Q&A: What to know about Pfizer’s COVID-19 vaccine for kids under age 5

The Food and Drug Administration said Tuesday it will consider authorizing Pfizer’s COVID-19 vaccine for kids as young as 6 months, opening the door to immunizing some 23 million American children — 2.4 million in California — for whom vaccines haven’t yet been available.

For many parents of young tots, that approval can’t come quick enough. They worry their kids will pick up the virus at day care and bring it home to the whole family, including grandma and grandpa. Others with reservations about the shots view the development with a sense of dread, fearing new mandates, and some health experts question the benefit of vaccinating young children who face the lowest risk from the disease.

Here’s what we know so far:

Q: What’s the timeline for getting the Pfizer COVID-19 vaccine for toddlers and preschoolers?

A: Pfizer announced Tuesday it is seeking FDA emergency use authorization for a COVID-19 vaccine the company has been developing for kids ages 6 months through 4 years. The FDA said Tuesday its expert advisory panel will meet Feb. 15 to consider the request, after which the agency and the Centers for Disease Control and Prevention could authorize the vaccines within days.

Q: Would the Pfizer vaccine for kids younger than 5 be the same as the one for older kids and adults?

A: Pfizer’s COVID-19 vaccines all use a new messenger-RNA technology that spurs the body’s immune system to attack proteins the virus uses to invade cells, and are given in two doses three weeks apart. Last fall, citing evidence of waning vaccine protection, U.S. health officials recommended a third “booster” shot five months after the second dose for everyone age 12 and older. Pfizer’s vaccine for adults and adolescents ages 12 and up is given at a higher dosage, 30 micrograms per shot, while the dosage for kids 5-11 is 10 micrograms each. The proposed dosage for kids 6 months through 4 years is 3 micrograms each, and Pfizer said it is being planned as a three-dose series, with the third shot given eight weeks after the second.

Q: Are other COVID-19 vaccines being given to kids this age?

A: Pfizer said Tuesday its vaccine would be the first available to help protect children under 5 years old from COVID-19.

Q: What are the safety concerns for children this young?

A: Pfizer reported in December that “no safety concerns were identified” in its clinical trials and that the 3 microgram dose “demonstrated a favorable safety profile in children 6 months to under 5 years of age.” The smaller dosage, Pfizer said, reflects its “commitment to carefully select the right dose to maximize the risk-benefit profile.” However the company also acknowledges “a remote chance that the vaccine could cause a severe allergic reaction” and a “very low” risk of heart inflammation, or myocarditis.

Q: Does the risk to toddlers from COVID-19 outweigh the risk, however small, from the vaccine?

A: That determination will be made by the FDA and Centers for Disease Control and Prevention in deciding whether to authorize the vaccine. For older kids and adults, the agencies have concluded COVID-19 is a greater threat.

Q: Isn’t the COVID-19 risk to children quite low?

A: Children of all ages are at the lowest risk of dying from COVID-19, though slightly more children under age 5 have died of the virus than older kids. According to the CDC, a total of 392 U.S. kids under age 5 have died of COVID-19, or 0.1% of all U.S. coronavirus deaths, compared with 256 children ages 5-11, 289 ages 12-15 and 283 ages 16-17. To put that in perspective, the CDC reported deaths in kids ages 1-4 in 2018 included 443 drownings, 353 homicides, 326 cancers and 292 traffic fatalities.

Children have been getting infected at higher rates during the surge from the highly contagious omicron variant than earlier in the pandemic. The American Academy of Pediatrics said Tuesday that the past month has seen the highest number of COVID-19 cases among children since the pandemic’s onset — more than 3.5 million new cases in children were reported in January, and more than 11.4 million children and teens have been infected by COVID-19 over the past two years.

Q: Aren’t these kids a bit young for vaccines?

A: Babies already get a variety of vaccines, the CDC says. The Hepatitis B vaccine is given at birth, with a third dose before age 2. By 6 months, kids already have a second shot of vaccines for rotavirus, diphtheria, tetanus, pertussis and polio, and at 6 months they can get annual flu shots.

Q: Since these children aren’t in school and aren’t at great risk, what’s the benefit?

“There’s an awful lot of kids ages 6 months to 5 years old that are in day care, so they’re at higher risk getting infected because they’re in congregate settings and can’t easily socially distance,” said Dr. John Swartzberg, clinical professor emeritus of infectious diseases and vaccinology at UC Berkeley’s School of Public Health. “They bring it back to mom and dad, and they get sick, or to grandma and grandpa and they get even sicker. So there’s a societal benefit to vaccinating children this age.”

Q: Will vaccinating toddlers help prevent more outbreaks?

A: Immunizing more than 20 million people, Swartzberg said, would “remove the virus from having a home where it can proliferate and perhaps generate mutations that would be advantageous for the virus.”