Moderna Asks FDA To Approve COVID-19 Vaccine For Kids Under 6
The company is also asking for approval of its other two vaccines for kids under 18.
Finally, some good vaccine news for parents with young kids: Moderna has asked the FDA to approve their COVID-19 vaccine for children between 6 months and 6 years of age. America’s youngest 18 million people are one step closer to getting vaccinated — but it’s still not clear when that will be.
A Moderna official said that it will take until about May 9 to get all of the paperwork to the government agency, and then it’s on the FDA to make a decision.
Moderna CEO Stéphane Bancel said in a statement: "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers."
The pharmaceutical company’s clinical trial data showed that the vaccine causes an antibody response in kids comparable with the response of the vaccine for adults ages 18 to 25. While Moderna says their trial wasn’t large enough to measure vaccine effectiveness, the data suggest that it’s 51 percent effective against symptomatic cases in kids younger than 2 and 37 percent effective against symptomatic cases in kids 2 to 5. That’s less effective than the original vaccine numbers for adults last year, but still significant protection.
Moderna said that the lower effectiveness levels were related to the fact that 80 percent of the infections they saw were the Omicron variant, which causes more breakthrough cases.
Moderna also reported that in the trial, the vaccine was safe — there were no signs of the heart inflammation that has been a concern (with both COVID-19 and with COVID-19 vaccines) and no sign that the vaccine causes more high fevers than other routine vaccines.
What does the timeline look like for actually getting jabs for our toddlers and babies?
It depends on a few factors.
Moderna is also asking the FDA to approve their COVID-19 vaccines for kids 5-11 and teens 12-17 at the same time. It’s unclear if the FDA will consider all three vaccines at once or focus on the vaccine for our smallest citizens, considering that they have been without protection for the entire pandemic. But if it considers all three at once, the timeline might be longer.
And last week, Dr. Fauci, the chief medical adviser to the White House, implied that the FDA might wait for the Pfizer clinical trial results so that they can compare the two and possibly release them at the same time, like they did with the adult vaccine. That would obviously also take longer.
Pfizer is working on a three-shot vaccine at one-tenth the strength of the adult dose. Moderna’s vaccine is a two-shot dose at one-fourth the strength of their adult dose.
The FDA itself said that it may be June until they look at the data, because they are asking their outside advisory panel of experts to review the data. Those close to the matter says that they will take their time with this and be extremely thorough before approving a vaccine for the youngest among us.
So it looks like parents are still looking at more time and more patience.
Moderna also stated that it has similar requests underway in other countries.