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"BNT162b2 (COVID-19 Vaccine) Development Program
– Clinical and Research Developments
• In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study to further evaluate the safety,
tolerability and immunogenicity of BNT162b2 in preventing COVID-19 in healthy children
between the ages of 6 months to 11 years old. The companies expect to have the safety and
immunogenicity data that could potentially support an Emergency Use Authorization (EUA) for
use in children ages 5 to 11 years old, if such an EUA is deemed necessary, by the end of
September. The full dataset from this study, which will be required to support licensure in this
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age group, is expected by the end of 2021. Similar data packages will be submitted shortly
thereafter to support EUA and licensure in children 6 months to 5 years of age.
• In July 2021, Pfizer and BioNTech provided an update on the ongoing Phase 1/2/3 booster trial of
a third dose of the current BNT162b2 vaccine. Initial safety and immunogenicity data from the
study demonstrate that a booster dose given at least 6 months after the second dose has a
consistent tolerability profile while eliciting high neutralization titers against the wild type and the
Beta (B.1.351) variant, which are 5 to 10 times higher than after two primary doses. In addition,
newly disclosed data demonstrates that a third dose elicits neutralizing titers against the Delta
(B.1.617.2) variant that are more than five times higher in younger people and more than 11 times
higher in older people than after two doses. The companies expect to publish more definitive data
about the analysis and all accumulated data will be shared as part of the ongoing discussions with
the FDA, EMA and other regulatory authorities in the coming weeks.
• In July 2021, Pfizer and BioNTech initiated the global Phase 3 portion of the clinical study to
evaluate the efficacy, safety and tolerability of a third dose of BNT162b2 compared to placebo,
including evaluating the booster’s efficacy at continuing to prevent COVID-19 infection. The
Phase 3 study will enroll 10,000 participants who participated in the original Phase 3 trial."
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