Covid 19 -

[T3rminator]

Originally Posted by russellw

Evaluation of the Pfizer Covid-19 Vaccine in Children 5-11 Years
Method A phase 1, dose-finding study and an ongoing phase 2–3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 M to 11 years of age. Note that this study was funded by Pfizer but has been peer reviewed.

We present results for 5-to-11-year-old children. In the phase 2–3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.

Results: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2–3 trial, a total of 2,268 children were randomly assigned to receive the BNT162b2 vaccine (1,517 children) or placebo (751 children). At data cut-off, the median follow-up was 2.3 months.

In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favourable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 [CI 0.93 to 1.18], a ratio meeting the prescribed immunogenicity success criterion. Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in sixteen placebo recipients for a vaccine efficacy of 90.7% [CI, 67.7 to 98.3].

Any stats on how many kids in that age group have fallen severely ill due to Covid? Or evidence of long Covid?

Just had word that my sis in the US has booked my nephew and niece in for their jabs. Nephew is 9, niece is 6. Can't say I'm too thrilled to be honest, and I told her so.......I'd much rather they wait a few months and see how the current rounds go. I'm saying this not with an anti vax stance (I've had both jabs of pfizer), but I did have a bit of a reaction 3 weeks after my first jab. They are keen to head to New York for Christmas, and NY is experiencing ~5000 cases a day, and hence why the "rush" to get it