After many months of anticipation, a COVID-19 vaccine for kids under 12 will finally be available beginning as early as this week. The Centers for Disease Control and Prevention (CDC) officially signed off on the Pfizer/BioNTech vaccine for children ages 5 to 11, making this the first COVID-19 vaccine available to children in this massive age group.
As of the evening of November 2, 2021, approximately 28 million children between the ages of 5 and 11 in the U.S. are officially eligible to receive Pfizer’s pediatric COVID-19 vaccine. Until now, kids in this age group haven’t had any options for immunization against the virus.
Distribution of the vaccines has already begun and will start ramping up next week to become available at thousands of locations, including pediatric doctor’s offices and pharmacies, according to the CDC press release. As with the adult vaccine from Pfizer, the pediatric version of the vaccine is given in two separate doses spaced three weeks apart. The dosage for people under 12 is about a third of the size of the adult dose.
The Advisory Committee on Immunization Practices (ACIP) at the CDC voted unanimously in favor of approving Pfizer/BionNTech’s mRNA pediatric vaccine. Committee members met this week to deliberate the research on the safety and effectiveness of the pediatric vaccine (among other COVID-19 vaccine-related issues), just days after the U.S Food and Drug Administration issued the necessary emergency use authorization (EUA) for this age group on October 29.
On Tuesday evening, following the committee’s vote that afternoon, CDC director Rochelle Walensky, M.D., MPH, endorsed the ACIP’s recommendation. “Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19,” Dr. Walensky said in the CDC press release. “We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine.”
The ACIP and FDA found in their evaluations of the evidence that the vaccine offers strong protection against COVID-19 for kids in this age group. In a clinical trial (including about 3,100 children who received the vaccine and about 1,500 who received a placebo), vaccination was found to be 90.7% effective at preventing symptomatic COVID-19 infections in kids ages 5 to 11, which is comparable with the level of protection seen in adults, per the CDC.
Pifzer/BioNTech’s COVID-19 vaccine for kids was also found to be generally safe, a primary concern among parents. It caused the common, temporary, and typically mild or moderate side effects that we’ve come to expect from the shots (including arm soreness, fatigue, headache, and fever). According to the FDA’s EUA, symptoms dissipated within one or two days, and more side effects were reported after the second dose than the first. The trial found no unexpected or severe side effects or complications.
As with previously recommended COVID-19 vaccines, the pediatric version will continue to undergo “the most intensive safety monitoring in U.S. history,” per the CDC release. Researchers will continue to surveil kids for rare and potentially severe side effects that could develop later, such as the heart inflammation (myocarditis and pericarditis) that has occurred in a small but significant number of young and adolescent people, particularly males. (In the absence of longer-term data, the FDA performed statistical modeling to predict the risks for these heart problems in this younger age group and concluded that the benefits of vaccination far outweighed the potential risks.)