There’s a good chance that younger kids will be able to start getting COVID-19 vaccines early next month, according to Anthony Fauci, M.D. In fact, “It’s entirely possible, if not very likely” that the Pfizer/BioNTech COVID-19 vaccine will become available to children ages 5 to 11 in the first or second week of November, Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases said in an interview on ABC This Week on Sunday.
Dr. Fauci based his most recent predicted timeline on a promising analysis of the trial data that regulators and experts at the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) will use to help make their determinations on whether to authorize and recommend the vaccine for this age group. “If you look at the data that’s been made public and announced by the company, the data looks good as to the efficacy and the safety,” Dr. Fauci told ABC News anchor George Stephanopoulos.
While Dr. Fauci cautioned that “you never want to get ahead” of the FDA or CDC in their decision-making process, he anticipates that both regulatory agencies will give Pfizer/BioNTech’s two-dose mRNA vaccine the green light in the next couple weeks, making it the first COVID-19 vaccine available to kids under age 12 in the U.S. “If all goes well, and we get the regulatory approval [from the FDA] and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from [ages] 5 to 11 within the first week or two of November,” Dr. Fauci said.
Dr. Fauci’s comments came two days after the FDA shared a document reviewing the evidence submitted by Pfizer and BioNTech on the safety and effectiveness of their vaccine in this age group. The data suggest that the vaccine produces a robust immune response in kids and is 90.7% effective at preventing symptomatic COVID-19, as well as 100% effective against hospitalizations. There were three cases of COVID-19 among 1,450 participants in the group that received the vaccine, compared to 16 cases among 736 participants in the group that received the placebo shot. (No genetic sequencing data was available so it’s not clear whether these cases were caused by the delta variant, for instance.)
When it comes to the safety of the shots, the FDA didn’t find any unexpected side effects or adverse events associated with the vaccine in this age group. The agency also used statistical modeling to predict the potential risk of rare heart problems (myocarditis and pericarditis) that have occurred among other younger groups of vaccine recipients (above age 12), and still found the protection offered by vaccination persuasive. Overall, according to the FDA’s analysis, “the benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks for ages 5-11 years.”
The next step in the regulatory process starts on Tuesday, October 26, 2021, when the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet to evaluate the evidence. After getting input from that independent panel of outside experts, the FDA will make its final decision on whether to issue an emergency use authorization (EUA) for the vaccine. Then, the FDA will hand over their decision to the CDC’s Advisory Committee on Immunization Practices (ACIP), who will offer their clinical recommendations on whether and how the vaccine should be administered. While the timeline here is not set, the panels generally move quickly. For instance, in May of this year, ACIP took two days to make its recommendations after the FDA issued an EUA for the Pfizer/BioNTech vaccine in kids ages 12 to 15.
Dr. Fauci’s new timeline for when the first COVID-19 vaccines will become available to children under 12 is a slight adjustment from his last estimate. In late September, the White House Chief Medical Adviser said he thought children could start getting the shots “hopefully, before the end of October,” as SELF reported at the time. But the first or second week of November is still generally in line with expert predictions, including that of an FDA official who said that the vaccines would be available by early to mid-winter. Regardless of the exact day that kids can start getting their shots, it will be a welcome and long-awaited one for families who have unvaccinated children.
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