Pfizer to expand testing Covid 19 vaccine in larger group of children below 12
On Tuesday, Pfizer said it would test its COVID-19 vaccine in a larger group of children under age 12, as the vaccine has been authorized for use in children as young as 12 in Europe, the United States, and Canada.
The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland, and Spain, the company said.
Based on safety, tolerability, and the immune response generated by 144 children in a phase I study of the two-dose shot, Pfizer said it would test a dose of 10 micrograms in children between 5 and 11 years of age and 3 micrograms for the age group of 6 months to 5.
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The vaccine — made by Pfizer and German partner BioNTech — has been authorized for use in children as young as 12 in Europe, the United States, and Canada. They receive the same dose as adults: 30 micrograms, according to Reuters.
Nearly 7 million teens have received at least one dose of the vaccine in the United States, according to the U.S. Centers for Disease Control and Prevention.
Inoculating children and young people is critical toward reaching “herd immunity” and taming the Covid-19 pandemic.
Still, scientists in the United States and elsewhere study the possibility of a link between heart inflammation and mRNA vaccines, particularly in young men. Both Pfizer and Moderna’s vaccines are mRNA shots.
Israel’s Health Ministry said last week it had found the small number of myocarditis cases observed mainly in young men who received the Pfizer vaccine there were likely linked to their vaccination. The cases were generally mild and short-lasting.
Pfizer has said that it is aware of the Israeli observations of myocarditis and that no causal link to its vaccine has been established.
Covid-19 vaccines and children
The Pfizer-BioNTech vaccine has already been approved for adolescents in the EU [Andreea Alexandru/AP Photo]
So far, the Food and Drug Administration has given emergency authorization only to the Pfizer-BioNTech vaccine for young people aged 12 to 17. Since December, the vaccine has been authorized for use in 16- and 17-year-olds since December, although in most states, eligibility for older teens was delayed until April. In May, children ages 12 to 15 became eligible for the Pfizer shot. Two other vaccines are likely to be given emergency authorization for children in the coming months. Moderna has tested its vaccine in 3,732 children ages 12 to 17 and may win authorization this month. Johnson & Johnson, in April, also began studying 12- to 17-year-olds.
Younger children will probably be eligible this fall. Pfizer plans to seek emergency authorization in September for children between the ages of 2 and 11. Moderna’s clinical trial results in children as young as 6 months are expected by the end of the year.
Dr. James Conway, a pediatric infectious disease specialist at the University of Wisconsin School of Medicine and Public Health who oversees vaccination programs there, said vaccines would likely be available for 5- to 11-year-olds in late 2021, and for babies over 6 months, toddlers, and preschoolers in early 2022, according to New York Times.
The Pfizer and Moderna vaccines use something called mRNA technology — the “m” stands for messenger. Think of the mRNA molecule like a set of instructions. While a traditional vaccine uses a weakened or inactivated germ to trigger an immune response in our bodies, the mRNA vaccines carry a set of instructions to teach our cells how to make a protein that will trigger an immune response and produce antibodies to the virus.
While children are less likely to develop severe illness from Covid-19, they are still at risk. Nearly four million children in the United States have tested positive for the virus since the start of the pandemic, according to the American Academy of Pediatrics, and more than 300 have died. In addition, this past winter, doctors reported growing numbers of patients with Multisystem Inflammatory Syndrome in Children, or MIS-C, a condition linked to Covid, which can affect multiple organs, including the heart.
Dr. Megan Ranney, an emergency room physician, and professor at Brown University in Providence, R.I., said she had “zero safety concerns” about the Pfizer-BioNTech vaccine, noting that hundreds of millions of people worldwide had received it.
“The risk of your child catching Covid and getting really sick is low, but it’s not zero,” said Dr. Ranney. “And the risk of them getting sick or hospitalized or worse with Covid or with the post-Covid multi-inflammatory syndrome is higher than the risk of something bad from this vaccine.”