An independent panel of experts advising the US Food and Drug Administration just voted unanimously "yes," expressing their confidence that a two-dose Covid-19 vaccine from Moderna is safe, effective, and beneficial for youngsters as little as 6 months old.
Their assessment is based on available data from the company, which trialed its vaccine in more than 5,000 young children, as well as an independent analysis of the data from FDA scientists.
The move sets up shots to begin going into the arms of little kids and babies nationwide as early as next week, pending vaccine authorisation from the FDA and a final recommendation from the Centers for Disease Control and Prevention, which is expected this weekend.
The FDA is also discussing Pfizer's three-shot Covid-19 vaccine for kids as young as 6 months old, and a vote on that vaccine is coming later this afternoon.
"Every paediatrician that I know at our hospital has been waiting eagerly for this vote to occur because they can't wait to start giving this vaccine," panel member Dr. Jay Portnoy from Children's Mercy Hospital in Kansas City, Missouri said during the meeting.
"For preventing severe disease, hospitalisation, and emergency visits, this vaccine is very effective, it's also very safe to use."
Parents have been waiting months for a vaccine
Many parents have been eagerly awaiting a vaccine for their babies and toddlers for over six months. Vaccines for kids 5 and up have been available since early November, making children under 5 the last remaining group which is not vaccine eligible in the US yet.
"We hear very much from parents how desperate they are," Dr. Peter Marks, who directs the FDA's centre where vaccines are evaluated, said during a May webinar with doctors. More than 400 children under the age of 4 have died from Covid-19 during the pandemic, and their rates of hospitalisation and death (while still low compared to adults) surpass those of older, vaccine-eligible kids.
"Hundreds of deaths are just not — it's just not — we don't consider that acceptable in any way, shape, or form," Marks said.
Thousands of parents in the US, Canada, and several other countries around the world volunteered for the Moderna and Pfizer trials, hoping to get their kids early access to vaccinations.
"Why would we want to leave our children unprotected?" Linsey Sandeen, who enrolled her three children in Moderna's pediatric trial in October 2021, previously told Insider.
The vaccines from Pfizer and Moderna are not perfect at stamping out all disease, especially with Omicron. During its ongoing trials of kids 6 months to 5 years old, Pfizer estimated its three-shot vaccine was around 80% effective, a preliminary number that was based on only 10 Covid-19 cases observed over the course of 40 days.
"Exactly what the efficacy is after dose three I think needs further data to inform," the FDA's Doran Fink said during the meeting.
Moderna's roughly 40 to 50% vaccine efficacy estimate for kids 6 months to 6 years old is also very subject to change, as it doesn't include a third dose (booster), which the company is testing out in that age group now.
But the true measures of success for these vaccines will be seen over time, based on whether people get them for their kids, and how well they do at keeping young kids out of the hospital, and preventing more Covid-19 deaths among babies and toddlers.
"I think we have to be careful that we don't become numb to the number of pediatric deaths because of the overwhelming number of older deaths," Marks said at the meeting on Wednesday.
Smaller shots, milder side effects
Moderna's pediatric Covid-19 vaccine isn't the same formulation adults get — it's a smaller, 25% dose. The vaccine is administered in two shots, spread four weeks apart. Pfizer's pediatric vaccine is also a much smaller dose than the adult shot.
Short-term side effects of both vaccines have been milder for babies and toddlers than for older people, with some of the most common symptoms including irritability, arm pain, and low-grade fevers for a day or two after vaccine administration.
This is a developing story. Check back for updates.