FDA Authorizes Pfizer’s Covid Vaccine for Children 5 to 11

The Food and Drug Administration approved Pfizer/BioNTech’s Covid-19 vaccine for emergency use in children 5 to 11 on Friday. The approval comes after the FDA’s vaccine advisory panel recommended that they authorize the vaccine for children earlier this week.

28 million children are now able to get one-third of the adult dose administered to them with two injections spaced three weeks apart. The Centers for Disease Control and Prevention is expected to approve the FDA’s decision, and when they do, the vaccine rollout for eligible children could begin as soon as next week.

The Biden Administration made sure that enough doses would be ready the moment the vaccine was approved. Dr. Vivek Murthy, the US’ Surgeon General, told interviewers on NBC’s “Today” show last week that the administration has been preparing for the decision from the FDA and CDC for the past several weeks.

Not only has the White House arranged for enough vaccines to cover all American children from 5-11, the tens of thousands of locations where they can receive the vaccines also had to be organized and prepared for the mass inoculation program. The Administration also has taken it upon itself to ensure that parents will be able to have ready answers for any possible questions regarding the vaccine, according to Murthy.

Murthy stressed that ensuring that all parents had their vaccine questions answered was “really important,” leading the White House and its team to coordinate a huge effort, along with doctors, nurses, teachers, parents and other entities to enable parents to get reliable information regarding the shot.

15 million doses are already prepared to ship specifically for children’s vaccinations, and the shots will be available at pediatrician offices, children’s hospitals, pharmacies, and community health centers.

Pfizer study found its vaccine was safe and effective for younger children

In September, Pfizer publicized its findings from Phase Two of its three trials, showing that the product was not only safe but activated a “robust” antibody response in those aged 5 to 11.

A total of 2,268 volunteer subjects, aged 5 to 11 received a two-dose regimen of the Pfizer inoculation, administered 21 days apart, according to a report from CNN. Unlike the adult doses, however, the trial geared to much younger children used 10-microgram doses, one-third of the amount of vaccine given to all those 12 and up.

Pfizer officials say that they measured the immune responses as seen in the amounts of neutralizing antibodies in participants’ blood, contrasting those levels to what had already been seen in a control group comprised of 16- to 25-year-olds who had received the larger 30-microgram shot series.

The company says that the immunity levels detected in the youngest children were comparable to those seen in the other group, making for a “strong immune response in this cohort of children one month after the second dose.”