Summary of safety profile: The safety of COMIRNATY was evaluated in participants 16 years of age and older in 2 clinical studies that included 21,744 participants that have received at least one dose of COMIRNATY.
In Study 2, a total of 21,720 participants 16 years of age or older received at least 1 dose of COMIRNATY and a total of 21,728 participants 16 years of age or older received placebo (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of 20,519 participants 16 years of age or older received 2 doses of COMIRNATY.
At the time of the analysis of Study 2, a total of 19,067 (9,531 COMIRNATY and 9,536 placebo) participants 16 years of age or older were evaluated for safety for at least 2 months after the second dose of COMIRNATY. This included a total of 10,727 (5,350 COMIRNATY and 5,377 placebo) participants 16 to 55 years of age and a total of 8,340 (4,181 COMIRNATY and 4,159 placebo) participants 56 years and older.
The most frequent adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
Tabulated list of adverse reactions from clinical studies: Adverse reactions observed during clinical studies are listed as follows according to the following frequency categories: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from available data). (See Table 2.)
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The safety profile in 545 subjects receiving COMIRNATY, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to local regulatory authorities per local requirements.
Alternatively, healthcare professionals can also contact respective company representatives of local suppliers/distributors for assistance in such reporting.