On Monday, May 10th the FDA approved the use of the Pfizer COVID-19 vaccine for emergency use on children from the age of 12 to 15. Until this week, the Pfizer vaccine was only available to those aged 16 or above. Pfizer requested the FDA to expand the vaccine’s emergency use on kids aged 12 to 15 after clinical trials found it has a 100% efficacy response.
“We know this is a big step for our country. Vaccinating a younger population brings us closer to returning to a sense of normalcy and to ending the pandemic,” said Janet Woodcock FDA Commissioner during Monday afternoons press briefing.
Pfizer revealed in late March that the vaccine was safe and entirely effective in children aged 12 to 15, which is close to the 95 % efficacy shown in adult clinical trials. Pfizer discovered zero cases of infection among the children who received the vaccine and 16 cases of infection in the children who received a placebo throughout a study of over 2,000 children.There were no cases of COVID among the 1,005 youth who were given the vaccine, but there were 16 cases of COVID in the 978 children who received the placebo, suggesting that the vaccine is 100% successful in combating and preventing COVID-19.
In the two or three days after the second dosage, youth reported a similar number of side effects as older teenagers and young adults, with cold-like symptoms being the most common. Guardians that are unsure about their child receiving the COVID-19 vaccine are
recommended to talk with their pediatricians, who could reassure them by citing and explaining trial and data information.
“The vaccine had an excellent profile in children, and though one can say that often children don’t get terribly sick from COVID-19, there are kids who do get very sick from it and in addition, they can bring it asymptomatically around to their grandparents and others,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “So this is part of the totality of getting our country protected against COVID-19, which is just waiting around the corner to have another wave if we don’t get to a sufficient degree of vaccination,” Marks said.
Most guardians may very well be hesitant to vaccinate their young ones, but Pfizer says it has been “extremely careful with children” and has
waited until larger numbers of the vaccine were tested in adults before even starting to trial the vaccination with those 15 and under.