Freedom Information request on number of participants received injections, with BNT162b2 and the placebo (FOI 21/902)
Published 27 April 2022
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7th August 2021 FOI 21/902
Dear
Thank you for your email.
As stated in Annex 1 of the Public Assessment Report, 2260 participants received injections, with 1131 receiving BNT162b2 and 1129 receiving placebo. Out of the 2,260 subjects that received Dose 1, 2,241 (> 99%) received Dose 2. The reason for not receiving Dose 2 was an adverse event (AE) in 2 cases of the BNT162b2 arm: pyrexia (related) and anxiety, depression (considered unrelated). The most frequent reason was a COVID-19 positive test, which was reported more frequently in the placebo arm.
In line with local reactogenicity data previously reported in adults, in the BNT162b2 arm, pain at the injection site was the most frequently reported local reaction in adolescents and young adults. The frequency was similar after Dose 1 and after Dose 2 in adolescents (86.2% vs 78.9%) and in young adults (83.4% vs 77.5%). After the first and second dose and in both age groups, most local reactions were mild or moderate in severity.
Up to 1-month post Dose 2, the incidence of serious adverse events in subjects that received BNT162b2 was very low in both age groups (0.4%) and none of the serious adverse events were considered related to treatment by the investigator.
Kind regards,
MHRA Customer Service Centre