A COVID-19 vaccine could be made available to young children as soon as early November, according to White House chief medical adviser Dr. Anthony Fauci.
The Food and Drug Administration’s expert advisory panel will meet on Tuesday to evaluate Pfizer and BioNTech’s request for emergency-use authorization of their COVID-19 vaccine in children ages 5 to 11. The panel—the Vaccines and Related Biological Products Advisory Committee—will provide the FDA with a recommendation on whether to authorize the vaccine or not.
Should the FDA follow the panel’s recommendation (which it often does), the Centers for Disease Control will then evaluate the FDA’s decision and offer its recommendation on the first few days of November, according to Fauci, who spoke on ABC’s This Week on Sunday.
Assuming the agencies see eye to eye on the vaccine’s safety and efficacy in children, parents could begin to get their young kids vaccinated in a matter of weeks.
“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci said during his ABC appearance. “If you look at the data that’s been made public and announced by the company, the data look good as to the efficacy and the safety.”
In a briefing document posted on the FDA’s website ahead of the Tuesday panel meeting, Pfizer and BioNTech shared results of a trial that found that their COVID-19 vaccine was 90.7% effective against symptomatic cases in children ages 5 to 11. The trial studied the responses of roughly 2,250 children to a 10-microgram dose of the vaccine, which is one-third of the adult dose. Each child received two doses, which were given three weeks apart.
The reduced dose still prompted a strong immune response among children while reducing the frequency of side effects seen in adolescents and adults, according to the companies. The study found that the most common side effects in children included fatigue, headache, muscle pain, and chills.
No new safety problems were identified in the study, and no cases of myocarditis or pericarditis were observed in the children studied following their receipt of the second dose. Myocarditis refers to inflammation of the heart while pericarditis refers to inflammation of the outer lining of the heart. Both are rare complications that have been reported among young men and boys who have received the vaccine.
However, the companies acknowledged that the sample size of the study was “not large enough to detect any potential risks of myocarditis associated with vaccination.” Still, because Israeli data suggests that the rate of rare post-vaccination myocarditis peaks in individuals ages 16 to 19 and declines in adolescents ages 12 to 15, the companies predict that post-vaccine myocarditis rates are likely to be even lower in kids ages 5 to 11 due to the reduced vaccine dose.
With these safety and efficacy numbers in mind, the FDA said in its own briefing document released on Friday ahead of the Oct. 26 meeting that the benefits of the vaccine outweigh its risks in children ages 5 to 11, suggesting the agency is likely to offer its stamp of approval.
Even if the FDA and CDC ultimately approve the vaccine, another obstacle to the White House’s goal of vaccinating all 28 million children in the 5-to-11 age group exists: parents. According to a September poll from the Kaiser Family Foundation, only about one-third of parents are planning on vaccinating their child against COVID-19 following regulatory approval of the shot. While that’s up from 26% in July, the KFF study also found that 32% of parents are taking a wait-and-see approach to vaccinating their young child while 24% are completely opposed to the concept.
Children ages 12 and up have been allowed to receive the COVID-19 vaccine since May.
More health care and Big Pharma coverage from Fortune:
- Foreign travelers to the U.S. will need to be vaccinated and present a negative COVID test before entering starting Nov. 8
- Florida Gov. DeSantis offers $5,000 bonus to lure anti-vaxx police from out of state
- Who is eligible for a Moderna booster?
- Thera-who? These biotech firms are looking to push what’s possible with blood
- 3 states limit nursing home profits in bid to improve care
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