5.9k Share this
Moderna announced Wednesday morning that it has successfully completed clinical trials for its COVID-19 vaccine in children as young as six months old – and it will soon submit data to federal regulators to get the shot approved.
The Phase 2 and 3 trials were recently completed and included the six months to two years old age group, and the two to six years old groups. Both received two 25 microgram vaccine doses.
The Cambridge, Massachusetts-based company hopes to have its shot available for young children as early as this summer.
Moderna’s vaccine is currently only approved for adults 18 and older, and has run into trouble – especially overseas – due to concerns of myocarditis forming in recipients under the age of 30.
‘Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,’ Stephane Bancel, CEO of the company, said in a statement.
If approved, Moderna could pull out an unlikely victory in the race against Pfizer to get its vaccine approved for children under the age of five years old.
Moderna announced Wednesday that it has completed Phase 2 and 3 clinical trials for its COVID-19 vaccine in children aged six months to six years old. The children will receive a dosage a quarter the size of what adults currently receive
Pfizer’s shot is currently the only one in America authorized for children, with those as young as five years old eligible, while only adults can get the Moderna shot.
Only 27 percent of five to 11 year olds in the country are fully vaccinated, and COVID-19 is generally more mild in children than adults.
The recently completed Moderna trials enrolled 6,700 children six months to six years old. Another group of around 5,000 children aged six to 17 were involved in Moderna clinical trials as well.
There were no severe cases in Moderna’s pediatric trial for either vaccine or placebo partipicants.
The dose size tested was 25 micrograms – a quarter of the dose that adults receive for each of their first two shots.
Moderna reports that the shot was just as effective in the younger age group as the full dose is for adults on average.
It was 44 percent effective against Omicron infection for the children aged six months to two years old, and 38 percent effective for those aged three to six.
There have been some concerns about the size of the dose. By comparison, the dosage of the Pfizer-BioNTech vaccine – which uses similar messenger RNA technology – was 10 micrograms for five to 11 year olds.
Pfizer is testing three microgram doses for children younger than 5.
‘FDA did ask us to evaluate lower doses and we intend to do so,’ said Moderna’s top scientist, Dr Jacqueline Miller.
‘However, we believe that the current data really support the dose selections that we have made in this age group… We are confident in the dose that we’ve chosen.’
The company has already submitted data from trials in children aged five to 11 to regulators, and announced that it plans to do the same for even younger children.
‘We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel said.
Not all experts agree that vaccines for children this young are necessary to end the pandemic, though.
Children face little risk from COVID-19, with a ever-growing trove of data showing that they are not nearly as affected by it as adults are.
The Centers for Disease Control and Prevention (CDC) reports that children only account less than 0.1 percent of Covid deaths in the U.S. since the pandemic first began.
Not all experts are convinced that children require the COVID-19 vaccine, since deaths are rare, they are less likely to have a symptomatic case and they may even be less likely to spread the virus
A study from the University of Utah last year found that 50 percent of pediatric Covid cases are asymptomatic. The study was performed before the more-mild Omicron variant emerged, meaning the risk for children to even feel symptoms is likely lower now.
Children may also be less likely to spread the virus when infected, with a German study finding that they release as little as only 25 percent of virus particles as adults do.
Data revealed by New York state officials at the end of last month also found that the shot was only 12 percent effective at preventing Covid infection for children aged five to 11.
Florida Surgeon General Joseph Lapado even issued guidance earlier this month recommending ‘healthy’ children aged 17 of younger not to get the shot.
There is also the concern of myocarditis which, while limited, has been higher for younger Moderna recipients than those of every other vaccine.
Pfizer has also attempted to get its Covid vaccine approved for children in the six months to six year old age group, but has run into issues as the small dosage had minimal effectiveness is older aged children
Last year, European countries like Sweden, Norway, Iceland, Denmark and France all either restricted or stopped the use of the Moderna shot in people 30 and younger out of fear of recipients developing rare heart inflammation.
Officials in those nations instead recommended younger people to receive the Pfizer vaccine.
Pfizer has run into some issues in getting its vaccine out to the youngest age groups too, though.
The company had to shift its Covid vaccine regimen for the youngest children up to three doses from two, as the smaller, three microgram doses, were almost entirely ineffective in children three and four years old.
The New York City-based firm has also submitted data to regulators for its Covid jab in children under the age of five, though the approval process was paused earlier this year.