Pharmaceutical giant Pfizer has amended its COVID-19 vaccine trial for younger children, announcing that results can be expect in just a few weeks, a researcher revealed Wednesday.
Dr. Alejandra Gurtman said that the study has been adjusted from two doses to three doses in light of the growing body of evidence showing the primary regimen’s effects wane as time goes on from vaccination.
Gurtman, part of Pfizer’s clinical research and development group, told a panel that advises the Centers for Disease Control and Prevention (CDC) on vaccine policy about the development during a virtual meeting.
Pfizer announced last month that a lower dosage of its vaccine did not provoke an adequate immune response among children aged 2 to 5.
The company relies on immunobridging, or comparable immune responses to already-cleared groups, to convince regulators to clear its shot for younger age groups.
Instead of increasing the dosage amount, Pfizer and German partner BioNTech decided to add a third dose to the study.
“It is becoming very clear that this might be a three-dose vaccine, and so this study is been amended to give a third dose to everybody who’s less than five at least eight weeks after the last vaccination,” Gurtman told the panel.
“At the present time, we are looking to have the data for the less than five—this three dose data, the immunogenicity data—by either end of March, beginning of April, so late of quarter one of this year, so a few months from now,” she added.
Gurtman says Pfizer workers see it as their “civic duty” to develop a vaccine for younger children due to the rise in hospitalizations with COVID-19 among the population.
Dr. Dorian Fink, a Food and Drug Administration official, told the panel that the increase in pediatric hospitalizations was concerning.
“We are evaluating what options are possible for moving forward with evaluating the vaccine in this age group in order to figure out how to best make available a safe and effective vaccine as quickly as possible,” Fink said.
Neither mentioned how hospitals are overcounting COVID-19 cases in children, according to Dr. Anthony Fauci, or how many children in hospitals with COVID-19 are actually admitted for another reason, according to the head of the CDC.
COVID-19 can cause severe illness across age groups but those who are older or have weakened immune systems are at far greater risk of hospitalization and death, federal data shows.
Young, healthy people are at higher risk of severe disease from influenza than from COVID-19, according to the data.
But Patricia Stinchfield, director of infectious disease at Children’s Hospitals and Clinics of Minnesota, said she was worried about data showing the highest rate of COVID-19 hospitalization has been among 0- to 4-year-olds in recent weeks and said parents have been asking her when a vaccine will be available for that age group.
That age group is “unprotected” without a vaccine, she said.