Pfizer has officially requested that the Food and Drug Administration (FDA) approve its COVID-19 vaccine for use in children under the age of five as an emergency vaccine.
The pharmaceutical company, along with BioNTech SE, submitted an emergency use authorisation (EUA) application to the FDA for their vaccination in children aged six months to four years. The corporations claimed they started the filing process in February, according to a statement released on Wednesday.
In May, Pfizer stated that a three-shot regimen was highly successful and elicited a strong immune response in youngsters under the age of five. Pfizer’s data was based on preliminary findings from a highly anticipated experiment that is expected to open the way for immunisation of newborns and toddlers.
The vaccination was reported to be 80.3 percent effective in preventing COVID infections in young children during early testing, with 10 infections occurring among all research participants. The final results will be known once all 21 youngsters engaged in the trial have been infected, according to the business.
Pfizer began a rolling assessment of data from the trial of 1,678 children under the age of five in February. The three-dose vaccine was well-tolerated, with a safety profile similar to that of the placebo, and the majority of side effects were mild to moderate.
The full application includes information on the product’s safety, efficacy, and capacity to elicit a proper immunological response in recipients.
Three doses were given to children under the age of five; each treatment included three micrograms, or one-tenth of the adult dosage.
The preceding is a summary of an article that originally appeared on The Gateway Pundit.