The FDA just authorized Pfizer's COVID-19 shot for kids 5-11 years old, opening a vaccination campaign to younger children
Shawn Rocco/Duke University/Handout via REUTERS
- The FDA has authorized the first coronavirus vaccine for younger children.
- The agency OK'd Pfizer's vaccine for use in 5- to 11-year-old kids.
- The CDC will finish the review process when its advisory panel meets on November 2 and 3.
The Food and Drug Administration on Friday authorized the first coronavirus vaccine for young children, opening up another chapter in the nation's immunization campaign.
The FDA issued an emergency OK for the Pfizer-BioNTech COVID-19 vaccine, making 5- to 11-year-old children eligible to receive the two-dose shot. This younger age group will receive two lower-strength doses of the vaccine spaced three weeks apart.
The FDA's authorization follows the agency's expert panel voting 17-0 on October 26 in support that the vaccine's benefits outweigh the risks for elementary school-aged children. A clinical trial enrolling more than 2,000 young children found the shot was 91% effective at preventing symptomatic illness in this younger age group.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization," Dr. Janet Woodcock, the agency's interim commissioner, said in a statement. "Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy."
Pfizer
In the final steps of the review process, the Centers for Disease Control and Prevention's advisory group will meet November 2 and 3 to discuss Pfizer's shot in younger children. If the CDC's review is also positive, younger children could start receiving the vaccine in a matter of days.
The CDC's review could place some limits on who is recommended to get the shot. Several members of the FDA panel said the CDC should consider only recommending young children at high risk of severe disease for now.
Reaching younger kids with shots could help quell the pandemic
AP Photo/Chris O'Meara, File
Vaccinating younger kids is another step forward in a nearly two-year fight against the pandemic.
Public-health experts hope this will not only stop children from getting sick with COVID-19, but more vaccinations will protect the broader population, by further dampening down the potential spread of the coronavirus.
While kids have largely avoided the worst outcomes of COVID-19, there have still been thousands of hospitalizations and dozens of deaths. The CDC has tallied 1.9 million cases, resulting in more than 8,600 hospitalizations and 166 deaths among children aged five to 11 years old in the US.
In a presentation to the FDA's advisory committee, CDC scientists said children as at least as likely as adults to be infected.
Pfizer's clinical trial enrolled 2,268 volunteers and recorded 19 COVID-19 cases, 16 among kids who got placebo shots and three cases in the vaccinated group. Across both the vaccinated and placebo groups, there were no severe COVID-19 cases or deaths. The most common side effects from the shot were injection-site pain, fatigue, and headache.
Even if OK'd, it's unclear how many young kids will be vaccinated if a shot is available. A Kaiser Family Foundation poll conducted in September showed parents of elementary school-aged children are split: 34% of parents said they would get their child vaccinated right away, while 32% said they would wait and see and 24% said definitely not. The other 7% said they would only if required.
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