Pfizer says COVID-19 vaccine now safe for 5 to 11-year-olds
ROCHESTER, N.Y. (WHEC) — Monday morning, Pfizer and BioNTech say their vaccination is safe and effective for children ages five to 11 to protect themselves from coronavirus.
The companies plan to get emergency use authorization from the Food and Drug Administration (FDA), much like they did for the adult version earlier this year. In a joint press release, the two drugmakers said the results from their phase two and three trials showed favorable and robust antibody responses for children with two doses, 21 days apart. Leading up to this announcement, vaccine trials started three months ago right here at the University of Rochester Medical Center.
Leading the efforts, Dr. Jennifer Nayak says the primary results of Pfizer’s pediatric COVID vaccine trials were deemed safe and under a watchful eye. Nayak, the chief of pediatric infectious diseases at URMC, explained how her team checked the safety of the vaccine and whether there is any difference between the adult and kids version.
“When the trials were being conducted, there was tremendous focus on safety to try to make sure that not only did the vaccine work but that the vaccine was also shown to be safe,” Dr. Nayak said.
“One of the adverse effects of special interest that we were looking at was the myocarditis, and from what I had seen, there were no cases reported,” Dr. Nayak said.
The months-long trial involved a series of testing and experimenting approximately 2200 participants ages five to 11 based on a dose escalation.
“They started in the kids closest to the teenagers where the vaccine had been studied. [They] started with a low dose and worked their way up in terms of dosing to try to find that good dose. For the five to 11- year-olds, the 10 microgram dose was the dose that was found to be the best dose in that part one of the study,” Dr. Nayak said.
The pediatrician further explains that with the existing data and trials on adults and teenagers already available, a lot of comparisons were made to help draw conclusions.
“With the studies in the five to 11-year-olds, what we were able to find is with one-third of the dose – adults got 30 micrograms – the five to 11-year-olds received a 10 microdose. With one-third of the dose we were able to have a neutralizing antibody response that was virtually the same as what we saw in the teens and the young adults,” Dr. Nayak explained.
The next step is for the FDA to review the studies and vote on the emergency use authorization. The companies expect the vaccine to be available for five to 11-year-olds as soon as the fourth quarter of this year…just in time for the holidays and family gatherings.