Pfizer says its COVID-19 vaccine is safe and effective in younger kids
Pfizer and its partner BioNTech on Monday said they will soon file for Food and Drug Administration (FDA) authorization after a clinical trial found their COVID-19 vaccine was “safe” and “well tolerated” by children ages 5 to 11, and “robust neutralizing antibody responses” were observed.
For its trial, the companies used a much smaller dose than what is given to people age 12 and older. Instead of giving two 30 microgram doses three weeks apart they used 10 microgram doses in the younger children.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the [Food and Drug Administration (FDA)] and other regulators with urgency,” Pfizer CEO Albert Bourla said.
Pfizer’s trial included 2,268 participants between the ages of 5 and 11. According to the company, the doses resulted in side effects comparable to what was observed among the trial for patients ages 16 to 25.
Many questions: Pfizer did not give much information. There were statements, but the company did not show the data to back up the assertions. There was no information about efficacy or specific side effects, meaning it’s unclear just how well children are protected. We don’t know if it prevents infections as well as hospitalizations, or at what levels.
But still encouraging: While there were complaints about “science by press release,” the announcement is likely encouraging for parents concerned about their unvaccinated children. Some experts also noted that regulators are likely going to have to make a decision based on limited data. Young children were not as impacted by the alpha variant, but as the delta variant spread, pediatric hospitalizations rose sharply. Scientists don’t know the full safety profile yet, but it’s not likely that a large enough clinical trial could be completed quickly enough given the public health urgency.
