Credit: Silk Yalova / Shutterstock.com
Three doses of Pfizer’s COVID-19 vaccine would provide potent protection against symptomatic disease in children under five years of age, according to this pharmaceutical company, which intends to offer the data supporting this claim to the Agency. Food and Drug Administration (FDA) soon, with the aim that the vaccine can be administered as soon as possible to younger children.
Pfizer’s vaccine for young children contains a tenth of the amount of drug that adults receive, but during the studies they found that two doses were not enough to protect minors and decided to administer a third dose to more than 1,600 children with ages aged between six months and four years during the wave of COVID that occurred in winter due to the omicron variant. The third dose of 3 micrograms was well tolerated among 1,678 children under five years of age, demonstrating similar safety to placebo.
Pfizer and its partner BioNTech have reported in a press release that the third dose of their vaccine accelerated the rise in SARS-CoV-2 antibody levels enough to meet FDA criteria for emergency use. of the vaccine without safety concerns. According to preliminary data, the effectiveness of administering three doses reaches 80% in the prevention of symptomatic COVID-19, according to the analysis carried out at a time when omicron was the predominant variant.
“The study suggests that a low 3-microgram dose of our vaccine provides young children with a high level of protection against recent strains of COVID-19.”
Pharmaceutical companies have warned, however, that this estimate is only based on 10 cases diagnosed among study participants at the end of April and that according to study rules, a minimum of 21 cases are necessary to formally determine effectiveness, so Pfizer has promised to update the data as soon as it is available.
“The study suggests that a low 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against recent strains of COVID-19,” he said in a statement. Dr. Ugur Sahin, CEO of BioNTech. For his part, Dr. Peter Marks, head of vaccines at the FDA, has assured that this organism “will move quickly without sacrificing our standards” when evaluating the small doses of Pfizer and Moderna. In addition, they point out “we are preparing the relevant documents and expect to complete the submission process to the FDA this week, with submissions to the EMA and other regulatory agencies in the coming weeks.”
.
