BREAKING: Moderna says its COVID-19 vaccine is safe for babies as young as six months after ‘successful’ completion of clinical trials
- Moderna announced on Wednesday that it has completed phases 2 and 3 clinical trials of its vaccine in children as young as six months old.
- The company hopes to make the vaccine available to very young children as early as this summer.
Moderna announced Wednesday morning that it has successfully completed clinical trials of its COVID-19 vaccine in children as young as six months of age and plans to submit data to regulatory authorities for vaccine approval soon.
Phase 2 and 3 trials have recently been completed, involving children aged six months to two years and groups of two to six years. Both receive two doses of the 25 mcg vaccine.
The Cambridge, Massachusetts-based company hopes to have the vaccine for young children as early as this summer.
The Moderna vaccine is currently only approved for adults 18 years of age and older, and has had problems, especially abroad, due to concerns that recipients under the age of 30 could develop myocarditis.
“Given the need for a COVID-19 vaccine for infants and young children, we are working with the US FDA and regulators around the world to provide this data as soon as possible,” said CEO Stéphane Bansel.
If approved, Moderna could win an unlikely victory in the race against Pfizer to approve its vaccine for children under the age of five.
The Pfizer vaccine is currently the only one in America that is legal for children, with children as young as five eligible for it, while only adults can get the Moderna vaccine.
Moderna’s recently completed trials included 6,700 children aged six months to six years. Another group of approximately 5,000 children aged 6 to 17 also participated in Moderna’s clinical trials.
The 25mcg dosage is a quarter of the 100mcg dose currently offered to adults.
The company has already submitted data to regulators for the latter age group and has announced that it plans to do the same for even younger children.
“We remain committed to helping end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel said.
However, not all experts agree that vaccines for such young children are needed to end the pandemic.
Children are at low risk from COVID-19 and there is a growing body of evidence showing that they are not as susceptible to the disease as adults.
The Centers for Disease Control and Prevention (CDC) reports that children have accounted for less than 0.1 percent of Covid deaths in the US since the pandemic began.
A study last year by the University of Utah found that 50 percent of Covid cases in children are asymptomatic. The study was done before a milder version of Omicron was available, which means the risk of children even experiencing symptoms is now likely lower.
Children may also be less likely to spread the virus when they become infected: a German study found that they shed just 25 percent of virus particles than adults.
Data released by New York State officials late last month also showed the vaccine was only 12% more effective at preventing Covid infection in children ages 5 to 11.
Florida Surgeon General Joseph Lapado even issued guidance earlier this month advising “healthy” children ages 17 and under not to get vaccinated.
There is also the risk of myocarditis, which, although limited, was higher in younger recipients of Moderna than with any other vaccine.
Last year, European countries such as Sweden, Norway, Iceland, Denmark and France either restricted or stopped the use of the Moderna shot in people aged 30 and under due to concerns that recipients would develop a rare inflammation of the heart.
Instead, officials in these countries recommended that young people get the Pfizer vaccine.
However, Pfizer has faced some challenges in distributing its vaccine to the youngest age groups.