- An FDA panel voted unanimously to endorse COVID-19 vaccines for babies and kids over 6 months old.
- The CDC still needs to decide to recommend the Pfizer and Moderna shots.
- First doses could be available starting next week.
A US Food and Drug Administration panel just voted unanimously “yes” for two baby-sized COVID vaccines.
The independent panel of experts advising the agency expressed confidence that Moderna’s two-dose shot and Pfizer’s three-dose shot is safe, effective, and beneficial for youngsters as little as 6 months old.
Their assessment is based on available data from the two companies, which collectively trialed their vaccines in more than 8,000 young children, as well as independent data analyses 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 authorization from the FDA and a final recommendation from the Centers for Disease Control and Prevention, which is expected this weekend.
Panel member Dr. Jay Portnoy from Children’s Mercy Hospital in Kansas City, Missouri, and several other members of the FDA committee stressed that while parents don’t have to vaccinate their young kids against COVID, providers owe it to the parents who do want vaccines for their kids to give them the option.
“Every pediatrician 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,” he said during the meeting.
“For preventing severe disease, hospitalization, 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 that’s 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 center where vaccines are evaluated, said during a May webinar with doctors.
More than 400 children under the age of 4 have died from COVID during the pandemic, and their rates of hospitalization 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.
Moderna’s vaccine appears effective after 2 shots, while Pfizer’s takes 3
The vaccines from Pfizer and Moderna are not perfect at stamping out all disease, especially with the highly contagious Omicron variant. And, they also take several weeks to give kids good disease protection. FDA charts suggest Moderna’s vaccine kicks in at around 40 days after the first of two shots, while Pfizer’s takes between two and three months to begin having an impact, depending on the timing of the third dose.
“It does worry me, actually, that there was no protection after dose two,” Dr. Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, said during the FDA meeting, referencing Pfizer’s vaccine, which he said might be too low of a dose for kids.
“For people who’ve gotten two doses of that vaccine, they have to know they’re not protected, and they’re going to have to wait a few months before they are protected,” he said.
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 cases observed over the course of 40 days. Multiple independent experts at the FDA meeting Wednesday stressed that isn’t a good indicator of the true efficacy of the shots.
Moderna’s roughly 40% to 50% vaccine efficacy estimate for kids 6 months to 6 years old is also subject to change, as it doesn’t include a third dose (booster), which the company is testing out in that age group now.
Dr. Amanda Cohn from the CDC said “I would really hope” that people don’t put too much stock in the 80% vs. 40% vaccine effectiveness numbers, though, because they are based on such a small number of cases over a short period of time.
“I believe the vaccine is effective — I do not have any idea what that number will actually end up being,” she said. “This was effectiveness after 30 days,” she added, saying that effectiveness “could fall off very quickly,” especially against mild disease.
The true measures of success for these vaccines will be seen over time, based on whether people get their kids vaccinated, and then how well the shots keep young kids out of the hospital, ICU, and preventing more COVID deaths among babies and toddlers.
Smaller shots, milder side effects
Moderna’s pediatric COVID 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, 10% dose of 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 content was originally published here.