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 ( more than 80% ), fatigue ( more than 60% ), headache ( more than 50% ), myalgia and chills ( more than 30% ), arthralgia ( more than 20% ), pyrexia and injection site swelling ( more than 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.
Adverse reactions observed during clinical studies are listed according to the following frequency categories:
Very common ( greater than or equal to 1/10 ): headache, arthralgia, myalgia, injection site pain, fatigue, chills, pyrexia [ a higher frequency of pyrexia was observed after the 2nd dose ], injection site swelling;
Common ( greater than or equal to 1/100 to less than 1/10 ): nausea, injection site redness;
Uncommon ( greater than or equal to 1/1,000 to less than 1/100 ): lymphadenopathy, insomnia, pain in extremity, malaise, injection site pruritus;
Rare ( greater than or equal to 1/10,000 to less than 1/1,000): acute peripheral facial paralysis;
Not known ( cannot be estimated from the available data ): anaphylaxis, hypersensitivity.
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.
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended. ( Xagena )
Source: EMA, 2020