Children ages 5 to 11 will likely soon have access to vaccination for COVID-19, as early as the week of Nov. 1. So what does it mean?
A panel of experts advising the Food and Drug Administration overwhelmingly voted Oct. 26 to approve emergency use authorization for administration of Pfizer-BioNTech’s COVID-19 vaccine to children ages 5 through 11. The FDA in the coming days will likely follow the panel’s recommendation, which voted to approve 17-0, with one abstention.
The next step involves the Centers for Disease Control and Prevention, which will need to recommend the shots and which children should get them. Yet the FDA’s advisors, serving on the Vaccines and Related Biological Products Advisory Committee, essentially gave the Pfizer product a green light. The CDC could give approval by next Tuesday, Nov. 2, which would mean kids could be getting the vaccine as early as two days later.
In an all-day meeting online, much of the time focused on potential risks of the vaccine, such as myocarditis in small numbers of vaccine recipients. But the panel was ultimately swayed by the benefits, especially when it comes to kids who are at greater risk of dying from COVID-19.
Current rates of the disease still require mitigation measures for kids, such as wearing masks and social distancing. Yet that practically can’t continue in perpetuity, one panelist noted. “We can’t forever have mitigation, particularly in schools,” said Dr. Hayley Gans, a clinical professor of pediatrics and infectious diseases at Stanford University School of Medicine and an acting chair on the committee. “Children need the more open life, as we all do.”
The White House is ramping up for a rollout of vaccines. The Biden administration has secured enough of the vaccine to inoculate the 28 million kids 5 to 11 who would be eligible. Logistics are slightly different than for people 12 and up. The doses for the Pfizer shot for kids 5 to 11 are one-third than those for people 12 and up, requiring separate handling. The kids are to receive two doses, three weeks apart.
Pediatricians nationwide have strongly supported the administration’s efforts, and are ready to act.
“This is a key moment in our nation’s response to the COVID-19 pandemic,” said Dr. Lee Savio Beers, president of the American Academy of Pediatrics, in recent statement. “Not all children have had access to vaccines, but we are hopeful that very soon, school-aged children will benefit from the life-saving protection of the COVID-19 vaccine.”
Kids are much less likely to be hospitalized due to COVID-19, making it harder to justify approving a vaccine so quickly without long-term data. But regulators argued before the panel it was well worth the risk, given that about 100 children have died during the pandemic, and thousands have been hospitalized.
The FDA relied on data supplied by the Pfizer and BioNTech. The data included a trial of about 2,300 participants in the age group. The results were comparable to those found in a trial of children aged 16 to 25, with 91% of the kids not reporting any COVID symptoms.
California Gets Ready
In the meantime, counties all over the state have been mobilizing to prepare for the emergency approval. In Los Angeles County, it means another 900,000 eligible for the vaccine. The county says it expects 96,000 doses in its first vaccine supply in the first week in November, with two large shipments arriving shortly afterwards. The doses are being distributed nationwide based on population rates. The county expects there will be ample vaccine to meet the demand to get kids vaccinated.
“Fully vaccinated children will be better protected at schools, youth activities, holiday gatherings and celebrations, and homes,” said Dr. Barbara Ferrer, director of public health for Los Angeles County, in a statement issued after the FDA ruling. “Once the CDC issues final approval and guidance, the county is prepared to begin offering doses to younger children as early as late next week through our vast network of countywide providers.”