The Vaccines and Related Biologics Advisory Committee voted unanimously with abstention that the benefits of the vaccine outweigh the potential risks, including a side effect of myocarditis (inflammation of the heart) which is very rare in adolescents and young adults who receive a much higher dose. The dose for young children is only a third of the Pfizer dose already recommended for everyone 12 years and older.
The FDA is not bound by the committee’s recommendation, but should take it into consideration and make its decision within days.
If the FDA allows doses for children, there is yet another step before children in the United States can get the vaccine. Next week, the Centers for Disease Control and Prevention will also have to decide whether to recommend the vaccines and whether all children should receive them or target groups.
Health Canada is currently reviewing Pfizer’s vaccine to decide whether or not to allow its use in children aged five to 11 in Canada.
While children are at lower risk of severe COVID-19 than older people, children aged 5 to 11 have faced significant illness – including more than 8,300 hospitalizations – about a third of them requiring of intensive care – and nearly 100 deaths, according to FDA chief vaccine officer Dr. Peter Marks told the advisory committee.
In addition, “the infections have caused many school closures and disrupted the education and socialization of children,” he said.
“I want to acknowledge that there are strong feelings” among the public for and against childhood vaccinations, Marks added, noting that the discussion would be about science “and not about immunization mandates, which are left to other entities outside of the FDA. ”
Full strength injections made by Pfizer and its partner BioNTech are already available for all ages 12 and older in the United States, but pediatricians and many parents are calling for COVID-19 protection for young children. The extra-contagious delta variant has caused an alarming rise in pediatric infections – and families are frustrated with school quarantines and have to say no to sleepovers and other childhood rites to keep the virus at bay.
States are preparing to roll out injections for little arms – in special vials with orange caps to distinguish them from adult doses – as soon as the government agrees. More than 25,000 pediatricians and other primary care providers in the United States have so far signed up to offer the vaccination.
The Pfizer study followed 2,268 children aged five to 11 who received two injections three weeks apart of either a placebo or a pediatric dose. The vaccinated children developed levels of anti-virus antibodies as strong as adolescents and young adults who received the injections at full strength, the company said.
And so far, 16 children who received sham injections have developed symptomatic COVID-19 compared to three young people who were vaccinated, meaning the vaccine was almost 91% effective. Most of the study data was collected in the United States in August and September, as the delta variant increased.
The dosage for children was also found to be safe, with similar or fewer temporary side effects, such as arm pain, fever, or body aches, experienced by adolescents. At the request of the FDA, Pfizer recently recruited another 2,300 young people into the study, and preliminary safety data showed no red flags.
The study is not large enough to detect extremely rare side effects, such as inflammation of the heart that occasionally occurs after the second dose, mainly in young men and adolescents.
FDA analysis calculated that in most continuing pandemic scenarios, the vaccine would prevent about 200 to 250 COVID-19 hospitalizations per 1 million vaccinated children, with about 58 hospitalizations for heart inflammation.
The risk of side effects is based on levels in adolescents, and Pfizer expects it to be much lower in young children receiving the child-sized dose.
Moderna is also studying smaller doses of its COVID-19 vaccine for use in children under 12.