BALTIMORE — Pfizer and BioNTech said Monday that their COVID-19 vaccine was safe, well-tolerated and produced a strong immune response in children ages 5 to 11, bringing hope to many parents that their children could soon be protected.
Officials for the vaccine makers said in a news release that they would take the data to federal regulators soon, prompting estimates that younger kids could be vaccinated by the end of October.
The companies also said they will seek authorization for the vaccine’s use in children younger than age 5 before the end of the year. The vaccine already is approved in adults and has emergency authorization for use in children as young as 12.
With pediatric COVID-19 cases on the rise in Maryland and across the country, Gov. Larry Hogan has pushed federal regulators at the U.S Food and Drug Administration and Centers for Disease Control and Prevention to expedite their reviews. While awaiting federal guidance, state health authorities already are planning for pediatricians to provide the bulk of vaccinations.
Below is a condensed interview about the process and timeline with Dr. James Campbell, a pediatric infectious disease specialist in the University of Maryland School of Medicine who is the principal investigator of a similar trial in Baltimore of the Moderna vaccine in children.
Q. What did Pfizer say about its vaccine for kids in the study released Monday?
A. Pfizer has been studying 5- to 11-year-olds, giving them a third of the adult vaccine dose, or 10 micrograms. They had over 2,000 kids in that study and two-thirds got the vaccine and one-third a placebo, 21 days apart.
They announced today that the safety profile looked as good or better than what they’d seen in young adults. And neutralizing antibodies are almost exactly the same a month after the second dose, when we have peak response in antibodies that can protect against COVID.
They need to meet a certain bar, that the vaccine results in young kids looks as good as results in young adults. They appear to have done that.
Q. If the dose is lower, does that mean fewer bad reactions, such as rare cases of heart inflammation called myocarditis seen in adolescents? What are more likely side effects?