‘Pfizer and BioNTech on September 20 announced positive results from a Phase 2/3 trial of their SARS-CoV-2 vaccine in children aged 5 to 11 years. The researchers found that a 2-dose regimen of 10µg doses administered 21 days apart demonstrated a favorable safety profile and robust neutralizing antibody response. The findings—which are neither published nor peer-reviewed—are a crucial step toward a SARS-CoV-2 vaccine becoming available for younger children, and the companies expect to submit an application to the US FDA for the vaccine’s authorization for that age group by the end of September. US regulators have issued warnings to the general public to wait for authorization before seeking vaccination for younger children, as the full adult dose of 30µg may put children at a higher risk for adverse side effects, including myocarditis.
‘The trial included nearly 2,300 children, and two-thirds of them in the vaccine group. The vaccinated children also were compared with a separate cohort of 16-25-year-old individuals who received the full adult course of the vaccine (2 doses of 30µg). The trial found that the neutralizing antibody response was similar between both vaccinated groups, with the neutralizing antibody levels within 5% of each other. Both groups also experienced similar post-vaccination adverse events.’
Read here (Pfizer news release) and here (Stat News, Sept 20, 2021)
