The advisory committee of the Food and Drug Administration (FDA, for its acronym in English) decides this Tuesday whether to recommend the approval of the first vaccine against COVID-19 for children 5 to 11 years old, manufactured by the pharmaceutical company Pfizer.
A study of elementary school students revealed that the vaccine is almost 91% effective in preventing symptomatic infection, despite the fact that children received only one-third of the dose given to adolescents and adults.
A 12-year-old boy is vaccinated against COVID-19 in Santa Ana, California, on May 13, 2021.Jae C. Hong / AP
In a preliminary analysis last week, FDA experts noted that the protection "clearly outweighs" the risk of a very rare side effect in almost all pandemic scenarios.
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If the advisers and then the FDA authorize the vaccine, it would only be that it receives the approval of the Centers for Disease Control and Prevention (CDC, for its acronym in English), which will meet to make a decision on the matter next week .
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Although children ages 5 to 11
are at less risk of developing a severe form of COVID-19
, they are also victims of the coronavirus.
So far there have been more than 8,300 hospitalizations of minors, of which about a third have ended up in intensive care and nearly a hundred have died, Peter Marks, the FDA's chief of vaccines, told independent advisers who are evaluating the vaccine.
"The infections have caused the closure of many schools and
affected the education and socialization of children,
" he added.
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"I recognize that there are strong opinions" among the public for and against childhood vaccination, Marks said, but the discussion will focus on the scientific data and "not on the mandates of vaccines, which are left to other entities outside the the FDA ".
The vaccine developed by the pharmaceutical company Pfizer and its partner BioNTech is already approved and recommended for those over 12 years of age, but pediatricians and parents claim
protection for the little ones
.
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The highly contagious delta variant of the coronavirus has caused an
alarming increase in pediatric infections,
and families are frustrated by school quarantines and having to renounce social habits to prevent the spread of the virus.
States are already preparing to organize the vaccination of children, with special vials with orange caps to distinguish them from adult vaccines, as soon as the government gives the green light.
More than 25,000 pediatricians and other primary care providers have so far signed up to administer the vaccine.
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A total of 2,268 children ages 5 to 11 participated in the Pfizer clinical study.
They received two injections three weeks apart.
Those vaccinated
developed levels of antibodies capable of fighting the virus
like adolescents and young adults.
The children's dose has also been shown to be safe, with temporary side effects similar to or less than those experienced by adolescents, such as arm pain, fever or malaise.
At the request of the FDA, Pfizer recently enrolled another 2,300 youth in the study, and preliminary safety data has shown no red flags.