVID-19-mRNA-Vaccine for children
Michael Palmer MD, Sucharit Bhakdi MD, Stefan Hockertz PhD
This expert statement was submitted by Italian lawyer Renate Holzeisen in conjunction
with a lawsuit that challenges the EU’s authorization of the use of Pfizer’s mRNA vaccine
on children of 12 years and older. The arguments made here specifically reference the
Pfizer vaccine, but they apply similarly to the Moderna mRNA vaccine, and many also
apply to the adenovector-based AstraZeneca and Johnson & Johnson vaccines.
Permission is hereby granted to freely share and distribute this document in unchanged
This expertise on the use of the Pfizer COVID-19 vaccine (Comirnaty, BNT162b2) in ado-
lescents is divided into three sections, which will deal with the following questions, in
1. Is vaccination of adolescents against COVID-19 necessary?
2. Is the Pfizer COVID-19 vaccine effective?
3. Is the Pfizer COVID-19 vaccine safe?
The arguments presented in Section 1 pertain to all COVID-19 vaccines, whereas those in
Sections 2 and 3 apply specifically to the Pfizer vaccine.
Section 1 will show that vaccination of adolescents COVID-19 is unnecessary, because
• in this age group the disease is almost always mild and benign;
• for the rare clinical cases that require it, treatment is readily available;
• immunity to the disease is now widespread, due to prior infection with the virus
(SARS-CoV-2) or with other coronavirus strains; and
• asymptomatic adolescents will not transmit the disease to other individuals who
might be at greater risk of infection.
Section 2 will demonstrate that the claims of efficacy which Pfizer attaches to its vaccine—
namely, 95% efficacy in adults, and 100% in adolescents—are
• misleading, because these numbers pertain to relative, not absolute efficacy, the latter
being on the order of only 1%;
• specious, because they refer to an arbitrarily defined, clinically meaningless eval-
uation endpoint, whereas no efficacy at all has been demonstrated against severe
disease or mortality;
• most likely altogether fraudulent.
Section 3 will show that the safety profile of the Pfizer vaccine is catastrophically bad. It
will be discussed that
• Pfizer, the EMA, and the FDA have systematically neglected evidence from preclinical
animal trials that clearly pointed to grave dangers of adverse events;
• the Pfizer vaccine has caused thousands of deaths within five months of its introduc-
• The agencies that granted emergency use authorization for this vaccine committed
grave errors and omissions in their assessments of known and possible health risks.
The only possible conclusion from this analysis is that the use of this vaccine in adoles-
cents cannot be permitted, and that its ongoing use in any and all age groups ought to
be stopped immediately.
1 Vaccination of adolescents against COVID-19 is unnecessary
1.1 What does the available evidence show? There are several lines of evidence that
show vaccination of adolescents against COVID-19 to be unnecessary.
1.1.1 The case fatality rate of COVID-19 in the general population is low. The vast ma-
jority of all persons infected with COVID-19 recovers after minor, often uncharacteristic
illness. According to world-leading epidemiologist John Ioannidis [1, 2], the infection fa-
tality rate of COVID-19 is on the order of 0.15% to 0.2% across all age groups, with a very
strong bias towards old people, particularly those with co-morbidities. This rate does
not exceed the range commonly observed with influenza, against which a vaccination of
adolescents is not considered urgent or necessary.
1.1.2 COVID-19 has a particularly low prevalence and severity in adolescents. In the
U.S. and as of April 2020, those younger than 18 years accounted for just 1.7% of all
COVID-19 cases [3, 4]. Within this age group, the most severe cases were observed among
very young infants . This is consistent with the lack in infants of cross-immunity to
COVID-19, which in other age groups is conferred by preceding exposure to regular respi-
ratory human coronaviruses (see Section 1.2.1). Among slightly older children, a peculiar
multisystem inflammatory syndrome was observed in early 2020 ; conceivably, these
patients, too, were still lacking cross-immunity.
Essentially no severe cases of COVID-19 were observed in those above 10 but below 18
years of age . This group accounted for just 1% of reported cases, almost all of which
were very mild. Thus, adolescents are at particularly low risk of harm from COVID-19
infection. Vaccination of this age group is therefore unnecessary.
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