Pfizer's release of data showing its three-shot COVID-19 vaccine is 80% effective among children under the age of 5 is welcome news for parents anxious to get their young children vaccinated more than two years into the COVID-19 pandemic.
With the Food and Drug Administration (FDA) set to meet in June to review data from both Pfizer and Moderna, a COVID-19 vaccine could be widely available to everyone in the United States ages 6 months and older by July.
The news comes as the U.S. is experiencing another COVID-19 wave, with cases rising in nearly every state and official infection numbers up to more than 100,000 per day, according to the Centers for Disease Control and Prevention (CDC).
In the U.S., 28% of 5- to 11-year-olds and 58% of 12- to 17-year-olds are fully vaccinated against COVID-19, according to the American Academy of Pediatrics' analysis of CDC data.
"I think we all want to be done with this pandemic but unfortunately, it's not quite done with us," said Dr. Sean O'Leary, vice-chair of the AAP's committee on infectious diseases. "We are in a much different place than we were two years ago in terms of both the therapeutics that are available to treat the disease and the vaccines, showing a decreased spread of the disease and a decrease in hospitalizations."
O'Leary, also a pediatrician and professor of pediatrics at the University of Colorado and Children's Hospital Colorado, spoke to "Good Morning America" to answer parents' top trending questions about the COVID-19 vaccine and kids.
1. What does the Pfizer vaccine efficacy news mean?
Earlier this year, Pfizer moved forward with studying three doses of its COVID-19 vaccine for kids 6 months to under 5 years old after disappointing data on a two-dose vaccine.
The new data released by the company Monday shows the three-dose vaccine is effective in kids, which means the vaccine is one step closer to being authorized by the FDA, according to O'Leary.
"This was really the news we've been waiting for from Pfizer on whether or not this third dose was going to meet the requirements required from the FDA," he said. "The immune response that the vaccine provided for the children in the trial was similar to the immune response that we saw in older adolescents and adults in who we know the vaccine is effective in preventing infection, hospitalization and death."
In addition to being effective, the new data also shows the three-dose vaccine "appears to be safe," O'Leary said.
2. What happens next for the Pfizer and Moderna vaccines for young kids?
Next month, FDA advisers will meet to discuss the COVID-19 vaccine applications for kids from both Pfizer and Moderna, which submitted its request to the FDA in April.
The FDA has tentatively scheduled the meetings for June 14 and 15, during which advisers will review applications for Moderna's COVID-19 vaccine for kids ages 5 to 17 and ages 6 months to under 6 years, as well as Pfizer's vaccine for kids ages 6 months to under 5 years.
Within one or two days of the FDA meetings, the applications go to a CDC advisory committee. From there, the director of the CDC, Dr. Rochelle Walensky, decides on whether or not to grant emergency use authorization for the vaccines.
With that timing, we could see a vaccine for kids under age 5 available as soon as mid-to-late June, according to O'Leary.
Pfizer's vaccine is currently available for people ages 5 and older, while Moderna's vaccine is authorized for people ages 18 and older.
3. Do kids under 5 get the same vaccine as adults?
The dosage of the vaccine is different for children than it is for adults, but the vaccine itself is the same for everyone, according to O'Leary.
If authorized, Pfizer's vaccine dosage for kids ages 6 months to under 5 years would be three shots of 3 micrograms each. Each dose is one-tenth the adult dose.
Moderna's vaccine for kids under age 6, if authorized, would be a two-dose, 25-microgram shot, about one-quarter of the dose used for adults, given 28 days apart.
4. How do I know the COVID-19 vaccine is safe for my child?
Pfizer's newly-released data on its three-dose vaccine for kids under age 5 showed "no significant safety" concerns, according to O'Leary.
The fact that a vaccine for the youngest children is coming after the vaccine has already been delivered to hundreds of millions of people around the world should bring comfort to parents, O'Leary said.
"There is no reason to expect in this age group that we're going to have some kind of different safety profile than what we saw in children, for example, 5 and older, in whom millions and millions of doses have been given," he said. "So we have a pretty good understanding of the safety profile."
The CDC has also released multiple studies over the past year showing COVID-19 vaccines are safe and effective for older children.
Overall, O'Leary said parents should remember that, based on data, the benefits of the COVID-19 vaccine in protecting kids outweigh any potential risks.
"I think we all know that the disease is most severe in the elderly and people who have problems with their immune system, but that's not to say that COVID-19 is a benign illness in children," he said. "We've seen tens of thousands of hospitalizations in children, and the risk to children under 5, actually, for hospitalization is higher than it is for older children, so absolutely there is a need to protect those children with the vaccine."
For parents of children of all ages who may be on the fence about getting their child vaccinated, O'Leary said to speak with your child's pediatrician.
"The best thing you could do is make an appointment with your pediatrician and talk with them about about the vaccine," he said. "I think it is important to get those kids vaccinated but, on the other hand, I do understand why parents have some questions, and your best source of information is going to be your child's pediatrician."
5. How long after having COVID-19 can my child get a vaccine?
If a child has not been vaccinated against COVID-19 and contracts the virus, they can get vaccinated "as soon as they're out of their isolation period, based on when they were infected and had symptoms," according to O'Leary.
"It doesn't need to necessarily be the next day but, in general, as soon as as they can to provide that protection," he said.
For people who are not vaccinated, CDC guidelines are to quarantine at home for five full days.
6. How do I know if my child needs a booster vaccine?
A booster dose of Pfizer's vaccine was authorized earlier this month for children ages 5 to 11 years old.
A child in that age range must wait at least five months after completion of a primary series to receive the booster, according to the FDA.
"I do think it's important," O'Leary said of fully vaccinated people ages 5 and older receiving a booster dose. "The data have been fairly clear over the last several months, and particularly during this omicron wave, that this booster really matters in terms of prevention of the severe outcomes."
7. What precautions should my family take until a vaccine for young kids is authorized?
O'Leary said families should continue to practice safety protocols including mask wearing for children ages 2 and older, hand-washing and social distancing.
"We know that crowded, indoor settings where people are not masked is one of the higher-risk places, so try to avoid those types of environments," he said.
O'Leary also said parents should make sure their kids of all ages are up to date on all their vaccinations.
"Honestly, for children, a lot of the diseases, although we don't see them anymore, are actually more severe in kids than COVID-19, things like measles," he said. "Going into the summer is a perfect time to make an appointment with your pediatrician for a checkup and make sure your kids are up to date on their vaccines."