Comirnaty study to be amended after study misses the mark in young children

20 December 2021
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US pharma giant Pfizer (NYSE: PFE) and Germany’s BioNTech (Nasdaq: BNTX) will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their Comirnaty COVID-19 vaccine in children six months to under five years of age.

The study will now include evaluating a third dose of 3µg at least two months after the second of the two-dose series to provide high levels of protection in this young age group.

While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose.

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