MOSCOW (Pakistan Point News / Sputnik - 20th September, 2021) Pfizer announced on Monday that the phase 2 clinical trials of the coronavirus vaccine developed jointly with BioNTech proved the shot's safety and effectiveness in minors aged between 5 and 11 years.
The developer published earlier in the day the first results of a pivotal trial of any COVID-19 vaccine in children in this age group.
"Pfizer ... and BioNTech ... today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 �g administered 21 days apart, a smaller dose than the 30 �g dose used for people 12 and older," the developer said in a statement.
The developers announced their plan to submit data for the full phase 3 trial for scientific peer-reviewed publication. They will also include the data from the phase 2 in a near-term submission for emergency use authorization with the US regulator and request the EU regulator to update the conditional marketing authorization in the near future.
