The move comes just hours after members of a panel that advises the CDC on vaccination strongly endorsed vaccination for this age group. Early Tuesday, the CDC’s 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Pfizer’s low-dose mRNA vaccine for children ages 5-11.
There are an estimated 28 million children in this age group in the United States.
“I feel I am responsible for making this vaccine available to children and their parents,” said committee member Beth Bell, MD, a clinical professor at the University of Washington in Seattle. Bell noted that all of the evidence the committee reviewed pointed to a vaccine that was safe and effective for younger children.
Their recommendations followed the FDA’s emergency approval for Pfizer-BioNTech’s vaccine for the same age group last week.
“I am voting in favor because I think it will have a great positive impact [kids’] Health and their social and emotional well-being, “said Grace Lee, MD, a pediatrician at Stanford University, chair of the CDC Advisory Committee on Immunization Practices.
Although masks are available to help reduce the risk of the virus to children, they are not perfect and transmission is still happening, Lee noted.
“Vaccines really are the only consistent and reliable way to provide that protection,” said Lee.
The Pfizer vaccine for children consists of 2 doses given 3 weeks apart. Each dose is 10 micrograms, one third of the dose used in adults and adolescents.
To avoid confusion, the smaller dose for children comes in bottles with orange labels and caps. The adult vaccine is packaged in purple.
Generally, pediatricians give a 4 day grace period around birthdays to determine what dose is needed. The same method is used for the COVID-19 vaccine, experts said.
Children who are 11 years old at the start of the series should receive an additional 10 micrograms dose after they turn 12 a few weeks later.
The news comes as COVID-19 cases in this age group soared in the summer and fall as the school reopened completely, sometimes without the use of masks.
In the first week of October, around 10% of all COVID-19 cases registered in the US were in children aged 5-11. About 1.9 million children in this age group have become infected since the pandemic began, although that is almost certainly an outnumbered. More than 8,300 were hospitalized and 94 children died.
Benefits vs. Risks
In clinical trials involving more than 4,600 children, the most common side effects were pain and swelling at the injection site. In some cases, side effects such as fever, fatigue, headache, chills, and sometimes swollen lymph nodes have also occurred. These type of side effects appear to be less common in children aged 5 to 11 than in adolescents and adults, and they were transient.
No cases of myocarditis or pericarditis – swelling of the heart – were observed in the studies. But myocarditis is a very rare side effect, and the studies have been too small to cover these cases.
Even so, the doctors say they are careful. In general, the greatest risk of post-vaccination myocarditis was seen in younger men between the ages of 12 and 30 years.
Even with no COVID-19 or vaccines in the mix, doctors expect up to two cases of myocarditis per 1 million people over the course of a week. The risk of myocarditis increases to about 11 cases for every 1 million doses of mRNA vaccine given to men aged 25-30. In boys between the ages of 12 and 24, it ranges from 37 to 69 cases per 1 million doses.
The smaller dose approved for children is intended to further minimize the risk of myocarditis.
The CDC says parents should call their doctor if a child develops chest pain, has difficulty breathing, or feels like their heart is beating or fluttering after the vaccination.
Models examining the effects of vaccines in this age group predict that nationally, if children were vaccinated, cases would decrease by about 8%.
The models also suggested that vaccinating children at this age would slow – if not stop – the emergence of new variants.
For every 1 million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections will be prevented in this age group, along with dozens of hospital admissions and post-COVID illnesses such as childhood multisystem inflammatory syndrome (MIS-C).
Vaccinating children can help slow down the transmission of the virus and give parents and other caregivers more confidence to participate in school and extracurricular activities, the CDC said.
CDC experts said they would use a variety of systems, including hospital networks, the Vaccine Adverse Events Reporting System (VAERS) open database, the V-SAFE mobile phone-based app, and insurance claims databases to look out for rare side effects in events Link to the vaccines in children.
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