Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.
The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.
The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.
In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.
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A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven patients rapidly resolved after symptom onset. The researchers recommended further monitoring and reporting of such cases in adolescents.
In the positive column, a recently released CDC study reports that the Pfizer-BioNTech vaccine and the Moderna vaccine are jointly 91% effective at reducing the risk of COVID-19 infection in people who are fully vaccinated.