Benefits outweigh risks in most scenarios, FDA review says of Pfizer vaccine for children

A review by the Food and Drug Administration (FDA) indicated on Friday that the Pfizer-BioNTech’s COVID-19 vaccine provided more benefits to children in most scenarios than possible risk, the latest sign that health agencies could give the green light on a vaccine for children as young as 5 years old in the coming weeks, The Washington Post reported.

An FDA review found that a two-dose regimen of the Pfizer vaccine for children provided more benefits to children than risks in three of four scenarios that the agency considered. 

The FDA noted that there could be the risk of more pediatric hospitalizations due to myocarditis stemming from the vaccine than COVID-19 in the scenarios of lower levels of COVID-19 transmission, but noted “the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario,” according to the newspaper.

Earlier on Friday, Pfizer released data from its study which indicated that the vaccine was 91 percent effective for children between the ages of 5 to 11 years old. Pfizer noted that when children were given two 10-microgram doses and spaced out between three weeks — a smaller dosage and timeline than for other age groups — the children indicated equal levels of protection against the delta variant and initial COVID-19 strain.  

An FDA advisory panel meeting will convene next Tuesday to consider if younger children should be recommended for the Pfizer vaccine. The FDA’s review of Pfizer’s study indicates that it could be recommended favorably. 

The Centers for Disease Control and Prevention (CDC) will weigh in once the FDA decides whether to accept the panel’s recommendation. It is anticipated that children could start receiving the Pfizer vaccine as soon as early November. 

That news would be seen as welcome relief to some parents who are anxious to have their children vaccinated in time for the holidays. Pfizer’s vaccine is only approved for children as young as 12 years old, but an authorization from both the health agencies could extend that to most children if they recommend Pfizer’s vaccine for children favorably.